Podcasts about Takeda

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.

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

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

Send us Fan MailFor decades, scientists have searched for better cancer drugs. But what if the biggest challenge isn't discovering the drug - it's getting it to the tumor? My guest today is developing programmable viruses designed to travel throughout the body, selectively amplify inside metastatic lesions, and transform tumors into factories for their own destruction.Dr. Eric Poma, Ph.D. is Chief Executive Officer of Calidi Biotherapeutics ( https://www.calidibio.com/ ), a biotechnology company developing targeted genetic medicines designed to deliver therapeutic payloads directly to tumors throughout the body.Dr. Poma brings more than three decades of experience across biotechnology, oncology drug development, business development, and capital markets. Prior to joining Calidi in 2025, he served as CEO of Molecular Templates, where he helped raise more than $250 million in equity financing and secured strategic partnerships with companies including Takeda, Vertex, and Bristol Myers Squibb.Earlier in his career, Dr. Poma held leadership roles at ImClone Systems during the rise of targeted cancer therapies, served as Vice President of Business Development at Innovive Pharmaceuticals, and worked as a healthcare and biotechnology analyst. He holds a Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill and an MBA from NYU's Stern School of Business.Today we will discuss one of the most difficult challenges in oncology - how to successfully deliver powerful therapies to metastatic tumors throughout the body - and how Calidi's RedTail platform aims to use engineered oncolytic viruses as targeted delivery vehicles capable of reaching cancer cells, modifying the tumor microenvironment, and potentially enabling a new generation of genetic medicines.#CancerResearch #Oncology #Immunotherapy #GeneTherapy #Biotechnology #CancerTreatment #PrecisionMedicine #OncolyticVirus #CancerScience #BiotechInnovation #MetastaticCancer #IL15 #VacciniaVirus #GeneticMedicine #SyntheticBiology #TumorMicroenvironment #FutureOfMedicine #DrugDelivery #Biopharma #EricPoma #CalidiBiotherapeutics #CancerBreakthrough #MedicalInnovation #LifeSciences #ProgressPotentialPossibilitiesSupport the show

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.

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.

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.

In deze podcast spreekt prof. dr. ir. Koos van der Hoeven met internist-oncoloog dr. Myriam Chalabi van het Antoni van Leeuwenhoek, Amsterdam. Jongstleden april ontving zij de prestigieuze ‘Innovators in Science Award' 2026 van Takeda en Nature voor haar innovatieve onderzoek naar neoadjuvante immunotherapie bij patiënten met colorectaal carcinoom en een mismatch repair deficiëntie. In de podcast bespreken zij waarom Chalabi de prijs kreeg, wat deze prijs inhoudt en wat ze ermee gaat doen. Daarnaast wordt uitgebreid ingegaan op het onderzoek van haar groep naar de rol van immunotherapie bij mismatch repair deficiënte en proviciënte colorectale carcinomen. Tot slot wordt teruggeblikt op Chalabi's wetenschappelijke co-voorzitterschap bij het ESMO Congres in 2025.

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

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 Dr. Chukwuemeka Oko, MD, MBA, on clinical trials. 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 GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:13] Holly introduces today's topic — clinical trials — and today's guest, Dr. Chukwuemeka Oko, a Clinical Research and Medical Affairs Professional supporting Duke University Hospital's Department of Gastroenterology and Transplant Hepatology.   [1:33] Dr. Oko explains that he is sharing general, educational information from his perspective and experience, not speaking on behalf of Duke University, nor any industry sponsor, nor any company he has worked for.   [1:50] Dr. Oko's goal today is to help the listeners feel clearer, more confident, and more in control when they are thinking about clinical research.   [2:29] Dr. Oko's work sits mainly at the intersection of clinical research and medical affairs. He helps translate evolving science into practical, patient-centered decisions.   [2:40] From an academic standpoint, he supports clinical trials and evidence generation from feasibility through education.   [2:49] Dr. Oko also engages investigators and thought leaders from industry sponsors in scientific exchanges that lead to insights, study design, and real-world care pathways.   [3:03] Dr. Oko had two reasons to study eosinophilic esophagitis and eosinophilic disease. The first is the patient journey and biology.   [3:11] On the patient side, many people spend a long time seeking answers. Sometimes they feel dismissed before they get a clear diagnosis and a plan that fits their life.   [3:24] On the biology side, eosinophilic disease teaches us a lot about how our immune signals can drive information differently across tissues like the esophagus and airways.   [3:40] Dr. Oko supported an EoE study experience with an industry sponsor in the past. The best research doesn't just test; it helps patients and clinicians make clearer decisions.   [4:12] Dr. Oko explains that a clinical trial is a carefully designed, carefully crafted study in people that answers specific medical questions, most often about safety, effectiveness, or dosing of the study drug or how a treatment should be used.   [4:32] A key structure of a study is a written protocol where safety monitoring is in place, and the defined outcome or results are very reliable. The FDA always oversees clinical trials in the U.S.    [4:44] Dr. Oko often describes a trial as a highly-monitored learning system. It's how medicine moves from "We think this might help" to "We know what helps, for whom, and also at what risk."   [5:09] Dr. Oko says clinical trials usually study what improves patient outcomes, for whom, and at what risk, using methods that we can trust. Trials may evaluate new medicines, devices, dosage strategies, or even procedures.   [5:31] Clinical trials can also study non-drug approaches such as diet interventions, symptom tracking, monitoring tools, and education strategies.   [5:44] Many trials have also included biomarkers, or signals in the blood or tissue, helping to support an EoE diagnosis so that the patients can get treated in an early and effective manner.   [6:36] Dr. Oko says patients sometimes ask him if they are guinea pigs. In reality, trials are heavily regulated and closely monitored, with strict safety reporting requirements. Participants are not guinea pigs.   [7:06] Dr. Oko also hears patients ask if they are "stuck" once they join the clinical trial. No, a trial is a completely voluntary participation, and they can withdraw at any time.   [7:25] Other patients ask if trials are only for people who are out of options. Many trials are designed for earlier stages, especially when the goal is to prevent complications or reduce steroid exposure.   [7:46] The last question Dr. Oko hears a lot is "Will I be in the placebo group?" He says it's an understandable fear. They are asking if they will go untreated in the placebo group.   [8:29] In many trials, a placebo is not the same as "no care". Often, the participants continue the standard-of-care treatment, and the study drug or placebo is added to the standard-of-care treatment.   [8:45] Trials typically involve symptom monitoring and a plan for what happens if the symptoms worsen. There are exit criteria.   [9:01] From the pharmaceutical side, it's the end of treatment once you decide to voluntarily exit the study.   [9:10] Dr. Oko's advice is, if you participate, ask the study team physicians to explain in plain language what you'll receive, what you can continue, and what happens if you flare up. Clear answers are always a part of ethical research.   [10:33] Holly asks what it means to participate in a Phase 1, Phase 2, or Phase 3 trial. Dr. Oko says a Phase 1 trial is focused mostly on the safety and the dosing regimen. It's usually a small group of five to 100 or so.   [10:52] A Phase 2 trial always looks for the drug's effectiveness and continues monitoring safety. It's usually a group of 100 to 300 subjects. They look for meaningful signals of the outcomes derived from the trial.   [11:10] A Phase 3 trial is usually large. It's multi-centered. It's called a complementary study. It involves thousands of patients. It can even be across nations and states.   [11:26] This is where they compare new interventions against a placebo or against a standard of treatment to provide clinical benefits and support for regulatory approval.    [12:03] Participating in any phase of a trial includes fitting the eligibility criteria of inclusion for that particular phase. If you are a good match, you can be in either a Phase 1, Phase 2, or Phase 3 trial.   [12:52] Holly says she knows that a lot of people with EoE or EGIDs are very curious about trials and how to participate in them.   [13:00] Ryan says we have a very active patient community, and everyone's looking for ways to get involved in research and new diagnostics or medications to improve their own outcomes and help everyone else.   [13:35] Dr. Oko says the benefits of participating in a clinical trial include access to potentially disease-modifying therapies years before they reach the market.   [13:47] Another benefit is extraordinarily close medical monitoring. When you're in a clinical trial, you have more frequent visits and more frequent labs than usual.   [14:01] Endoscopies are out of the normal standard of care, but will be more frequent than normal to analyze the efficacy of the study drug.   [14:11] Dr. Oko says one of the risks is the unknown side effects the study drug comes with, because we are still understanding the biology.   [14:21] The time commitment for visits can be more than typical for a patient, especially if there is a long travel time involved. Patients may arrive at 7:00 or 8:00 a.m. They may need to find a place to live nearby, depending on the pace of the trial.   [14:57] Holly lives in Maine, and a lot of the trials are in Boston. It's a lot of travel. For people with any kind of chronic illness, all we think about is money. Holly asks if people pay to be part of a clinical trial.   [15:25] Dr. Oko states that the patients do not have to pay anything to be part of a clinical trial. Patients do get compensated by the trial sponsor for travel, accommodation, parking, and a meal for the days they are onsite.   [16:33] Dr. Oko says that patients tend to bring up insurance. It is a misconception that the study will pay for their standard-of-care medication during the study. Patients need to ask the study team what insurance will pay for and what the study will pay for.   [16:59] Dr. Oko says the insurance usually covers the regular standard-of-treatment, but any other additional treatment, procedures, and visits are all covered by the study sponsor.    [17:29] The study sponsor may ask for an endoscopy to be done six months before the study to determine eligibility for the study. If it is done within a year, the study sponsor will determine if you are qualified. That is part of the eligibility criteria in some cases.   [18:26] Dr. Oko tells patients to always ask questions, like what the schedule of events is in the clinical trial.   [18:35] The schedule of events tells you how many visits are required for you to be part of this study. They will list the activities to be done. They will list the labs you will need at what week. They will list when you need endoscopies, at week one and later.   [19:05] If you exit from the study, if you don't want to participate anymore, you are still required to come on site just to make sure that you are in good shape. Those are called formal visits.   [10:29] Dr. Oko explains that formal visits are necessary for the patient's safety and to make sure that the data points collected in the study will be effective.   [20:01] Patients enrolling in a clinical trial can also ask about the known risks of the symptom monitoring plan. They can ask what is covered and what is not covered by insurance, and what will be considered out of pocket.   [20:20] If patients are in the placebo group, what will happen if symptoms worsen? In the protocol, there is always a rescue plan. If a symptom flares up, the Principal Investigator carries out the rescue plan.   [20:58] The study team is available on a 24/7 hotline. The questions you ask are very important. No question is too small to ask. Every question and every symptom you report is important. You can withdraw at any time, and there is always a follow-up.   [22:19] Dr. Oko says the trial data that has already been collected from part of our eosinophilic studies has led to various FDA approvals of the biologics. We are working  to try to transform EoE from a steroid-dependent or diet-only disease into a position of long-term control.   [22:37] Trial findings have shaped care, expanding evidence-based options, clarifying which patients benefit the most, and improving how we measure our outcomes, the symptoms, and quality of life, as measured by patients' quality-of-life surveys.   [23:06] Quality-of-life surveys are very important for the study team. They help to measure safety, too. The evidence generated from this data leads to insights and improves study design, protocol design, and ultimately, improves patient care.   [23:40] Ryan says the community is interested in clinical trials because they benefit patients, researchers, and clinicians. We're thankful for the clinicians and researchers putting in all the work to make these clinical trials happen.   [24:01] Ryan adds, we're also thankful for the patients who are interested in these trials. For patients who are looking to participate, how can they find clinical trials to participate in and join?   [24:15] Dr. Oko says people can find the website ClinicalTrials.gov. It's an important tool in looking for various clinical research. Scientists are recruiting at a given time. You can use the Advanced Search option to narrow the search by state and criteria.   [24:54] You can always discuss clinical trials with your primary care physicians. You can look for major academic medical centers. Most of them always have clinical research studies going on.   [25:07] Dr. Oko says APFED.org is a very good tool. It always maintains up-to-date trial listings and patient-friendly summaries where patients can read about the studies.   [25:30] Ryan says he's very appreciative of the mention of APFED. There is a link on APFED.org so people can find studies. There are clinical trials listed that people can research more and join.   [25:46] Holly asks Dr. Oko to share advice for listeners who are considering participating in a clinical trial. He shares, "I want each one of you to approach the decision with the same care you would with any major medical choice. Review the Informed Consent Form (ICF)."   [26:23] "The word informed means you should be informed. It's your right to get informed with every line, every detail. The Consent Form can be 30 pages long, but please just know that you are not in a rush to answer."   [26:43] "You can take the Consent Form and discuss it with your friends, your family, your primary care physician, your gastroenterologist, and your allergist and get more information."   [27:00] "When you join an interventional trial, or a registry, your contribution accelerates the science and benefits the entire eosinophilic community."   [27:12] "From my years of reviewing medical charts and supporting new recruitments, I feel patients feel most satisfied when they are fully informed and genuinely partnered with the study team. That's how I partner with the patients. I am always there to help."    [27:40] Ryan says that is great advice for patients, and hopefully, some of our listeners to this episode will go out there and look for clinical trials to participate in or ask their physicians, next time they're getting care.   [27:52] For patients who would like to know more about eosinophilic disorders, we encourage you to visit APFED.org and check out the links in the show notes below, specifically to research opportunities listed on APFED.org. [28:08] If you've been personally impacted by eosinophilic disorders and are interested in sharing your experiences, we encourage you to please check out APFED.org/shareyourstory.   [28:17] Ryan thanks Dr.Oko for joining us today. This was really helpful and insightful, and hopefully, we'll have many new patients interested in joining clinical trials. Dr. Oko thanks Ryan and Holly for having him on and thanks every listener who has joined us.   [28:33] Dr. Oko says it has been a genuine pleasure and privilege for him. He has spent years seeing patients, reviewing their charts, and hearing their stories. We see you, we hear you. Science is advancing rapidly and shaping outcomes. You are not alone.   [30:17] Holly thanks Dr. Oko for his research and clinical trials, and 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 apfed.org/research/clinical-trials Duke University Hospital's Department of Gastroenterology Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "Many people spend a long time seeking answers. Sometimes they feel dismissed before they get a clear diagnosis and a plan that fits their life." — Chukwuemeka Oko, MD, MBA   "On the biology side, eosinophilic disease teaches us a lot about how our immune signals can drive information differently across tissues like the esophagus and airways." — Chukwuemeka Oko, MD, MBA   "In many trials, a placebo is not the same as no care. Often, the participants continue the standard-of-care treatment, and the study drug or placebo is added to the standard-of-care treatment." — Chukwuemeka Oko, MD, MBA   "I tell patients to always ask questions, like what the schedule of events is in the clinical trial." — Chukwuemeka Oko, MD, MBA   "[If a patient exits the study], formal visits are necessary for the patient's safety and to make sure that the data points collected in the study will be effective." — Chukwuemeka Oko, MD, MBA   "From my years of reviewing medical charts and supporting new recruitments, I feel patients feel most satisfied when they are fully informed and genuinely partnered with the study team." — Chukwuemeka Oko, MD, MBA   Guest Bio: Chukwuemeka Oko, MD, MBA

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. 

This episode covers: Cardiology This Week: A concise summary of recent studies Time for physiological pacing in heart failure? Same-day discharge after EP procedures: from evidence to practice EHRA 2026 Scientific Highlights Host: Gerd Hindricks Guests: Haran Burri, Emma Svennberg, Julia Vogler Want to watch that episode? Go to: https://esc365.escardio.org/event/2555    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 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. Haran Burri has declared to have potential conflicts of interest to report: institutional research and fellowship support or speaker honoraria from Abbott, Biotronik, Boston Scientific, Medtronic, Microport. 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 honorary from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Gerd Hindricks has declared to have potential conflicts of interest to report: institutional research and fellowship support or speaker honoraria from Abbott, Biotronik, Boston Scientific, Medtronic, Microport. 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. Helmut Puererfellner has declared to have potential conflicts of interest to report: speaker fees, honoraria, consultancy, advisory board fees, investigator, committee member, etc., including travel funding related to these activities for the following companies: Abbott, Biotronik, Biosense Webster, Boston Scientific, Daiichi Sankyo, Medtronic. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson. Julia Vogler has declared to have potential conflicts of interest to report: honoraria for talks: Abbott.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most intriguing advancements and strategic moves shaping the future of drug development and patient care. Regeneron has recently ventured into the radiopharmaceuticals market through a substantial $2.1 billion agreement with Australia's Telix Pharmaceuticals. This move marks a significant diversification from Regeneron's traditional focus, such as obesity treatments, to an area that combines radioactive isotopes with targeting molecules for diagnosing and treating diseases like cancer more effectively. The strategic alliance positions Regeneron as a formidable player in this emerging field, promising to expand its therapeutic portfolio and revenue streams. In oncology innovation, GSK is pushing forward with a bold initiative, conducting Phase 3 trials for antibody-drug conjugates (ADCs) in collaboration with Hansoh Pharmaceutical. This effort underscores GSK's commitment to expanding its oncology pipeline, particularly in targeting unmet medical needs through innovative therapies. Antibody-drug conjugates are designed to deliver cytotoxic agents directly to cancer cells, minimizing damage to healthy tissues and offering a precision approach to cancer treatment. Allogeneic CAR-T therapies are also making waves, with Allogene Therapeutics reporting promising early data from their off-the-shelf CAR-T therapy, cema-cel. This therapy effectively eradicated minimal residual disease in lymphoma patients, highlighting the potential of allogeneic approaches to provide accessible cancer treatments without the logistical complexities of autologous methods. In another significant milestone, Ideaya Biosciences, in collaboration with Servier, achieved success with their eye cancer drug candidate meeting its primary endpoint in a crucial Phase 2/3 trial. This success sets the stage for an accelerated FDA approval filing, offering new hope for patients dealing with this challenging condition. Revolution Medicines has made notable progress in oncology as well, with its highly anticipated RAS inhibitor demonstrating improved survival outcomes in a Phase 3 trial for pancreatic cancer. Extending survival by an average of six months compared to chemotherapy could redefine treatment paradigms for one of the most aggressive cancer types. Not every development has been favorable, however. Replimune faced its second FDA rejection for its melanoma candidate RP1, leading to workforce reductions—a testament to the rigorous nature of regulatory approvals and the challenges companies face when bringing novel therapies to market. Meanwhile, BioNTech and Synox Therapeutics are advancing towards FDA approval for their tumor-targeting therapies. These efforts could intensify competition within the oncology space, challenging established giants like AstraZeneca and Daiichi Sankyo. In pain management, AbbVie has expanded its portfolio through a $745 million deal with Haisco Pharmaceutical Group for two non-opioid pain treatment candidates. This move aligns with growing demand for non-opioid alternatives amid the opioid crisis, reflecting a strategic shift towards safer pain management solutions. Spyre Therapeutics has also reported positive Phase 2 results for its ulcerative colitis drug, setting it up as a potential competitor against Takeda's Entyvio. Success here could enhance therapeutic options for patients struggling with this chronic condition, highlighting continued innovation in gastrointestinal disorders. Eli Lilly's recent success with its BTK inhibitor Jaypirca marks a pivotal moment in chronic lymphocytic leukemia (CLL) treatment strategies. Having demonstrated substantial efficacy in a Phase 3 clinical trial—the fourth positive readout—Jaypirca establishes itself as an industry first. Its fixed-duratioSupport the show

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.  

This Biotech CEO Created The RedTail Platform To Fight Cancer. Guest:Eric PomaCEO of Calidi Bio CLDI Company Name:Calidi BiotherapeuticsWebsite: https://www.calidibio.com/Ticker: NYSE: CLDIEric's Bio:Eric Poma, Ph.D. has served as Chief Executive Officer and board director of Calidi since April 2025 and brings more than 30 years of experience in the biopharmaceutical industry, with a strong record of capital fundraising, big pharma collaboration agreements, and clinical program development.Prior to joining Calidi, Dr. Poma served as CEO of Molecular Templates (NASDAQ: MTEM), a clinical-stage biotech focused on the development of a novel class of therapeutic agents with unique biology in oncology. At Molecular Templates he raised over $250 million in equity financing and secured over $150 million in strategic capital through agreements with Takeda, Vertex and BMS. He previously served as Vice President, Business Development of Innovive Pharmaceuticals. Prior to that he held various senior level positions at Imclone Systems, Inc., primarily in business development. Earlier, Dr. Poma served as a Healthcare & Biotechnology Analyst with the healthcare fund Eagle Growth Investors, LLC.Dr. Poma received a Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill, an M.B.A. from the Leonard N. Stern School of Business and a Bachelor of Science in Biology from the University of North Carolina at Chapel Hill.Company Bio:Calidi Biotherapeutics is a biotechnology company pioneering the development of targeted genetic medicines for cancer and other diseases through its RedTail platform. The company's lead compound, CLD-401, is a systemically delivered oncolytic virus that expresses high levels of IL-15 superagonist only in the tumor microenvironment. The company expects to file an IND to initiate clinical studies for CLD-401 by the end of 2026. The company continues to advance what the RedTail platform can achieve and will be presenting additional data throughout the year.

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 challenges shaping these dynamic sectors. AstraZeneca has reported promising results with an immunotherapy combination involving Imfinzi (durvalumab) and Imjudo (tremelimumab) for treating locoregional liver cancer. This combination has demonstrated a significant progression-free survival benefit, potentially setting a new standard in liver cancer treatment. The success of this regimen highlights the critical role of immunotherapies in oncology, offering new hope for patients with cancers that have been historically difficult to treat. Turning to regulatory news, Eli Lilly's new GLP-1 receptor agonist pill, Foundayo, has received FDA approval. This marks a significant milestone as it's the first new molecular entity approved under the FDA's National Priority Voucher Program. Foundayo's approval intensifies the competition in the obesity treatment market, challenging Novo Nordisk's established position with Wegovy. Analysts forecast a major rollout for Foundayo, predicting over 5 million prescriptions by 2026. This advancement underscores the increasing focus on addressing obesity, a critical global health challenge. In geopolitical news, former U.S. President Donald Trump is reportedly considering imposing a 100% tariff on certain pharmaceutical imports from non-Most Favored Nation countries. Such a policy could significantly impact international pharmaceutical trade and supply chains, forcing companies to reevaluate their global manufacturing and distribution strategies. In vaccine development news, a Belgian court has ordered Poland and Romania to pay Pfizer $2.2 billion over contested COVID-19 vaccine doses, underscoring the complexities of international vaccine agreements and their financial ramifications during the pandemic. Conversely, Pfizer and BioNTech have halted their US Phase 3 trial for the Comirnaty COVID-19 vaccine due to recruitment challenges. This reflects ongoing difficulties in maintaining participant engagement for booster studies post-pandemic. On the clinical trial front, Valneva's Lyme disease vaccine program with Pfizer remains a topic of interest despite missing its primary endpoint in Phase 3 trials. Valneva's CEO remains optimistic about its regulatory future, framing it as a matter of negotiation. This situation highlights the intricate nature of clinical trial outcomes and regulatory negotiations. Meanwhile, Gilead Sciences has faced setbacks with its HIV drug pipeline due to an ongoing FDA clinical hold on a mid-stage trial. This incident underscores the challenges companies encounter while navigating regulatory hurdles to ensure drug safety. In other industry trends, there's an increased reliance on pharmacovigilance outsourcing to enhance efficiency within pharmaceutical companies. This allows firms to concentrate more on core activities impacting patient care and drug innovation directly. The industry also saw exciting advancements in radioligand therapy, which holds promise for targeting up to 80% of cancers with precision therapies. Such developments illustrate how understanding biological pathways can lead to significant breakthroughs in cancer treatment paradigms. In business developments, Axsome Therapeutics has partnered with Takeda for Balipodect, a schizophrenia asset involving undisclosed payments. This partnership highlights the trend towards strategic collaborations in neurological disorders aimed at fostering therapeutic innovation. Furthermore, Zai Lab and Amgen are collaborating on a global Phase 1b trial focusing on small cell lung cancer using antibody-drug conjugates and bispecific T-cell engagers. This research emphasizes growing interest in precision oncology treatments offering targeted therapeutic oSupport the show

This episode covers: Cardiology this Week: A concise summary of recent studies What's new in hypertension? Why I favour a critical approach in cardiology Snapshots Host: Sabiha Gati Guests: Konstantinos Koskinas, Gianfranco Parati, John Mandrola, Yasmina Bououdina Want to watch this episode? Go to: https://esc365.escardio.org/event/2561 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. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati, Nicolle Kraenkel and John Mandrola 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. David Duncker has declared to have potential conflicts of interest to report: honorary 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. Gianfranco Parati has declared to have potential conflicts of interest to report: Merck Sharp and Dohme, Omron Healthcare, Viatris. 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: Sabiha Gati Guest: Gianfranco Parati Want to watch this extended interview? Go to: https://esc365.escardio.org/event/2561?resource=interview Want to watch the episode? Go to: https://esc365.escardio.org/event/2561 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. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati 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. David Duncker has declared to have potential conflicts of interest to report: honorary 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. Gianfranco Parati has declared to have potential conflicts of interest to report: Merck Sharp and Dohme, Omron Healthcare, Viatris. 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.

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. About the Guest: Colby Takeda is Co-Founder & CEO of Pear Suite. With a background in public health, senior living, and community-based care, he founded the company to help community health workers and community-based organizations better navigate the operational side of delivering meaningful support. Under his leadership, Pear Suite has built a tech-enabled model that combines workflow tools, reimbursement support, credentialing, contracting, and claims infrastructure to help community-based providers work more effectively with health plans and the broader healthcare system. Things You'll Learn: Why community health workers are becoming more central to modern, whole-person care models. How Pear Suite helps community-based providers document care, manage compliance, and get reimbursed for their work. Why policy shifts and Medicaid reimbursement are creating new momentum for community-based care. How AI can support community health workers by reducing administrative burden without replacing trust-based relationships. Why connecting health plans, providers, and community organizations is key to making community-based care sustainable at scale. Resources: Connect with Colby Takeda on LinkedIn Learn more about Pear Suite Explore Pear Suite for Providers Follow Pear Suite on LinkedIn

iuscan.org.   --> not for profit discussed in this podcast episode.    Title: Intestinal Ultrasound for Diagnosis and Management of Inflammatory Bowel Disease Target Audience This activity is directed to physicians, medical students, nurse practitioners, nurses, and physician assistants. Objectives: Upon completion of this activity, participants should be able to: Review how Inflammatory Bowel Disease (IBD) is traditionally diagnosed and managed.  Review how intestinal ultrasound works and how it has been used to diagnose and manage IBD and review the data.  Review the benefits and limitations of intestinal ultrasound for IBD management and diagnosis.  Course Directors: Tony R. Tarchichi MD — Associate Professor, Department of Pediatrics, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC.) Paul C. Gaffney Division of Pediatric Hospital Medicine. No relationships with industry relevant to the content of this educational activity have been disclosed. Michael Dolinger MD - Assistant Professor, Department of Pediatrics, NYU Grossman School of Medicine Dr. Dolinger disclosed he is a consultant for Abbvie, Pfizer, Johnson & Johnson, Celltrion, Takeda, Sanofi and Samsung Corp. Conflict of Interest Disclosure: No other planners, members of the planning committee, speakers, presenters, authors, content reviewers and/or anyone else in a position to control the content of this education activity have relevant financial relationships to disclose.   Accreditation Statement: In support of improving patient care, the University of Pittsburgh is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. The University of Pittsburgh School of Medicine designates this enduring material activity for a maximum of 0.5 AMA PRA Category 1 CreditsTM. Physicians should only claim credit commensurate with the extent of their participation in the activity. Other health care professionals will receive a certificate of attendance confirming the number of contact hours commensurate with the extent of participation in this activity. Disclaimer Statement: The information presented at this activity represents the views and opinions of the individual presenters, and does not constitute the opinion or endorsement of, or promotion by, the UPMC Center for Continuing Education in the Health Sciences, UPMC / University of Pittsburgh Medical Center or Affiliates and University of Pittsburgh School of Medicine. Reasonable efforts have been taken intending for educational subject matter to be presented in a balanced, unbiased fashion and in compliance with regulatory requirements. However, each program attendee must always use his/her own personal and professional judgment when considering further application of this information, particularly as it may relate to patient diagnostic or treatment decisions including, without limitation, FDA-approved uses and any off-label uses. Released 3/23/26, Expires 3/23/28 The direct link to the course is provided below: Coming soon!

In this episode of Let's ComBinate, Subhi Saadeh sits down with Joseph Luminiello, CEO and Co-Founder of RCG Intel, to break down how competitive intelligence is actually used in biopharma and why most companies get it wrong.Joe introduces a practical framework built on three pillars: data (scientific publications and congresses), signal intelligence (press releases and filings), and human intelligence, which provides the context needed to interpret what those signals actually mean. While data and AI tools are becoming more accessible, Joe explains why interpretation and real-world insight remain the true differentiators in strategic decision-making.The conversation covers real-world applications across pharma strategy, including evaluating low-cost API suppliers, make-versus-buy decisions, competitor assessments, and forecasting. Subhi and Joe also discuss how cultural incentives and assumptions often shape forecasts more than data, and why even well-built models can miss significantly.Timestamps00:00 Introduction00:51 What is competitive intelligence02:57 Human intelligence in practice05:37 How insights are sourced07:59 Validating and triangulating data12:37 Forecasting and key assumptions18:01 Common client blind spots20:31 Speed of change in pharma23:56 Why context matters more than raw data27:27 Tools, congress strategy, and wrap-upLinksRCG Intel:https://rcgintel.com/Joseph Luminiello on LinkedIn:https://www.linkedin.com/in/joeluminiello/Joseph Luminiello is the CEO and Co-Founder of RCG Intel, a boutique competitive intelligence consultancy serving the pharmaceutical and biotech sector. With more than 40 years of experience across healthcare, biopharma, and strategic intelligence, Joe has built his career around what he calls prescience, the ability to synthesize disparate data points and anticipate how they will shape the future. Before launching RCG Intel, Joe served as CEO of multiple biopharma companies, including AVM Biotechnology and Third Coast Therapeutics, where he raised capital and advanced drug development programs. As Founder and CEO of SmartHealth Catalyzer, he built a 150-member senior executive operations team and sourced over 130 intellectual property projects from Midwest universities. Earlier in his career, he spent six years at Takeda Pharmaceuticals, where he rose to Vice President of Business Development, contributed to diligence for Takeda's acquisition of Nycomed, and helped launch Takeda Canada as its second employee.Subhi Saadeh is the Founder and Principal at Let's ComBinate BioWorks. He is a Certified Quality Auditor and ISO 13485 Certified Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences. Subhi has extensive experience across drug-device combination products, including supplier quality, development quality, design controls, purchasing controls, audits, and management of contract manufacturers and external partners. Through Let's Combinate, he is focused on bridging the gap between pharma and devices by creating educational content, participating in industry groups, and providing consulting support to align development, quality, and regulatory expectations.

Dr. Monty Pal and Dr. Vamsi Velcheti discuss the evolving treatment landscape in EGFR-mutated non-small cell lung cancer, including landmark trials like FLAURA2, novel drug therapies, and the growing importance of ctDNA and MRD testing. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist and professor and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, I'm truly delighted to introduce Dr. Vamsi Velcheti, who's a professor of medicine and the chief of hematology-oncology at the Mayo Clinic in Jacksonville, Florida. We'll be discussing the expanding treatment landscape in EGFR-positive lung cancer and how to navigate the challenges of balancing treatment efficacy, toxicity, and patient quality of life in the EGFR-positive space.  Just FYI, our full disclosures are available in the transcript of this episode.  Vamsi, it's so great to have you on the podcast. Thank you so much for being here. Dr. Vamsi Velcheti: Thank you, Monty. It's a pleasure to be here with you. It's a really exciting topic and there are a lot of updates in the EGFR space. Dr. Monty Pal: So, I'm going to need your help with this because I'll be honest with you, I see very little lung cancer, if any, in my practice. I'm pretty much exclusively kidney cancer these days. I'm coming on 20 years at City of Hope now, and I still remember when trials like ECOG 1599 were presented with, you know, platinum doublets. And, of course, the field has changed a lot since then. But tell us a little bit about the first-line landscape, and I think just for the sake of time, we're going to stick with EGFR-positive disease here. What does it look like these days? Dr. Vamsi Velcheti: Monty, the foundation of care remains the third-generation EGFR inhibitors. These are selective EGFR inhibitors, like osimertinib. We've had an evolution of the development of these TKIs. Like, you know, we had the first-generation, second-generation, not-so-selective EGFR inhibitors. Now we have mutant-selective EGFR inhibitors in the clinic, and they're doing a really good job. And these are quite effective in patients who have classical activating mutations. But the reality is that these have not been transformative. These agents have fundamentally changed the response patterns, excellent CNS penetration, and very good tolerability profile. However, we don't see a lot of durability in terms of the response. So, what's different today is now there have been several trials in combination with these third-generation EGFR inhibitors that have really laid the foundation of how we kind of think about EGFR-positive disease. At the high level, there are a lot of challenges to selecting the patients for these combination-based modalities. I'm assuming we'll be talking more about these different trials and different approaches. Some of these combination-based strategies have really moved the needle in terms of improving overall survival and really improving long-term outcomes and durability in our patients. Dr. Monty Pal: And we are going to get into the weeds on this in just a moment. But I did kick off this podcast talking about chemotherapy, ECOG 1599. It does seem as though chemotherapy is still a component of management in advanced non-small cell lung cancer. So, can you tell us about, perhaps first, you mentioned osimertinib, you know, some of these next-generation EGFR inhibitors. Tell us about the role of chemo plus osimertinib. Dr. Vamsi Velcheti: That's exactly where I was going with the combination-based strategies. You know, we first started off with our earlier trials in the EGFR space evaluating the question of, are targeted therapies, are these highly effective, third-generation, EGFR-selective inhibitors, superior to platinum-doublet chemotherapy? And we've had multiple trials demonstrating that, like the FLAURA trial and in the past with second-generation EGFR inhibitors like erlotinib and gefitinib and afatinib. So, we know that these TKIs actually perform better than platinum-doublet chemotherapy. Now, we have a large, global, phase 3 trial data from the FLAURA2 trial, which looks at the question, "Hey, you know, osimertinib is better than chemotherapy, platinum-doublet chemotherapy. Can we do even better by combining osimertinib with platinum-doublet chemotherapy?" So, FLAURA2 answered that question. This is a large, phase 3 trial, and it's a positive trial with improved durability of disease control and improving overall survival with combination with chemotherapy. So, it's a very important and landmark trial, and essentially combining osimertinib with a platinum-based chemotherapy improved responses, deepened responses, and improved overall survival and really changing the disease trajectory. And this strategy is definitely compelling, especially in patients who have certain clinical high-risk features like, you know, patients who have high disease burden or patients who are sometimes having rapid disease progression early on osimertinib, especially with patients who have a lot of visceral disease burden. So, intensifying treatments up front could alter the natural trajectory of the disease. Dr. Monty Pal: So, you sort of alluded to this in that last part there, but is that kind of how you in clinical practice select? Is it based on, you know, visceral involvement? Is it based on rapidity of disease where you think about adding chemotherapy to osimertinib? Maybe you can give us the corollary. Which patients do you just use osimertinib alone in, for instance? Dr. Vamsi Velcheti: Definitely, there are some patients who have low disease burden and they have the classical mutations, like an exon 19 deletion. And these patients, especially if they don't have a lot of disease burden, they don't have CNS involvement, there may be a subset of patients who could just do fine on osimertinib of course, with close monitoring of the disease. I guess we'll get into that later, how do we do that with either ctDNA or like closer imaging or both. So, there may be some opportunity to kind of escalate patients' treatments based on certain clinical characteristics or radiographic characteristics or certain biological characteristics informed by ctDNA or other approaches. Dr. Monty Pal: No, that's interesting. And you're right, we will chat about ctDNA in just a bit. But before we get there, I think one of the big agents that has really sort of come to the fore in advanced non-small cell lung cancer is amivantamab. I've heard a lot about this in the context of even kidney cancer because in certain subsets, I'm interested in MET-directed therapies and so forth, right? So maybe tell us a little bit about the mechanism of amivantamab first, and then maybe tell us about this pivotal MARIPOSA trial where it's combined with lazertinib. Dr. Vamsi Velcheti: So, the MARIPOSA trial compared lazertinib alone with amivantamab plus lazertinib. And this trial demonstrated overall survival advantage, and there were key differences in terms of tolerability and the safety of amivantamab, which is an EGFR and MET bispecific, and there were certain kind of unique toxicity profiles that make it a little different than the intensification approach with chemotherapy through the FLAURA2 trial. So, there's a trade-off in terms of the toxicity profile. It's a different agent and a different management protocol in terms of dermatological toxicity management that clinicians need to be comfortable with. And also, there are certain unique issues in terms of amivantamab; there's a higher rate of infusion-related reactions, there's an increased risk for edema and VTEs because of amivantamab. Certainly a different toxicity profile, different management paradigm there in terms of longitudinal care of these patients requiring dermatological care and like, you know, close monitoring and prophylaxis VTEs. But having said that, definitely it's a different strategy, and it kind of changes the biology and the natural history of the cancers, and we do see some durability of responses that we see with the MARIPOSA. So, it's certainly a great alternative, at least for some patients. Dr. Monty Pal: That was a great overview of MARIPOSA. Now comes the really difficult question, which is, how do you choose between the two? You have these two great options, right, for EGFR-positive patients. You've already highlighted some of the distinctions in terms of toxicity. I think the audience is well aware of the side effects of chemo-doublet, perhaps even the EGFR-based therapies. Amivantamab is quite new. Give us a sense of how you in clinical practice decide between the two potential options here. Dr. Vamsi Velcheti: Yeah, I think that's the big challenge. I think these are two independent strategies that have evolved through the phase 3, and both of them have demonstrated overall survival benefit. So, the way I think about this is in three dimensions, right? Like, the disease biology, the patient priorities, and feasibility of care delivery. So, when I talk about the disease biology, you know, the mechanism is very different, and MET is a very dominant driver of disease in EGFR-altered patients and it's a significant mechanism of resistance, acquired resistance to TKIs. So, certainly I think there's a patient population that could benefit from a MET-directed therapy up front. However, we don't have great data to kind of really demonstrate how using amivantamab in the front line is going to change that. And are there like perhaps like some patients who we could identify who would benefit from such a strategy? Very recently, there have been some approvals in the second-line setting in lung cancer, not in the EGFR space, but like in generally in lung cancer, with the MET ADCs, and those drugs are approved with a companion diagnostic, which requires MET IHC testing. So, what has happened, at least in large academic practices and also I think in the community now, they have been checking for MET IHC expression more routinely in lung cancer. What we have been doing in our institution is we have been doing MET IHC as a reflex for all patients with EGFR, not just EGFR, but all non-small cell lung cancer patients. What that has done is now, like, we have been increasingly testing patients with EGFR for MET. And there's clearly a subset of patients who have de novo MET expression and a high MET expression. And those patients, I've been kind of like preferentially treating them with the MARIPOSA regimen. But again, I have to caution the audience that we still don't have data that MET IHC is going to help us make those decisions, whether it's better than like a FLAURA2 regimen. But however, in the second-line setting in the CHRYSALIS trial, we know that MET is a very powerful predictor of response to amivantamab. We really need more data there, but that's what I have been doing in my practice. But also, there's a lot of patient preference here. Like, there are some patients who don't want chemotherapy, and they want a non-chemotherapy approach. So, certainly there are some patients who prefer to have amivantamab. And now with the amivantamab, the subcutaneous version, the infusion reactions and the logistics of actual administration of amivantamab are more favorable with the subcutaneous approval. So, those are some of the elements that we need to take into account. Dr. Monty Pal: Well, I want to hone in on that because this subcutaneous administration route has been a big debate that I've seen on social media. Tell us, how much easier does it actually make the amivantamab experience? Does it cut down on the rash? Is it just infusion reactions? What's been your clinical experience? Vamsi Velcheti, MD: So, the subcutaneous administration of amivantamab has definitely improved the infusion reaction issue. Very rarely patients have infusion reaction now with the subcutaneous injections. And also, the infusion time is much, much shorter. Like we don't need a lot of infusion time, which is sometimes a challenge in busy infusion clinics. We need to take that into account. As far as the impact of the subcutaneous formulation on dermatological toxicity, we haven't really seen significant difference in terms of the intensity or rates of dermatological toxicity with subcutaneous. The benefits are really with the infusion reaction, the ease of administration. And interestingly, in the PALOMA trial, it also seems to be, even though this was not the primary endpoint of the study, there seems to be some suggestion that the subcutaneous amivantamab seems to have improved OS compared to the IV amivantamab. We don't really understand why, but that's a finding from the trial that's very intriguing. Dr. Monty Pal: That is really fascinating. I'm kind of curious to see how that's going to pan out. I'm going to shift gears a little bit here. And, you know, as we sort of close, I wanted to talk a little bit about biomarkers. I mean, this is obviously not a lung cancer-specific issue. It's something we think about across the board. But what I will say is that there are certain commonalities, and in bladder cancer, we think a lot now about ctDNA. But you've been way ahead of the game in lung cancer. Tell us how you guys use ctDNA, maybe both from the standpoint of monitoring for mutational status, but if you can, maybe offer some insights into some of these new MRD tests that are available too. Dr. Vamsi Velcheti: Yeah, it's rapidly evolving. Certainly, I think in the lung cancer space, you know, this has really kicked off in the lung cancer space with incorporating ctDNA into the workflow. Of course, you know, like baseline evaluation, we still kind of heavily rely on tissue genomic sequencing. But as you know, with targeted therapy, a lot of these patients have disease that evolves over time, and changes in terms of mutational pattern driving acquired resistance is a major issue across different molecular subtypes. And especially so in EGFR, when there are certain actionable opportunities associated with that transformation. So, we need to kind of have like a longitudinal snapshot of how we monitor these patients. So, the ctDNA has come to be like a tool that has now come to the forefront of clinical workflow, and almost all my patients who are having disease progression have ctDNA for kind of evaluating for resistance and informing treatment decisions, especially in EGFR. But having said that, there are a lot of challenges in terms of using ctDNA as a tool for monitoring. There are a lot of different types of assays and different platforms, and being able to use this as a quantitative tool that would be used along with the CT scans that we routinely use in clinical practice has been a challenge. And I think I would love to hear your perspectives as well, Monty, about how you're thinking about that in bladder and other disease contexts. But having said that, I think there's a lot of opportunity to incorporate ctDNA and MRD assays into clinical decision-making. Right now, in terms of clinical trials and clinical development, there have been some very interesting trials that are currently ongoing, especially in the EGFR space. We know that patients who clear ctDNA, based on some retrospective data and also like some retrospective-prospective data from trials that have already read out, that patients who clear ctDNA early with target therapy tend to do much better. They have a longer durability of response. There may be a subset of patients who have, even though they're having radiographic response, they have persistent ctDNA after a certain time point of initiation of targeted therapy. Those patients may require escalation of therapy. We don't yet know. I can't recommend that as a standard right now because we don't have clinical evidence to support that. But however, some of the clinical trials, like the ELIOS trial that's being done right now, that's actually completed enrollment, we'll hopefully see the results very soon. So, there is an emerging thought that instead of intensifying treatment for all patients with EGFR, there may be a population that may be just fine with frontline osimertinib monotherapy and introducing the intensification strategy at the time of emergence of MRD or progression on ctDNA before radiographic progression. So, there are a lot of adaptive molecular response criteria that we are kind of exploring in clinical trials that could inform how the future is going to look like for EGFR and other perhaps targeted therapies as well. So, it's fascinating, and I think there's a lot of opportunity there. Dr. Monty Pal: You know, you asked for my perspective. I actually think that what you highlighted there is the most interesting opportunity for ctDNA: the ability to de-escalate therapy. In terms of drug development, we've done so much to bring new therapies to patients, and now it's a bit of an embarrassment of riches, but the downside is that I feel like we tend to overtreat a lot of patients in the clinic. So, I definitely view MRD, you know, some of these other ctDNA techniques with methylation and so forth that may not be sort of tumor-dependent or bespoke could be incredibly, incredibly helpful. You touched on sort of the future, right, in this last section here with biomarkers. But give us a sense now in terms of novel drug therapies in the EGFR space. What are you most excited about moving forward in 2026 and beyond? Dr. Vamsi Velcheti: Yeah, I think there's a lot going on in this space, and not just this space, but across lung cancer and others as well. Like looking at the next generation of targets for ADCs. And I think a lot of these have to do with…so far in the drug development space, as you know, the improvements in clinical outcomes has been very incremental. So, we really need to make that big leap. And I think the big leap is not going to come from, in my opinion, from the next ADC, but it's going to come from how we tailor treatments and how we monitor disease better and how do we kind of incorporate the next treatment earlier and not wait for the radiographic progression. So, there's a lot of opportunity there to integrate biomarkers and dynamic biomarkers into clinical trial design and incorporating the recent advances in terms of drug design. You know, we have a lot of assets in the EGFR space, the next-generation EGFR inhibitors that are kind of designed with resistance in mind and rational combination, knowing when to introduce those combinations is also equally important. So, there's a lot going on, really exciting times to be in drug development. The one thing that I really hope will come to the forefront in drug development, not just for lung cancer, but all disease groups, is to kind of really be thoughtful about how we incorporate these really cool molecular monitoring tools and creating a composite score with imaging to be able to like really design the next generation of clinical trials. Dr. Monty Pal: You're so spot-on with that. I definitely think that we're getting to this point where, you know, we could think about the next BiTE, the next CAR-T, the next ADC. But, you know, maybe it's time for us to start really honing in on appropriate applications of these drugs, honing in on the right dose and what have you, because I definitely see some issues there.  Vamsi, this has just been terrific. I really want to thank you so much for sharing your fantastic insights with us today on the ASCO Daily News Podcast, and I really appreciate all your efforts to move the field of lung cancer forward. Dr. Vamsi Velcheti: Thanks, Monty. I really enjoyed the conversation. Dr. Monty Pal: Yeah, this was terrific.  And thanks to our listeners as well. If you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:     Dr. Monty Pal   @montypal  Dr. Vamsi Velcheti @VamsiVelcheti Follow ASCO on social media:          ASCO on X    ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview     Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical     Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Vamsi Velcheti:   Honoraria: Galvanize Therapeutics  Consulting or Advisory Role: Bristol-Myers Squibb, Merck, AstraZeneca/MedImmune, GSK, Amgen, Taiho Oncology, Novocure, Regeneron, Takeda, Janssen Oncology, Picture Health Research Funding (Inst.): Genentech, Trovagene, Eisai, OncoPlex Diagnostics, Alkermes, NantOmics, Genoptix, Altor BioScience, Merck, Bristol-Myers Squibb, Atreca, Heat Biologics, Leap Therapeutics, RSIP Vision, GlaxoSmithKline

For years, Samantha adapted quietly. She chewed longer, sipped water with every bite, avoided certain foods, and assumed the discomfort was just reflux. It wasn't. In this patient voice episode, Samantha shares the moment she realized something more serious was happening — and how that journey led to a diagnosis of eosinophilic esophagitis (EoE). She opens up about the subtle symptoms many people overlook, the daily adjustments she made without realizing it, and what finally pushed her to seek answers. If swallowing sometimes feels harder than it should, this story may sound familiar. This podcast is for educational purposes only and is not a substitute for medical advice. Always consult your healthcare provider regarding your symptoms or condition. This educational initiative was developed with support from Takeda.  

Enterprises are operationalizing artificial intelligence at scale, moving from experimentation to accountability. Gabriele Ricci of Takeda and Board Director Karenann Terrell discuss how leaders can embed AI into core operations, address unfinished digital foundations, and measure success by outcomes—not through pilots.

Episode 103 features Coach Chijo Takeda! Coach Chijo is a volleyball coach, educator, and content creator known for teaching the fundamentals of indoor volleyball with clarity, articulation, and energy. Through his online platforms, he has built a rapidly growing community of youth athletes and coaches who value skill development, confidence-building, and culture-driven leadership. In addition to coaching on the court, Chijo shares in-depth volleyball insights on YouTube and Instagram, regularly hosting IG Lives to answer questions and support coaches around the world. He also offers an online membership community designed to help coaches grow their knowledge, leadership, and impact. Coach Chijo is passionate about developing not just better players, but better people through the game of volleyball. Coach Chijo's Links: Website: https://coachchijo.com/ Youtube Channel: https://www.youtube.com/@CoachChijo Instagram: https://www.instagram.com/coachchijo/ Tik Tok: https://www.tiktok.com/@coachchijo In this episode we discuss: • Building real confidence in young athletes • Creating a culture that develops leaders • Coaching without ego • The mindset behind elite performance • What the next generation of volleyball truly needs This conversation is for players, coaches, and parents who want more than just skill development, they want growth from the inside out. Coach Chijo shares what it really takes to develop inspired, confident, resilient athletes in today's game. If you're serious about volleyball and personal growth, this episode is for you.