Podcasts about Takeda

How do you take a model that works in process development and get it accepted for use in GMP manufacturing? That question stalls most bioprocess modeling projects before they start. Ignasi Bofarull-Manzano, Senior Data Scientist and CMC Consultant at Körber Pharma, pushes back on the premise: the process you run today is already governed by a mathematical model, fitted once at small scale during process characterization and then left untouched for years, even as the process shifts.Part 1 separated digital models from digital shadows and digital twins, and made the case for starting with the decision rather than the data. Part 2 goes into the plant: what regulators actually require, what the numbers looked like on a real biologics process, and where a team should start on Monday morning.Topics covered:Core differences—and surprising similarities—between modeling in development versus manufacturing (02:35)Regulatory requirements: credibility assessments, model risk, and validation steps for digital twins (05:07)Real-world example: How deploying an end-to-end process model led to 35% yield increase for Takeda, and considerations for ROI in manufacturing (08:34)Advice for startup leaders on when to invest in modeling and how to scale efforts case-by-case (11:42)Steps for scientists new to modeling: identifying bottlenecks, starting simple, and proving value offline before scaling up (12:26)The importance of understanding basic statistics before relying on AI-generated models (15:22)A stepwise summary for deploying digital modeling effectively in biotech (16:01)Smart insight: The digital twin is the last step, not the first. Identify the bottleneck, build the simplest model that supports the decision, and concatenate it end to end so you can see how a parameter moves final drug substance quality rather than one unit operation's output. Prove the value offline. Only then connect interfaces, because that is where the cost and the validation burden live. Teams that lead with the twin arrive at the C-level with a proof of concept and no evidence. Teams that lead with the offline model arrive with a number.Before a digital twin can earn its keep, you need connected data, the right model, and a clear decision for it to support. These four episodes cover that ground — data silos, hybrid and mechanistic modeling, and twins built to survive regulatory scrutiny.Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya BurkovEpisodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovEpisodes 17 - 18: How Extracting Gold From Your Data Accelerates Process Development with Ioscani Jiménez del ValEpisodes 263 - 264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David HardyConnect with Ignasi Bofarull-Manzano:LinkedIn: www.linkedin.com/in/ignasi-bofarullKörber Pharma website: www.koerber-pharma.comSupport the show

Takeda is entering one of the most pivotal moments in its 245-year history, with a late-stage pipeline poised to transform patient outcomes across three therapeutic areas. Chief Scientific Officer Chris Arendt goes Inside the ICE House to discuss the science behind drug candidates targeting narcolepsy, polycythemia vera, and psoriasis. He explores how AI and computational technologies are reshaping drug discovery and why building the right data foundation is critical to supercharging Takeda's R&D engine.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's episode delves into the latest innovations and strategic shifts propelling the industry forward. A notable dialogue emerging in psychiatric drug development comes from TLDR Biotech's engagement with Shlomi Raz and Ken Belotsky, co-founders of Palomar Labs. This conversation heralds a transformative shift in psychiatric treatments, moving beyond traditional psychedelics toward novel approaches deeply rooted in human experience. Initially inspired by the therapeutic potential of psychedelics such as psilocybin, early research, notably from Johns Hopkins, sought to establish these compounds within a biopharmaceutical framework. Despite historical evidence supporting their efficacy, challenges persisted in reclassifying these Schedule I substances as viable therapies. Raz and Belotsky, pioneers in this initial psychedelic wave, now lead efforts at Palomar Labs to develop next-generation therapeutics targeting serotonin receptors without the hallucinogenic effects typical of classical psychedelics. This approach seeks to dismantle longstanding industry biases against specific receptor targets known as "anti-targets." A critical concept in their methodology is "neuroplastogens," as popularized by David Olson at UC Davis. These compounds are believed to induce beneficial neuroplastic changes without causing hallucinations. However, Palomar Labs exercises caution, viewing neuroplasticity not as a definitive biomarker for therapeutic efficacy but rather as one of many aspects to consider. Their unconventional "reverse" drug development model begins with anecdotal human experiences and is validated backward through preclinical animal models before advancing to clinical trials. This method relies on overlooked data sources—such as discarded trial reports and traditional medicine use cases—to uncover therapeutic candidates traditionally ignored due to biases against certain receptor targets. For example, they explore therapies for Parkinson's disease bypassing direct dopamine receptor modulation and treatments for Alzheimer's-related aggression avoiding heavily sedative antipsychotics. Palomar Labs' venture studio model emphasizes disciplined capital allocation and an unbiased approach to research outcomes. By prioritizing drug candidates with strong evidence from human experiences, they aim to swiftly advance promising therapies to proof-of-concept stages, readying them for further development by pharmaceutical partners or venture-backed entities. This paradigm shift from target-centric development to a model grounded in empirical human data represents a significant advancement in psychiatric drug discovery. In other industry news, Replimune has successfully navigated regulatory hurdles to secure FDA approval for its melanoma therapy, Tudriqev, following two prior rejections. This achievement underscores the resilience required in drug development and strategic regulatory engagement. The approval highlights the potential of oncolytic virus therapies—Tudriqev employs an innovative approach by using viruses to selectively infect cancer cells while sparing healthy tissue, simultaneously stimulating an immune response. Meanwhile, Eli Lilly continues its dominance in the obesity treatment market with Zepbound, despite new oral competitors. The enduring preference for injectable solutions highlights established efficacy and safety profiles that continue to resonate with healthcare professionals. In China, TransThera has gained regulatory approval for a bile duct cancer treatment, marking a significant step forward for Chinese innovation in oncology. Such advancements not only diversify treatment options but also elevate China's status as a pivotal contributor to global drug development. Challenges persist across the sector, exemplified by Fresenius Kabi's recall of a mislabeled morphine lot due to overdose risks. This incident underscores the vital importance of stringent quality control measures essential for patient safety. The biopharmaceutical landscape also sees Takeda securing FDA approval for its first-in-class orexin receptor agonist targeting narcolepsy—a testament to innovative approaches addressing unmet needs in sleep disorders. Amidst these developments, BioMarin has opted to terminate its $270 million rare disease asset following unsatisfactory Phase 3 results. Such decisions highlight the inherent risks within drug development pipelines and underscore the necessity for strategic flexibility. Leadership changes are shaping corporate trajectories too; BioNTech's appointment of Guido Oelkers as CEO exemplifies this trend. His experience will likely drive strategic realignments crucial for navigating complex industry challenges. Finally, the industry's focus on digital transformation is evident through Bausch + Lomb's partnership with VerilyMe—a collaboration aimed at enhancing dry eye education via digital and AI technologies. These stories collectively embody the dynamic nature of the pharmaceutical and biotech industries—where regulatory achievements, strategic pivots, and technological advancements are continuously redefining therapeutic landscapes and enhancing patient care worldwide. As we continue navigating this rapidly evolving field, staying informed on these developments is crucial for leveraging opportunities and addressing challenges within this innovative sector.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're delving into a series of pivotal advancements that underscore the dynamic nature of our industry. Starting with Moderna, which has recently secured FDA approval for its mRNA-based influenza vaccine, MFLUSIVA. This marks a monumental leap in leveraging mRNA technology beyond its initial role in COVID-19 vaccine development. The approval not only highlights the technology's adaptability and efficiency but also hints at a transformative future for seasonal vaccines, potentially allowing for rapid responses to influenza virus mutations. In tandem with this development, Takeda has achieved FDA approval for Orzeyful (Oveporexton), an innovative therapy targeting narcolepsy type 1. This represents a significant breakthrough as it targets the root cause of the disorder through orexin receptor modulation. The implication here is profound—offering new hope for patients who have long been underserved by existing treatments and potentially setting a new standard in managing sleep disorders. On the leadership front, Sarepta Therapeutics welcomes new CEO Michael Severino during a critical growth phase. Known for its focus on rare diseases, Sarepta faces the challenge of maintaining its competitive edge and meeting stakeholder expectations in a rapidly evolving market landscape. Meanwhile, AstraZeneca and CSPC Pharmaceutical are enhancing their manufacturing capabilities through a joint venture aimed at bolstering biologics production in China—a strategic move that positions them well within one of the fastest-growing markets for such treatments. This partnership is expected to accelerate the availability of biologic therapies across Asia. In another significant leadership change, Fujifilm Biotechnologies appoints Maja Pedersen as president, signaling a strategic shift towards strengthening its contract development and manufacturing organization operations. This move is reflective of broader industry trends emphasizing operational efficiency and strategic restructuring amid changing market demands. Elsewhere, Emergent BioSolutions has eliminated its top R&D role as part of sweeping restructuring efforts. This decision underscores ongoing challenges companies face in balancing innovation with operational efficiency amidst market pressures. In legal arenas, Galderma Laboratories emerged victorious over Sanofi regarding claims made about its blockbuster drug Dupixent. This victory highlights the importance of substantiating promotional claims in an increasingly competitive pharmaceutical marketing landscape. Turning to clinical trials, Biovie's recent study on Parkinson's disease has sparked debate due to its emphasis on composite endpoints rather than primary ones. While offering insights into specific patient subgroups, this approach raises questions about trial design and result interpretation—a critical factor for drug development success. Investment activities are also shaping industry trends significantly. Notably, Lifemine Therapeutics has secured substantial funding from high-profile investors like Bill Gates and Jeff Bezos. This investment reflects burgeoning interest in innovative biotech platforms capable of addressing complex diseases through unique mechanisms. Moreover, Icon's collaboration with Anthropics aims to integrate AI into clinical trials—an exciting development poised to streamline these processes significantly. By leveraging artificial intelligence capabilities, this partnership could accelerate drug development timelines and improve trial outcomes. Overall, these developments highlight transformative changes within the pharmaceutical and biotech sectors. Innovative therapeutics, strategic partnerships, leadership transitions, regulatory milestones, and technological advancements collectively drive significant progress in patient care and drug development. As we navigate these changes, it's crucial for industry stakeholders to capitalize on emerging opportunities while addressing associated challenges such as regulatory compliance, market competition, and operational efficiencies. Thank you for tuning into Pharma Daily—stay informed and stay ahead!Support the show

“The least expensive CDMO on the first day of bidding may not be the optimum value CDMO three years later.”Choosing a contract development and manufacturing organization is not about who quotes the lowest unit price. It's mainly about who keeps your clinical timeline intact.Prakash Savarirayan is a life sciences procurement leader with more than two decades of sourcing experience, over a dozen years of it in biopharma, including senior roles at Takeda (formerly Shire) and Roche's Spark Therapeutics. He has led complex CDMO partnerships, supported M&A integrations, and built governance models across small molecules, biologics, and gene therapy, and now advises pharma and biotech clients in consulting capacity.In the latest PharmaSource podcast episode, Prakash explains why getting CDMO selection right matters more than negotiating the lowest price, how procurement earned a strategic seat at the table, and why the right partner protects both patient safety and enterprise value.Read the full article.

Send us Fan MailMr. Dempsey brings more than two decades of domestic and global experience in the ophthalmic space, driving successful drug development, business transactions, and commercialization. Mr. Robert's CEO and Board Director experience spans extensive transaction and portfolio expertise across venture capital, investment banking, and strategies to successfully secure funding and advance M&A opportunities for multiple companies. His professional network in the eye care community is broad and well-established, complemented by his philanthropic leadership as Co-Founder and Board Member of the Holland Foundation for Sight Restoration. Robert also serves as an independent director on multiple ophthalmicBoards.Mr. Dempsey currently serves as Chief Executive Officer of OKYO Pharma, a public, clinical-stage biopharmaceutical company developing investigational therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases. The company's lead candidate, urcosimod, has received FDA Fast Track designation for treating NCP. Previously, Mr. Dempsey served as Interim Chief Executive Officer of Ashvattha Therapeutics, where he led development of Migaldendranib (MGB), a novel targeted nanomedicine platform designed to normalize VEGF expression for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). Earlier in his career, Mr. Dempsey served as President and Chief Executive Officer of AsclepiX Therapeutics, where he oversaw the rapid clinical development of a new chemical entity targeting ocular diseases and cancer through naturally occurring, self-regulating homeostatic pathways. Prior to that, he served as Chief Executive Officer of TearClear, where he accelerated the company's business and commercial strategy, leading to multiple value-inflection points, including a successful Series B financing and positive FDA engagements.Mr. Dempsey formerly served as the Group Vice President and Head of Global Ophthalmology at Shire, which was acquired by Takeda, and was responsible for closing one of only 3 ophthalmology transactions with >$1B upfront in the last 2 decades for Xiidra that transacted again 4 years later for $1.7B to Bausch & Lomb.At Shire, he swiftly established a highly regarded reputation for Shire as a new company in the ophthalmology and optometry markets. Leading the commercialization strategy that resulted in an industry-leading launch, while overseeing the acquisition of four companies that contributed to the franchise pipeline of innovative candidates aimed at improving vision-related quality, was anaccomplishment about which he is most proud.In his spare time, he enjoys spending time with family on the lake and watching Boston sports.Here's another episode about neuropathic pain on The OI Show: https://theoishow.buzzsprout.com/1601521/episodes/15618641-167-the-oi-show-neuropathic-pain-with-kaleb-abbott

Tyler and Konnery are joined by siren Jeronimo Moran and lotus eater Cameron Takeda to break down one of the oldest franchises in history and Christopher Nolan's new film, "The Odyssey"! Together they hop around the Mediterranean at every point that Odysseus and his crew land, True IMAX 70mm and all the different formats this film is playing in, 2004 epic Troy, Emily Wilson's translation of The Odyssey, the stacked yet curious cast, Polyphemus' cheese, and so much more on this epically poetic episode of The Friendchise Podcast! Follow The Friendchise Podcast on socials:   TikTok Threads Instagram What's New? Kon: The Witches (1990), Troy (2004) (Rental) Tyler: Troy (Rental), The Iliad (Emily Wilson translation) Cameron: Bad City (Prime Video), Baby Assassins trilogy (Tubi) Jeronimo: Anime Expo, One Piece (Crunchyroll), That Time I Got Reincarnated as a Slime (Crunchyroll), raving

In this month's episode of the HAE Speaks Podcast, one family shares their journey of living with Hereditary Angioedema (HAE) together. From navigating diagnosis and treatment to supporting one another through the challenges of daily life, they offer an honest conversation about what it means to face HAE as a family. Through their shared experiences, listeners will gain insight into the power of resilience, the importance of understanding each family member's perspective, and the strength that comes from navigating HAE together.Thank you to our 2026 Sponsors: BioCryst, CSL, IONIS, and Takeda

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of events that underscore the dynamic nature of these industries, characterized by scientific advancements, strategic partnerships, and regulatory milestones. Johnson & Johnson has made headlines with its substantial $785 million upfront payment to Sail BioMed for an in vivo CAR-T cell therapy deal. This agreement includes an option for Johnson & Johnson to acquire Sail BioMed for $2.58 billion, underscoring the sustained interest in cell therapies, particularly for autoimmune diseases. In vivo CAR-T therapies represent a significant leap forward by modifying T cells directly within the patient's body. This method offers potential advantages over traditional ex vivo techniques by simplifying the manufacturing process and potentially reducing both costs and time to treatment. Such transactions highlight Johnson & Johnson's commitment to expanding its cell therapy portfolio, which could significantly enhance patient care by making advanced treatments more accessible. Eli Lilly and Resilience have announced a significant $750 million investment aimed at boosting the production of diabetes and obesity medications in the United States. This move comes as a response to the global rise in these conditions, necessitating increased production capacities to meet growing demand. The focus on injectable drug devices emphasizes efforts to improve drug delivery systems, ultimately enhancing patient compliance and therapeutic outcomes. Sanofi's financial outlook for 2026 is promising, driven by robust sales of Dupixent, which exceeded €5 billion in quarterly sales. Dupixent, a monoclonal antibody used for treating atopic dermatitis and other autoimmune conditions, has been a significant revenue driver for Sanofi. The success of Dupixent reflects its effectiveness and strong market adoption, highlighting the potential of monoclonal antibodies as cornerstones of modern pharmacotherapy, particularly for chronic inflammatory diseases. Regeneron and Sanofi's Dupixent continues performing strongly with $6 billion in sales during Q2 2026—marking its largest quarterly revenue since the pandemic began—illustrating robust demand across various indications within both companies' portfolios. On the regulatory front, Alfasigma's Linerixibat (Lynavoy) has received a positive opinion from the CHMP for treating cholestatic pruritus in primary biliary cholangitis following successful Phase 3 trials. As an IBAT inhibitor targeting bile acid metabolism pathways, Lynavoy introduces a novel therapeutic approach for managing symptoms associated with this autoimmune liver disease. Meanwhile, ImmunityBio's Anktiva has gained marketing authorization in the UAE for non-muscle invasive bladder cancer and metastatic non-small cell lung cancer. Anktiva, an IL-15 cytokine-based protein therapy, exemplifies the growing interest in harnessing immune system modulators for cancer treatment. Takeda's recent decision to discontinue its nanoparticle therapy (TAK-101) for celiac disease highlights the inherent challenges in developing new therapies for autoimmune disorders. The disappointing Phase 2 results suggest that achieving immune tolerance to dietary gluten remains a significant scientific hurdle. From a strategic perspective, Sanofi's CEO has emphasized stricter go/no-go decisions during Phase 3 clinical trials amid pipeline cuts and significant impairment losses. This approach could lead to more efficient resource allocation and potentially higher success rates for late-stage drug candidates. The industry is witnessing significant transformations through strategic shifts driven by executives like Sanofi's new CEO Belen Garijo. Her vision includes reversing recent challenges faced by Sanofi by capitalizing on its strengths while addressing setbacks such as discontinuing certain late-stage clinical programs like the joint venture with Regeneron on the IL-33 candidate itepekimab. This strategic pivot mirrors broader industry trends toward optimizing late-stage pipelines to enhance competitive positioning and drive future growth. Advancements in AI-powered drug discovery continue gaining momentum through collaborations like those between GSK and Relation Therapeutics, alongside Causaly and Sage. These partnerships aim to leverage AI and machine learning technologies to accelerate drug discovery processes by integrating vast amounts of scientific literature into data analytics platforms. GlaxoSmithKline's $110 million deal with an AI biotech firm further signals increased integration between artificial intelligence technologies and pharmaceutical research efforts aimed at enhancing dataset quality thereby accelerating innovation throughout drug discovery processes. Bristol Myers Squibb faces further delays regarding its Alzheimer's psychosis treatment Cobenfy—a postponement reflecting ongoing complexities related to neurological drug development which requires overcoming high scientific hurdles alongside regulatory scrutiny. Alnylam Pharmaceuticals recently experienced a 29% drop in stock value following disappointing sales of Amvuttra and a downward revision of its ATTR franchise outlook for 2026. Such fluctuations highlight volatility within biotech investments when market expectations are not met. These collective developments reveal significant trends shaping today's pharmaceutical landscape: strategic pipeline optimization efforts alongside robust investment initiatives targeting high-demand therapeutic areas—all while leveraging technological advancements like AI integration aimed at improving R&D efficiency ultimately impacting patient care worldwide through innovative therapies addressing unmet medical needs globally.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the most exciting scientific breakthroughs and regulatory developments that are shaping the future of healthcare. Eli Lilly's retatrutide, a promising small molecule GLP-1 receptor agonist, has achieved significant results in Phase 3 trials, leading to an impressive 22.6% weight loss in patients with obesity and cardiovascular disease. This breakthrough underscores the potential of GLP-1 receptor agonists in transforming treatment paradigms for metabolic disorders. The drug's ability to target metabolic pathways associated with obesity and type 2 diabetes could herald a new era in managing these conditions, offering hope for millions struggling with obesity—a major risk factor for cardiovascular diseases. In oncology, Johnson & Johnson has unveiled remarkable results with its combination therapy of Tecvayli (teclistamab) and Talvey (talquetamab), achieving an 89% reduction in disease progression risk for multiple myeloma patients during a Phase 3 trial. This bispecific antibody approach targets BCMA and GPRC5D, representing a significant advancement in treating this challenging hematological malignancy. Such efficacy could set a new standard for multiple myeloma treatment strategies, enhancing patient outcomes considerably. Meanwhile, GSK has made strides with FDA approval of Jideytro (zidesamtinib) for ROS1-positive metastatic non-small cell lung cancer. This small molecule kinase inhibitor targets the ROS1 mutation, providing a targeted therapeutic option that aligns with the progress in precision medicine—offering treatments based on patients' genetic profiles. On the regulatory front, the passage of FDA Modernization Act 3.0 by the House reflects a shift towards more ethical preclinical testing methods by updating outdated animal testing regulations. This legislative change could expedite drug development timelines and improve the translation of preclinical findings into clinical success—an encouraging step forward for the industry. In China, Takeda's Orzeyful (oveporexton) received approval as the first ox2r agonist for narcolepsy type 1 treatment. This approval marks advancements in addressing neurological conditions through novel mechanisms targeting orexin receptor pathways. Similarly, Haisco Pharmaceutical's Ciprocopan has been approved as an oral complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH), offering a more convenient treatment option compared to existing therapies. AstraZeneca's Etcamah (camizestrant) gained EU approval following its success in Phase 3 trials for estrogen receptor-positive, HER2-negative advanced breast cancer. As an oral selective estrogen receptor degrader (SERD), it presents an innovative approach to targeting ESR1 mutations and could be combined with CDK4/6 inhibitors to enhance therapeutic efficacy further. On the strategic collaboration front, partnerships like those formed by Arcus Biosciences with Aveo Oncology and Summit Therapeutics exemplify efforts to advance drug discovery capabilities, particularly in kidney cancer treatments. These collaborative approaches reflect a broader trend in oncology therapeutics development. Financial investments are also fueling growth within the sector. Mentari Therapeutics secured $200 million to propel its migraine prevention biologics pipeline forward, highlighting confidence in biologic treatments for neurological disorders. Beone Medicines has committed $300 million to expand manufacturing capabilities, demonstrating ongoing investment in infrastructure to support future drug production demands. In summary, these developments illustrate significant scientific advancements and regulatory progress within the pharmaceutical and biotech industries. The implications are profound: improved patient care through innovative therapies, enhanced precision medicine approaches tailored to genetic mutations, and accelerated drug discovery processes facilitated by evolving regulatory frameworks. As these trends continue to evolve, they promise to reshape patient outcomes and redefine standards across various therapeutic areas. Thank you for tuning into Pharma Daily today. Stay informed as we continue to bring you updates on cutting-edge advances that are transforming healthcare worldwide.Support the show

This episode covers: Cardiology This Week: A concise summary of recent studies Risk factors and longevity in women and in men  Mythbusters: Smartphone interference with pacemakers, ICDs Host: Rasha Al-Lamee Guests: JP Carpenter, Christina Magnussen Want to watch that episode? Go to: https://esc365.escardio.org/event/2559 Want to watch that extended interview on risk factors and longevity in women and in men, go to: https://esc365.escardio.org/event/2559?resource=interview   Disclaimer  ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Christina Magnussen has declared to have potential conflicts of interest to report: speaker fees from Novartiq, Novo Nordisk, Bayer, Boehringer Ingelheim and Edwards. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Rasha Al-Lamee Guests: Christina Magnussen Want to watch that extended interview on risk factors and longevity in women and in men, go to: https://esc365.escardio.org/event/2559?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/2559   Disclaimer ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Christina Magnussen has declared to have potential conflicts of interest to report: speaker fees from Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim and Edwards. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Recent advancements in these sectors highlight a fascinating intersection of technology and medicine, underscoring a push towards innovation that promises to reshape healthcare delivery. Bristol Myers Squibb has expanded its collaboration with NVIDIA, aiming to create what could become the most powerful AI infrastructure dedicated to life sciences. This partnership is set to harness artificial intelligence and machine learning technologies to revolutionize drug discovery and development. By enhancing data analysis and predictive modeling, this collaboration may lead to more efficient identification and validation of drug targets, reflecting a growing industry trend towards leveraging AI to streamline R&D processes. In infectious diseases, Gilead Sciences and Merck & Co. have reported promising phase 3 clinical trial results concerning their combination therapy for HIV treatment. This regimen, combining islatravir and lenacapavir, could become the first weekly oral medication for HIV, offering a significant improvement over daily treatments. Such developments not only promise enhanced patient adherence but also mark a pivotal step forward in long-term HIV management by potentially increasing quality of life for patients. Oncology diagnostics are also seeing significant strides as Tempus AI plans to acquire Personal Genome Diagnostics for $1.5 billion. This acquisition is poised to bolster Tempus's portfolio in cancer minimal residual disease diagnostics. The integration of capabilities from Personal Genome Diagnostics is expected to enhance precision oncology efforts, providing more comprehensive data for personalized cancer treatment plans. Regulatory updates bring more promising news with Takeda's dengue vaccine, Qdenga, securing approval in India. This live-attenuated vaccine targets all four serotypes of the dengue virus, representing a major advancement in regions burdened by dengue fever. Similarly, JCR Pharmaceuticals has received marketing authorization in the UAE for Izcargo, an enzyme replacement therapy that penetrates the blood-brain barrier to treat Hunter syndrome, showcasing innovations in treating rare genetic disorders. Strategic partnerships continue to be a focal point in industry growth. Menarini Asia-Pacific has joined forces with Pharmacosmos to commercialize Cosela across Asia-Pacific regions. Additionally, Halozyme Therapeutics has partnered with Incyte on subcutaneous formulations of a monoclonal antibody using their proprietary Enhaze technology, highlighting advancements in drug delivery systems. Financially, Novartis has shown resilience by returning to sales growth driven by products like Kisqali and Kesimpta amidst generic competition challenges. Meanwhile, Axiom Biosciences is gearing up for an IPO in Hong Kong, indicating a growing interest in stem cell therapies for neurological and rare diseases. Yet not all news has been positive. Novartis has discontinued its phase 2 radioligand therapy targeting gastrin-releasing peptide receptors due to underwhelming results in solid tumors. Agios Pharmaceuticals has similarly halted development of its pyruvate kinase activator for sickle cell disease following unsatisfactory phase 2 data. Legal battles continue as well, with Novo Nordisk suing Eli Lilly over GLP-1 agonists efficacy claims and Moderna locked in patent disputes with CureVac over COVID vaccine technologies. These stories reflect dynamic shifts emphasizing innovation through AI collaborations and novel therapeutic developments in HIV and oncology treatments. They also highlight strategic acquisitions enhancing diagnostic capabilities while revealing challenges such as competitive pressures and regulatory hurdles that companies must navigate. Turning our attention back to scientific breakthroughs, Jennifer Doudna's venture into AI-powered protein design underscores how artificial intelligence continues transforming biotechnology. Her exploration highlights AI's potential to accelerate drug discovery by enabling more precise targeting of disease-related proteins. Additionally, recent successes in personalized medicine include the establishment of a new center dedicated to genetic therapies. Spearheaded by leading scientists, this initiative aims at developing tailored treatments based on individual genetic profiles—advancing precision medicine and reducing adverse effects. In conclusion, these developments illustrate a vibrant landscape where scientific breakthroughs intersect with strategic business maneuvers. As companies navigate these complex waters—balancing innovation with regulatory scrutiny—they continue pushing boundaries that promise improved patient outcomes worldwide while reshaping future healthcare landscapes.Support the show

Co-hosts Ryan Piansky, a patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Science Advisory Council, interview Dr. Claire Beveridge about EoE and dysphagia. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:49] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners AstraZeneca, GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, research on eosinophilic esophagitis (EoE) and dysphagia.   [1:24] Holly introduces and welcomes today's guest, Dr. Claire Beveridge, a gastroenterologist at the Cleveland Clinic. Dr. Beveridge heads the EoE Adult Clinic and the Transition from Pediatric to Adult EoE Clinic.   [1:36] Holly, a speech pathologist, says she is very excited to dive into the research Dr. Beveridge did with EoE and dysphagia. Holly asks Dr. Beveridge to share some of her background.   [1:48] Dr. Beveridge was recruited to the Cleveland Clinic about five years ago to head the EoE Center. She loves the work they have done there.   [1:57] Dr. Beveridge says it's been nice to center everything on their EoE patients and have multidisciplinary care with speech-language pathologists, allergists, dietitians, pulmonologists, and more. It's been a great experience.   [2:15] Dr. Beveridge says the other thing they are really proud of is having a Transition Clinic. It can be tough for patients to transition from pediatric to adult care.   [2:23] Dr. Beveridge says this is something she was inspired to do when she was finishing her training at the University of Pennsylvania, where they had been doing some of that. It was really important to her when she joined Cleveland Clinic.   [2:34] Dr. Beveridge, with her Co-director, Dr. Sophia Patel, helps patients transition from pediatric to adult care.   [2:41] Holly speaks of the challenge of transitioning from pediatric care at a multidisciplinary clinic to adult care.   [3:08] Dr. Beveridge says you can't do any training at Northwestern without loving the esophagus. She did her residency there, got exposed to esophagology, and got to know Dr. Gonsalves and Dr. Hirano really well.   [3:33] Drs. Gonsalves and Hirano are really big names in EoE. Dr. Beveridge was fascinated by the disease. She loved the patients and wanted to help them and make them feel better. It's a burgeoning field.   [3:48] Dr. Beveridge says that it's only in the last few years that we have had FDA-approved medications for it, and that we have been jerry-rigging asthma medications to treat our patients.   [4:03] Dr. Beveridge says it's really exciting to see the treatment options we can offer.   [4:10] Ryan says it's exciting to see how EoE management has changed.   [4:16] Ryan says we see so many patients who are untreated or poorly treated for years, who have restructuring of their esophagus and present with dysphagia, or have strictures and rings leading to food impactions; the long-term effects of untreated EoE.   [4:34] Ryan says it's exciting that now we do have better treatment options for people, right off the bat.   [4:43] Dr. Beveridge conducted some research on EoE and dysphagia and presented a poster at the 2024 Digestive Diseases Week.   [4:51] The poster was titled, "Esophageal Luminal Diameter is Associated with Dysphagia and Eosinophilic Esophagitis: Implications for Endoscopic Dilation Therapy."   [5:11] Dr. Beveridge says dysphagia means issues with swallowing. It's a feeling of something getting stuck or something slowly moving down. There are also subtle symptoms that can happen.   [5:31] Dr. Beveridge says patients who have had EoE for a long time become accustomed to how they swallow. Things a patient may think are normal, like needing water and taking a sip after each bite, are learned accommodating behaviors.   [5:58] Dr. Beveridge says accommodating behaviors are that you're needing to imbibe extra water, you're modifying how you're eating, extra chewing, avoiding pills, avoiding other certain foods, and things like that that can be modifying factors.   [6:19] So, difficulty with swallowing, things getting stuck, slowly moving down, but also keeping in mind some of those modifying behaviors that we may end up using.   [7:23] Dr. Beveridge says her motivation was seeing patients in her clinic who were having persistent symptoms, and getting them into histological remission. The goal of treating your EoE is to get the eosinophils less than 15; close to zero is great.   [7:45] Dr. Beveridge says we have patients who, despite doing their endoscopies and taking biopsies, things look fine; they're still having issues with swallowing. Why is that the case?   [7:58] Dr. Beveridge says in a different research paper she had done, looking at some of the predictors for that, one of them was fibrostenosis. There are also other things that can contribute, like esophageal hypervigilance and a fear of swallowing.   [8:21] If a patient has had a food impaction, it's going to be scary to try to swallow again. Some of it is behavioral, but some of it is structural. At what luminal diameter (the size of the esophagus) is that causing a clinical problem for patients?   [8:45] A normal esophagus is 20 to 24 mm in diameter. Traditionally, around 14 to 16 mm in diameter has been when we say that patients get symptoms or they're feeling the issues with swallowing.   [9:03] Dr. Beveridge says a lot of those studies have never been done specifically for EoE patients.   [9:08] Dr. Beveridge wanted to know, if we exclude cancer, if we exclude acid reflux, and all of these other things, and just look at our EoE patients, what size of the esophagus are we looking at?   [9:20] Dr. Beveridge explained they specifically looked at patients whose histology was under control and then compared those who continued to experience symptoms with those who did not. The goal was to determine the histologic threshold at which patients begin to experience dysphagia.    [9:54] Dr. Beveridge says they saw this threshold at 16 mm (1.6 cm). That's still quite the difference from a normal esophagus of 20 to 24.   [10:08] Dr. Beveridge says our esophagus can definitely handle being smaller, but then, once you get to that 16 mm, for a lot of patients, it really does cause that feeling of things getting stuck or slowly moving down.   [10:20] Holly says what's cool about the retrospective data Dr. Beveridge looked at, and the parameters she placed in the research, is that when a patient goes in for an endoscopy, the doctor can measure and say maybe this is why dysphagia is going on.   [10:48] Holly finds that adult patients with food impactions are scared to eat the same food again. She loves having this data to share with patients and say, let's look at what your esophagus measures at. Let's do a smaller bite. Let's add a dip and liquid.   [11:12] Holly says data can push so much progress. Holly, having multiple chronic illnesses, loves when doctors can say, this is going to be safe. This is the mode that we're going to go with.   [11:30] Dr. Beveridge says in the retrospective study, they were looking at stuff that had already been done. We decided from here to assess patients more prospectively. All of this was based on chart review from when the note said symptoms or no symptoms.   [11:53] Dr. Beveridge says when she started this EoE clinic at the Cleveland Clinic, part of it was to standardize better how we were collecting data from patients to understand their symptoms.   [12:07] Dr. Beveridge has a standardized questionnaire for patients to understand if they are having heartburn and difficulty with swallowing, so she can know that at each point of their endoscopy.   [12:18] Dr. Beveridge says it will be nice, hopefully in the future, when she can give a little more detail and depth in terms of assessing this more prospectively and seeing if that same number holds up or if she needs to tweak it a little bit.   [12:34] Holly thinks it's fascinating. Numbers give us so much information, to know if my mm is this versus this, the next time, or during allergy season or not.   [12:53] Ryan says it's cool that you're able to look back at existing patient records and identify this information. Now we have that 16 mm number in mind to say maybe this is where we'll start to see increased risk of dysphagia in these patients.   [13:28] Dr. Beveridge says, how we had to do it retrospectively was based on the endoscopist estimating what the size is. Gastroenterologists recognize they're not always the best at estimating the size of the esophagus.   [13:50] Dr. Beveridge says, if your endoscope could not pass through, or it was snugly passing through, you know the diameter of the endoscope. If a dilation was done, at what size dilation do we start to see a disruption?   [14:19] Dr. Beveridge says, the goal of a dilation is to get a disruption because there's scar tissue we want to break open. A patient might think disruption means a perforation or something more scary, but that is the goal. We want to break open that scar tissue.   [14:42] Dr. Beveridge says, once we see that scar tissue break open a little bit, then we can estimate what the diameter is, based on the size dilator we used.   [15:10] Dr. Beveridge says for adults, we use a standard adult upper endoscope, and that's about 13 mm. The ones we use for kids are about 6 mm.   [15:35] Dr. Beveridge says the adult endoscope is around 13 mm, and it's around 14 to 16 mm when we start to see the symptoms.   [16:07] Dr. Beveridge says there are two main types of dilation that we do. One is the Savary dilator or wire-guided dilator, a long dilator that stretches the entire esophagus, from the mouth down to the stomach.   [17:20] Dr. Beveridge says another way of doing it is while you have the endoscope in, you thread a catheter. At the end of the endoscope, there's a balloon. You fill the balloon with saline up to different sizes. Typically, they go up by 3 mm, so 12 to 15 mm.   [18:01] Dr. Beveridge says the catheter balloon dilator is good for discrete strictures because the balloon isn't going to do the entire esophagus; it's just going to do one area of the esophagus, and you're watching it the whole time.   [18:19] For the wire dilator, you remove the scope. You're not able to see, so it's important to assess ahead of time how narrow things are, so you start at a safe dilation. You go in each time to see if there's starting to be disruption, and then you can do more.   [18:44] Holly asks if a gastroenterologist doing an upper endoscopy with sedation sees that it's tight, would the gastroenterologist automatically do a dilation? Or, can a patient with dysphagia symptoms request to have a dilation?   [19:28] Dr. Beveridge says, right before an endoscopy, she discusses it with the patient and gets consent. She asks, even if their symptoms are good, but in the endoscopy she sees a narrowing where she would recommend a dilation, if they're OK with that.   [20:05] Dr. Beveridge says, if they're having issues with swallowing, often she will ask if they're OK with her doing a dilation. If she sees a narrowing, she can focus on that area and dilate it.   [20:19] Dr. Beveridge says not everywhere in the esophagus can we see as well. The very beginning of the esophagus is challenging to see and challenging to evaluate on imaging.   [20:32] Dr. Beveridge talks about empiric dilation. You don't see a narrowing, but you want to rule it out, so you do a dilation at a safe size, like 16 or 18 mm, to make sure you're not missing something up high.   [20:58] Dr. Beveridge says she always talks about that with her patients. Most say, go ahead. Some patients definitely want dilation; other patients say no, they really don't.   [21:12] Dr. Beveridge then asks the patient if there's real narrowing that may cause a food impaction, would they want dilation then, or hold off for another day?   [21:30] Dr. Beveridge never wants to do something the patient is not comfortable with. She also doesn't want them to need another endoscopy unnecessarily, if she can avoid that for them in the moment.   [21:46] Dr. Beveridge mentions the BougieCap used in Europe. It's a cap you put at the end of the endoscope. You use your endoscope as the dilator. You watch the whole time. It is hard plastic that causes a nice dilation. We may see it come to the U.S.   [22:37] Dr. Beveridge speaks of the FLIP catheter, which is a catheter with a balloon that doesn't cause dilation but distends and helps measure the diameter.   [23:33] Holly asks if Dr. Beveridge gives tips to patients on how to prepare for dilation and the recovery process.   [23:49] Dr. Beveridge had an upper endoscopy. She says there's nothing like experience to understand it better. She didn't have a dilation, but the biopsies caused discomfort.    [24:21] Dr. Beveridge says a lot of her patients have been through upper endoscopies, so they know how it feels. She warns them that the biopsies and dilation can cause discomfort.   [24:33] What's challenging is that everyone is different. Some patients are going to be more hypersensitive to it, and other patients are going to say they felt nothing and they were fine.   [24:46] Dr. Beveridge says some patients need to modify their diet for a few days to avoid significant chest pain. You never want someone to have to go to the ER for significant chest pain when it will just heal over time, and there's no perforation.   [25:12] Dr. Beveridge says other patients will be like her, eating chips and pretzels and saying they're fine. Dr. Beveridge typically has them start with liquids, nothing too hot or too cold, and advance as tolerated.   [25:28] Dr. Beveridge says patients can always use TylenolⓇ and over-the-counter numbing agents. You'll still have patients who will get significant discomfort. For the most part, starting with liquids has worked for Dr. Beveridge's patients.   [25:44] Holly recommends over-the-counter when her patients call, after she talks to their GI. Holly says after she has an endoscopy, she starts on liquids and shakes. On day three, she's fine. Holly says individualized care is amazing. We all are different.   [26:14] In the pediatric setting, the parents get the counseling, and they have not had sedation, but on the adult side, you're talking with the patient, who had sedation. Sometimes they don't remember.   [26:40] Dr. Beveridge says when possible, she waits for family members to come back and tells them they're going to have to "be the memory" because the patient probably won't remember this conversation.   [26:55] If a patient says no, they don't want them to come back and hear about it, always respect that. But Dr. Beveridge always tells them, you may not remember what we say.   [27:30] Ryan asks about data on how many times someone may need dilations. Dr. Beveridge says it comes down to the patient, but the biggest issue can be uncontrolled inflammation.   [27:44] Dr. Beveridge says if a patient's EoE is not controlled, inflammation leads to continued scarring down. That's why we talk about dilation as being an adjunctive measure, but not a treatment for EoE. It doesn't do anything for the inflammation.   [28:03] Dr. Beveridge says she has patients who ask why she can't just do a dilation every now and then. Dr. Beveridge considers dilation to be safe when needed, but if you can avoid it, that would be nicer for everyone.   [28:21] Dr. Beveridge says there's no great data on whether you only need one, or whether you're going to need 10, but one big theme is just: have we gotten your inflammation under control? That's also true for other conditions, such as acid reflux.   [28:45] Holly wasn't diagnosed until she was in her mid-twenties, and she had several upper endoscopies as a teenager and college student to dilate her, to help the situation.   [29:17] Holly says she had to get more endoscopies to figure out her weird food triggers that are not typical for everybody, so even if she's treated, she still has inflammation. That's why she had so many upper endoscopies.   [29:30] Ryan talks about underlying issues causing inflammation. Dilation is not treating those underlying causes. It's just helping with one symptom of this dysphagia, by expanding the esophagus.   [29:50] Ryan asks, What changes in symptoms should patients expect after the dilation? Dr. Beveridge says, ideally, if there's been a stricture, you're going to start to feel like your swallowing is better. You can get pills and food down better.   [30:07] Dr. Beveridge says, immediately post-dilation, sometimes people feel a little bit worse. Everything you swallow may be uncomfortable for you. But if it's been a successful dilation, hopefully, you're going to feel that things are going down better.   [30:40] Holly says she is so grateful that Dr. Beveridge looked into this, and hopefully, there will be a new protocol in the future. Holly asks what other key takeaways from this research may interest Dr. Beveridge in researching something further.   [31:02] Dr. Beveridge says, making sure that we're not missing scar tissue is big and important. One thing that we're trying to look at with our Pediatric GI colleagues is what threshold we should be looking at for the pediatric patient population.   [31:19] Dr. Beveridge says a pediatric patient's esophagus is a different size than an adult patient's. Understandably, we are more cautious when doing a dilation in the pediatric patient population than we are with adults.   [31:34] Dr. Beveridge may recommend empiric dilation for an adult but will feel more cautious about that with pediatric patients than with adult patients. Understanding what that threshold should be for the pediatrics is going to be really interesting.   [31:57] Dr. Beveridge says the diameter threshold we discussed is going to be important to know about, but everyone is different. You may have a diameter of 14 mm, you feel fine, and you don't want a dilation; you can accommodate OK. That's reasonable.   [32:15] Dr. Beveridge says she has had patients who get up to 18 mm, and that helps them, but they need a little bit more. If someone needs more of a dilation, we do that. Yes, have a threshold to assess, but always assess for what's personal for your patient.   [33:04] Dr. Beveridge says not just to assess the luminal diameter, but a thing that is helpful for gastroenterologists to know will be if there are other factors at play. As in her study of dysphagia predictors, anxiety, depression, and hypervigilance can play roles.   [33:37] Dr. Beveridge has patients who have to have a critical narrowing for them to finally feel an issue. Other patients, if they have the slightest of narrowing, are feeling something. Some patients are just more vigilant of what's happening in their esophagus.   [34:07] Dr. Beveridge says there's definitely a role for asking if your anxiety is under control. If there's feedback in the nerves, should we ask your GI Psychologist to be involved in terms of CBT for your esophagus? Take a look at everything.   [34:27] Dr. Beveridge says another part of the study they looked at was: are there different thresholds of eosinophils that we should be looking at? Is it just less than 15, or do some patients need it to be lower? Less than six? Less than 10?   [34:43] Dr. Beveridge says look at it as a whole for your patient.   [34:53] Dr. Beveridge says next, she will be working on a very long-term project: Can we identify a non-invasive method of screening a patient, diagnosing a patient for EoE, or monitoring a response to therapy?   [35:13] Dr. Beveridge has looked at transnasal endoscopy, which is put into this category of minimally invasive. It's still invasive; you're putting a scope through someone's nose, but it doesn't require sedation, which is a nice thing for some patients.   [35:29] There's the EnteroTrack, which started in Colorado. A patient swallows a string, and it stays in their esophagus for an hour, and we look at the proteins to see if things are active or not active.   [35:45] Dr. Beveridge is also looking at the breath metabolome. If we breathe into a bag and take a look at all the volatile organic compounds that are in our breath, can we find a signature related to EoE?   [36:01] It's assessing about 100 different compounds, not looking at one in particular, but how the whole thing looks. What signature is there, based on looking at all the compounds?   [36:15] Dr. Beveridge presented some of that data at DDW and has a grant from the ACG to look at this and assess patients with and without EoE.   [36:33] Dr. Beveridge says further, doing longitudinal data of looking at patients once they've gotten into remission on treatment and seeing, do we then see a signature change?   [36:47] Dr. Beveridge says no one is under any illusion that endoscopies are going away. They will always be part of what we do in gastroenterology, but there are limitations: sedation, a full day away from work, nothing by mouth, and a driver, etc.   [37:04] If there are alternatives to help supplement that, it would be nice. One of the barriers for patients doing diet elimination is the number of endoscopies that are required. If there's a way to assess by breath if a food is a trigger, that would be good.   [37:32] Dr. Beveridge says that's the big thing she's looking at, but it will take years. It's not going to be a quick, easy one, but it's very interesting to take a look at.   [37:45] Holly speaks of how much treatment has changed since she was diagnosed. She has done all the scopes. She says this sounds amazing. She loves that people like Dr. Beveridge are thinking of how to make testing less invasive and more comfortable.   [38:12] Dr. Beveridge says another thing she is excited about is the transition of care. She recently did a survey and is analyzing the data to assess what the barrier is from the physician perspective in terms of helping our patients transition.   [38:40] Dr. Beveridge is also looking at doing a nice multi-center consensus to help this as well, led by Dr. Sophia Patel and Dr. Emily McGowan, who are fantastic in the EoE world, looking to see how we can make this better for our patients.   [38:58] Ryan says, with so much interesting work coming up, we'll have to have you back to chat about some of these additional projects. Everyone is super interested in less invasive stuff and better treatment pathways. Transition of care is an important part of that.   [39:11] Ryan appreciates Dr. Beveridge for joining the conversation and hopes to have her back on another episode so we can learn more about EoE and these different future research endeavors.   [39:20] For our listeners who would like to learn more about EoE today, you can visit apfed.org/EoE and check out the links in the show notes below. [39:27] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder, available at apfed.org/specialist.   [39:36] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [39:46] If you have personally been impacted by eosinophilic disorders and are interested in sharing your experience, please check out apfed.org/shareyourstory.   [39:55] Ryan thanks Dr. Beveridge for joining us. This was a fun conversation and really insightful. Holly thanks APFED's Education Partners AstraZeneca, GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.orgapfed.org/specialist apfed.org/connections Claire Beveridge, MD Cleveland Clinic Education Partners: This episode of APFED's podcast is brought to you thanks to the support of AstraZeneca, GSK, Sanofi, Regeneron, and Takeda.   Tweetables (Edited):   "I have loved the work that we've done [at the Cleveland Clinic]. It's been really nice to center everything on our EoE patients and have nice multidisciplinary care with speech-language pathologists, allergists, dietitians, pulmonologists, and everyone." — Claire Beveridge, MD   "It's a little crazy to think that it's only in the last few years that we have had FDA-approved medications for [EoE], and that we have been jerry-rigging asthma medications to treat our patients." — Claire Beveridge, MD   "On the whole, dysphagia means issues with swallowing. … It's a feeling of something getting stuck or something slowly moving down. There are also subtle symptoms that can happen." — Claire Beveridge, MD   "The goal of a dilation is to get a disruption because there's scar tissue we want to break open." — Claire Beveridge, MD   "I am looking at the breath metabolome. If we breathe into a bag and take a look at all the volatile organic compounds that are in our breath, can we find a signature related to EoE?" — Claire Beveridge, MD   Guest Bio: Claire Beveridge, MD, is a Staff Member in the Department of Gastroenterology and Hepatology and heads the Eosinophilic Esophagitis (EoE) adult clinic as well as the transition pediatric to adult EoE clinic. Dr. Beveridge's specialty interests include: EoE, Achalasia, Barrett's esophagus, GERD, esophageal swallowing disorders, and esophageal motility disorders.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're navigating through a myriad of transformative advancements reshaping the industry. From artificial intelligence-driven research breakthroughs to strategic acquisitions in emerging therapeutic areas, these developments are setting new benchmarks in drug discovery and patient care. **Strategic Acquisitions and Expansions:** Samsung Biologics' recent proposal to acquire Swiss CDMO Polypeptide for $1.8 billion marks a significant expansion into peptide production, underscoring the growing therapeutic importance of peptides. Their specificity and efficacy make them particularly appealing for metabolic disorders such as obesity. This acquisition reflects a strategic move to capture emerging market opportunities as demand for innovative metabolic treatments rises. Eli Lilly's bold $2.8 billion acquisition of Atai-Beckley highlights the pharmaceutical industry's shifting focus towards psychedelics. As mental health disorders like depression and PTSD become more prominent, psychedelics hold great promise for new therapeutic approaches. This acquisition may pave the way for further research and acceptance of psychedelics within mainstream medicine, offering new hope for patients. Another notable development is Tempus' acquisition of Personalisis for $1.5 billion. This move strengthens Tempus' cancer treatment portfolio by leveraging genomics-driven insights, emphasizing precision medicine's critical role in oncology. **AI Integration and Technological Innovation:** Bristol Myers Squibb is doubling down on AI integration by expanding its collaboration with Nvidia to build what promises to be the most powerful AI supercomputer dedicated to life sciences. This development is pivotal as it signifies a deeper commitment to harnessing computational power in R&D. By accelerating drug discovery and optimizing clinical trial processes, AI stands to revolutionize how treatments are developed and tailored to individual patients. Overall, these developments indicate a dynamic phase characterized by technological innovation and strategic collaborations. The integration of AI into drug development processes stands out as a transformative force, promising enhanced efficiency and efficacy in bringing new treatments to market. **Regulatory Milestones and Clinical Trials:** In regulatory news, Takeda's Qdenga has achieved a milestone by becoming India's first approved dengue vaccine. This approval is crucial in addressing neglected tropical diseases, with significant implications for public health in regions where dengue is prevalent. By reducing dengue fever incidence, this vaccine could play a vital role in improving health outcomes in many tropical countries. Promising results have emerged from clinical trials across various therapeutic areas. 4D Molecular Therapeutics reported an 87% reduction in treatment burden for wet AMD using their gene therapy candidate 4D-150 in Phase 2b trials—demonstrating potential as a transformative approach with reduced intervention frequency. Latigo Biotherapeutics' Nav1.8 inhibitor LTG-001 outperformed Vicodin in Phase 2 trials for acute pain, offering a non-opioid alternative amidst the opioid crisis. Meanwhile, Regenxbio's five-year data on surabgene lomparvovec shows sustained efficacy in wet AMD and diabetic retinopathy—underscoring its potential as a long-term treatment option. **Financial Performance and IPO Activity:** Financially, Abbott exceeded expectations with strong sales from their device and diagnostic divisions, prompting an upward revision of their full-year profit forecast. This reflects sustained demand for innovative diagnostic solutions and medical devices—highlighting Abbott's strategic market positioning. The IPO landscape remains active with companies like Nuvox Therapeutics seeking to raise funds for advancing oxygen therapeutics targeting hypoxia-related diseases—showcasing renewed investor interest and confidence within biotech innovation. Latigo Biotherapeutics is preparing for an IPO to advance its pipeline, demonstrating a strategic response to the opioid crisis. By developing alternatives that minimize addiction risks while providing effective relief, Latigo underscores the industry's commitment to safer pain management solutions. Turning to clinical trials, Scribe Therapeutics plans a $96 million IPO to advance its CRISPR-based lipid-lowering therapies, marking significant interest in genetic solutions for cardiovascular diseases like hyperlipidemia. The precision offered by CRISPR technology could revolutionize treatment options for conditions contributing significantly to cardiovascular health burdens. **Geopolitical Influences:** Geopolitical factors are also influencing market dynamics, particularly in the UK biotech sector where IPO plans are being shaped by global uncertainties despite robust venture capital backing. This situation underscores the complex interplay between regional economic conditions and global investment trends in biotech innovation. As these trends continue unfolding across the industry landscape—from AI-driven research advancements to strategic acquisitions—the potential impact on patient care paradigms remains profound. These developments not only promise new possibilities within drug development but also influence broader healthcare delivery models aimed at improving patient outcomes globally.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of industry-shaping events, reflecting the ever-evolving landscape of drug development, regulatory challenges, and strategic maneuvers. In a significant move within the sector, Jasper Therapeutics has merged with Kira Pharmaceuticals, a strategic decision aimed at expanding its footprint in autoimmune therapeutics. This merger brings to Jasper a valuable asset in KP-104, a dual-inhibitor with the potential to address rare diseases—an area of considerable unmet need. Such consolidations highlight an industry trend where companies seek to bolster their portfolios with promising candidates that can tackle complex medical conditions. The merger exemplifies how strategic expansions are becoming increasingly integral to maintaining competitive edges in the biotech arena. Turning to clinical trials, Takeda's Zasocitinib has demonstrated promising results for patients suffering from moderate-to-severe plaque psoriasis. In Phase 3 trials, a significant 75% of patients achieved clearance of scalp psoriasis. Zasocitinib operates as a TYK2 inhibitor, targeting the IL-23 pathway—a crucial mechanism in autoimmune diseases like psoriasis. This breakthrough promises to enhance patient care by providing a more effective treatment option for those struggling with difficult-to-treat psoriasis. On the regulatory front, Novartis' Fabhalta (Iptacopan) has gained FDA approval for its role in slowing kidney function decline in patients with primary immunoglobulin A nephropathy. As a small molecule complement inhibitor, Iptacopan introduces a novel treatment class for this autoimmune kidney disorder. This approval underscores ongoing innovation within nephrology and offers renewed hope for improved patient outcomes. Recent regulatory updates also saw Novartis securing full FDA approval for Fabhalta—an affirmation of progress in addressing immunoglobulin A nephropathy through innovative therapeutic options. Business development remains a driving force in shaping industry landscapes. The acquisition of Mission Therapeutics' AKI candidate MTX652 by Dimerix is a prime example. This $5 million deal, with potential milestones up to $292 million, reflects high stakes and ambitions to advance treatments for acute kidney injuries—a field with significant unmet medical needs. The integration of artificial intelligence continues to revolutionize drug discovery processes. Aqemia's collaboration with Sanofi highlights this trend, showcasing AI's crucial role in expediting drug development and uncovering novel therapeutic targets. Their partnership potentially worth $140 million underscores AI's transformative potential within pharmaceutical research. Notably, Nobel laureate Jennifer Doudna's foray into AI-powered protein design signifies an exciting intersection between gene-editing technology and artificial intelligence. Her involvement signals potential revolutions in drug discovery through enhanced precision in protein engineering. However, regulatory challenges persistently loom over the industry. Novo Nordisk and Alvotech have faced FDA scrutiny concerning manufacturing deficiencies—an issue that accentuates the importance of stringent quality control and operational excellence in biologics manufacturing. The American Society of Health-System Pharmacists (ASHP) report on U.S. drug shortages during Q2 2026 reveals vulnerabilities within supply chains, notably impacting oncology drugs. These shortages emphasize the critical need for robust strategies to ensure consistent drug availability for essential therapies. Furthermore, geopolitical dynamics are influencing pharmaceutical supply chains. A U.S. Senate bill aimed at increasing transparency highlights concerns over China's dominance in drug ingredient supplies—an issue necessitating strategic adjustments by globally operating companies. Elsewhere within the sector, GSK made headlines by discontinuing the development of its chronic cough treatment camlipixant following mixed Phase 3 trial results—a setback illustrating the critical nature of trial outcomes in determining drug viability and market potential. In market trends, biotech IPOs have surged during the first half of 2026—a sign of robust investor interest fueled by innovations and favorable funding environments despite associated market volatility risks. Strategic adjustments continue across companies with mergers and acquisitions leading to workforce reductions—projected layoffs exceeding 14,000 within biopharma during H1 2026—as organizations streamline operations or pivot towards more promising research domains. Lastly, Merck's FDA approval for an oral PCSK9 inhibitor marks a significant achievement in cardiovascular care—representing another stride forward in therapeutic innovation. In summary, these developments encapsulate a landscape defined by scientific pursuits yielding mixed results amidst evolving regulatory interactions and strategic realignments—all contributing towards innovative healthcare solutions while navigating complex industry dynamics.Support the show

Send us Fan MailWe tend to think of menopause as a personal health issue - but in the workplace it quietly shows up as one of the largest unmodeled productivity shifts in the modern economy.Recent data from the Korn Ferry Institute, in collaboration with Vira Health, suggests nearly half of women report that perimenopause or menopause symptoms impact their work performance. And research cited by the Mayo Clinic estimates menopause-related productivity loss in the U.S. alone at roughly $1.8 billion annually.So the question becomes: what happens when a normal biological transition starts to meaningfully affect workforce participation, retention, and productivity?Karen Bishop, MS is Senior Director of HR Rewards at Astellas Pharma US ( https://www.astellas.com/en ), where she leads global benefits, compensation strategy, and employee well-being programs.Across more than two decades in HR leadership roles at organizations including MilliporeSigma, Shire (now Takeda), Cabot Corporation, and Putnam Investments, Karen has built deep expertise in total rewards strategy, healthcare benefits design, retirement systems, and organizational change.At Astellas, Karen has helped evolve an internal menopause workplace pledge into a broader global initiative focused on manager education, employee support systems, and benefits navigation - positioning menopause as part of a larger conversation around workforce health, retention, and productivity.#menopause #workplacewellbeing #hrleadership #futureofwork #corporatestrategy #workforceanalytics #womenshealth #hrtech #talentmanagement #employeeexperience #healthcareeconomics #productivity #leadershipdevelopment #totalrewards #organizationaldesign #publichealth #biologicalaging #genderequity #workplaceculture #healthpolicySupport the show

M&A enthusiasm is carrying biotech amid tepid reception for launches. On the latest BioCentury This Week podcast, BioCentury's analysts discuss BioCentury's 3Q26 Public Markets Preview, asking whether M&A momentum can carry biotech through year-end and what happens if the AI trade goes bust?Editor in Chief Simone Fishburn gives her perspective on what incoming Prime Minister Andy Burnham's agenda means for U.K. life sciences. The analysts also discuss Ionis' ATTR-CM miss and Takeda's orexin program. This episode of the BioCentury This Week podcast has been brought to you by CBRE.View full story: https://www.biocentury.com/article/660118#BiotechMA #BiotechInvesting #PublicMarkets #LifeSciences #DrugDevelopment00:01 - Sponsor Message: CBRE01:46 - 3Q Market Preview10:54 - Burnham's Britain19:40 - Ionis' ATTR-CM Miss29:12 - Takeda Orexin ProgramTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

This episode covers: Cardiology This Week: A concise summary of recent studies AI & digital solutions in emergency medicine Management of heart failure in cardiac amyloidosis Spotlight: Orthodexia-Platypnoea Syndrome Host: Emer Joyce Guests: Marianna Fontana, Wolf Hautz, Konstantinos Koskinas Want to watch that episode? Go to: https://esc365.escardio.org/event/2551 Want to watch that extended interview on the management of heart failure in cardiac amyloidosis, go to: https://esc365.escardio.org/event/2551?resource=interview   Disclaimer  ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Wolf Hautz and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI.  Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Marianna Fontana has declared to have potential conflicts of interest to report: consultancy for Alnylam, Alexion/Caelum Biosciences, Astra Zeneca, Bridgbio/Eidos, Prothena, Attralus, Intellia Therapeutics, Ionis Pharmaceuticals, Cardior, Lexeo Therapeutics, Janssen Pharmaceuticals, Pfizer, Novo Nordisk, Bayer, Mycardium. Research grants from: Alnylam, Bridgbio, Astra Zeneca, Pfizer. Share options in LexeoTherapeutics and shares in Mycardium. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Emer Joyce Guests: Marianna Fontana Want to watch that extended interview on the management of heart failure in cardiac amyloidosis, go to: https://esc365.escardio.org/event/2551?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/2551   Disclaimer  ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Marianna Fontana has declared to have potential conflicts of interest to report: consultancy for Alnylam, Alexion/Caelum Biosciences, Astra Zeneca, Bridgbio/Eidos, Prothena, Attralus, Intellia Therapeutics, Ionis Pharmaceuticals, Cardior, Lexeo Therapeutics, Janssen Pharmaceuticals, Pfizer, Novo Nordisk, Bayer, Mycardium. Research grants from: Alnylam, Bridgbio, Astra Zeneca, Pfizer. Share options in LexeoTherapeutics and shares in Mycardium. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

In this special live episode recorded from the SLEEP 2026 annual meeting in Baltimore, host Dr. Seema Khosla welcomes Dr. Sanjay Patel, director of the clinical sleep program at University of Pittsburgh Medical Center, to discuss groundbreaking medications for sleep disorders poised for FDA approval in 2026 and 2027. The pharmaceutical landscape for sleep medicine is undergoing unprecedented transformation. Dr. Patel surveys the emerging drug pipeline that will fundamentally change how clinicians treat obstructive sleep apnea, narcolepsy, and idiopathic hypersomnia. For obstructive sleep apnea, Dr. Patel discusses AD-109 (atomoxetine and R-oxybutynin), explaining the mechanistic rationale and practical considerations including use with tirzepatide. The Incannex drug combining dronabinol and acetazolamide receives analysis for different patient populations, and sultiame is discussed as a carbonic anhydrase inhibitor option. A critical framework emerges: Should treatment be symptom-based or airway-focused when PAP-intolerant patients present? Tirzepatide, the GLP-1 agonist FDA-approved for moderate-to-severe OSA, receives comprehensive coverage including muscle loss concerns, long-term use, and emerging oral GLP-1 options. Retatrutide, the triple-hormone agent combining GLP-1, GIP, and glucagon, is also discussed. The episode's most exciting segment focuses on orexin agonists for narcolepsy. Three pharmaceutical companies—Alkemeres, Centessa (purchased by Lilly), and Takeda—are developing these mechanistically novel agents. Dr. Patel clarifies how these medications differ, discusses why one medication disrupted nocturnal sleep (suggesting continued roles for oxybates), and addresses how clinicians will choose between similar medications. Dr. Patel emphasizes a fundamental question: Should the field prioritize symptom management versus airway patency for OSA, and mechanistic approaches versus symptom management for narcolepsy? Whether you're interested in emerging OSA treatments, narcolepsy innovations, or the future of pharmacological sleep medicine, this live episode provides essential updates on medications that will soon reshape clinical practice. Join us for this exciting conversation about how sleep medicine will transform in the coming years.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of remarkable advancements and strategic maneuvers that are shaping the future of drug development and patient care. Starting with Roche's breakthrough in oncology, their small molecule inhibitor, Divarasib, has shown promising results in a Phase 3 trial for patients with KRAS G12C-mutated non-small cell lung cancer. This trial demonstrated superior efficacy over competitors like Amgen's Lumakras and Bristol-Myers Squibb's Krazati. Historically, KRAS mutations have been difficult to target, but Divarasib's success underscores the potential of precision medicine in oncology. These findings could lead to more effective treatment options for NSCLC patients, showcasing how targeted therapies are revolutionizing cancer treatment by focusing on specific genetic mutations. In regulatory news, Vertex Pharmaceuticals has made significant strides with Casgevy (exagamglogene autotemcel), a gene therapy that now includes pediatric patients with sickle cell disease and transfusion-dependent beta thalassemia in its FDA-approved label. This marks a pivotal moment for gene therapy applications in blood disorders. Utilizing CRISPR technology, Vertex offers potentially curative solutions for debilitating conditions, signaling a new era where genetic disorders can be addressed at their root cause. Similarly, Novartis has gained European Commission approval for Itvisma to treat 5q spinal muscular atrophy in patients aged two years and older, further cementing gene therapies' role in mainstream medical practice. Strategic partnerships remain essential in driving innovation. Takeda's collaboration with Insilico Medicine on AI-driven drug discovery is a case in point. The $600 million partnership highlights the growing reliance on AI and machine learning to expedite therapeutic development processes. Platforms like Pharma.AI are being leveraged to identify novel drug candidates more efficiently. Additionally, AstraZeneca's alliance with CSPC Pharmaceutical Group to develop siRNA-based therapies for kidney diseases reflects the burgeoning interest in RNA therapeutics as these technologies open new avenues to address complex diseases. On the financial front, BridgeBio's ability to attract $1 billion in convertible preferred equity from Sixth Street and Healthcare Royalty underscores investor confidence in rare disease therapeutics. This funding will bolster its pipeline targeting cardiovascular and rare conditions, emphasizing the profitable potential found within niche markets of the pharmaceutical landscape. Manufacturing is also seeing expansion as Lonza deepens its partnership with an unnamed U.S. drugmaker to enhance biologics programs. Anticipated investments reaching into multi-billion Swiss Francs underscore the critical importance of robust manufacturing infrastructure to meet growing demands for biologics and antibody-drug conjugates. Clinical trials continue to yield promising results. Can-Fite Biopharma's Phase 2a trial for Namodenoson in treating advanced pancreatic ductal adenocarcinoma has shown promising survival data when combined with therapies targeting Wnt/β-catenin signaling pathways. At the same time, Otsuka's Phase 3 data for Voyxact (sibeprenlimab-szsi) demonstrated improved kidney function in patients with immunoglobulin A nephropathy, bolstering traditional FDA approval pathways. On the acquisitions front, GNI Group's acquisition of Ayumi Pharmaceutical for approximately JPY 44.8 billion highlights strategic moves to enhance global biopharma operations focusing on pain management solutions. Yet not all news is positive; Sanofi's Genzyme Ireland unit received an FDA warning letter regarding manufacturing violations related to Altuviiio production, pointing to ongoing regulatory challenges within production practices. Moving on to geopolitical considerations, recent congressional letters to major pharmaceutical CEOs have raised concerns about clinical trials conducted within China due to national security concerns. This tension illustrates the delicate balance between leveraging China's economic potential and safeguarding US interests—a critical issue as international collaborations continue to expand. Meanwhile, AstraZeneca's ongoing collaborations with CSPC Pharmaceutical Group further signify strategic bets on China's capabilities despite geopolitical tensions. Their joint efforts focus on kidney disease treatments while adding to existing agreements addressing obesity and chronic diseases. The FDA remains pivotal as key decisions anticipated this quarter could significantly influence investment strategies and research priorities. This includes revisiting applications previously delayed or rejected—decisions that could reshape industry dynamics. In conclusion, this dynamic landscape is marked by significant scientific breakthroughs and complex global interactions guiding pharmaceutical and biotech sectors toward a transformative era. Gene therapy advancements underscore progress in personalized medicine while geopolitical factors continue influencing strategic industry decisions. As regulatory bodies evolve their approaches alongside increasingly international partnerships, these developments collectively herald profound implications for drug development and patient care globally.Support the show

Ryan Piansky, a patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, interviews Maddie, a young adult living with EoE, about her journey with EoE and navigating an elimination diet. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:51] Host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda.   [1:07] Ryan introduces today's topic, eosinophilic esophagitis (EoE). EoE is a chronic, allergic, inflammatory disease of the esophagus. It occurs when eosinophils, a type of white blood cell, accumulate in the esophagus in elevated numbers, causing inflammation that can make eating or swallowing difficult or uncomfortable.   [1:25] Ryan introduces and welcomes today's guest, Maddie, also known as Eosinophilic Chick on Instagram. She's a patient advocate living with EoE.   [1:38] Maddie was diagnosed with EoE in 2021. She has been symptomatic for 10 to 12 years, but was not familiar with the condition itself until then. In her childhood, she was afraid of the upper endoscopy procedure, so she avoided it as much as she could.   [2:06] Besides the patient advocacy that she does, Maddie is an actuary. Throughout the week, she dedicates time to the healthcare industry space in the Philadelphia area. Maddie is 26, navigating her 20s with EoE.   [2:24] Ryan says he feels like being diagnosed as a young adult can be a very big shift. You're going through a lot of other changes: graduating from college, having to figure out work, and having to start managing a chronic illness like EoE.   [2:46] When Maddie was 12 years old, she would have a blockage in her throat. Typically, she walked away from the dinner table and had to regurgitate the food she had consumed.   [3:02] Since heading into college and becoming aware, with the pandemic, of the symptoms of COVID, shortness of breath is one that she leaned into. When she was 21, she felt like she couldn't breathe. It turned out that she was choking on food.     [3:18] There was an impaction, which Maddie obsessed about over time. In addition, around the time she was 21, her symptoms got the best of her. She wasn't able to keep up with thriving, day to day.   [3:31] As a child, some of her symptoms weren't normal, but they were manageable to adapt to: throwing up after a meal, here and there. Her symptoms started to pick up, and she started to lose a lot of weight in her 20s. That's when she sought a diagnosis.   [4:18] Maddie thought it was related to her lung function. She started to lean toward getting diagnosed with asthma, but after testing, that wasn't clear. Her gynecologist thought it was more of a hormonal conflict. They did a lot of labs but got no diagnosis.   [4:45] Meanwhile, Maddie was getting sick. As a last resort, she headed over to gastro. They didn't find anything initially. They did a barium swallow test, another lung function test, and finally, an upper endoscopy.   [5:04] Maddie had spent most of the summer before her senior year of college just trying to figure out what was going on, doing a multitude of tests, and that upper endoscopy with a biopsy captured the EoE.   [5:17] Maddie was able to get support from a specialist who dedicates all of their day-to-day work to EoE treatments.   [5:25] Ryan says it can be tricky to figure out right away what's going on; there are so many other conditions that could be the answer. Until you get to that final diagnosis, it can be a very long process. He's glad she got an answer, eventually.   [5:53] Maddie says, given the timeline of her life, a lot of people were anxious and worried about her future.    [6:08] Once she was able to get that answer, Maddie noticed a lot of relief from a ton of her symptoms, once she was able to get to work on it. Maddie also had an ulcer from frequent vomiting.   [6:25] Maddie had to slow everything down and be very intentional about the things she ate.   [6:51] Maddie lost 15 pounds that summer, as she was trying to gain weight. Whatever she ate, she still lost weight. She was worrying about that rather than about graduating that year.   [7:08] Maddie wanted to know how to register as a disabled student at her university to make sure she got all the resources she needed to be successful.   [7:18] Maddie was rewiring the things she once was worried about, relative now, to what this condition has packaged with it. It was a difficult time. It taught her a lot about discipline, making sure that hard things don't turn her away from achieving the goal.   [7:46] It taught Maddie about being intentional with her time and energy, what's best for her, what's going to make her succeed with whatever goal she's achieving.   [8:07] Ryan says now that Maddie is properly diagnosed, he hopes she's a little bit more in control of her health. Maddie says, "Answers are the biggest power with this condition."   [8:30] Maddie says that before her condition was managed, she went to the ER three times. The first time she was hospitalized, she could not keep down food for two days, so she had to get IV treatment. It wasn't necessarily an impaction, but she wasn't able to eat.   [9:04] The second and third times Maddie went to the ER were related to throwing up again.    [9:26] Maddie's goal was to stop vomiting altogether. She started to get serious with diet therapy, leaning into her six-food elimination diet.   [9:39] Maddie started the diet the week after she graduated, just to be home and have a lot of variables controlled to try the diet, rather than cutting corners. It was really simple to do at home.   [10:04] Maddie first tried cutting dairy, eggs, and shellfish. Her sister is allergic to those foods and is anaphylactic; Maddie is not. That elimination diet was helpful, but it didn't check all the boxes where all her symptoms were free.   [1024] Maddie tried swallowing medication from an inhaler instead of inhaling it into her lungs, trying to coat her esophagus with it. It was effective in the biopsy results, but she was still getting sick, so she did not feel comfortable proceeding with that treatment.   [10:42] All roads led to the six-food elimination diet that could reveal what the culprits were and what was causing her to be so sick. The results were surprising.   [11:06] Soy was a big trigger that surprised Maddie. She consumed so many soy products. That was quite humbling to hear. That was one of her biggest triggers.   [11:34] Maddie completed the six-food elimination diet with triggers of soy, eggs, dairy, nuts, and shellfish. Because of all those groups, it was really difficult for her to manage her diet effectively when going out to eat.   [11:52] Sometimes soybean oil is in a salad dressing or how foods are fried, to a point where Maddie wasn't able to maintain her EoE count below 15 eosinophils per high-powered field.   [12:08] With that, she started with a biologic, dupilumab. That enables her to eat all her trigger foods. An injectable is tough for Maddie as she's not fond of needles.    [12:36] Now Maddie can eat all of the food groups, which is definitely a huge win in terms of her treatment plan. It lessens the impact of living every day with EoE.    [12:53] Ryan says he is on dupilumab, as well. It works well for him. Maddie says she is not avoiding any food triggers, and that's the best part.   [13:24] Ryan says it takes a huge mental load off when you're not having to think about whether there may be soy in what you order from a restaurant, or having to check all the ingredients at the store to make sure that you're not accidentally being exposed.   [13:53] Maddie says, the best advice I would give [to someone on an elimination diet] is focusing on the perimeter of the grocery store. A lot of those foods are dedicated to being whole foods. So, I found that approach to be the most successful.   [14:12] Maddie says, and still finding things that you love and can find new things to enjoy. You're entitled to absolutely enjoy food. It brings a lot of joy into my life.   [14:23] Maddie says, I would specifically love traveling to a bunch of different grocery stores and exploring the allergy aisle. Everyone had their unique niche for it. So, you'll definitely find ones that are more favorable to your preferences than others.   [14:37] Maddie says, but find things, too, that you still enjoy beyond just feeling fully nutritious, and strong, and equipped. You're entitled to indulge, too, even with all the restrictions that you have.   [15:00] Ryan agrees there are a lot of options out there. Exploring and finding something can be really impactful from a quality-of-life perspective, just to have something new. Sticking to the border of the grocery store is a good way of putting it.   [15:13] Ryan says it's everything in those center aisles that gets so complicated. There are always some good, whole food options on the edges, which is nice.   [15:23] Maddie says read every food label, even if you think that you know what's in the food products. A brand of hummus had soybean oil in it. I had to retest, and it added six additional weeks onto my game plan because of that silly mistake.   [15:40] Read everything, even if you think you know it. Odds are, you don't. Don't trust any label until you've fully read it and are confident.   [15:56] Ryan says one of his trigger foods is rice and it does pop up in weird places. Once he was eating potato chips, but then he looked at the ingredients. Rice flour was the second ingredient!   [16:33] If you're not paying attention, it can catch you by surprise. Definitely read labels. It's time-consuming, but it's always a good idea.   [16:42] Ryan asks what other treatment options Maddie tried besides a swallowed inhaled steroid. When she had GI symptoms, she immediately tried a PPI, but was still symptomatic.    [17:47] Maddie says, facing the hard things, getting in front of a problem, and actually attacking it with the solution, is something she consistently dismissed in her teenage years. It took a lot of effort to find the perfect solution that fit.   [18:06] Maddie says, she'll continue to make sure that this is the best solution for her, as her lifestyle and needs change over time.   [18:14] Maddie says, attacking things that might seem intimidating, like 360-plus days of dieting, and not going out to eat, something that was really isolating for her; it just proved so much value in her journey.   [18:29] Maddie says, she is now equipped with that knowledge to make additional decisions as more treatments hopefully come out for EoE. You never know if there are more resources in the pipeline.   [18:48] Maddie says, with this knowledge that I've had, I think it's equipped me to face anything new, and/or ensure that my disease is managed, ultimately.   [18:57] Ryan says, there's a ton of ongoing research and all sorts of new treatments coming out. Ten years ago, he could not have imagined a treatment option like dupilumab.    [19:08] Ryan says, now that we have that, and it's proving so effective for so many people, he thinks that's so exciting and so wonderful. The fact that there are more treatment options like that coming out is so exciting.   [19:27] Maddie says she thinks accepting the illness, and accepting that she's not normal, and the way she lives comes with complexities, relative to her peers. It's frustrating.   [19:40] Maddie says she would love to just not take my dupilumab dose and eat whatever she wants, and not have an annual visit, not do upper endoscopies, and put all this effort, money, and mind all towards this illness.   [19:56] Maddie says accepting that she is unique and this illness will always be a part of her. Coming to terms with that is something she continues to struggle with, just recognizing her peers are not going through the same thing.   [20:12] Maddie says her peers are supportive, but she wonders why she is different and how she got there. She's still working through that.   [30:21] Ryan talks about all the small details a person living with EoE has to think about when traveling or going out for food after work. It's an extra level of anxiety that other people don't have to worry about.   [20:54] Maddie has suggestions for people living with EoE: Inform your peers about your condition. Share your knowledge with your community. With their understanding, they can empower you in social situations, rather than isolate you.   [21:14] When Maddie was dieting, her closest friend's family made sure she had something to eat rather than asking why she wasn't eating. Once she had to tell friends at a dinner that she wasn't eating, she was there to socialize.   [21:55] The more you work towards your acceptance, the more you inform your community, the more you inform yourself, those situations will come a lot lighter. There's always going to be a new scenario where you have to explain your condition.   [22:15] Maddie says, If you can get everybody to pronounce eosinophilic esophagitis, that's a huge win itself. I typically stop at EoE.   [22:32] Ryan talks about anxiety about not eating at dinner. Everybody's just happy you show up and are willing to socialize. Advocating for yourself is such a good lesson to take away from this.   [23:10] Ryan talks about Maddie's patient advocacy work. He follows her on Instagram. She puts so much great information out there. She also works in a professional career.   [23:30] Maddie talks about balancing her activities and illness. She aligns her content with her passion, so it's a hobby she enjoys. She hopes others find value in it. Outside of work, Maddie likes to advocate for EoE. It's busy, but she's super passionate about it.   [24:08] Ryan engages and advocates mostly through APFED, because they provide a lot of wonderful support. He's glad that Maddie uses her experiences to advocate through Instagram and her day-to-day life.   [24:33] Ryan says it's such a great way to approach living with a chronic illness.   [24:40] Maddie's initial goal was to create content so she could explore her growth in her journey. It was a diary about all the things she had done with EoE.   [24:58] Maddie mentions milestones in the community: dupilumab having FDA approval during that timeline, it was exciting to witness with her community.   [25:12] When Maddie was diagnosed, she found information online. The social media community is very powerful in making it real. Maddie loves APFED's content and the comments of folks impacted by the disease. It adds organic, natural reality.    [25:37] Maddie says she loves sharing her story, and she will continue to share it. This isn't ending yet. It's chronic, so EoE will be with her for quite some time. Hopefully, they'll find a cure, but in the meantime, it's not going anywhere.   [25:59] Maddie started her account when she got diagnosed in the Fall of 2021. She focused on alternative foods in the grocery store and dairy-free and egg-free cooking.   [26:18] When she transitioned to the six-food elimination diet, she focused on recipe creation and innovation. She tried to make a deep-dish Chicago-style pizza that was gluten-free. It was a huge mess! She gives respect to the gluten-free community.   [26:46] Ryan describes a poor experience with a chicken-crust gluten-free pizza.   [27:31] Maddie pushes for awareness because there are more people than you think in your community who have undiagnosed EoE. Some are quiet warriors with the condition, working behind the scenes, managing it, not sharing with their community.   [27:54] Between 2021 and now, Maddie has crossed paths with a lot of individuals, even down to childhood neighbors, who have the condition. It's humbling to know that other individuals are going through the same thing, quietly.   [28:13] Maddie says, being able to connect and unify that community is something she wishes she could promise her 2021 self: There's a community out there waiting for you with open arms that will support you through this journey.   [28:30] There are a lot of great people in this space who are unfortunately impacted by this disease. Knowing the community is there is something I would tell myself.   [29:02] Ryan invites Maddie to share a message of encouragement for people living with eosinophilic-associated diseases.   [29:08] Maddie would say, failure is not always a failure. In this case, it took her four forms of therapy treatments until she found the perfect one for her. Try to keep your mind open on the pathways of managing your symptoms.    [29:30] It may cause you to run into a couple of failures, which is so frustrating. She has been in tears before about this, but sometimes failure brings you one step closer to success, or in this case, relief in managing your symptoms.   [31:04] Maddie and Ryan discuss the string test, relating to upper endoscopies, and the benefits of a shorter test without anesthesia. Maddie is excited by the things in the pipeline for potential treatments or maintenance options.   [32:06] Ryan has talked to people who have had the string test, and it sounds like a much better experience until they have to pull it back up, and then it sounds like maybe you wish you were asleep for that part. Overall, it sounds so much more pleasant.   [32:21] Ryan and Maddie discuss trans-nasal endoscopies, with a thinner tube and no anesthesia. It's on Ryan's radar. Endoscopies are not fun.   [34:37] Maddie is excited that there are commercials starting with EoE, talking about the condition on television.   [35:21] Ryan says, it is exciting that there's so much more understanding about this disorder. There is more public awareness now. Maybe 10 years ago, you never would have known that your neighbor also has EoE.   [35:34] Now people can get these diagnoses, understand what's going on, and talk about it more openly, which is really exciting.    [35:45] Maddie says APFED had a great campaign in May, promoting EoE awareness. The more we do that, the more everybody impacted by this disease will win, for sure.   [36:01] Ryan thanks Maddie for her work promoting EoE awareness. It's great to have people out there pushing advocacy and getting information out there. Ryan thanks Maddie for joining us today for this great conversation.   [35:22] For our listeners who would like to learn more about eosinophilic disorders, please visit apfed.org and check out the links in the show notes. [36:28] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder, available at apfed.org/specialist.   [36:37] If you have personally been impacted by eosinophilic disorders and are interested in sharing your experiences, please check out apfed.org/shareyourstory.   [36:45] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [36:56] Ryan thanks Maddie. Ryan thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.orgEsophageal string test (early research was supported by an APFED grant)  apfed.org/specialist apfed.org/connections Eosinophilic.Chick — Maddie on Instagram Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables (Edited):   "I have officially been diagnosed with EoE since 2021. So, coming up on fiveish years now with the condition, knowing that I have it. I've been symptomatic for over 10 to 12 years, call it, just not really familiar with the condition itself." — Maddie   "My symptoms started to pick up, and I started to lose a lot of weight in my 20s. That's really when I started to get a lot of attention towards my diagnosis." — Maddie   "I first tried cutting dairy, eggs, and shellfish. My sister has an allergy to those foods and is anaphylactic; I am not. That diet was good, but it didn't check all the boxes where all my symptoms were free." — Maddie   "I completed the six-food elimination diet with triggers of soy, eggs, dairy, nuts, and shellfish. Because of all those groups, it was really difficult for me to manage my diet effectively when going out to eat." — Maddie   "I started my [Instagram] account when I got diagnosed in the Fall of 2021. I focused on alternative foods in the grocery store and dairy-free and egg-free cooking. … When I transitioned to the six-food elimination diet, I focused on recipe creation and innovation." — Maddie   Guest Bio: Maddie is the creator behind Eosinophilic Chick, a platform dedicated to raising awareness about eosinophilic esophagitis (EoE), food allergies, and life with chronic illness. Diagnosed with EoE as a young adult, Maddie shares her experiences navigating elimination diets, medical treatments, endoscopies, and the emotional impact of living with a chronic condition. Through honest storytelling, practical tips, recipes, and advocacy, she aims to help others feel less alone.

Tyler and Konnery are joined animation enjoyer and Life Auditor to cover the emotional send off that is "Toy Story 3"! Together they discuss the direction of the third film's story, Ken-shaming, accepting the inferno, how drawn to the toys' personalities Tyler still is, giving up childish things, what makes a great Toy Story villain, and so much more on this Bookworm-disapproving episode of The Friendchise Podcast!   TikTok Threads Instagram What's New: Tyler: Sonic Team Racing (PS5), Fast & Furious (Blu-Ray) Kon: Absolute Batman by Scott Snyder, Absolute Wonder Woman by Kelly Thompson, Widow's Bay (Apple TV+) Cameron: Another World (In Theaters), Life Lessons with Uramichi Oniisan by Gaku Kuze

Host: Emer Joyce Guest: Lorenz Raeber Want to watch that extended interview on https://esc365.escardio.org/event/2558?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2558   Disclaimer ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Lorenz Raeber has declared to have potential conflicts of interest to report: consultation/speaker fees from Abbott, Boston Scientific, Occlutech, and research grants to the institution by Abbott, Heartflow, Novo Nordisk and Heartflow. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology This Week: A concise summary of recent studies Host: Emer Joyce Guests: Yasmina Bououdina, JP Carpenter, Milton Packer, Lorenz Raeber Want to watch that episode? Go to: https://esc365.escardio.org/event/2558 Want to watch that extended interview on PCI guidance by intracoronary imaging, go to: https://esc365.escardio.org/event/2558?resource=interview   Disclaimer  ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Milton Packer has declared to have potential conflicts of interest to report: 89bio, Abbvie, Actavis, Altimmune, Alnylam, Amarin, Amgen, Ardelyx, ARMGO, AstraZeneca, Attralus, Biopeutics, Boehringer Ingelheim, Caladrius, Casana, CSL Behring, Cytokinetics, Daiichi Sankyo, Imara, Lilly, Medtronic, Moderna, Novartis, NovoNordisk, Pharmacocosmos, Regeneron, Roche, Salamandra. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Lorenz Raeber has declared to have potential conflicts of interest to report: consultation/speaker fees from Abbott, Boston Scientific, Occlutech, and research grants to the institution by Abbott, Heartflow, Novo Nordisk and Heartflow. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

I betalt samarbete med Takeda. Vi är många som drömmer om att resa bort för att prova på livet utomlands under en kortare eller längre period – med eller utan familj. Annika och hennes familj (man och tre barn) har spenderat flera längre perioder på Koh Lanta i Thailand, där barnen har gått i svensk skola. Hur fungerar ett sådant upplägg rent praktiskt, vad kostar det, vilka utmaningar och möjligheter innebär en längre utlandsvistelse och vilka svenska skolor finns det […] Inlägget 144: Att resa på longstay dök först upp på Att resa-podden.

AI can analyze data faster than any human—but strategy still requires judgment. In this episode of Med Tech Gurus, we sit down with Joe Luminiello, Founder and CEO of RCG Intel, a competitive intelligence firm operating at the intersection of healthcare, biopharma, and AI-driven decision making. With more than 40 years of life sciences leadership experience—including helping launch Takeda's Canadian business and leading a 650-person commercial organization responsible for over $1B in annual sales—Joe brings a unique perspective on what separates data from real strategic insight. Joe explains why many life sciences companies struggle to translate information into action. While AI can rapidly analyze clinical data, market signals, and competitive activity, it cannot replace the contextual intelligence that comes from human conversations with physicians, key opinion leaders, and frontline healthcare professionals. We explore how commercial teams can avoid the common disconnect between product development and market strategy, why cross-functional communication is critical for successful product launches, and how companies can use AI to enhance—not replace—human decision-making. If you're a MedTech founder, biotech executive, investor, or commercial leader navigating AI, competitive intelligence, and product commercialization, this episode offers powerful insights into turning data into strategy and strategy into execution.

Moderna's mRNA-based flu vaccine made headlines in February when the FDA declined to even review the application. Days later, the agency reversed course, setting a decision date for August and later scheduling an advisory committee meeting for June 18. In documents released ahead of that meeting, the FDA and Moderna seem to have reached alignment, though the agency did flag certain data gaps for advisors to review.Biotech IPOs are off the charts—literally. This past month has seen not one but two record-setting public debuts. First there was Kailera Therapeutics, which hit the market with $625 million in April, outpacing Moderna's 2018 IPO of $600 million. And now we have Parabilis Medicines, which last week dethroned Kailera as the largest biotech IPO of all time, with $670 million.Meanwhile, the number of employees laid off spiked by almost 50% year-over-year in May, though that jump is mostly due to significant cuts at Takeda and BioNTech.Genentech also made a big change last week.Eli Lilly continued its dealmaking spree with AlzeCure, striking a licensing agreement worth up to $1 billion centering on a small-molecule asset for Alzheimer's disease. But the bigger Lilly news in the past week was clinical results that show promise for the pharma's $2.3 billion acquisition of Ajax Therapeutics in April.Earlier this month, the FDA held a public session to glean feedback regarding the Commissioner's National Priority Voucher program, in which several groups called for a temporary pause to the pilot, citing concerns about transparency and political involvement. While the future of that program hangs in the balance, two voucher holders got updates this week. First, Sanofi's diabetes drug Tzield was greenlit for older kids and teenagers, though it's unclear whether a voucher was associated with the approval. Meanwhile, Disc Medicine's rejected rare disease drug bitopertin appears to be back on track, with the biotech announcing last week that the FDA will allow its current Phase 3 trial to support another regulatory filing.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of remarkable updates that highlight the dynamic evolution of drug development, regulatory landscapes, and industry strategies. Takeda has made waves with its TYK2 inhibitor, Zasocitinib, which recently outperformed Bristol Myers Squibb's Sotyktu in a pivotal Phase 3 trial for plaque psoriasis. This trial is particularly noteworthy as it involves TYK2 inhibitors, a class of drugs targeting tyrosine kinase 2 to modulate immune responses. The success of Zasocitinib not only strengthens Takeda's competitive position but also underscores the potential of these inhibitors in treating autoimmune conditions like psoriasis. As we look forward to its market launch next year, this development represents a significant stride in the realm of targeted therapies aimed at complex diseases. Shifting gears to regulatory advancements, Johnson & Johnson's Darzalex (daratumumab) has received endorsement from NICE for its quadruplet therapy in newly diagnosed transplant-ineligible multiple myeloma cases. This approval is based on favorable Phase 3 trial results and highlights the therapeutic potential of targeting CD38 on myeloma cells. This marks a crucial step in offering potent treatment options to patients who cannot undergo transplants, emphasizing the growing importance of combination therapies in oncology. In another significant development, Johnson & Johnson is expanding its rare disease portfolio with promising Phase 2/3 trial data for Imaavy. Poised to become the first approved treatment for warm autoimmune hemolytic anemia, this advancement highlights the industry's pivot towards addressing rare diseases with limited treatment options. In India, AstraZeneca has secured CDSCO approval for Enhertu (trastuzumab deruxtecan) combined with pertuzumab as a first-line treatment for HER2-positive unresectable or metastatic breast cancer. This approval signifies a milestone in HER2-targeted therapies, spotlighting the pivotal role of antibody-drug conjugates that deliver cytotoxic agents directly to cancer cells, enhancing efficacy while minimizing systemic exposure. Moving on to business developments, Servier's partnership with N-Lorem Foundation to develop antisense oligonucleotide therapies for rare neurological disorders reflects the industry's increasing focus on precision medicine. This collaboration underscores the burgeoning interest in nucleic acid-based therapies aimed at addressing genetic disorders lacking effective treatments. On the financial front, Kardigan's planned $320 million IPO signals robust confidence in advancing cardiovascular pipeline assets. This move highlights Kardigan's commitment to tackling substantial unmet needs in cardiovascular diseases—an area still rife with challenges despite existing therapies. From a regulatory perspective, China's update of its Good Clinical Practice guidelines aims to streamline clinical trial processes, fostering biotech innovation. This change is expected to enhance drug development efficiency and attract global biotech investments to China's rapidly growing pharmaceutical market. Meanwhile, Pfizer CEO Albert Bourla has raised concerns about Germany's healthcare reform plans, warning that they might deter future investments. His comments underscore the delicate balance between cost containment policies and maintaining an environment conducive to pharmaceutical innovation. Additionally, Novo Nordisk's CEO Mike Doustdar expressed optimism about the company's strategic focus on market positioning through innovation and efficiency improvements. This aligns with broader industry trends where large pharma companies strive to maintain leadership roles amid fierce competition. Eli Lilly's sponsorship of short films premiered at Tribeca Festival illustrates an industry-wide trend toward patient-centric approaches and authentic portrayals of people with diseases onscreen. Such efforts aim to enhance communication strategies that resonate with diverse audiences. Furthermore, transformative technologies like cell and gene therapies are gradually moving towards mainstream clinical adoption. This transition necessitates zero-tolerance logistics to ensure these complex therapies reach patients safely and effectively—a paradigm shift offering potential cures but also posing logistical challenges. Finally, industry events such as ASCO continue to spotlight cutting-edge research developments in oncology. Such conferences are pivotal in advancing treatment paradigms and fostering collaborations that drive innovation across the sector. These updates reflect a period marked by groundbreaking scientific advances and strategic initiatives poised to reshape patient care and global healthcare solutions. As companies navigate these complexities while addressing regulatory and economic challenges, maintaining a focus on innovation will be key in charting future growth trajectories within the pharmaceutical and biotech sectors.Support the show

This episode covers: Cardiology This Week: A concise summary of recent studies Transcatheter treatment of tricuspid regurgitation Carcinoid heart disease Milestones: MADIT-II Trial Host: Wilfried Mullens Guests: Stephan Baldus, Heidi Connolly and Konstantinos Koskinas Want to watch that episode? Go to: https://esc365.escardio.org/event/2560 Want to watch that extended interview on transcatheter treatment of tricuspid regurgitation, go to: https://esc365.escardio.org/event/2560?resource=interview   Disclaimer  ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Heidi Connolly, Nicolle Kraenkel and Wilfried Mullens have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. Stephan Baldus has declared to have potential conflicts of interest to report: research grant from Abbott, lecture fees from Abbott and Edwards. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Wilfried Mullens Guest: Stephan Baldus Want to watch that extended interview, go to: https://esc365.escardio.org/event/2560?resource=interview Want to watch that entire episode? Go to: https://esc365.escardio.org/event/2560   Disclaimer ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Wilfried Mullens have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. Stephan Baldus has declared to have potential conflicts of interest to report: research grant from Abbott, lecture fees from Abbott and Edwards. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Join HAEA Director of Health & Research Services, Troyce Venturella, and HAEA Health Services Manager, Mandy Granat, as they discuss important summer safety considerations for individuals and families living with HAE. The conversation is designed to help the HAEA community stay safe, healthy, and prepared while enjoying summer activities with family and friends!Thank you to our 2026 Sponsors: BioCryst, CSL, IONIS, and Takeda

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant advancements shaping the landscape of our industry. As technology continues to redefine traditional paradigms, the collaboration between Pfizer and Chai Discovery exemplifies this trend. By harnessing artificial intelligence, particularly through custom models like Chai-3, this partnership aims to revolutionize drug discovery. The integration of AI promises not only to accelerate the identification of biologics and antibodies but also to optimize resource allocation in research and development. Such technological integration could pave the way for an enhanced pipeline of innovative treatments, marking a transformative shift in how therapeutic candidates are developed. In the realm of regulatory developments, Lupin's Ranluspec has recently received FDA approval as an interchangeable biosimilar targeting VEGF-A for various retinal conditions. This move underscores the importance of biosimilars in providing cost-effective alternatives to expensive biologics, thereby expanding patient access to essential treatments for conditions like macular degeneration. Additionally, the MHRA's marketing authorization for Aujemflu, an adjuvanted trivalent influenza vaccine for adults aged 50 and over, reflects ongoing efforts to bolster protection against infectious diseases among vulnerable populations. Clinical trial advancements continue to highlight significant progress in therapeutic development. Otsuka Pharmaceuticals' Phase 3 data on Voyxact has shown promising stabilization of kidney function in patients with Immunoglobulin A nephropathy. This protein therapy targets autoimmune pathways, offering new hope for managing this chronic kidney condition. Similarly, Autobahn Therapeutics' Elunetirom has advanced to a pivotal trial following Phase 2 success in treating bipolar depression. This showcases the potential of small molecule therapies targeting thyroid hormone receptors. Meanwhile, Hikma Pharmaceuticals' victory in a landmark patent case regarding skinny labels marks an important development in pharmaceutical intellectual property rights. The unanimous Supreme Court ruling against Amarin supports the legitimacy of using skinny labels to market generic versions of drugs for non-patented indications. This decision could enhance market competition and drive down healthcare costs, setting a precedent for future intellectual property disputes. On the business front, strategic partnerships and mergers continue to shape industry dynamics. Gilead Sciences' acquisition of Ouro Medicines for $1.675 billion strengthens its autoimmune inflammation pipeline. This transaction exemplifies how major deals are reshaping therapeutic portfolios in response to growing demand for treatments targeting rare diseases. Financially, Solix Pharmaceuticals' success in raising $71 million to advance its siRNA pipeline across multiple therapeutic areas demonstrates investor confidence in RNA-based therapeutics as a promising frontier for innovative treatments. Conversely, challenges persist as evidenced by Takeda's $2.5 billion legal provision over an antitrust case related to Amitiza, underscoring ongoing financial risks associated with litigation in the pharmaceutical sector. Corporate restructuring also signals shifts within the industry landscape. Fulcrum Therapeutics' decision to lay off 85% of its workforce following the discontinuation of its sickle cell disease candidate highlights the volatility and high stakes inherent in drug development. Overall, these developments illustrate a dynamic landscape where scientific innovation is propelled by AI-driven approaches and strategic collaborations while regulatory victories and financial maneuvers shape market dynamics. These trends have profound implications for patient care by potentially accelerating the availability of novel therapies and fostering a competitive environment that drives down costs. As we look ahead, stakeholders must navigate these complexities effectively to harness opportunities and address challenges within this rapidly evolving industry landscape. The ability to adapt and capitalize on emerging trends will be crucial as these sectors continue to evolve, ultimately enhancing patient care and advancing therapeutic frontiers globally. Thank you for joining us today on Pharma Daily; stay tuned for more insights into the ever-changing world of pharmaceuticals and biotech.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll explore a landscape teeming with strategic partnerships, groundbreaking clinical trial results, regulatory shifts, and innovative therapeutic approaches that are redefining patient care and drug development. Pfizer's monumental $10 billion collaboration with Innovent Biologics stands out as a testament to the shifting dynamics of the oncology sector. This partnership aims to develop 12 antibody-drug conjugate (ADC) and multispecific antibody programs, spotlighting these therapies' growing significance in oncology. The precision of antibodies in delivering cytotoxic agents directly to cancer cells offers a new frontier in minimizing collateral damage to healthy tissues—a crucial advancement in cancer treatment. The deal not only highlights Pfizer's commitment to expanding its oncology pipeline but also underscores the strategic importance of leveraging China's accelerated drug development ecosystem. In regulatory news, AstraZeneca's Imfinzi has garnered FDA approval for BCG-naive high-risk non-muscle-invasive bladder cancer. This milestone for PD-L1 inhibitors reflects the evolving landscape of immunotherapy. By harnessing monoclonal antibodies in combination therapies, the potential for enhanced anticancer efficacy is significant. With few therapeutic alternatives available, this approval presents a lifeline for many bladder cancer patients. Clinical trial outcomes also continue to capture attention. Eli Lilly's Nectin-4 targeting ADC showed promising results in advanced urothelial cancer, positioning itself as a potential competitor to Padcev. This innovation in ADC technology demonstrates the industry's relentless pursuit of targeted therapies that can revolutionize treatment paradigms. Bristol Myers Squibb's mezigdomide offers another example by showing a 52% reduction in progression risk for relapsed or refractory multiple myeloma patients, emphasizing the focus on addressing specific molecular pathways. In the realm of bispecific antibodies, Phanes Therapeutics' CLDN18.2/CD47 targeting therapy reported encouraging Phase 2 results in metastatic pancreatic ductal adenocarcinoma. These antibodies' ability to simultaneously engage multiple targets enhances their therapeutic efficacy against stubborn cancers, broadening the horizon for treatment possibilities. Meanwhile, Replimune's resubmission of its RP1 melanoma Biologics License Application (BLA) highlights the intricate dance between drug development and regulatory processes amid organizational shifts at the FDA. Such efforts reflect the continual adaptation required within the industry to navigate complex regulatory landscapes. On the funding front, Psilera's successful $8.8 million seed round indicates growing interest in psychedelic therapies for neurological conditions. Similarly, Reprogram Biosciences raised $6 million for its AI-driven cell reprogramming oncology platform, illustrating how artificial intelligence is becoming integral to advancing drug discovery and development. However, not all updates were positive. Agios Pharmaceuticals faced setbacks as their pyruvate kinase activator failed a Phase 2b trial for lower-risk myelodysplastic syndromes, serving as a sobering reminder of the inherent risks involved in drug development. Dizal Pharma emerges as a beacon of hope in lung cancer treatment following Takeda's EGFR exon 20 drug setback. By challenging existing treatments with promising small molecule data, Dizal exemplifies precision medicine's role in redefining oncology protocols—offering personalized patient options that could set new standards in treatment efficacy. The issue of drug pricing remains contentious, particularly highlighted by an AARP analysis showing an 81% increase post-launch prices stateside compared to a 13% decrease abroad. This disparity raises critical questions about achieving equitable access across markets amid Medicare negotiations and global pricing strategies like "most favored nation" policies. Regulatory updates continue with Johnson & Johnson's Tremfya label expansion stateside and AbbVie's EU extension for Venclyxto—moves that reflect efforts to maximize therapeutic reach and commercial viability across diverse geographies. Finally, Gilead Sciences' decision to discontinue its lead rheumatoid arthritis drug from MiroBio underscores ongoing challenges within emerging fields like BTLA agonists—a reminder of both innovation's promise and its perilous nature when faced with unproven therapeutic avenues. As these varied developments unfold, they collectively signal an era characterized by rapid scientific innovation and strategic collaborations across geographies alongside evolving regulatory landscapes—all driving towards enhanced patient care through more effective treatments globally. This concludes today's insights from Pharma Daily—a world where dynamic change continues reshaping healthcare delivery standards towards unprecedented possibilities for patient outcomes worldwide. Thank you for joining us; stay tuned for more updates on tomorrow's horizon-shaping advancements.Support the show

Plant a Simple Seed and Watch Your Mindset Grow with Katie Wood  What if the smallest shift in perspective could change the entire trajectory of your life? In this powerful and heartfelt episode, Carrie sits down with thought leader, educator, and bestselling author of Simple Seed, Katie Wood—fresh off her recent appearance on the Today Show—for a conversation that will stay with you long after it ends. Get ready for goosebumps as Katie shares deeply personal stories that reveal how life's hardest moments are often the very ones shaping our resilience, character, and grit. From a moving story about her daughter's stitches that beautifully mirrors how we heal and grow, to the transformational journey of a teacher who went from burnout to Teacher of the Year by using the powerful practices inside Katie's journal—this episode is packed with moments that will shift the way you see your own story. Together, Carrie and Katie explore how planting simple, intentional “seeds” of gratitude and perspective can create lasting change—not just for ourselves, but for the next generation. As a former teacher turned mission-driven entrepreneur, Katie is on a path to bring these life-changing tools into schools—teaching what many of us were never taught, but needed most. In this episode, you'll discover: Why your hardest moments may be shaping your greatest strength How a simple shift in perspective can transform your entire story The real impact of gratitude practices—inside classrooms and beyond And don't miss the unforgettable moment at the end—when Katie shares the one sentence from a college basketball coach that completely changed the course of her life. This is more than a conversation—it's a reminder that the story you're telling yourself matters… and you have the power to change it. Tune in this Monday 5/25/26 at 5am & 5pm ET to listen live on the radio https://dreamvisions7radio.com/look-for-the-good/ Hey friends, although this is my last episode airing on Dreamvisions7Radio Network, the podcast is not going anywhere! You can still listen and download your weekly episodes at your favorite podcast platform  AND if you prefer to watch it live, find all the videos here: https://carrierowan.com/look-for-the-good-podcast-carrie-rowan/ Thank you Dreamvisions7Radio for spreading the goodness across the international airwaves! Forever grateful!  xoxo Carrie BIO: Katie Wood is a thought leader, entrepreneur, and author of the bestselling journal A Simple Seed who transitioned from a 10-year career in special education teaching to entrepreneurship in 2014 to help others grow through mindset, leadership, and personal development. She speaks at schools across the country as well as organizations including Athenahealth, Takeda, Splunk, Boston College, and Providence College, and has shared stages with Herm Edwards and Matthew Slater while also being featured on Today and in Entrepreneur Magazine. Her journal, A Simple Seed, became an Amazon bestseller and was recently acquired by Penguin Random House, while Katie continues to inspire audiences through her speaking, writing, and dedication to her family as a mom of four and proud fire-wife. FIND out MORE about A Simple Seed and Katie's powerful work with kids and schools at: www.GrowwiththeGoodness.com Want to find out when the next incredible episode of Look for the Good is dropping? Sign up for the Look for the Good Podcast Chat weekly newsletter to get behind the scenes insights, special tips, and insider only offers. Click HERE to sign up today! Learn More about Carrie here: https://carrierowan.com/

Host: Rick Grobbee Guest: Kristina Haugaa Want to watch that extended interview on https://esc365.escardio.org/event/2563?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2563   Disclaimer ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Kristina Haugaa and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology This Week: A concise summary of recent studies The heart in high altitude Mitral annular disjunction Mythbusters: Weekend mortality Host: Rick Grobbee Guests: JP Carpenter, Kristina Haugaa, Silvia Ulrich Want to watch that episode? Go to: https://esc365.escardio.org/event/2563 Want to watch that extended interview on mitral annular disjonction, go to: https://esc365.escardio.org/event/2563?resource=interview   Disclaimer ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Kristina Haugaa, Nicolle Kraenkel and Silvia Ulrich have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Science Advisory Council, interview Phillip Arceneaux, PhD, on his journey with EoE and balancing his career. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:50] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:12] Holly introduces today's topic. It's May, and each year in May, there are several awareness observances for eosinophilic-associated diseases, including National Eosinophil Awareness Week, World Eosinophilic Diseases Day, and World EoE Day.   [1:29] Throughout May, APFED is sharing stories from individuals and families living with eosinophil-associated diseases to highlight the impact of these chronic conditions.   [1:38] Ryan says, Today, we'll be discussing eosinophilic esophagitis (EoE). EoE is a chronic allergic inflammatory disease of the esophagus. It occurs when eosinophils, a type of white blood cell, accumulate in the esophagus in elevated numbers, causing inflammation that can make eating or swallowing difficult or uncomfortable.   [1:56] Holly introduces today's guest, Dr. Phillip Arceneaux, a patient advocate living with EoE since 2019.   [2:18] Phil is 35. He was born and raised in Lafayette, Louisiana. He received his undergraduate degree there. He worked at the U.S. Naval Academy in Annapolis, Maryland. Then he worked at the University of Oregon.   [2:38] Phil moved to Florida and did his Ph.D. in Mass Communication at the University of Florida. Since 2020, he has been based out of the Cincinnati area, working at Miami University of Ohio.   [3:05] Phil was diagnosed with EoE in March of 2019, while finishing his degree at UF.   [3:12] Phil was eating dinner with his girlfriend. He took a bite of a roast beef sandwich, and it didn't go down smoothly, it became impacted.    [3:56] Phil thought he had food stuck in his windpipe. He was running around banging his chest. He calmed down and was able to get some of the food out, and he was breathing again.   [4:12] Phil thought he was fine. He quickly realized he wasn't. He still had a partial impaction. He didn't know what was going on in his chest. He spent about 30 minutes moving around, coughing, and trying to get his chest to feel right.   [4:44] After about an hour, Phil decided to go to the ER. His girlfriend insisted on driving him to the hospital. It was spring break, so the ER was not busy. It still took a couple of hours to be seen and treated.   [5:25] The doctors assessed him. They gave him medicine to induce vomiting. About 12 hours after the initial choking, his impaction cleared. They kept him overnight and gave him an endoscopy in the morning to check his esophagus and take biopsies.   [6:31] Phil was in the ER for four to six hours before anyone told him what they thought he had. Then the ER doctor told him he was 95% certain Phil had eosinophilic esophagitis. Phil had never heard of it.   [7:04] The ER doctor gave Phil a rundown of EoE. He said Phil would have an endoscopy, and then he would be referred to a GI and set up for treatment. The doctor said he couldn't confirm it before the endoscopy, but he thought it was EoE.   [7:31] Ryan says he's talked to people who have had months-long processes of getting their diagnosis. Phil gives all the credit to the hospital. He was fortunate that his experience was good.   [7:55] Phil says that the staff at the ER and the GI specialist were so knowledgeable about the research and where things were going in this area of medicine. They were very confident about the diagnosis and treatment plan.   [8:11] Dr. Arcenaux gives a shout-out to his GI. He spent well over an hour with him during his initial consult. He explained how EoE would impact him, from diet, grocery shopping, and challenges eating at restaurants, because of cross-contamination.   [8:42] The GI specialist talked him through impacts on dating and dining out  and how to approach social activities.   [9:09] Phil's GI specialist talked to him about employers. He would need employers with health insurance that will cover the endoscopies and treatments for EoE. Phil appreciated the initial onboarding for his EoE diagnosis.   [9:41] Ryan says he needs to discuss this with Phil, as he just finished his Ph.D. a few months ago, and he's looking at insurance for his new job, and how to figure out business lunches.   [9:51] Ryan says Ph.D. students are so motivated by free food. As someone with EoE, that never applied to him. Ryan says shifting from normal eating habits to an EoE diet is a major shift.   [10:27] Phil knows now that there were signs and symptoms, but he had no idea about them before his diagnosis.   [10:33] Phil is on a special diet for his EoE. When he's not great at avoiding his trigger foods, he starts to see dysphagia symptoms in his swallowing, and he has quite a bit of regurgitation. He had been seeing that for months before this initial major food impaction and ER visit.   [10:54] Phil had no idea what was going on. He just thought it was weird that he was regurgitating more than he used to. Sometimes food didn't go down well. Once or twice, he had a small aspiration event. He thought he needed to chew better.   [11:11] He didn't know what those symptoms meant, and he wrote them off. None of it made sense until that diagnosis. Even then, it took a while to wrap his head around it. Years removed, he sees there were so many signs and symptoms he never processed.   [11:28] Holly asks what Phil means by aspiration. He says he means water going down his windpipe, making it hard to breathe, with liquid in his lungs. Holly says that aspiration can be caused by inflammation in people who have EoE.   [12:07] Holly says people with EoE can be sent for a swallow study to look at the anatomy of their swallow function. That's a subject for another episode!   [12:35] Ryan says Phil noticed he was regurgitating more than normal and remarks that people with chronic illnesses don't realize that most people don't normally regurgitate at all. It's a sign that something's wrong.   [13:03] The ER doctor didn't offer Phil any other diagnosis than EoE. The doctor was 95% sure he had EoE, but confirmed it with an endoscopy.   [13:20] Holly asks Phil what food allergies he has. As an infant, he had an egg allergy that limited his vaccines. Now he knows his primary allergen is egg, and it led to his EoE issues.   [13:51] When Phil started his Ph.D. program, he wanted to eat healthier foods. He cut out fast food, and he ate more eggs. He consumed many eggs during his Ph.D. program. A snack was scrambled eggs or something with scrambled eggs.   [14:22] Phil went through a carton of 18 eggs in less than a week. He knew that when he was younger, he'd had egg sensitivity, but as an adult, he'd eaten eggs and nothing happened that registered as an issue. He thought he had outgrown it.   [14:40] Phil says he had outgrown other food allergies. He assumed eggs were fine, so he adopted a heavy egg diet to increase his protein intake and be healthier. Then all these symptoms manifested.   [15:00] Phil never associated the symptoms with eggs. His treatment plan is dieting and minimizing egg as much as possible. That is not easy in the United States, where everything is processed and often contains egg.   [15:19] Holly says she has seen an influx of adult-onset EoE patients with a history of a dairy or egg allergy who were putting cottage cheese and eggs in everything, and all of a sudden, started having regurgitation and food getting stuck.   [15:51] Phil doesn't eat scrambled eggs anymore. One slice of a cake with eggs in it will not send him to the ER. It takes a couple of days of high exposure to reach that point. He knows what he can have daily that will not impact him in the long term.   [16:20] Holly and Ryan agree that it's important to know your limits, and consult with your physicians about foods. Rice is a trigger for Ryan, but if brown rice syrup is about the 20th ingredient, he can have it and be fine. If he were to eat a lot of rice, he will have issues. [17:21] Phil says he recently got married, and his wife is a health nut. She has radically changed his diet. They eat very high-protein, low-fat, and low-carb. It's been easy to manage that without eggs. They eat a lot of chicken, turkey, and fish.   [17:41] Being from Louisiana, Phil says if he had to give up seafood, he doesn't know what he would do. He's a huge craft beer lover. If he had to give up gluten, he doesn't know what he would do. He can manage without eggs.   [18:21] Ryan says dairy was a big trigger for him when he was younger, but now he's on dupilumab, a biologic approved for treating EoE, and that's helped him a lot. He's started to integrate whey protein and milk protein back into his diet.   [18:47] Phil says once he finished with school, he graduated and lost health insurance. He didn't have a source of income or health insurance, so he declined to have dilation therapy. That's also why he deferred to dietary therapy. He removed his allergens one by one.   [19:12] Phil was diagnosed in 2019, not long before the pandemic hit. He lived in a bubble for two to three years and kept to a very regimented diet. That's where he started to find his balance.   [19:30] Phil travels quite a bit as a professor. He goes to international conferences. In 2022, a big annual conference opened in Paris, France. He was living his best life, but didn't register that every pastry he put in his mouth had an egg wash.   [20:14] Phil was there for seven days. On the sixth night, he was eating a tough, dry steak. He had a severe food impaction, worse than the one in 2019. He was with colleagues who didn't know what he had.   [20:40] He paid, excused himself, went to his hotel room, and tried to vomit it up. He couldn't do it. He called an Uber and went to the nearest ER. He had an emergency endoscopy. It's not easy to navigate another country's healthcare system, but he did it.   [21:14] When Phil returned from the conference, he said he needed to get serious. He had a GP, but he needed a GI specialist. Cincinnati has multiple great health systems, so he got a GI specialist and started down a path of treatment.   [21:38] He told his GI specialist, this has happened to me, and I never want it to happen again. What can we do? He started with proton pump inhibitors. No effect. He doesn't have acid reflux. Next was the topical corticosteroid, swallowed budesonide.    [22:22] Phil used a pump for asthma, but this was to swallow. After two weeks, he developed a bad case of thrush that took a long time to get rid of. He had never had thrush and didn't know what it was. It took a couple of rounds of treatment to clear up.   [22:43] After that, in 2022, he moved to dupilumab. The FDA had just approved it as a course of treatment for EoE. Phil did not do well with the treatment, and has since gone back to  back to a diet-only course of treatment.    [24:13] Phil says the dupilumab shots did help. He had been having reactions to some foods for years, and after a couple of weeks on the shot, those reactions went away, and he could eat the foods, like avocado and watermelon, again.   [24:39] The dupilumab did him some good, as he returned to some foods that he loved, but it wasn't a long-term solution for him.   [24:50] Ryan shares that he started his Ph.D. in 2019. He felt great, he had no symptoms, and he was following up with his GI every year. With no symptoms, he wasn't scoped until 2025 for insurance reasons. His scope was horrible.   [25:11] His symptoms were in remission, but his esophagus looked terrible. He had to switch up his treatment plan. Ryan advises all listeners to follow up with their GI.   [26:14] Phil says he thinks he's in a very lucky position that what his allergen is, what his dietary preferences are, and how he manifests symptoms, do not significantly impact his day-to-day.   [26:36] Phil's doctor in 2019 had advised him that EoE would impact his work and his business lunches. With the treatment plan he has opted into, it doesn't impact his day-to-day. He says he is very lucky, compared to what other patients deal with.   [26:50] It hasn't impacted his day-to-day, but the problem is, when it does impact something. It's very big, very noticeable, and it's in front of everyone. He recalls his Paris episode. He's very vocal about it. That's why he reached out to APFED.   [27:13] Phil likes talking about it. The only way we know more about it is when we talk about it and share our stories. His colleagues all know he has EoE. They don't understand exactly what it is, but when he's having trouble, they understand.   [27:44] When Phil has an issue, he doesn't tell anyone; he just gets up and walks out of the room and paces the hall, doing his stretches.   [28:09] Largely, it's just letting people know he has EoE. They recognize that he manages it himself, and he's OK.   [28:24] Phil says figuring out your medical treatment plan and balancing your quality of life is different from having a disease that can eventually be treated.   [28:51] This is something you have to deal with the rest of your life. That's going to fundamentally change things, not drastically, but in fairly subtle ways.    [29:18] No matter how comfortable you get, you have to be diligent. You always have to be cognizant of your symptoms and stay on whatever your treatment plan is, whether that's dieting or medication. This will not go away. You're always going to have it.   [29:37] Phil says you have to frame it as a lifelong marathon and find a very sustainable pace. That's where the quality of life is so important. We're human beings. We have to enjoy life. Settle in for the long haul. That's how it will be sustainable.   [30:18] Ryan thinks self-advocacy is important, whether talking with doctors, co-workers, or friends. Take care of yourself and make sure you're doing OK. Make sure you're putting yourself in a position to stay healthy, especially while balancing a career.   [30:45] Ryan says those are great things for our listeners to keep in mind.   [30:49] For our listeners who do want to learn more about eosinophilic disorders, we encourage you to visit APFED.org and check out the links in the show notes below. [30:55] If you're looking to find a specialist who treats eosinophilic disorders, we encourage you to use APFED's Specialist Finder. available at APFED.org/specialist.   [31:04] If you have personally been impacted by eosinophilic disorders and are interested in sharing your experience, please check out APFED.org/shareyourstory.   [31:12] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at APFED.org/connections.   [31:23] Ryan thanks Phil for joining us today. This was a super interesting conversation. Phil thanks Ryan and Holly for having him on. He is happy to represent on the podcast.   [31:35] Holly thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast Apfed.org apfed.org/specialist apfed.org/connections Phillip Arceneaux, PhD Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables (Edited):   "I took a bite of a roast beef sandwich, and it wasn't going down smoothly. I drank some water. The bite became an impaction. The water stayed in my esophagus, and I started to aspirate." — Phillip Arceneaux, Ph.D.   "The ER doctor told me he was 95% certain I had eosinophilic esophagitis. I had never heard of it. He gave me a quick rundown of what it was." — Phillip Arceneaux, Ph.D.   "I want to give a shout-out to my GI. He spent well over an hour in my initial consult. He explained how [EoE] would impact me, from diet, grocery shopping, and eating at restaurants, because of cross-contamination." — Phillip Arceneaux, Ph.D.   "I never associated the symptoms with eggs. My treatment plan is diet and minimizing egg as much as possible. That is not easy in the United States." — Phillip Arceneaux, Ph.D.   "This is something you have to deal with the rest of your life. That's going to fundamentally change things, not drastically, but in fairly subtle ways." — Phillip Arceneaux, Ph.D.   "No matter how comfortable you get, you have to be diligent. You always have to be cognizant of your symptoms and stay on whatever your treatment plan is, whether that's dieting or medication. This will not go away. You're always going to have it." — Phillip Arceneaux, Ph.D.   Guest Bio: Dr. Phillip Arceneaux is an Assistant Professor of Strategic Communication at Miami University in Ohio, where he teaches mass communication courses focusing on media psychology and content strategy. Phil was diagnosed with EoE in 2019 following an ER visit to UF Health Shands Hospital that required an emergency endoscopy. A Cajun French native of Lafayette, Louisiana, he earned his Ph.D. from the University of Florida and has resided in Cincinnati since 2020.  

Marco Quarta is co-founder and Chief Scientific Officer of Rubedo Life Sciences, a precision-therapeutics company developing medicines that target the pathological cell states that drive age-associated disease. Marco's first appearance on the show was three years ago, in February 2023 (Episode 35), when Rubedo was a much earlier-stage company committed to the then-contrarian premise that "the senescent cell" is not a single entity but a heterogeneous family of cell states that needs to be deconvoluted at the single-cell level. In March 2026, Rubedo reported preliminary Phase 1b/2a clinical data for its lead candidate, RLS-1496, a first-in-class topical GPX4 modulator. Marco returns to the show to discuss what survived contact with human biology.In this episode, Chris and Marco unpack the readout from Rubedo's basket trial across four skin indications — psoriasis, atopic dermatitis, actinic keratosis, and photoaged skin — and the biology that underlies it. RLS-1496 came clean on safety in all four indications, with significant efficacy signals despite small patient numbers and short (20–30 day) treatment courses. More provocatively, the clinical and translational data have pushed Marco to redefine what kind of drug this actually is. Rather than a next-generation senolytic, GPX4 modulation appears to act as a state-gating intervention: it triggers ferroptosis in deeply senescent cells that have already crossed a redox threshold, while inducing a hormetic "redox reset" in stressed-but-recoverable cells that restores them to a healthier state. Marco proposes a new category to capture this dual action — adaptive senotherapeutics, or senoadaptive drugs — distinct from senolytics and senomorphics.The conversation traces the arc from Rubedo's founding thesis to a clinically validated platform (ALEMBIC, the AI-enabled single-cell multiomics engine that surfaced GPX4 as a target), through the strategic logic of leading with skin, into the broader question every longevity-biotech founder eventually has to answer: when does a disease-by-disease franchise become a credible preventive geroscience platform? Marco lays out the GLP-1 analogy explicitly — an anchor indication and a label-expansion roadmap that could carry GPX4 modulation from dermatology into respiratory, neurodegenerative, and metabolic disease, and ultimately into the use case where biomarkers of cellular senescence flag patients for therapy decades before disease becomes clinically apparent.The Finer Details:How Marco's 2023 contrarian view — that "senescent cells" hide a tissue- and state-specific reality — has been reinforced by the clinic, and how Rubedo's framing has shifted from "targeting senescent cells" to "targeting pathological cell states"The biology of GPX4 as a lipid-peroxidation gatekeeper, why senescent cells have intrinsic vulnerabilities (p16, p21, CDK4/6 inhibition) that make them ferroptosis-sensitive, and how Rubedo's approach differs from oncology-focused GPX4 programs at Takeda and othersThe "senoadaptive" mechanism — RLS-1496 eliminates GPX4-dependent senescent cells via ferroptosis while triggering NRF2/Keap1-driven redox reset, autophagy, and epigenetic remodeling in recoverable cells, restoring tissue trajectory from degenerative to regenerativeWhy Rubedo led with skin: clean regulatory path, accessible tissue, the ability to read out aging biology anddisease in the same trial, and a label-expansion runway into systemic indicationsPhase 1b (Europe) and Phase 2a (US) basket-trial results across psoriasis, atopic dermatitis, photoaged skin, and actinic keratosis: clean safety in 4/4 indications and significant efficacy signals — itch reduction in atopic dermatitis, decreased lesional thickness in psoriasis, target-engagement-correlated clinical improvement in photoaged skinThe richness of the translational dataset: biopsies, tape-stripping, spatial transcriptomics, proteomics, multiplex histomics, plasma biomarkers — all feeding back into ALEMBIC to refine the platformWhy actinic keratosis is the most strategically important indication — an age-related, chronic-inflammatory, precancerous condition where Rubedo can simultaneously test disease modification and biological-age reversalThe Rubedo–Beiersdorf partnership and the cosmetic vertical as a parallel commercial axisPipeline beyond skin: targeting aberrant basaloid stem cells in IPF and other pulmonary indications using different modalities (prodrugs, PROTACs, ADCs) to achieve cell-state selectivityThe longer-arc vision: senescence biomarkers as a "prediabetes-style" early signal, with senoadaptive drugs deployed decades before disease — and what a GLP-1-scale franchise might look like for GPX4 modulationQuotes:"There is not such a thing as a senescent cell — like there is not a cancer cell. And that was the initial idea. I'm glad that over time the field evolved. Now this is an accepted concept in the senotherapeutic space.""We are really talking about a dual function of RLS-1496 that can modulate the cell state depending on the adaptive response. That's why we call this — de facto — a new class of senotherapeutics. We call them adaptive senotherapeutics, or senoadaptive drugs — not a senolytic or a senomorphic, but working by modulating the cell state.""The best animal model for human therapies is human. As much as you can do preclinical work in animal models, it's always an approximation. We were able to test this directly in patients for safety, and in 4 out of 4 indications, we didn't have any safety signal.""Imagine you're taking care of a growing tree, and this tree has some dead leaves and some are a little bit stressed. If you shake the tree, the dead leaves will fall; the healthy leaves will not, because they're healthy and they resist the shake. But that shake actually gives the stressed leaves space and breathing room, and helps them to regain vitality. That's a little bit what GPX4 modulation does.""Senotherapeutics is a large, growing field — an untapped therapeutic opportunity. There is no such thing as a pan-senolytic or a pan-senotherapeutic, like there is no pan-oncotherapeutic. You need to understand the context. But these will all be part of the arsenal for true longevity medicine.""I don't see this as prevention of disease. The way I see therapies like ours, and the way the field of longevity is developing, is treating diseases decades before they develop. That's not a new concept — that's what we're doing in diabetes. You can be diagnosed with prediabetes today and reverse those biomarkers with lifestyle changes or metformin, and maybe never develop diabetes. That's exactly what we're doing here.""First of all, celebrating the first approved drugs from Rubedo — I don't think we're too far from that. But that's also a beginning, because you learn from the big momentum the GLP-1 agonists created: how a drug can start in one indication, create a new field, and prove that you can go beyond that. I hope in a few years we come back and talk about the next GLP-1 — this could be GPX4 modulators, or the senoadaptive drugs that are first in our pipeline."Links:Rubedo Life Sciences: https://www.rubedolife.comMarco Quarta's previous appearance on Translating Aging: Ep 35 — Targeting Pathologic Cells to Preserve Biological Youth

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive into the latest happenings shaping the landscape of this dynamic industry. The pharmaceutical and biotech sectors are navigating a complex landscape replete with scientific advancements and regulatory challenges. A significant legal development comes from Takeda, which faces an $885 million verdict in a landmark pay-for-delay antitrust case. This ruling highlights the intense scrutiny of pharmaceutical companies over antitrust regulations, with potential implications for drug pricing strategies and industry practices. The possibility of tripling damages under these laws could set a precedent affecting future business operations, as Takeda plans to appeal, underscoring the high stakes involved in such litigation. Meanwhile, on the regulatory front, the White House's decision to include 600 generic medications in the TrumpRx purchasing portal marks a strategic effort to improve drug affordability. While its overall impact remains uncertain, this initiative aims to bridge gaps in medication accessibility for cost-sensitive populations. Similarly, Roche's licensing agreement with the Medicines Patent Pool to allow generic versions of Xofluza in 129 developing countries is a noteworthy step towards enhancing global access to essential medicines. These efforts underscore ongoing attempts to address affordability and accessibility concerns on a global scale. In clinical developments, UCB's Bimzelx has shown promising results against AbbVie's Skyrizi in treating psoriatic arthritis, demonstrating a statistically significant reduction in disease activity compared to Skyrizi in a Phase 3b trial. With nearly half of the patients showing improved outcomes at week 16, Bimzelx is poised to become a competitive therapeutic option, potentially redefining treatment protocols for psoriatic arthritis. Novartis's termination of its contract with Chinese CDMO Porton Pharma Solutions due to regulatory issues underscores the challenges inherent in cross-border pharmaceutical partnerships. The $64 million legal claims looming over this decision highlight the financial and operational risks associated with international collaborations. Meanwhile, biopharmaceutical buyers are increasingly turning to artificial intelligence and local expertise to navigate rising licensing costs in China. Sanofi and Wave Life Sciences are making progress in addressing α1-antitrypsin deficiency (AATD), a genetic disorder that has witnessed limited therapeutic innovation for decades. Their efforts were highlighted at the American Thoracic Society meeting, showcasing ongoing attempts to bridge treatment gaps for rare diseases through next-generation approaches. Strategic investments continue to shape the industry, as evidenced by Lauxera Capital Partners' successful EUR520 million fundraising aimed at advancing healthcare technologies. Additionally, Merck's agreement to supply Keytruda for Exelixis' colorectal cancer trial exemplifies collaborative efforts crucial for advancing cancer research. These developments reflect an industry balancing innovation with regulatory compliance and market dynamics. Scientific progress is also evident in Relay Therapeutics' advancement with its PI3K inhibitor, which has shown promising Phase 2 data in treating blood vessel disorders. This underscores the potential of PI3K inhibitors to address unmet medical needs by targeting pathways significant in cancer and other diseases. The integration of artificial intelligence into drug discovery processes is another critical trend. Incyte's collaboration with Edison Scientific aims to enhance decision-making and streamline drug discovery, showcasing AI's potential to revolutionize R&D efficiency. However, persistent challenges remain as AI scales up but doesn't yet resolve clinical trial protocol issues fully. On the business front, Bristol Myers Squibb considers investing $1 billion in a Houston manufacturing plant, emphasizing strategic infrastructure investments crucial for meeting growing pharmaceutical demands. In drug approvals, AstraZeneca's Baxfendy has received FDA approval for treating uncontrolled hypertension by targeting aldosterone synthesis—offering a novel approach as a combination therapy. Moreover, Merck & Co.'s sacituzumab tirumotecan has achieved Phase 3 success in endometrial cancer trials, demonstrating superior survival outcomes compared to chemotherapy. This highlights the growing impact of targeted therapies in oncology and the ongoing shift towards precision medicine. Despite these positive developments, challenges persist. BioMarin Pharmaceutical's BMN 401 faced setbacks after missing key Phase 3 endpoints for skeletal healing in ENPP1 deficiency patients—highlighting complexities in rare disease drug development. In conclusion, these diverse developments reflect an industry steadfastly committed to advancing healthcare through scientific innovation while navigating regulatory hurdles and operational challenges. As these sectors evolve further, maintaining a balance between rapid innovation and rigorous oversight remains essential to ensuring impactful treatments reach patients worldwide promptly. Thank you for tuning in to Pharma Daily—stay informed and stay ahead of industry trends with us tomorrow!Support the show

What happens when some of healthcare's most trusted workers are still operating outside the systems that document, reimburse, and scale care? In this episode, Colby Takeda, Co-Founder & CEO of Pear Suite, joins Saul Marquez live at ViVE to explore why community health workers are becoming a more essential part of the healthcare ecosystem. Drawing from his background in senior living and public health, Colby explains how Pear Suite helps community-based providers move beyond paper and spreadsheets with tools to document care, navigate credentialing and contracting, submit claims, and get paid for the value they deliver. The conversation also looks at Pear Suite's broader vision for connecting community-based organizations, health plans, and providers in a more coordinated system of care. Colby shares why AI should reduce administrative burden instead of replacing trusted relationships, how co-design with frontline workers has shaped the platform, and where he sees the biggest opportunity to make community-based care more sustainable and accessible at scale. Tune in to hear how community health workers are becoming more essential to the healthcare ecosystem, and how better infrastructure and smarter technology can make community-based care more sustainable and scalable. Resources: Connect with Colby Takeda on LinkedIn Learn more about Pear Suite Explore Pear Suite for Providers Follow Pear Suite on LinkedIn

In this episode of Bowel Sounds, hosts Dr. Temara Hajjat and Dr. Peter Lu talk to Dr. Maureen Leonard, a pediatric gastroenterologist and Associate Professor at Massachusetts General Hospital. Dr. Leonard discusses the latest research on early life factors that can increase celiac disease risk for susceptible children, including potentially modifiable risk factors. Dr. Leonard's disclosures include:  Consultant for Takeda, Chugai, Anokion, Sonoma, and Interlude Biopharma and research support from Takeda, Pfizer, Regeneron, Moderna, and Mead Johnson Nutrition.Learning objectivesUnderstand early life determinants for celiac diseaseUnderstand environmental influences on developing celiac diseaseSend us Fan MailSupport the showThis episode may be eligible for CME credit!  Once you have listened to the episode, click this link to claim your credit.  Credit is available to NASPGHAN members (if you are not a member, you should probably sign up).  And thank you to the NASPGHAN Professional Education Committee for their review!As always, the discussion, views, and recommendations in this podcast are the sole responsibility of the hosts and guests and are subject to change over time with advances in the field.Check out our merch website!Follow us on Bluesky, Twitter, Facebook and Instagram for all the latest news and upcoming episodes.Click here to support the show.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of transformative events shaping the industry landscape, from scientific breakthroughs to regulatory shifts and strategic realignments. Eisai's progress with its Alzheimer's treatment, Leqembi, marks a significant milestone in addressing one of the most challenging neurological disorders. With a sales forecast of $900 million, this development underscores the growing demand for effective Alzheimer's treatments. Eisai's partnership with Biogen plays a crucial role in this context, aiming to provide a solution to a disease that has long eluded effective therapeutic intervention. This collaboration highlights the intricate interplay between scientific innovation and strategic alliances in tackling complex health challenges. Biogen's recent data on Alzheimer's disease advances our understanding of neurodegenerative disorders by reinforcing the tau hypothesis alongside longstanding amyloid-beta research. This insight opens new avenues for therapeutic interventions targeting tau proteins—a potentially pivotal shift given prior limited success with amyloid-centric approaches. Denali Therapeutics may benefit from this paradigm shift thanks to its proprietary technology that enhances central nervous system drug delivery—a crucial factor for effective tau-targeting therapies. Concurrently, organizational restructuring at Novartis reflects broader industry trends. As companies increasingly focus on optimizing operations and honing in on core therapeutic areas, Novartis's strategy to streamline its biomedical research arm could potentially impact innovation timelines and resource allocation. This move is indicative of a wider industry shift aimed at enhancing research efficiency and maintaining competitive edges in a rapidly evolving market. Regulatory updates continue to be pivotal, as seen with the U.S. Supreme Court's decision to temporarily restore telehealth access to the abortion pill mifepristone. This ruling not only underscores the intersection between healthcare access and legal frameworks but also highlights potential implications for patient accessibility to medications across the U.S. Meanwhile, AstraZeneca's Imfinzi received swift regulatory endorsement from NICE for perioperative use in stomach cancer just 17 days post UK approval. Such rapid endorsements are crucial in expanding treatment options and improving patient outcomes, particularly in oncology where timely interventions can be life-saving. In market dynamics, Novo Nordisk's Wegovy pill has experienced its first decline in total prescriptions, as tracked by Fierce Pharma through their new oral GLP-1 tracker. This development suggests shifting preferences among clinicians and patients within the competitive landscape of weight management therapies. It points to an environment where continuous innovation and adaptation are necessary to maintain market presence. Biopharmaceutical pipelines are increasingly dominated by biologics, presenting both opportunities and challenges. A report highlights manufacturing complexities that pose hurdles for new product launches, emphasizing the industry's shift from small molecules to biologically-derived therapies. As demand grows, advancements in manufacturing technologies and processes become essential to meeting these needs effectively. Aardvark Therapeutics' decision to unblind its phase 3 Prader-Willi syndrome study data following an FDA-imposed hold illustrates the regulatory hurdles that can occur during drug development. These holds often delay critical data analyses but also present opportunities for reevaluating trial strategies, ensuring that patient safety remains paramount. Aardvark Therapeutics faces regulatory challenges as its Prader-Willi syndrome trials encounter an FDA-imposed hold due to cardiac safety concerns. These developments highlight both scientific promise and the stringent safety standards essential within drug development processes. Technological innovation is reshaping drug discovery efforts through targeted protein degradation—a method allowing researchers to address previously "undruggable" targets. This approach signifies a potential revolution in developing novel therapeutic modalities across various diseases, highlighting the industry's capacity for groundbreaking advancements. On the policy front, bipartisan lawmakers have reintroduced legislation aimed at preventing pharmacy benefit managers from owning retail pharmacies. This legislation seeks to address conflicts of interest that could impact drug pricing and access, underscoring the ongoing scrutiny on practices affecting healthcare costs. In oncology, Genmab's recalibration of its antibody-drug conjugate pipeline signals competitive pressures within this innovative space where differentiation is key to maintaining market leadership. Similarly, Create Medicines' entry into CAR T-cell therapies—backed by substantial funding—reflects ongoing investment in breakthrough cancer treatments while balancing immediate clinical opportunities with strategic long-term goals. Amidst these transformative developments are broader industry trends involving employment shifts and funding dynamics. Despite workforce reductions like those at Takeda as part of its transformation strategy, there remains strong momentum within sectors such as California's vibrant biotech scene—illustrating resilience amid economic pressures. These stories exemplify an industry characterized by transformation driven by scientific insights into disease mechanisms coupled with regulatory vigilance ensuring patient safety remains paramount throughout all stages—from discovery through commercialization—ultimately striving towards improved patient care outcomes addressing various unmet medical needs worldwide.Support the show

This episode covers: Cardiology This Week: A concise summary of recent studies Biomarkers in heart failure Digoxin in HFrEF Scientific Highlights from Heart Failure 2026 Host: Wilfried Mullens Guests: Lynne Stevenson, Dirk van Veldhuisen, Theresa McDonagh Want to watch that episode? Go to: https://esc365.escardio.org/event/2565 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. A ny views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel, Dirk van Veldhuisen and Lynne Warner Stevenson have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report:Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi.  Theresa McDonagh has declared to have potential conflicts of interest to report: honoraria from Boeringer Ingelheim. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into the dynamic shifts and breakthroughs shaping this ever-evolving industry. In a significant regulatory update, the resignation of FDA Commissioner Marty Makary has stirred discussions across the pharmaceutical landscape. Over his 13-month tenure, Makary faced considerable scrutiny for his controversial decisions, including the rejection of several rare disease drugs. This leadership change at the FDA may herald a period of uncertainty as the agency searches for new direction amidst criticisms and operational challenges. The implications are vast, potentially affecting drug approval processes and public health policies, making it crucial for stakeholders to watch closely how the agency adapts to this transition. Simultaneously, Takeda's announcement to lay off 4,500 employees marks a strategic move to streamline operations and focus on core competencies. This decision reflects a broader industry trend where companies are optimizing their structures to enhance financial health in a highly competitive market. The cost savings from this restructuring are expected to be substantial, allowing Takeda to pivot towards more sustainable business models and focus on areas that promise future growth. Eli Lilly and Novo Nordisk continue to lead in drug development with their GLP-1 receptor agonists. Both companies have reported promising data on early response and long-term weight loss maintenance in patients, positioning their therapies as pivotal in treating obesity. Eli Lilly's obesity treatments Foundayo (orforglipron) and Zepbound (tirzepatide) have shown sustained weight-loss maintenance in Phase 3 trials, reinforcing their efficacy in metabolic health interventions. These developments not only highlight the intense competition in the GLP-1 space but also underscore the potential impact on addressing global obesity challenges effectively. The strategic landscape of mergers and acquisitions is also evolving with Merck KGaA's announcement to bolster its pipeline through strategic M&A activities. This move is emblematic of an industry-wide strategy where companies seek external innovation to fill pipeline gaps, ensuring sustained growth and competitiveness. In a related vein, BioMarin's $4.8 billion acquisition of Amicus Therapeutics signifies a firm commitment to addressing unmet needs in rare diseases, illustrating how consolidation can enhance capabilities in niche markets with significant potential. In vaccine development, Valneva's decision to reduce its workforce by up to 15% highlights ongoing challenges in the sector, particularly for travel-related vaccines affected by global market trends. This restructuring is indicative of the volatility faced by companies as they adapt strategies for long-term sustainability amidst shifting consumer behaviors. Pfizer's expansion into Europe with its hemophilia treatment Hympavzi marks a critical regulatory milestone, broadening its market presence and offering expanded therapeutic options for patients. This approval not only strengthens Pfizer's foothold in the hemophilia market but also exemplifies the global reach of innovative treatments. Technological integration continues to revolutionize R&D processes, as evidenced by AstraZeneca's licensing agreement with Owkin for AI capabilities. This partnership aims to harness AI-driven insights for drug discovery, showcasing how technology is reshaping traditional research methodologies and enhancing efficiency. Similarly, advancements in AI-powered diagnostics are evidenced by Boehringer Ingelheim's collaboration with Brainomix in pulmonary fibrosis imaging, reflecting broader trends towards personalized medicine through precise disease characterization. Kyverna Therapeutics is advancing in cell therapy with Support the show

Host: Wilfried Mullens Guest: Marc Dweck Want to watch that extended interview on https://esc365.escardio.org/event/2564?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2564   Disclaimer ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Antonio Greco and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Marc Dweck has declared to have potential conflicts of interest to report: consultancy fees from Novartis, Silence, and AstraZeneca related to aortic stenosis and development of a medical therapy. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology This Week: A concise summary of recent studies Genetics and genetic testing in HCM Asymptomatic aortic valve stenosis Statistics Made Easy: Mediation analysis Host: Wilfried Mullens Guests: JP Carpenter, Caroline Coats, Marc Dweck Want to watch that episode? Go to: https://esc365.escardio.org/event/2564 Want to watch that extended interview on asymptomatic aortic valve stenosis, go to: https://esc365.escardio.org/event/2564?resource=interview   Disclaimer  ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails.  ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.    Declarations of interests Stephan Achenbach, Yasmina Bououdina, Antonio Greco and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Caroline Coats has declared to have potential conflicts of interest to report: in the last 5 years, consultant/advisor to Bayer, Bristol Myers Squibb, Cytokinetics, Sanofi, Roche Diagnostics. Marc Dweck has declared to have potential conflicts of interest to report: consultancy fees from Novartis, Silence, and AstraZeneca related to aortic stenosis and development of a medical therapy. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Send us Fan MailIt's a rare piece of good news. A single-dose dengue vaccine developed in Brazil as part of an international collaboration protected people against at least two strains of the virus for five years or longer, and did so safely. The vaccine was already being tested across Brazil and the findings helped boost confidence in its use. “This is a big deal,” says Dr. Andre Siqueira, Head of the Dengue Global Program at the Drugs for Neglected Diseases Initiative (DNDI).  Dr. Siqueira, who is also an Infectious Diseases Consultant at Brazil's Instituto Nacional de Infectologia Evandro Chagas, a hospital that is part of the Oswaldo Cruz Foundation (Fiocruz), helped develop the vaccine. He chatted with One World, One Health about the work in 2024. The new vaccine worked almost perfectly to keep people from being hospitalized with severe dengue symptoms, Dr. Siqueira and the team reported in Nature Medicine.  That's a big deal. Dengue can cause terrible symptoms, including severe abdominal pain, internal bleeding, severe muscle aches, and long term fatigue. From January 2025 to January 2026, dengue killed more than 4,000 people. The only other dengue vaccines currently available are a two-dose formula made by Japanese manufacturer Takeda and Sanofi's Dengvaxia, which the company is discontinuing because of a lack of demand. In this episode, Siqueira updates host Maggie Fox about the latest findings on the new vaccine's efficacy and its rollout in Brazil. 

Does it fee like food gets stuck when you swallow? Or like swallowing takes more effort than it should?  These symptoms are often dismissed—but they may be signs of Eosinophilic Esophagitis (EoE), a condition that frequently goes undiagnosed for years. In this episode of Gastro Girl, Jacqueline Gaulin sits down with Dr. Neil D. Parikh to break down what these symptoms really mean—and when it's time to take action.  In this episode: Why food may feel like it's getting stuck The difference between reflux and something more Early warning signs many people overlook When swallowing problems need medical evaluation How EoE is diagnosed and why timing matters If you've ever adjusted how you eat, avoided certain foods, or felt like swallowing just isn't right—this episode will help you connect the dots. Produced by Gastro Girl, a trusted digestive health education platform and official patient education partner of the American College of Gastroenterology. This educational initiative was developed with support from Takeda.