Podcasts about Sanofi

French pharmaceutical company

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Pharma and BioTech Daily
Jasper Merges with Kira for $292M | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 20, 2026 5:19


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

Recruiting Future with Matt Alder
Ep 809: The Data Foundation For AI In Hiring

Recruiting Future with Matt Alder

Play Episode Listen Later Jul 17, 2026 30:10


Agentic AI is only as useful as the data it can access, and getting that foundation right is proving to be the harder half of the work. Years of mergers, acquisitions, and local decision-making have left many talent operations running on data and processes that were never meant to work together, and no amount of AI on top will fix what lies beneath. Some organizations are now rethinking their technology strategy in light of that problem. So what does getting AI-ready actually involve, and what does it change about the decisions you make? My guest this week is Lia Manafova, Talent Technology Strategy Lead at Sanofi, a global pharmaceutical company hiring at scale across more than 70 countries. In our conversation, Lia explains why the data foundation must come first, what an anchor product strategy looks like in practice, and what she has learned about making technology stick. In the interview, we discuss: Why AI readiness starts with data, not AI Building a bridge between the business and the digital team The challenge of constant transformation and change fatigue What is an anchor product strategy? How the Workday, Paradox and HiredScore acquisitions changed the options Best-of-breed or a single source of truth? Keeping recruiters in one system rather than three Piloting with the people who will use it every day The case for keeping the semi-automated option Building an ROI story the business understands What does the future look like?

Pharma and BioTech Daily
Merck's $5B Lipfendra FDA Approval Revolutionizes Cholesterol | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 17, 2026 4:46


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The industry continues to forge ahead, making significant strides in scientific advancements, regulatory approvals, and strategic business developments. These moves are reshaping the landscape of drug development and patient care. Starting with Merck & Co.'s recent FDA approval for Lipfendra, the world's first oral PCSK9 inhibitor, this marks a pivotal shift in managing hypercholesterolemia. Traditionally, PCSK9 inhibitors have been administered via injection, but Lipfendra offers a more convenient oral alternative. This could significantly improve patient adherence and outcomes by easing the administration process for those managing cholesterol levels. The drug's approval highlights a crucial advancement in cardiovascular treatment, with expectations of reaching peak annual sales of $5 billion, underscoring its market potential. In another significant development, Eli Lilly has entered the burgeoning field of psychedelic therapeutics with its acquisition of Ataibeckley for up to $3.8 billion. This move reflects a growing trend toward exploring novel therapeutic avenues for psychiatric disorders. Psychedelic compounds promise new hope for patients with depression and other mental health conditions where conventional therapies have shown limited efficacy. Eli Lilly's investment signals confidence in the transformative potential of psychedelics, which could revolutionize treatment paradigms for conditions like depression and PTSD. Turning to obesity treatment, Novo Nordisk's Wegovy pill has received European Commission approval for obesity and overweight adults. As a small molecule GLP-1 receptor agonist, semaglutide enhances satiety and reduces caloric intake. This development underscores the increasing focus on metabolic disorders and highlights the competitive landscape as companies race to dominate the weight management sector with innovative oral formulations. In oncology news, Merck & Co.'s Keytruda has achieved a milestone in becoming the first PD-1 inhibitor to demonstrate phase 3 benefits as a single agent in frontline mismatch repair-deficient endometrial cancer. This success not only reinforces Keytruda's role in oncology but also emphasizes the importance of precision medicine approaches targeting specific genetic mutations in cancer therapy. The industry is also seeing substantial financial maneuvers aimed at bolstering research capabilities and market reach. Johnson & Johnson has raised its 2026 financial guidance following Tremfya's impressive $2 billion revenue milestone with its IL-23 inhibitor for autoimmune diseases. Additionally, their strategic supply chain restructuring reflects efforts to enhance operational efficiency amid a broader U.S. manufacturing push. On the regulatory front, Johnson & Johnson received UK MHRA approval for Akeega in BRCA1/2-mutated metastatic prostate cancer, highlighting ongoing focus on precision medicine and targeted therapies in oncology. Meanwhile, Medtronic's recall of Harmony Catheter Delivery Systems due to safety concerns serves as a reminder of ongoing vigilance in medical device safety regulations. In clinical trial advancements, InnoCare Pharma's TYK2 inhibitor demonstrated efficacy in a Phase 2 trial for nonsegmental vitiligo, achieving its primary endpoint and paving the way for Phase 3 studies. This highlights TYK2 inhibition as a promising strategy for autoimmune diseases like vitiligo. Moreover, we witness movements towards public offerings with companies like Vogenx and Braveheart Bio aiming for IPOs to fund their respective drug development projects. These efforts underscore the continuous drive for capital to propel innovative therapies through clinical trials and towards commercialization. Finally, turning to regulatory updates, Sanofi has entered new chapters in mRNA patent litigation against Pfizer and Moderna, reflecting ongoing tensions over intellectual property rights within the high-stakes realm of COVID-19 vaccines and mRNA technology. The outcomes here could have far-reaching implications for mRNA-based therapeutics and vaccine development. As we look at these developments collectively, they illustrate a vibrant period for pharmaceutical and biotech companies innovating new treatments while navigating complex regulatory terrains. The implications for patient care are profound, with potential improvements in therapeutic options driven by new scientific breakthroughs and strategic industry shifts. These dynamics promise to reshape the future landscape of global healthcare delivery and pharmaceutical innovation as these trends continue to unfold.Support the show

Pharma and BioTech Daily
Veradermics' $2B Hair Loss Market Move with Oral Minoxidil | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 16, 2026 5:48


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore the latest advancements shaping the future of drug discovery and patient care. Veradermics is making significant strides with its oral minoxidil formulation aimed at addressing female pattern hair loss. The mid-stage clinical trial results have analysts optimistic about Veradermics' potential to capture a significant portion of this underserved market. The oral form of minoxidil, traditionally used in topical Rogaine products, offers a novel delivery method that could enhance patient adherence and improve outcomes, marking an innovative leap in dermatological treatments. Johnson & Johnson is navigating the expiration of Stelara's patent protection with resilience, as Tremfya steps up to fill the revenue gap. With quarterly sales exceeding $2 billion, Tremfya underscores the critical role of strategic lifecycle management and robust product pipelines in weathering patent cliffs. This success highlights the necessity for pharmaceutical companies to sustain growth through a well-rounded portfolio that can absorb such impacts. In oncology, Celcuity has achieved a pivotal milestone with FDA approval for its small molecule inhibitor targeting breast cancer. This therapy promises blockbuster potential and could become a new standard-of-care, expanding treatment options for patients. The approval reflects ongoing innovation in oncology, where small molecules continue to play an essential role alongside biologics in advancing cancer therapies. AI-driven drug discovery is gaining traction as Insilico Medicine partners with CDMO Bora in a potentially $2.5 billion deal. This collaboration underscores AI's transformative potential in accelerating drug discovery and development processes. By leveraging artificial intelligence, Insilico aims to identify new drug candidates more efficiently, expediting their journey from bench to bedside. Kelun-Biotech is marking significant progress with its SAC-TMT program targeting non-small cell lung cancer (NSCLC), filling gaps left by Merck's phase 3 efforts. This development is crucial for providing more tailored therapeutic options in oncology, illustrating how advancements in drug development are driving forward personalized medicine. Roche continues its exploration of Alzheimer's disease treatments with a multifaceted approach that includes both amyloid and tau proteins as targets. While its phase 3 amyloid program is prominent, Roche's interest in tau protein highlights the complexity of tackling neurological disorders and the need for diverse therapeutic strategies. Meanwhile, Biogen remains steadfast in defending its anti-tau Alzheimer's candidate following mixed phase 2 results that showed slowed cognitive decline. Despite stock volatility, this endeavor illustrates the high-stakes nature of Alzheimer's research as companies pursue novel approaches to this challenging disease. Regulatory landscapes are also shifting as Johnson & Johnson halts development of an eye disease gene therapy after disappointing phase 2b results. This move reflects the inherent risks involved in gene therapy and underscores the necessity for thorough evaluation at each clinical stage. Medtronic's recall of its Harmony delivery catheter system due to potential detachment risks serves as a reminder of the paramount importance of safety and quality control in medical device manufacturing. Such recalls impact patient safety and emphasize regulatory vigilance over device reliability. In summary, these innovations demonstrate the dynamic nature of the pharma and biotech industries where cutting-edge science drives progress. Integrating AI into drug discovery, managing product lifecycles post-patent expiry, advancing personalized medicine, and maintaining regulatory diligence collectively shape a landscape focused on improving patient outcomes worldwide. Turning to recent scientific developments: Eli Lilly's presentation at AAIC 2026 on their anti-amyloid Alzheimer's drug Kisunla explores maintenance therapy possibilities once amyloid levels fall below a threshold. This potential shift could signify a paradigm change by extending therapeutic benefits and possibly improving long-term outcomes for patients with Alzheimer's. Biogen's advances with its anti-tau Alzheimer's therapy partnered with Ionis Pharmaceuticals further validate the tau hypothesis. The promising mid-stage data on their antisense drug Diranersen opens opportunities for other companies like Denali Therapeutics to explore similar avenues for treating neurodegenerative diseases. The industry is also witnessing a resurgence in biotech IPOs during 2026's first half, recovering from a sluggish 2025. This surge signals investor confidence in biotechnological innovation while providing capital for advancing research pipelines. Financial activities within the sector are robust as Attovia Therapeutics files for an IPO to fund its competitive pipeline against Sanofi's Dupixent. Meanwhile, Advancell's $315 million Series D funding supports advancing prostate cancer candidates into Phase 3 trials, backed by big pharma confidence in radiotherapy's potential. Lastly, regulatory transparency improves as the FDA resumes releasing drug rejection letters after a temporary pause—a move likely to influence future submissions significantly by offering clearer guidance on regulatory expectations. These developments collectively highlight how scientific innovation and strategic maneuvers transform pharmaceutical landscapes, promising profound impacts on patient care through advanced therapies and novel treatments worldwide. As these trends unfold, they reflect an industry increasingly reliant on technological integration and collaborations to drive future growth and innovation.Support the show

The MM+M Podcast
Health brands take the pitch at the 2026 FIFA World Cup: Where the world comes to play

The MM+M Podcast

Play Episode Listen Later Jul 16, 2026 29:35


Whether you call it soccer or football, people all around the world love the “beautiful game” – including health brands.  When the 2026 FIFA World Cup kicked off about a month ago across 16 locations in North America, there were 48 teams competing for the gold trophy.  But more importantly for our sake, there were also several major health brands marketing and advertising throughout the five week tournament, including provider organizations and drugmakers.  Bristol Myers Squibb launched its We Won't Lose media campaign in mid-June and has served as an official supporter of New York New Jersey as a host city.  Similarly, its Big Pharma rival Sanofi served as an official supporter of Boston as a host city, while consumer health company Haleon served as the official consumer healthcare product partner of U.S. Soccer. The World Cup has been the main attraction for weeks now, so as it comes to a dramatic close in the coming days, our summer intern Lola Offenback brings us a jumbo World Cup episode with back-to-back interviews.  First up is Opeyemi Oluwole-Sowore, chief marketing officer at Hackensack Meridian Health, who details how the New Jersey-based health system has served as an official supporter of New York New Jersey as a host city. Then, you'll hear from Cologuard's marketing director Tara Cunningham about how the Exact Sciences brand produced its Halftime ad featuring U.S. women's soccer stars Abby Wambach and Julie Foudy. Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Breakfast Business
The business of Schneider Electric Ireland

Breakfast Business

Play Episode Listen Later Jul 14, 2026 8:59


The French national holiday Bastille Day is a chance to look at the significant investment in this country by France, The highest in the EU. It includes Sanofi, Pernod Ricard and Veolia. It also includes Schneider Electric which is one of the biggest suppliers of energy company also has a significant R&D hub in Galway.Joining Joe on the show Rhonda Doyle, Country President of Schneider Electric Ireland.

Pharma and BioTech Daily
Sanofi's FDA Approval: $160M Boost for Sarclisa in Cancer Care | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 13, 2026 5:16


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 transformative updates and strategic shifts within the industry, reflecting both remarkable progress and inherent challenges. Sanofi's recent achievement marks a significant milestone in oncology with the FDA approval of Sarclisa Escena (isatuximab) as the first on-body injector for multiple myeloma treatment. This monoclonal antibody, targeting CD38, offers a novel subcutaneous delivery method, simplifying administration and potentially enhancing patient compliance by reducing the need for frequent clinic visits. This aligns with the industry's ongoing shift towards patient-friendly drug delivery systems, emphasizing convenience without compromising efficacy. In another promising development, GSK and Hansoh Pharmaceutical have reported positive results from their Phase 3 trial evaluating risvutatug rezetecan for small cell lung cancer. This antibody-drug conjugate, targeting B7-H3, has shown potential when combined with chemotherapy to extend patient survival. Given the aggressive nature of small cell lung cancer and limited treatment options, these findings underscore the potential of targeted therapies to improve clinical outcomes significantly. Forte Biosciences' FB102 also takes a spotlight in clinical advancements. In its Phase 1b trial for vitiligo, FB102 demonstrated a 45.8% placebo-adjusted benefit. This monoclonal antibody works by modulating immune responses through the IL-15 pathway via CD122, offering new hope for patients with this challenging autoimmune condition. On the regulatory front, ARPA-H's commitment of up to $160 million towards developing personalized genetic medicines for rare diseases is noteworthy. This investment is set to accelerate innovations in gene therapy and personalized medicine platforms. Such advancements promise to revolutionize pediatric care and extend beyond by tailoring treatments to individual genetic profiles, enhancing efficacy while minimizing adverse effects. Strategic collaborations continue to reshape the industry landscape. Rani Therapeutics' partnership with PegBio aims at advancing oral delivery systems for obesity and metabolic diseases. Similarly, Simcere Pharmaceutical's collaboration with Schrödinger leverages AI-driven drug discovery efforts. These alliances highlight an increased reliance on computational platforms to streamline therapeutic development processes. From a financial perspective, Mesoblast Limited reports substantial revenue from its cell therapy product Ryoncil, signaling strong commercial viability for cell-based treatments targeting rare diseases. Additionally, Cue Biopharma's successful $50 million fundraising underscores investor confidence in advancing therapies for immunological disorders. However, not all news is positive. Roche has decided to halt two programs targeting Huntington's disease due to inadequate efficacy and safety concerns. This decision reflects the complexities involved in developing effective treatments for neurological disorders—a field fraught with scientific challenges yet rich with potential rewards. In market dynamics, McKinsey's report advocates for a structural redesign of biopharmaceutical R&D to fully leverage AI's capabilities. This recommendation resonates with current industry trends focusing on strategic innovation to maximize efficiency and discovery potential. The FDA's third rejection of Hengrui Pharma and Elevar Therapeutics' combination therapy for liver cancer underscores the rigorous scrutiny such treatments face despite their promise in addressing complex cancers. In contrast, BioNTech's preparation to launch its HER2 antibody-drug conjugate (ADC) signifies its strategic pivot back towards oncology after mRNA vaccine successes. Bayer's decision to sell a minority stake in its contraceptives business demonstrates how companies are strategically realigning portfolios to focus on core areas while securing funding for innovation. This move reflects broader trends within pharma as companies navigate financial landscapes to support long-term research goals. Amid these developments, regulatory environments continue evolving. NICE's stance against future Lumakras reimbursement in the UK highlights ongoing challenges in balancing cost-effectiveness with access to innovative therapies. Meanwhile, ARPA-H's significant funding allocation signals robust governmental support for advancing precision medicine within genetic therapies. In conclusion, today's updates reveal an industry characterized by a relentless pursuit of innovation amidst complex regulatory landscapes. As companies navigate these dynamics through strategic collaborations and scientific breakthroughs, their efforts hold promise for enhancing patient care across diverse therapeutic areas globally. Stay tuned as we continue to track these exciting developments shaping the future of pharmaceuticals and biotechnology. Thank you for tuning into Pharma Daily—your go-to source for up-to-date insights from the world of pharmaceuticals and biotechnology.Support the show

Pharma and BioTech Daily
Ipsen's Dysport Hits Phase 3 Milestone vs. Botox | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 10, 2026 5:13


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 and challenges shaping the landscape of these dynamic sectors. Starting with Ipsen's Dysport, which has made notable strides in its Phase 3 trials for migraine prevention. The trials covered both episodic and chronic conditions, marking a first in the neurotoxin market. Dysport's success positions it as a formidable competitor to AbbVie's Botox, expanding therapeutic options for individuals battling migraine disorders. This achievement showcases the potential efficacy of botulinum toxin-based therapies in neurology and pain management, offering promising new avenues for patient care. In regulatory news, Boehringer Ingelheim has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for Jascayd, a small molecule PDE4B inhibitor with antifibrotic properties. This approval marks a significant milestone in the treatment of idiopathic and progressive pulmonary fibrosis. Jascayd's addition to the therapeutic arsenal offers new hope for managing this debilitating condition, emphasizing the ongoing efforts to improve patient outcomes through innovative treatments. The arena of business development sees HanChorBio partnering with InxMed to advance oncology research. By combining HCB101 with FAK inhibitors and FAP-targeted ADCs, this collaboration aims to leverage antibody and small molecule drug discovery techniques. The goal is to develop innovative cancer treatments that could redefine therapeutic approaches in oncology. Keenova Therapeutics has also reported success with Xiaflex for plantar fibromatosis. This enzyme injection therapy offers a novel approach by targeting collagen, thus providing an innovative solution for musculoskeletal conditions. Similarly, Fate Therapeutics' FT819, an off-the-shelf CAR-T therapy, has shown early promise in tackling treatment-resistant systemic sclerosis, underscoring the potential of cell therapies beyond oncology. Meanwhile, MindRank's successful Series B funding round of $52 million highlights the growing role of AI platforms in drug discovery. The funding will propel its AI-discovered oral GLP-1 obesity pill into Phase III trials, exemplifying how technology-driven solutions are gaining traction in addressing metabolic diseases like obesity. On the regulatory front, Saol Therapeutics has resubmitted SL1009 (DCA) to the FDA for pyruvate dehydrogenase complex deficiency. This submission underscores ongoing efforts to address rare metabolic disorders using small molecule therapies. Additionally, Sanofi's concessions to the EU regarding flu vaccine marketing illustrate the complexities of competitive dynamics and regulatory scrutiny within the vaccine market. However, not all developments are favorable. AstraZeneca and Ionis Pharmaceuticals faced a setback as their drug Wainua failed its Phase 3 trial for transthyretin-mediated amyloid cardiomyopathy. This outcome highlights the challenges inherent in developing effective treatments for complex cardiovascular conditions. Meanwhile, regulatory processes remain contentious as the FDA pauses its release of complete response letters amid debates over proprietary information disclosures. In another noteworthy development, GSK has terminated its $2.2 billion collaboration with Alector after underwhelming results from Alzheimer's drug trials. This decision highlights both financial implications and strategic shifts as companies reassess risk tolerance in neurodegenerative disease research. Conversely, Roche's success with its KRAS G12C inhibitor divarasib in Phase 3 lung cancer trials underscores the promise of precision medicine. Divarasib outperformed competitors Amgen's Lumakras and Bristol Myers Squibb's Krazati, positioning Roche to potentially redefine standards of care based on genetic profiles. In a move reflecting industry trends towards collaboration and innovation risk-sharing models, AstraZeneca has partnered with Sino Biopharmaceutical on respiratory disease research. This strategic alliance represents a substantial investment aimed at expanding AstraZeneca's pipeline in respiratory therapeutics. Lastly, amidst these developments, psychedelic drugs are experiencing a renaissance in psychiatric care. Companies like Compass Pathways are pioneering clinical validation for their use in treating depression, signaling a potential paradigm shift from traditional SSRIs to newer therapeutic classes pending safety and efficacy data. Overall, these stories illustrate a dynamic interplay of scientific progress and regulatory navigation within the pharmaceutical and biotech sectors. While challenges persist—particularly in neurodegenerative disease treatment—the breakthroughs in oncology and metabolic disorder therapeutics offer hopeful prospects for improving patient care. As these industries continue evolving, integrating advanced technologies such as AI will likely play a pivotal role in shaping future therapeutic landscapes.Support the show

ESC TV Today – Your Cardiovascular News
Season 4 - Ep.13: AI & digital solutions in emergency medicine - Management of heart failure in cardiac amyloidosis

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jul 9, 2026 21:49


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.

ESC TV Today – Your Cardiovascular News
Season 4 - Ep.13: Extended interview on the management of heart failure in cardiac amyloidosis

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jul 9, 2026 14:48


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.

Vital Health Podcast
Michael Penn: What The IRA Means For Oncology Innovation

Vital Health Podcast

Play Episode Listen Later Jul 9, 2026 27:47


In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Michael Penn, US Head of Reimbursement and Public Policy at Sanofi, to discuss how pricing policy, the Inflation Reduction Act (IRA), small-molecule incentives, orphan drug provisions, and Most Favored Nation (MFN) proposals could shape oncology innovation, patient access, and U.S. biopharmaceutical competitiveness. Key Topics: IRA and Oncology: Late-stage research shifts, follow-on studies, lead asset selection. Small-Molecule Incentives: Pill penalty concerns, portfolio reassessment, biologic comparisons. Orphan Drug Policy: Orphan Cures Act provisions, rare disease investment, post-market indication development. Patient Access Risks: Fewer treatment options, affordability questions, unmet needs in oncology. U.S. Competitiveness: MFN proposals, global R&D incentives, comparisons with China and Europe. Our new preprint on the IRA’s impact on late-stage R&D is available on our website and examines declines in small-molecule oncology research and orphan oncology studies. Opinions expressed are those of the speakers. Recorded at ASCO 2026 on 5/31/26. The Vital Health Podcast is a production of Vital Transformation LLC © 2026.See omnystudio.com/listener for privacy information.

The Dermalorian Podcast
ADVENT On Air: Burden of Disease and Diagnosis

The Dermalorian Podcast

Play Episode Listen Later Jul 7, 2026 18:48


Drs. Donna Culton and Russell Hall explore the Burden of Disease and Diagnosis of BP.Dermalorian™ special edition sponsored by Sanofi and Regneron.Like what you're hearing? Want to learn more about the Dermatology Education Foundation? Explore assets and resources on our website.

Pharma and BioTech Daily
Novartis' $1.1B Myricx Acquisition Boosts ADC Pipeline | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 7, 2026 5:12


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The first quarter of 2026 has brought a wave of significant changes and advancements in the industry, marked by crucial regulatory updates, strategic acquisitions, and shifts in the competitive landscape. A pressing issue for many companies is the looming patent cliff for several branded biologics. This situation presents both challenges and opportunities for biosimilars in the U.S. market. The introduction of biosimilars for major products like AbbVie's Humira, Johnson & Johnson's Stelara, and Regeneron/Bayer's Eylea is shifting the narrative from slow adoption to a more competitive biosimilar market landscape. Vertex Pharmaceuticals has achieved a milestone with the FDA expanding the label for its gene therapy Casgevy, now approved for treating children as young as two with sickle cell disease or transfusion-dependent beta thalassemia. This expansion emphasizes the potential of gene therapies to revolutionize treatment options for younger patients suffering from these conditions. In a pivotal development, Novartis announced a significant acquisition of UK biotech Myricx. With an upfront payment of $1.1 billion and potential total value up to $1.5 billion, this acquisition is set to enhance Novartis' antibody-drug conjugate (ADC) pipeline by incorporating Myricx's novel payload technology and NMT inhibitor payloads. This move reflects Novartis' focus on precision oncology by improving ADC efficacy through targeting critical enzymatic pathways involved in tumorigenesis. Amgen faced a setback with a voluntary recall of approximately one million bottles of its heart medication Corlanor due to potential contamination, highlighting the critical importance of maintaining rigorous manufacturing quality control to ensure drug safety. The regulatory landscape continues to evolve, illustrated by Robert F. Kennedy Jr.'s Department of Health and Human Services revoking lingering COVID-19 emergency authorizations. This signals a transition towards post-pandemic normalcy and an evolving focus on pandemic preparedness frameworks. Sanofi's Genzyme unit in Ireland faced criticism after an FDA inspection linked to Altuviiio resulted in a Form 483 notice. This incident underscores ongoing challenges in maintaining compliance with stringent regulatory standards and emphasizes the importance of robust quality assurance mechanisms. Lonza is expanding its capacity for producing ADCs and enhancing its partnership with a large U.S. drugmaker, aligning with industry trends toward outsourcing complex biologics manufacturing amid growing demand for ADCs. Genentech is undergoing restructuring, resulting in 103 layoffs as part of a strategic rethink of its early development group. Despite these changes, Genentech entered a $490 million collaboration focused on breast cancer, demonstrating its commitment to innovation amid organizational shifts. AstraZeneca continued its collaborative efforts by signing a $1.7 billion kidney drug discovery pact with Chinese biotech CSPC Pharmaceutical. This partnership emphasizes AstraZeneca's strategy to leverage global collaborations to accelerate drug discovery and development efforts. Scribe Therapeutics filed for an Initial Public Offering (IPO) to advance its CRISPR-based gene editing technologies targeting cardiovascular diseases at a genetic level, highlighting an ongoing shift toward personalized medicine. Celea Therapeutics raised $180 million in venture funding to advance Deupirfenidone into late-stage clinical trials for Idiopathic Pulmonary Fibrosis (IPF), signaling confidence in its therapeutic potential amid ongoing investment trends targeting rare diseases. The Medicines and Healthcare products Regulatory Agency expanded approval for Novo Nordisk's Wegovy for Metabolic-Associated Steatohepatitis with moderate-to-advanced liver fibrosis. This expansion represents significant progress given MASH's rising prevalence and progression risks. BridgeBio's ATTRibute-CM study yielded promising results with Acoramidis offering kidney-protective benefits in transthyretin amyloidosis cardiomyopathy patients—a potential new approach managing this rare disease. Revolution Medicines reported encouraging data for its KRAS inhibitor Zoldonrasib in combination therapies targeting metastatic pancreatic ductal adenocarcinoma—offering new strategies against aggressive cancer types. Brii Bio's phase 2b trial results show promise for a combination therapy aimed at achieving a functional cure for chronic Hepatitis B Virus infection—offering hope for millions affected by this condition. Robust fundraising activities continue within biotech sectors as Monash University and Atisama Therapeutics secure funding from MRFF grants developing therapies targeting chronic lung diseases. Overall, these developments highlight dynamic transformations reshaping therapeutic landscapes through precision medicine approaches leveraging cutting-edge technologies promising improved patient care across various domains within pharmaceutical industries globally.Support the show

PharmaSource Podcast
CMC Strategies Transforming Biologics Drug Development

PharmaSource Podcast

Play Episode Listen Later Jul 6, 2026 36:06


“CMC was not usually a core part of the planning — it was more of an afterthought. Now that funding has tightened, that is changing.”Siddhartha Jain, President of Shoolin Management Company, has spent two decades in biologics CMC across Novartis, Regeneron, Sanofi, and other major companies, contributing to the development and manufacturing of over 10 clinical and commercial molecules.In this episode of the PharmaSource podcast, Sid shares why raw material variability remains one of the industry's most underestimated risks, what separates a technically proficient CDMO from one that is merely experienced, and why digital CMC transformation fails when it ignores people and process.Read the full article.

Pharma and BioTech Daily
Roche's Divarasib Surpasses Amgen in Trials | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 3, 2026 5:26


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

The NACE Clinical Highlights Show
CME/CE Podcast: Continuing the Conversation - Clinical Trial Updates in Asthma

The NACE Clinical Highlights Show

Play Episode Listen Later Jul 1, 2026 18:17


For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/learn/course/recent-research-into-biologics-in-asthma-10830Program DescriptionThis podcast activity provides an in-depth review of several recent trials in severe asthma management, highlighting the ongoing shift in asthma precision medicine towards identifying the right patients for the right treatments. Clinicians will examine clinical data from the NIMBLE trial (depemokimab), alongside the WAYFINDER trial (tezepelumab), as well ZEPHYR 5 (benralizumab), REMOMEPO (mepolizumab), VESTIGE (dupilumab) and VALLIANT (verekitug). This activity will grant clinicians critical insights to move beyond simple exacerbation reduction and precisely align advanced biologic therapies with the underlying cellular biology driving each patient's symptoms.Educational ObjectiveAt the conclusion of this activity, participants should be better able to:Review recent updates in the asthma literature, including recent guideline revisions and evolving clinical trial data for newer biologic therapies.Accredited ProvidersThe National Association for Continuing Education in partnership with the Association for Pulmonary Advanced Practice Providers (APAPP).The National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.25 Physicians should claim only the credit commensurate with the extent of their participation in the activity. The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.25 contact hours (which includes 0.25 hours of pharmacology).FacultyCedric Rutland, BS, MD, FCCPVolunteer FacultyUniversity of CaliforniaPulmonary Critical Care Internal Medicine, ProducerRutland Medical GroupNewport Critical Care PhysiciansLake Forest, CADr. Rutland has disclosed the following financial relationships:Consultant: Sanofi (asthma, diabetes, NP, RSV, AD), Boehringer Ingelheim (IPF, PPF), Regeneron (asthma, diabetes, NP, RSV, AD), Chiesi (asthma), Baxter (bronchiectasis), Insmed (bronchiectasis), AstraZeneca (asthma, cough)Advisor/Advisory Board: Sanofi (asthma, AD, NP), Regeneron (asthma, AD), Chiesi (asthma), Boehringer Ingelheim (IPF, PPF), AstraZeneca (asthma, cough)Speaker: Sanofi (asthma, NP, AD, AFRS, urticaria, EoE), Regeneron (asthma, NP, AD, AFRS, urticaria, EoE), Boehringer Ingelheim (IPF, PPF), AstraZeneca (asthma, cough), Chiesi (asthma), Baxter (bronchiectasis)These relationships have ended within last 24 months:Consultant: GSK (asthma, cough, RSV)Advisor/Advisory Board: GSK (asthma, cough, RSV)Speaker: GSK (asthma, cough, RSV)Diego J. Maselli, MD, FCCP, ATSFProfessor and ChiefDivision of Pulmonary Diseases & Critical CareUT Health at San AntonioDirector, Respiratory Care, University Health SystemDirector, Severe Asthma Program, University Health SystemSan Antonio, TXDr. Maselli has disclosed the following financial relationships:Consultant: AstraZeneca (asthma, COPD), Sanofi/Regeneron (asthma, COPD), GSK ( asthma, COPD), Amgen (asthma, COPD), Insmed (bronchiectasis)Speaker: GSK (asthma, COPD), AstraZeneca (asthma, COPD), Amgen (asthma, COPD), Sanofi/Regeneron (asthma, COPD)All of the relevant financial relationships listed for these individuals have been mitigated.Nurse Planner and Peer ReviewerMarjorie Crabtree, DNP, FNP, ANPHaymarket Medical EducationSteering CommitteeNurse Practitioner Healthcare FoundationAccredited Provider Program DirectorBellevue, WADr. Crabtree has no relevant conflicts of interest with any ACCME-defined ineligible company.Accredited Provider DisclosureNACE staff has no relevant financial relationships to disclose.Intended AudiencePulmonology, allergy/immunology, and critical care clinicians (physicians, nurse practitioners, and physician associates), as well as primary care and geriatric medicine clinicians caring for patients with asthma.Commercial SupportersThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.Please visit  http://naceonline.com to engage in more live and on demand CME/CE content.

Pharma and BioTech Daily
FDA Fast-Tracks Eli Lilly & Regeneron | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 1, 2026 4:41


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 significant advancements and strategic shifts reshaping the industry landscape. To begin, the U.S. Food and Drug Administration has taken a noteworthy step by selecting key industry players, including Eli Lilly, Regeneron, Fujifilm, and Kriya Therapeutics, for its PreCheck pilot program. This initiative is designed to enhance U.S. drug manufacturing capabilities, emphasizing the importance of robust domestic production. By reducing dependency on international supply chains, the program aims to expedite the delivery of critical therapies, highlighting a strategic move towards self-reliance in pharmaceutical manufacturing. In oncology news, Beone's Brukinsa (zanubrutinib), a small molecule BTK inhibitor, has demonstrated a remarkable 43% reduction in risk of progression for patients with first-line mantle cell lymphoma in its Phase 3 trial. This breakthrough offers a promising chemotherapy-free option for non-Hodgkin lymphoma treatment, marking significant progress in targeted cancer therapies that could improve patient outcomes in previously underserved areas. Meanwhile, Boulevard Bio and Metis TechBio have sealed a substantial licensing agreement valued at $1.6 billion for MTS-128, a trispecific T-cell engager aimed at autoimmune diseases. This collaboration reflects a broader industry trend towards leveraging advanced AI and machine learning technologies to enhance the development of precision medicine and personalized therapies. Such partnerships indicate a shift towards more innovative approaches to tackling complex disease mechanisms and illustrate burgeoning interest in multispecific biologics within immunotherapy domains—offering new avenues for targeting multiple disease pathways simultaneously. On the regulatory front, Sanofi is advancing efforts to expand the U.S. label for Nexviazyme (avalglucosidase alfa) following successful Phase 3 trials for infantile-onset Pompe disease. As an enzyme replacement therapy targeting GAA enzyme deficiency, Nexviazyme could address a critical gap in treatment options for this debilitating genetic disorder, underlining the importance of regulatory pathways in facilitating access to life-saving therapies. Financially, Beeline Medicines has garnered $126.3 million in Series A extension funding to propel its autoimmune programs originally sourced from Bristol Myers Squibb. Similarly, SmartBax has raised €6.3 million to advance its lead antibiotic program targeting multi-drug resistant infections. These investments underscore an unwavering focus on addressing unmet medical needs through innovative therapeutic solutions. Regulatory challenges persist as well; Unicycive Therapeutics faced FDA rejection due to third-party manufacturing deficiencies surrounding oxylanthanum carbonate. This setback emphasizes the critical importance of maintaining rigorous quality standards throughout drug production processes to secure regulatory approvals and ensure patient safety. Globally, China has achieved a milestone with the approval of the world's first CAR-T therapy for solid tumors—a significant leap forward given the historical challenges of applying CAR-T technology beyond hematological malignancies. This approval could transform cancer treatment paradigms globally and prompt similar regulatory advancements in other regions. In other developments, Abbvie and Genmab's combination therapy involving Epkinly has shown promise in diffuse large B-cell lymphoma (DLBCL) trials following prior challenges with monotherapy approaches. This success story highlights the potential of combination therapies in enhancing outcomes for patients battling complex cancers like DLBCL. From a corporate perspective, Klick Health's acquisition of Oxford Pharmagenesis marks its third purchase in 18 months, expanding its global footprint and scientific capabilities—a testament to ongoing consolidation trends aimed at augmenting expertise and strategic growth within the sector. These developments collectively paint a picture of an industry dynamically evolving amidst scientific breakthroughs and regulatory recalibrations. As companies navigate this transformative landscape, their ability to adapt and innovate remains paramount for sustaining growth and addressing global healthcare challenges effectively. Stakeholders must remain agile to seize opportunities while mitigating inherent risks in this high-stakes environment that increasingly prioritizes patient-centric innovations.Support the show

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Tzield, Retatrutide, New Clues About Type 1 and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jun 30, 2026 15:02


It's In the News - a look at the top diabetes headlines and stories happening now. Our top stories: More information about type 1 and COVID, including the vaccine, why is the latest GLP-1 medication, not yet FDA approved, showing up all over the place, what table sugar and vinegar could mean for drug costs, a new inhaled insulin study and much more  I'll see you at Friends for Life next week. Come find me at Table T18 Learn more about our in-person events here: https://diabetes-connections.com/events/ Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Omnipod - Simplify Life All about Dexcom  All about VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Transcript & links:    Okay.. our top story this week: XX A large Swedish study found that the increased risk of being diagnosed with type 1 diabetes after COVID-19 infection is mostly limited to the first 30 days after infection and does not continue long term. Researchers followed nearly the entire Swedish population under age 80 from 2020 through 2023 and found that while SARS-CoV-2 infection was linked to a temporary rise in new type 1 diabetes diagnoses, the risk declined over time. The study also found no evidence that COVID-19 vaccination increases the long-term risk of developing type 1 diabetes. Vaccination did not significantly change the relationship between COVID-19 infection and diabetes risk, and any small increase in diagnoses seen among adults shortly after a first vaccine dose was not seen after later doses or during longer follow-up. The researchers concluded that their findings do not support changing current COVID-19 vaccination recommendations because of concerns about type 1 diabetes risk. https://www.infectiousdiseaseadvisor.com/news/covid19-infection-may-increase-short-term-type-1-diabetes-risk/ XX Two new studies are challenging the traditional view that type 1 diabetes develops solely because the immune system attacks insulin-producing beta cells. Researchers from Indiana University found evidence that beta cells themselves may play an active role in determining whether they survive or succumb to the stresses that lead to type 1 diabetes. In the first study, scientists discovered that some healthy human beta cells can quickly activate an antiviral defense system when exposed to interferon-alpha, an immune signal often produced during viral infections. This response relies on molecules called reactive oxygen species (ROS), which are usually associated with cell damage but, in this case, appeared to help switch on protective antiviral genes. Researchers found this defense program in healthy cells and in people at risk for type 1 diabetes, but not in beta cells from people who already had the disease. The findings suggest that losing this built-in defense mechanism may make beta cells more vulnerable during the development of type 1 diabetes. The second study focused on autophagy, the process cells use to recycle damaged or worn-out components. Using a new imaging technique, researchers observed that beta cells in a mouse model of type 1 diabetes showed defects in autophagy before blood sugar levels began to rise and even before a full immune attack was underway. This suggests that problems inside the beta cells may occur early in the disease process rather than being caused entirely by the immune system. Together, the studies point to a more complex picture of type 1 diabetes. While they do not show that beta-cell defects cause the disease, they suggest that differences in how beta cells respond to stress, viral signals, and cellular damage may influence who develops type 1 diabetes and how the disease progresses. https://medicalxpress.com/news/2026-06-beta-cells-players-diabetes.html XX Researchers have created the most detailed map yet of how the human pancreas develops during childhood, offering new clues about why children are especially vulnerable to developing diabetes. The study, published in Nature Communications, examined pancreatic tissue from 123 children without diabetes, ranging from newborns through age 10. Using advanced imaging techniques, scientists tracked how insulin-producing islet cells grow and mature during the first decade of life. The researchers found that pancreas size varies dramatically at birth, with some infants having pancreases nearly four times larger than others. They also discovered that insulin-producing beta cells grow more slowly after birth than previously thought, suggesting that much of a person's lifelong beta cell capacity may be established before birth and during early childhood. Other findings showed that insulin-producing cells mature earlier than glucagon-producing cells and that new hormone-producing cells may continue to form after birth. The researchers hope this new understanding of pancreas development will help scientists identify diabetes risk earlier and develop better strategies for prevention and treatment in children. https://news.vumc.org/2026/06/29/unlocking-diabetes-secrets-pediatric-organ-donors-help-map-a-path-to-a-cure-and-prevention/   XX At the American Diabetes Association annual meeting, 2-year results from the SUPPRESS-EARLY trial showed that initiating tirzepatide (Mounjaro, Zepbound) early in the course of type 2 diabetes led to substantially higher rates of near-normal glycemic control and also led to broader metabolic improvements compared with intensive conventional therapy.   In this MedPage Today video, investigator Stefano Del Prato, MD, of the University of Pisa in Italy, discusses the findings.     Following is a transcript of his remarks:   What happened is that in the tirzepatide-treated arm, 85% of the population at the end of the second year was on the maximum dose of tirzepatide 15 mg. And then the remaining 15 with the different doses.   Interestingly, in the population that had been treated with the intensive conventional approach, 85% of them ended up to have, on top of metformin, a GLP-1 receptor agonist, mainly represented by subcutaneous semaglutide [Ozempic, Wegovy], 60+%, another 15% on oral semaglutide [Rybelsus], and the remaining on dulaglutide [Trulicity].   And I have to say that maybe the recommendation to really push along the line to try to achieve and to strive to achieve [glycemic] control was successful in these individuals. Because the population that had been recruited in the study started off with a baseline A1C of 7.8% and it went down to 6.3% in the conventionally intensive treatment, which is not bad at all, on average is below the target of 6.5%.     However, when we look at the effect of tirzepatide, the final level of A1C at the end of the second year was 5.6%, which is on average below the upper limit of the normal range for A1C, 5.7%. This also translates into more people not only achieving normal glycemia, if we can define normal glycemia as A1C below 5.7%, greater than what we observed in conventionally treated individuals. So it was around three times more people achieving an A1C of 5.7%, in the range of around 65%, as compared to 28% with people on a conventional optimized treatment.   Now, this is not surprising knowing the potency of tirzepatide. But again, going back to the rationale of the design, can we change what is the natural history of the disease? This seems to be at least of interest and it's possibly changing the trajectory of the disease for glycemic control, as I mentioned, but also in terms of the body weight and waist circumference because both body weight and waist circumference went much lower with tirzepatide compared to the conventional treatment.   Tirzepatide also was associated with an improvement in the lipid profile, in particular with the LDL, triglycerides, and the triglyceride concentration and non-HDL cholesterol, and also with a statistically significantly lower systolic blood pressure with a numerical reduction in the diastolic blood pressure.   And also the other thing that probably will ... become more apparent with the study continuing is that the investigators were allowed to add on any other treatment ... needed to achieve their target. So tirzepatide was just metformin and tirzepatide. In the control group, there was already 10% of people who were receiving two drugs on top of the metformin.   So another potential result of the trial is that it's possible to achieve and maintain better glycemic or better metabolic control over the time without really needing to increase the number of medications in order to achieve that goal. And we know that type 2 diabetes is a progressive condition often requiring intensification of the treatment.   So these initial results really stand for a great opportunity with tirzepatide. Of course, we need to wait for the 4 years just to confirm that this is indeed the case, but the initial result seems to point along that line. https://www.medpagetoday.com/meetingcoverage/adavideopearls/121967 XX A study from the University of Virginia found that high blood pressure is extremely common among people with diabetes, even among those who believe their blood pressure is under control. Researchers measured blood pressure in 172 adults with type 1 or type 2 diabetes during routine eye clinic visits and found that only 8% had normal readings. About half had stage 2 hypertension, and more than 10% had blood pressure levels high enough to be considered a medical emergency. The study also revealed that many patients were unaware of how serious their blood pressure problems were. Among those who thought their hypertension was well controlled, more than half still had stage 2 hypertension. Nearly 60% of participants were advised to contact their primary care provider, and one patient required an emergency department referral. Most patients supported blood pressure screening during eye exams, leading researchers to suggest that routine blood pressure checks in ophthalmology clinics could help identify undiagnosed or poorly controlled hypertension before it leads to serious complications such as heart attack, stroke, or worsening diabetic eye disease. https://medicalxpress.com/news/2026-06-routine-eye-exams-reveal-stage.html XX What is going on with retatrutide? This is the next generation GLP-1 but it's not authorized outside of clinical trials. Big investigation by CBS shows retatrutide is for sale all over the internet, a phenomenon they say has no modern precedent. CBS News identified more than 120 websites selling or promoting retatrutide, including more than 50 clinics staffed by licensed medical professionals. After being contacted by CBS News, at least 21 clinics abruptly removed retatrutide from their websites or changed the language to state they don't offer it. Others defended prescribing it, saying they're confident enough in results from clinical trials sponsored by drugmaker Eli Lilly that they didn't need to wait for the FDA's independent, rigorous review. An FDA spokesperson said retatrutide "has not been found safe or effective for any condition," adding that it "cannot be manufactured or distributed except for investigational use." The Justice Department is prosecuting two cases – in Utah and Florida – involving the sale and prescription of retatrutide. But the first line of enforcement is often at the state level. Ohio's Board of Pharmacy has taken action against several pharmacies and clinics providing retatrutide, and just last month, Alabama's Medical Board warned physicians against prescribing research-grade medications. The FDA has sent 14 warning letters to companies that have advertised retatrutide since 2024. Of these, at least six have continued to offer it online, including a business called Pink Pony Peptides. A TikTok account associated with the firm responded to the warning in April by taunting the FDA, boasting that the business "just had the best 24 hours ever." In May, Eli Lilly announced that participants in a large clinical trial taking the highest dose of retatrutide lost an average of 28% of their body weight over 80 weeks. Side effects – including nausea, diarrhea, constipation and vomiting – were comparable to similar therapies, the company said. "Anyone purporting to sell retatrutide to consumers is breaking the law," an Eli Lilly spokesperson said https://www.cbsnews.com/projects/2026/experimental-weight-loss-drug/ XX Pioneering research has developed a new way of creating carbohydrate-based medicines, which could ultimately replace costly drugs for common health conditions, using two cheap basic ingredients – table sugar and vinegar. These medications include SGLT2 inhibitors, widely prescribed drugs used to treat type 2 diabetes, heart failure and chronic kidney disease. Co-lead author Professor Phil Baran, Dr. Richard A. Lerner Endowed Chair at Scripps Research, in San Diego, California, said: "The point of this is to show that anyone in a garage can make an SGLT2 inhibitor with reagents that are widely available. We have not patented this method, so we welcome any generic drug company – or anyone else – who wants to use it to help bring costs down for patients." https://www.newswise.com/articles/new-study-shows-table-sugar-could-hold-a-cheaper-quicker-key-to-making-vital-drugs-for-diabetes-heart-failure-and-chronic-kidney-disease XX England and Wales approve teplizumab to slow progression of T1D. At the moment, the Scottish Medicines Consortium does not have an appraisal of Tzield on the go, so, there is likely to be a disparity in access within the UK for the time being. In Northern Ireland, access will depend on a review and adoption of NICE guidance.  Sanofi is expecting to see an uptick in momentum thanks to two subsequent FDA approvals, one in children as young as one with stage 2 T1D, and a second to delay the decline in endogenous insulin production in children aged eight to 17 years recently diagnosed with stage 3 T1D. btw you might here more people referring to stage 4 diabetes. They've added that to include people diagnosed with type 1 who've been on insulin for a longer period of time – basically long enough to not be eligible for the current guidelines for Tzield. https://www.bbc.com/news/articles/ce8mzd94r76oXX XX Obesity Association, a division of the American Diabetes Association® (the association), announced the next section in the Standards of Care in Overweight and Obesity, "Screening, Diagnosis, Evaluation, and Staging of Obesity in Adults," published in Diabetes, Obesity, and CardioMetabolic CARE® and BMJ Open Diabetes Research & Care.  Key highlights of the guidance: Early screening: Annual BMI screening with emphasis on tracking weight trends to identify risk earlier, including a longitudinal life-event weight graph tool for standardized assessment. Enhanced diagnosis: Combines BMI with waist measurements and population-specific thresholds to improve accuracy. Notably, the guidelines recommend that BMI in the overweight range together with central adiposity measurements warrant a formal obesity diagnosis. Comprehensive evaluation: Holistic assessment including medical, behavioral, and social factors. Offers a fully integrated obesity diagnostic algorithm. Risk stratification: Use of tools like the Edmonton Obesity Staging System to guide care. Chronic care approach: Ongoing monitoring and follow-up to support long-term management. Reducing bias: Promotes person-centered, non-stigmatizing care and system-level improvements at the clinical workflow level and encourages screening for prior weight bias/stigma experiences. https://www.prnewswire.com/news-releases/new-standards-of-care-in-overweight-and-obesity-section-screening-diagnosis-evaluation-and-staging-of-obesity-in-adults-302809670.html XX Dexcom (Nadsaq:DXCM) today announced the launch of its fully reimagined Stelo over-the-counter (OTC) sensor app experience. San Diego-based Dexcom plans to formally begin the new app rollout in July for Apple iPhone and Android users in the U.S. Dexcom said its reimagined app aims to make glucose insights easier to understand and act on. It hopes to help build awareness of how food, activity, sleep and stress influence overall wellbeing.   The company also reiterated plans to launch Stelo internationally. It expects to bring the sensor to the UK, Australia, New Zealand and South Korea later this year, continuing into 2027. https://www.drugdeliverybusiness.com/dexcom-launches-enhanced-stelo-app/ XX MannKind Corporation recently announced it received a grant from Breakthrough T1D to support the INHALE-1 clinical study of Afrezza, its ultra rapid-acting inhaled insulin, in newly diagnosed pediatric type 1 diabetes patients aged 10 to under 18 years. This external funding for a trial focused on early use of Afrezza in children highlights growing third-party support for inhaled insulin in pediatric diabetes care. https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-mnkd/mannkind/news/afrezza-pediatric-trial-grant-might-change-the-case-for-inve XX Alexander Zverev heads into Wimbledon with plenty of momentum. The French Open champion returns to the All England Club looking to build on his first Grand Slam title and gain ground on Carlos Alcaraz in the race for the No. 2 spot in the ATP rankings. Zverev has an opportunity to make up points quickly after a first-round exit at Wimbledon last year. But his final tune-up before Wimbledon came with an unexpected challenge. During his semifinal loss to Taylor Fritz at the Halle Open, Zverev said a malfunctioning glucose sensor led to serious diabetes management issues on court. The sensor incorrectly showed his blood sugar was high when it was actually low, causing him to take more insulin than needed. "I had huge problems with the sugar because the sensor I use gave me a completely incorrect reading," Zverev said after the match. "During the match, or rather during the first 45 minutes, I had to consume about 350 grams of sugar. I felt absolutely terrible." Despite feeling unwell, Zverev pushed the match to three sets before falling 6-7(4), 6-4, 7-5 to Fritz. He credited his opponent with playing the better match and said the diabetes-related issue was not an excuse for the result. Zverev, who was diagnosed with type 1 diabetes at age 4, uses Medtronic diabetes technology to help manage his glucose levels while competing on the ATP Tour. He said the sensor error was the first major problem he has experienced after nearly a decade of using the technology. The German said the incident should not affect his Wimbledon preparations. With the sensor issue behind him, Zverev will begin his Wimbledon campaign focused on adding another strong result to what has already been a breakthrough season.   https://www.reuters.com/sports/tennis/zverev-says-glucose-sensor-malfunction-affected-halle-semi-final-loss-fritz-2026-06-21/

OncLive® On Air
S17 Ep40: Medical Crossfire®: Turning Therapeutic Innovation Into Practice—Personalizing Care in Multiple Myeloma

OncLive® On Air

Play Episode Listen Later Jun 30, 2026 30:46


Highlights from the PER® CME activity "Medical Crossfire®: Turning Therapeutic Innovation Into Practice—Personalizing Care in Multiple Myeloma" — this podcast is not certified for credit. To participate in the full accredited activity and earn CME credit, use the link below.In this podcast, experts Philippe Moreau, MD; Suzanne Lentzsch, MD, PhD; and Shaji Kumar, MD, discuss therapeutic innovations in the treatment of multiple myeloma, including frontline quadruplet therapy, administration considerations for therapy, and optimal sequencing of CAR T-cell therapy, bispecific antibodies, and antibody-drug conjugates.Earn CME credit by completing the full accredited activity (available through June 5, 2027):https://www.gotoper.com/courses/medical-crossfire-turning-therapeutic-innovation-into-practicepersonalizing-care-in-multiple-myeloma-p2f5This podcast, including the narration, was developed by PER® (Physicians' Education Resource®, LLC) editorial staff from the full online CME activity developed with these faculty. The narration was voiced by a PER staff member or by an AI tool. The podcast contains no product advertising. The full activity is supported by an educational grant from Sanofi.This content is for educational purposes only and is not a substitute for the independent clinical judgment of a health care professional. Faculty may discuss investigational or off-label uses; consult prescribing information for any products discussed.

UXpeditious: A UserZoom Podcast
How to close the growth gap: turning customer insights into business results with Robyn Bolton

UXpeditious: A UserZoom Podcast

Play Episode Listen Later Jun 29, 2026 30:10


Episode summary: In this episode of Insights Unlocked, Nathan Isaacs sits down with Robyn Bolton, founder of Mile Zero and author of Unlocking Innovation: A Leader's Guide to Turning Bold Ideas into Tangible Results, to explore why innovation fails so often inside successful companies—and what leaders can do about it. Drawing on her experience at P&G, BCG, and Innosight (Clayton Christensen's firm), Robyn shares the frameworks, mindset shifts, and leadership behaviors that separate real innovation from the illusion of it. Robyn makes the case that innovation isn't an idea problem—it's a leadership problem. She dives into how to set the right conditions before any brainstorming begins, why "innovation theater" breeds cynicism rather than creativity, and how customer insights are the most underutilized asset in most organizations. She also weighs in on AI: what separates the companies genuinely benefiting from it versus those just chasing the next shiny object. You'll learn: Why innovation is a leadership problem, not an idea problem How to define a "growth gap" before you ever go to the whiteboard What "innovation theater" looks like and why it backfires Why customer insights are everyone's job—not just the research team's How to build a culture of innovation (and why it takes years, not events) What separates companies getting real value from AI from those just experimenting A practical "George Costanza" leadership habit you can try this week Innovation starts with leadership, not ideas Robyn Bolton has spent her career helping large, successful companies do something that doesn't come naturally to them: innovate. From launching Swiffer at P&G to working with companies like Medtronic, Nike, and Sanofi, she's seen firsthand what makes innovation work—and what kills it. Her core argument is simple but counterintuitive: innovation doesn't fail because companies run out of ideas. It fails because leaders don't create the conditions for those ideas to survive. Culture, she says, is "the perception of what matters, as evidenced by the actions of executives." If you want a culture of innovation, you have to invest in it consistently for years—not just run an annual hackathon and hope for the best. Customer insights are everyone's job Few topics generate more conviction from Robyn than customer insights. She believes deeply that understanding customers—not just gathering data about them—is a responsibility that belongs to everyone in an organization, including executives. Her prescription is simple: get out of the office, be present with customers in their actual environment, and have the humility to listen rather than explain. Too many "insight sessions" turn into selling sessions, she notes. Real discovery means asking open-ended questions and resisting the urge to justify why the product works the way it does. She shared a vivid example: while working with a medical device company, she and the president of the business unit watched video footage of patients using their products. Within ten minutes, R&D team members were shouting at the screen—convinced the patients were doing it wrong. "They're not wrong," Robyn said. "They're teaching us." Resources & links Robyn's website, Mile Zero (https://www.milezero.io/) Robyn's book, Unlocking Innovation (https://www.amazon.com/Unlocking-Innovation-Leaders-Turning-Tangible/dp/1774585618) Robyn's personal website (https://robynmbolton.com/) Robyn on LinkedIn (https://www.linkedin.com/in/robynmbolton/) Nathan Isaacs on LinkedIn (https://www.linkedin.com/in/nathanisaacs/) Learn more about Insights Unlocked: https://www.usertesting.com/podcast

Pharma and BioTech Daily
Replimune's RP1 Resubmission to FDA: Will It Finally Pass? | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jun 29, 2026 5:11


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 transformative events reshaping the landscape of this dynamic industry. Replimune has made headlines with the resubmission of its oncolytic virus-based immunotherapy, RP1, to the U.S. Food and Drug Administration for treating advanced melanoma. The FDA's acceptance after two prior rejections is significant, suggesting a shifting regulatory landscape that could favor innovative cancer therapies like oncolytic viruses. These therapies represent a novel approach to engage the immune system in targeting tumors, and if RP1 gains approval, it may open doors for similar treatments, potentially offering new hope for melanoma patients. On the regulatory side, Amgen has encountered challenges with Tavneos after losing European Union endorsement due to data integrity issues. This serves as a stark reminder of the critical importance of maintaining stringent data management throughout drug development. With an FDA hearing on the horizon, the implications are far-reaching, emphasizing increased scrutiny from regulatory bodies worldwide. This scenario could lead to more rigorous guidelines governing data practices in the future. The European Commission's approval of Henlius' Hetronifly as a first-line treatment for squamous non-small cell lung cancer marks a milestone in cancer immunotherapy. This approval highlights the ongoing efforts to improve patient outcomes through innovative PD-1 inhibitor-based combination therapies, showcasing progress in the fight against one of the most challenging forms of cancer. Epicrispr Biotechnologies brings promising news from its phase 1/2 trial of EPI-321, a gene therapy for facioscapulohumeral muscular dystrophy. The trial's success in enhancing muscle function through epigenetic silencing underscores significant advancements in gene therapy applications for neurological disorders. Similarly, Abbisko Therapeutics' phase 2 trial reports a 90% objective response rate using FGFR2/3 and PD-L1 inhibitors for gastric cancer, demonstrating the potential of targeted small molecule therapies in oncology. In financial developments, Definium Therapeutics and Ligachem Biosciences have made substantial funding strides to bolster their drug development pipelines. Definium's $805 million raise aims to advance psychiatric and neurological treatments, while Ligachem's funding will enhance its antibody-drug conjugate platforms. These investments reflect strong investor confidence in next-generation therapeutic platforms and underscore innovative financing strategies crucial for sustaining research and development efforts. Bayer's recent legal victory at the Supreme Court overturning a $1.25 million verdict related to its Roundup product is another focal point. This ruling not only positively impacts Bayer's financial standing but also highlights the complexities surrounding product liability cases within pharmaceuticals and agrochemicals. Strategically, Moderna has unveiled an ambitious R&D roadmap aiming for break-even by 2028 with over seven new products on the horizon. By focusing on mRNA vaccines for oncology and rare diseases, Moderna continues to leverage its technology beyond COVID-19 applications, potentially transforming treatment paradigms across various therapeutic areas. Shifting focus to industry trends, Sanofi finds itself under investigation by the European Commission for antitrust violations linked to its flu vaccine marketing practices. This situation underscores growing scrutiny over competitive practices within the pharmaceutical sector and could influence regulatory compliance strategies across global markets. In technological advancements, Eli Lilly is employing artificial intelligence to raise awareness about Alzheimer's disease through creative engagements like a European radio show road trip. These initiatives reflect an industry-wide shift towards technology-driven marketing strategies aimed at personalizing patient interactions. Lastly, Merck KGaA's $11 billion acquisition of Bio-Techne exemplifies a strategic move to enhance capabilities in immune cell therapy production. This deal underscores the growing importance of manufacturing innovations in bringing advanced therapies to market and highlights strategic collaborations increasingly seen across the sector. The landscape is further defined by significant scientific breakthroughs such as Revolution Medicines' development of a second RAS blocker, showing improved chemotherapy responses in pancreatic cancer patients. These advancements underscore the need for continued investment in targeted therapeutics research as they promise better patient outcomes and highlight ongoing innovation within oncology. As these developments unfold, they reflect an industry poised for transformation amid evolving scientific, regulatory, and market dynamics aimed at improving patient care globally. With these insights into current trends and future directions, it's clear that the pharmaceutical and biotech sectors are navigating a period rich with potential for groundbreaking advancements that will shape healthcare outcomes worldwide.Support the show

Molecule to Market: Inside the outsourcing space
From Big Pharma to Biotech CEO

Molecule to Market: Inside the outsourcing space

Play Episode Listen Later Jun 26, 2026 53:46


In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Rachel Sha, CEO at Terrestrial Bio.   Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology ecosystem with Rachel, covering: Navigating the Genzyme Sanofi acquisition and building a leadership career on the other side of the transaction Being in the right place at the right time to pursue entrepreneurship, and the steep learning curve of stepping into a biotech CEO role The decision to adopt a dual strategy, partnering with biopharma on a platform technology while also advancing internal programs Leading a $50M Series C raise in a challenging funding environment and evolving the company's identity The real world trade offs between building manufacturing capabilities in house versus outsourcing to CDMOs Rachel Sha is the CEO at Terrestrial, a company focused on transforming the delivery of next generation therapies with its microarray skin patch that provides a patient friendly experience that is injection free and without the hassle of cold chain.  Prior to Terrestrial, she was an Operating Partner at Engine Ventures, a venture fund spun-out of MIT that invests in Tough Tech companies primarily in the Boston area.  She advised companies and worked with the investment team in exploring investment themes, opportunities, and programming.  Before her time in venture, she spent seventeen years at Genzyme and Sanofi where she held leadership positions in business development, strategy, and commercial.  Her last role at the firm was the Global Vice President of Digital Strategy, Partnering and Governance at Sanofi where she led global strategy, business development, and governance of digital programs to transform Sanofi and healthcare.   She has long been a supporter of developing women entrepreneurs and has supported organizations like Mass Next Gen and Springboard Enterprises.  She was recognized by the Boston Business Journal in the 2025 class of Women Who Lead in Life Sciences.  Rachel holds a BS from Massachusetts Institute of Technology in Chemistry and an MBA from Harvard Business School.   Please note: Vaxess Technologies is now Terrestrial (Terrestrial Bio, Inc.). This change reflects a brand evolution and is not part of a merger or acquisition. There has been no change in control or operations. All contracts, relationships and business activities continue uninterrupted under our new name.   Molecule to Market is also sponsored by Bora Pharmaceuticals, and supported by Lead Candidate. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!

Não Inviabilize
DIFÍCIL DE ENGOLIR

Não Inviabilize

Play Episode Listen Later Jun 25, 2026 24:46


Alarme é um quadro do canal Não Inviabilize. Aqui você ouve as suas histórias misturadas às minhas!Use a hashtag #DificilDeEngolir e comente a história no nosso grupo do telegram: https://t.me/naoinviabilizePUBLICIDADE SANOFI E ESOFAGITE EOSINOFÍLICAComo parte da campanha “Difícil de engolir é não tratar a EoE”, da Sanofi, esse episódio conta a jornada de uma paciente de Esofagite Eosinofílica, com depoimentos de Dr. Gabriel Benevides, CRM 152074, e Dra. Mariele Morandin, CRM 162098. O relato é baseado na experiência real da paciente e não constitui evidência de estudos clínicos, utilizado apenas para fins de conscientização. Para ter as referências e saber mais, acesse: www.dificildeengolir.com.br / MAT-BR-2602010QUER OUVIR MAIS HISTÓRIAS? BAIXE NOSSO APLICATIVO EM SUA LOJA APPLE/GOOGLE, CONHEÇA NOSSOS QUADROS EXCLUSIVOS E RECEBA EPISÓDIOS INÉDITOS DE SEGUNDA A SÁBADO: https://naoinviabilize.com.br/assineEnvie a sua história bem detalhada para naoinviabilize@gmail.com, seu anonimato será mantido, todos os nomes, profissões e locais são trocados para preservar a sua identidade.Site: https://naoinviabilize.com.brTranscrição dos episódios: https://naoinviabilize.com.br/episodiosYoutube: https://youtube.com/naoinviabilizeInstagram: https://www.instagram.com/naoinviabilizeTikTok: https://www.tiktok.com/@naoinviabilizeX: https://x.com/naoinviabilizeFacebook: https://facebook.com/naoinviabilizeEdição de áudios: Depois O Leo Corta MultimídiaVinhetas: Pipoca SoundVoz da vinheta: Priscila Armani

ESC TV Today – Your Cardiovascular News
Season 4 - Ep.12: Potassium in heart failure - PCI guidance by intracoronary imaging

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jun 25, 2026 21:57


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.

ESC TV Today – Your Cardiovascular News
Season 4 - Ep.12: Extended interview on PCI guidance by intracoronary imaging

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jun 25, 2026 20:34


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.

Pharma and BioTech Daily
Carsgen's $2T Satricabtagene Approval Milestone | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jun 24, 2026 5:14


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're delving into the latest scientific breakthroughs, regulatory advancements, and strategic industry movements that are shaping the landscape of healthcare innovation. Kicking off with significant strides in drug approvals, Carsgen Therapeutics has marked a major milestone with the approval of satricabtagene autoleucel by China's National Medical Products Administration. This cell therapy is designed to target Claudin18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma, a notoriously tough solid tumor. The approval follows successful Phase 2 trials, underscoring progress in targeted cancer therapies—a field particularly crucial for gastric cancers due to their heterogeneous nature. Meanwhile, Sanofi's Cenrifki (tolebrutinib) has gained approval in the EU for secondary progressive multiple sclerosis treatment. As a small molecule BTK inhibitor, it demonstrated efficacy during Phase 3 trials, providing a new avenue for managing progressive neurological disorders. This approval marks an important addition to therapeutic options for conditions with historically limited treatments. In parallel developments reflecting the shift towards precision medicine, Pierre Fabre's Braftovi (encorafenib) received European Commission approval as a first-line treatment for BRAF V600E-mutant metastatic colorectal cancer. Similarly, Gilead Sciences' Trodelvy (sacituzumab govitecan) has been approved as a first-line treatment for unresectable or metastatic triple-negative breast cancer in the EU, highlighting the expanding role of antibody-drug conjugates in oncology. AbbVie's Skyrizi (risankizumab) also gained European endorsement for pediatric use in moderate to severe plaque psoriasis. As an IL-23 inhibitor monoclonal antibody, Skyrizi exemplifies the growing trend of biologics targeting autoimmune conditions with high specificity and efficacy. On the regulatory front, the U.S. Department of Health and Human Services and FDA have launched an unprecedented initiative to reduce clinical trial timelines. This reform aims at reinforcing U.S. leadership in drug development by addressing operational efficiencies crucial for accelerating new therapies' availability, especially in oncology and rare diseases. Efforts to expedite Phase 1 clinical trials by up to 12 months are underway by federal health agencies aiming to enhance U.S. competitiveness against China's burgeoning clinical development capabilities. Economic forecasts are predicting that Eli Lilly's tirzepatide will lead a surge in global drug sales driven by obesity treatments, potentially reaching $2 trillion by 2032. As a GLP-1 receptor agonist, tirzepatide's success underscores the growing emphasis on metabolic disorders as major therapeutic targets due to their widespread prevalence and impact on public health. Strategic partnerships continue to shape the industry landscape. Merck KGaA and Versant Ventures have launched Saturnus Bio with a $50 million investment aimed at advancing therapies for rare genetic heart diseases. In another instance of strategic collaboration, Bayer is working with Iambic Therapeutics to leverage AI-driven discovery for challenging small-molecule targets, reflecting an increasing reliance on artificial intelligence to overcome traditional drug discovery hurdles. In clinical trials, Corxel Pharmaceuticals' CX11 met primary endpoints in Phase 2 studies for obesity, showcasing promising weight loss results with an oral GLP-1 small molecule. This advancement could potentially offer more accessible treatment options compared to injectable formulations. However, challenges persist as seen with Sangamo's bankruptcy filing amidst acquisition interest from Eli Lilly and Astellas, highlighting financial vulnerabilities even among pioneering gene therapy entities. Additionally, setbacks in pivotal trials like Exelixis' Zanzalintinib missing its colorectal cancer endpoint illustrate the high-risk nature of oncology drug development despite anticipated FDA approval. Across the sector, Pfizer's acquisition of Seagen faced hurdles when their antibody-drug conjugate sigvotatug vedotin failed in a Phase 3 trial for non-small cell lung cancer. This setback highlights risks inherent in biopharmaceutical investments and innovations. As these developments unfold, they reflect a dynamic industry driven by scientific innovation, strategic collaborations, and regulatory shifts aimed at enhancing patient care through more effective and tailored therapies. The increasing integration of technology such as AI in drug discovery further underscores the evolving landscape of pharmaceutical R&D toward precision medicine and operational efficiency. Today's insights not only signify groundbreaking scientific advances but also illustrate how companies adapt to regulatory environments and market opportunities—all critical elements that will shape the future direction of global healthcare delivery. Stay tuned for more updates as we continue exploring these transformative changes across the pharmaceutical and biotech industries on Pharma Daily.Support the show

BioSpace
AbbVie keeps M&A rolling, FDA's reversal train chugs along, BIO 2026 dispatch, more

BioSpace

Play Episode Listen Later Jun 24, 2026 21:36


This year has been partly defined by a return to M&A. In the first quarter of 2026, biopharma spent nearly $47 billion in acquisitions across 19 deals, and this week, AbbVie notched another one for the second quarter, scooping up Apogee Therapeutics and its IL-23 blocker for atopic dermatitis for around $10.9 billion. The deal follows GSK's $10.6 billion Nuvalent Bio acquisition earlier this month. These deals come as several big pharmas face patent cliffs. Sanofi, for example, will lose patent protection on Dupixent in 2031. New CEO Belén Garijo made a major play to build out Sanofi's pipeline this week, announcing that Xaira veteran Paulo Fontoura will step in as R&D chief as Houman Ashrafian exits.  Another key trend over the past 18 months has been regulatory uncertainty. This trend continues, with both uniQure and REGENXBIO announcing FDA reversals for their gene therapies for Huntington's disease and Hunter syndrome, respectively. Both companies will submit for approval of their products—a first submission for uniQure and a resubmission for REGENXBIO—in the third quarter, after the agency, under the leadership of acting commissioner Kyle Diamantas, deemed their current data sufficient. Also at the FDA, a policy memo on the agency's consideration of Sanofi's Commissioner's Priority Review Voucher for type 1 diabetes drug Tzield threw more fire on the CNPV program, which has already been mired in controversy. And the agency debuted an investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months. For a special treat, we heard from BioSpace Managing Editor Jef Akst and Senior Editor Annalee Armstrong who are currently in San Diego enjoying BIO 2026. And finally, on the Eli Lilly front, a new report from Evaluate projects that the company's weight loss franchise will account for nearly half of the total sales of the top 10 drugs in 2032. But Lilly isn't resting on this envisioned success: the juggernaut is one of two companies circling Sangamo's assets as the biotech files for bankruptcy.

Pharma and BioTech Daily
Carsgen's CAR-T Breakthrough in China for Solid Tumors | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jun 23, 2026 4:39


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of groundbreaking advancements and strategic shifts that are shaping the future of healthcare. In a remarkable development from China, Carsgen has achieved approval for the world's first CAR-T therapy targeting solid tumors. This therapy focuses on Claudin18.2, marking an unprecedented expansion of CAR-T applications beyond hematologic malignancies. The significance of this breakthrough cannot be overstated, as it opens new avenues for treating cancers resistant to traditional therapies, offering hope to patients worldwide. Meanwhile, in regulatory news, the U.S. is closely examining Germany's proposed drug spending reforms due to concerns over "persistent underpayment" for new medications. This scrutiny highlights the complexities of international pharmaceutical pricing and could have profound implications for drug accessibility and pricing strategies across Europe. Sanofi is undergoing transformative changes under CEO Belen Garijo's leadership. The departure of R&D chief Houman Ashrafian and the appointment of Paulo Fontoura, known for his work at Roche, signal a strategic pivot to rejuvenate Sanofi's research and development pipeline. This move aims to address challenges within Sanofi's pipeline and inject new energy into its R&D initiatives. Reflecting broader industry trends, Eli Lilly is reevaluating its marketing strategies amid increasing emphasis on pharmaceuticals in mainstream health discussions. This introspection aligns with efforts across big pharma to enhance corporate image alongside product portfolios. The Federal Trade Commission recently mandated that Aurobindo divest four drugs as part of its $250 million acquisition of Lannett, addressing antitrust concerns and ensuring competitive balance in the generics market. Pfizer has made headlines with a rapid $10 billion oncology deal with Innovent Biologics. This collaboration underscores an industry trend towards swift, large-scale partnerships aimed at expanding global pharmaceutical ambitions. The deal's finalization in under five months illustrates the increasing pace at which such collaborations are being forged. Moderna continues to expand its mRNA capabilities beyond COVID-19 with unanimous FDA advisory committee support for its influenza vaccine candidate. This advancement signifies Moderna's strategic entry into broader vaccine markets, leveraging its mRNA platform to potentially transform vaccine development for seasonal influenza. AbbVie's acquisition of Apogee Therapeutics for $10.9 billion marks a competitive maneuver in the dermatology space. With a promising late-phase eczema drug candidate, AbbVie positions itself against market leaders like Eli Lilly, Regeneron, and Sanofi. Definium Therapeutics has announced promising phase 3 data for its novel LSD-based treatment for depression. This development has the potential to revolutionize mental health treatment paradigms by demonstrating unprecedented efficacy in psychedelic therapeutics. In an innovative stride forward, Insilico Medicine's collaboration with SK Biopharm on an AI-driven drug discovery initiative highlights the growing reliance on artificial intelligence to accelerate drug development pipelines. Targeting neuroimmune disorders, this partnership could be valued at over $2.5 billion, exemplifying AI's transformative potential in pharmaceutical innovation. These developments collectively highlight an industry characterized by rapid scientific advancements and strategic realignments. By expanding CAR-T therapies to solid tumors and integrating AI-driven drug discovery approaches, alongside significant regulatory updates and strategic collaborations, the pharmaceutical and biotech sectors are poised for continued evolution in patient care and drug development methodologies. As we continue to witness these transformative changes across pharmaceuticals and biotechnology, it remains crucial for stakeholders to adapt swiftly and collaborate effectively. The integration of novel technologies such as mRNA platforms, gene editing advancements, and AI-driven research will undoubtedly shape future healthcare outcomes and redefine traditional approaches to medicine. Thank you for tuning into Pharma Daily. We hope you found today's insights valuable as we navigate these dynamic shifts within the pharmaceutical and biotech landscapes together. Stay informed and join us next time as we continue to explore the cutting-edge developments driving healthcare innovation forward.Support the show

The Factor, a Global Medical Device Podcast
GLP-1 Ripple Effect: Reshaping Injectable Drug Delivery

The Factor, a Global Medical Device Podcast

Play Episode Listen Later Jun 23, 2026 33:22


The rapid evolution of biologics and blockbuster obesity therapies is creating an unprecedented demand on the injectable drug delivery market. As these treatments mature and reach millions of patients, the pharmaceutical industry is being forced to rethink dose volumes, supply chain sustainability, and device design.In this episode of Life Science Solutions, host Chris Adkins sits down with Paul Jansen, a recognized industry voice and veteran leader in medical device development and combination products. Drawing from his extensive background, including leadership roles at Sanofi, Paul explains how the massive success of GLP-1 therapies is shaking up the industry and forcing innovators to adapt.Topics Include:The GLP-1 Ripple Effect: Why the current model of one injection per device is environmentally and economically unsustainable for mass markets, driving the shift toward fixed-dose pens and the future of auto-indexing needles.The Rise of Dual Chamber Systems: How the expiration of key patents is opening the door for dual chamber cartridges, allowing for easier lyophilization reconstitution and the sequential delivery of complex, mixed therapies.Wearable Injectors: Why on-body wearables haven't hit their predicted "hockey stick" growth yet, and why the industry needs to focus on creating affordable, less-featured baseline devices rather than over-engineering them.The Reality of Connected Devices: Why smart connectivity provides massive value for highly motivated patients (such as those undergoing fertility or oncology treatments), but still lacks a clear value proposition for broader populations.Platform Innovation: The critical need for device companies to build adaptable technology platforms, collaborate closely with pharma, and integrate patient-centric usability engineering right from the start.Stay up to date on industry trends as this conversation offers a clear roadmap for the future of combination products.

Global Hemophilia Report
WFH 2026: Spotlight on Humanitarian Aid

Global Hemophilia Report

Play Episode Listen Later Jun 18, 2026 43:59


At the World Federation of Hemophilia World Congress in Kuala Lumpur, thousands gathered to discuss the future of bleeding disorders care. Gene therapies. Rebalancing agents. Artificial intelligence. New possibilities seemed to be everywhere. But beneath the excitement, one question echoed throughout the meeting: who still gets left behind? In this episode of the Global Hemophilia Report, Patrick Lynch sits down with Believe Limited's Amy Board, WFH Humanitarian Aid Director Assad Haffar, and Sanofi's Bonnie Anderson to explore the promises of innovation, the realities of global inequity, and the humanitarian efforts working to close the gap. From breakthrough science to life-changing access programs, this conversation examines what "Treatment for All" really means in 2026. Guests: Amy Board – Director, Engagement and Programs, Believe Limited Assad Haffar – WFH Humanitarian Aid Director Bonnie Anderson –  Head of Humanitarian Aid, Rare Diseases at Sanofi   Senior Advisor: Donna DiMichele, MD   Hosted by: Patrick James Lynch   Featured Advertiser: Sanofi   Subscribe to the Global Hemophilia Report Show Notes:   Connect with the Global Hemophilia Report Global Hemophilia Report on LinkedIn Global Hemophilia Report on X/Twitter Global Hemophilia Report on Facebook   Connect with BloodStream Media: BloodStreamMedia.com BloodStream on Facebook  BloodStream on X/Twitter   

The Lead Podcast presented by Heart Rhythm Society
The Lead Episode 156: A Discussion of The Association Between Atrial Fibrillation Burden and Quality of Life: A Substudy of the SHAM-PVI Trial

The Lead Podcast presented by Heart Rhythm Society

Play Episode Listen Later Jun 18, 2026 15:58


In this episode of The Lead, host Christopher Kowalewski, MD, is joined by John M. Mandrola, MD, and Nassir F. Marrouche, MD, FHRS, to discuss the journal article, The Association Between Atrial Fibrillation Burden and Quality of Life: A Substudy of the SHAM-PVI Trial. Together, they explore the relationship between atrial fibrillation burden and quality of life, reviewing findings from this substudy of the SHAM-PVI Trial and discussing their relevance to patient-centered outcomes. Learning Objectives Review the key findings from the SHAM-PVI Trial substudy examining the association between atrial fibrillation burden and quality of life. Discuss the relationship between atrial fibrillation burden and patient-reported quality-of-life outcomes. Explore the implications of assessing both arrhythmia burden and quality of life when evaluating treatment outcomes in atrial fibrillation.   Host: Christopher Kowalewski, MD Guests: John M. Mandrola, MD and Nassir F. Marrouche, MD, FHRS   Disclosures: Christopher Kowalewski, MD No relevant disclosures   John M. Mandrola, MD No relevant disclosures   Nassir F. Marrouche, MD, FHRS •       Honoraria/Speaking/Consulting Fee/Speaker's Bureau: Biosense Webster, Inc., Boston Scientific, AtriCure, Inc., Abbott, Sanofi •       Research: Abbott, Biosense Webster, Inc., Medtronic, Siemens, General Electric, Boston Scientific, Sanofi, Samsung

Tech&Co
Emmanuel Frenehard, vice-président exécutif et directeur digital de Sanofi – 18/06

Tech&Co

Play Episode Listen Later Jun 18, 2026 10:25


Emmanuel Frenehard, vice-président exécutif et directeur digital de Sanofi, était l'invité de François Sorel dans Tech & Co, la quotidienne, ce jeudi 18 juin. Il s'est penché sur l'amélioration et l'accélération des recherches avec l'IA, ainsi que le développement d'un assistant IA pour tous les collaborateurs de Sanofi, sur BFM Business. Retrouvez l'émission du lundi au jeudi et réécoutez la en podcast.

Tech&Co
L'intégrale de Tech & Co, la quotidienne, du jeudi 18 juin

Tech&Co

Play Episode Listen Later Jun 18, 2026 78:20


Jeudi 18 juin, François Sorel a reçu Thibault Sottiaux, responsable Produits et Plateforme chez OpenAI, Luc Julia, expert en IA et objets connectés, Jérôme Colombain, journaliste et créateur du podcast « Monde Numérique », Christophe Aulnette, Senior advisor chez Seven2 et ancien président de Microsoft France et Asie du Sud, Emmanuel Frenehard, vice-président exécutif et directeur digital de Sanofi, Octave Klaba, fondateur et PDG d'OVHcloud, et Fabrice Valentin, vice-président responsable de l'Intelligence Artificielle chez Airbus, dans l'émission Tech & Co, la quotidienne sur BFM Business. Retrouvez l'émission du lundi au jeudi et réécoutez la en podcast.

BioSpace
Moderna's FDA adcomm, IPO mania, biopharma layoffs, more

BioSpace

Play Episode Listen Later Jun 17, 2026 25:33


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.

ESC TV Today – Your Cardiovascular News
Season 4 - Ep.11: Transcatheter treatment of tricuspid regurgitation - Carcinoid heart disease

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jun 11, 2026 21:47


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.

ESC TV Today – Your Cardiovascular News
Season 4 - Ep.11: Extended interview on transcatheter treatment of tricuspid regurgitation

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jun 11, 2026 11:34


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.

Pharma and BioTech Daily
Pfizer CEO Rethinks Germany Investments Amid Reform Concerns | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jun 11, 2026 4:58


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The pharmaceutical and biotech industries are undergoing significant transformations, driven by scientific advancements, regulatory changes, and strategic investments. These developments are shaping the landscape of drug development and patient care in profound ways. In recent news, Pfizer's CEO, Albert Bourla, is reconsidering investments in Germany due to proposed healthcare reforms. These reforms have sparked concerns about their potential impact on the pharmaceutical industry. This situation highlights the intricate balance between regulatory frameworks and corporate strategies, illustrating how policy changes can influence investment decisions and operational strategies within the pharma sector. The tension between regulatory environments and corporate interests is a recurring theme that continues to shape strategic directions within the industry. Meanwhile, heightened scrutiny over biotechnology operations is evident with Wuxi AppTec's inclusion on the Pentagon's blacklist under the Biosecure Act. This move reflects growing concerns about biosecurity and the necessity for stringent oversight in handling sensitive biotechnological advancements. Such actions underscore a global focus on safeguarding national security while fostering scientific innovation. Teva Pharmaceuticals is navigating restructuring efforts by laying off 250 employees at its Active Pharmaceutical Ingredients unit as it seeks a new owner. This restructuring underscores the challenges companies face in maintaining operational efficiency amid ownership transitions. These challenges are emblematic of broader industry dynamics where companies strive to adapt to changing market conditions while ensuring stability and growth. On the scientific front, Novo Nordisk's cagrisema and Eli Lilly's retatrutide are emerging as next-generation incretin therapies. Although early comparisons have been made, Novo Nordisk's chief scientific officer suggests it is premature to declare a definitive leader. This competition reflects the dynamic nature of drug development as companies strive to innovate and improve treatment options continuously. Additionally, Sonothera's successful $125 million Series B funding round for its bubble-based genetic delivery system highlights the biotech industry's momentum fueled by mergers and acquisitions (M&A) and partnerships. Such technologies promise to advance genetic therapies by enhancing delivery mechanisms, potentially transforming treatment paradigms for various genetic disorders. AbbVie's Skyrizi narrowly surpassing Johnson & Johnson's Tremfya in May drug ad spending underscores the competitive nature of pharmaceutical marketing. Despite a general slump in advertising expenditures among leading drugs, strategic marketing remains crucial for maintaining brand presence and market share. Increased M&A activity and partnerships are further bolstering the industry's growth trajectory. The resurgence of Initial Public Offerings (IPOs) and venture capital funding is fostering innovation and expansion within the sector, providing fuel for continued advancement in biotech. On the regulatory front, Johnson & Johnson's Darzalex received a new endorsement from NICE after a prior reversal. Such regulatory updates emphasize the evolving nature of drug approvals and market access strategies essential for pharmaceutical companies' success. Novartis' second deal with Orionis Biosciences worth up to $1.4 billion exemplifies strategic investments aimed at expanding research capabilities and addressing unmet medical needs through molecular glue technologies targeting challenging therapeutic areas. Conversely, Sanofi's decision to halt a Phase 3 autoimmune trial due to insufficient efficacy highlights the inherent risks in drug development pipelines. These setbacks emphasize the importance of robust clinical trial designs and adaptability in R&D strategies. Emerging insights into GLP-1 drugs like Novo Nordisk's semaglutide reveal potential antidepressant effects linked to gut microbiota modulation. These findings open new avenues for exploring psychiatric applications of metabolic drugs, although conflicting data necessitates further investigation. Overall, these developments illustrate a complex interplay of scientific innovation, regulatory dynamics, and strategic corporate actions driving the future of pharmaceuticals and biotechnology. The sector continues to navigate challenges while capitalizing on opportunities to enhance patient care through advanced therapeutic solutions. The industry's trajectory promises transformative impacts on patient care through novel therapies designed not only to treat symptoms but also address root causes via innovative science-driven solutions. As these advancements unfold, they herald a new era of targeted, effective treatments that hold promise for improving patient outcomes across diverse medical landscapes.Support the show

Biotech 2050 Podcast
Ardelyx Leaders Mike Raab & Laura Williams on Building Biotech Around Patients

Biotech 2050 Podcast

Play Episode Listen Later Jun 10, 2026 41:21


Synopsis: While biotech is increasingly measured by clinical milestones and financial outcomes, Rahul Chaturvedi welcomes two leaders who argue that true success begins and ends with patients. In this deeply personal and inspiring conversation, Mike Raab, President & Chief Executive Officer of Ardelyx, and Laura Williams, Chief Patient Officer, share how empathy, resilience, and patient advocacy have shaped both their careers and the culture of the company they've built. Mike reflects on an unconventional journey that spans pharmaceutical sales, rare disease leadership at Genzyme, venture capital at NEA, and ultimately leading Ardelyx through some of biotech's most difficult challenges—including a Complete Response Letter, massive layoffs, and a historic FDA reversal that resulted in approval without additional clinical trials. Laura shares her path from rural Mississippi to becoming a physician, recounting the transformative patient experience during the HIV epidemic that inspired her move from academia into industry and ultimately into a pioneering Chief Patient Officer role. Together, they explore what patient-centricity truly means beyond corporate slogans, how Ardelyx embedded patient advocacy into the C-suite, and why empathy must be a core competency for biotech leadership. The discussion also dives into clinical trial diversity, commercializing therapies for underserved populations, navigating regulatory adversity, responsible capital allocation, and the future of building enduring biotech companies. It is a powerful reminder that when patients become the North Star, resilience, innovation, and impact naturally follow. Biography: Mike Raab Mike has served as Ardelyx's President and Chief Executive Officer since March 2009. Before Ardelyx, Mike was a partner at New Enterprise Associates (NEA), one of the world's largest and most successful venture capital firms, where he specialized in healthcare investments focusing on the biotechnology and pharmaceutical sectors. Prior to joining NEA in 2002, Mike spent 15 years in commercial and operating leadership roles in the biotech and pharmaceutical industries. He was senior vice president, therapeutics and general manager of the renal division at Genzyme Corporation, a Sanofi company. In this position, Mike launched and oversaw the sales growth of sevelamer, the leading phosphate binder for the treatment of hyperphosphatemia, with over $1.0 billion in worldwide sales in 2013. Mike was also instrumental in the worldwide launch of Genzyme's therapies for Gaucher disease, Ceredase and Cerezyme. Laura Williams, MD, MPH Laura has served as Ardelyx's Chief Patient Officer since 2025, having joined the company in November 2020 as Senior Vice President, Global Therapeutic Strategies and Patient Advocacy. Laura was later promoted to Chief Medical Officer in 2021. Laura is a life science enterprise leader with extensive experience as a pharmaceutical drug developer, healthcare policy advisor, patient advocate, and portfolio strategist. She is an accomplished, results-oriented, physician scientist and board member who is committed to discovering, developing, and commercializing innovative therapies that address unmet medical need. With nearly 30 years of pharmaceutical experience, across all clinical development phases and multiple therapeutic areas, in both large pharma and smaller biotech, Laura has a proven track-record in drug development, as indicated by her leadership and major contributions toward eight drug approvals.

Capital
Capital Intereconomía 9:00 a 10:00 10/06/2026

Capital

Play Episode Listen Later Jun 10, 2026 56:59


En Capital Intereconomía seguimos la apertura del Ibex 35 y del resto de las bolsas europeas en una sesión marcada por las expectativas sobre la política monetaria del BCE y por los movimientos corporativos que están protagonizando algunas de las compañías más relevantes del mercado internacional. En el análisis de mercados, David Cortina, responsable de Renta Variable de Santander Private Banking, examina las claves de una jornada en la que los inversores permanecen muy atentos a la esperada subida de tipos del BCE y a sus posibles implicaciones sobre el crecimiento económico, la inflación y los distintos sectores bursátiles. Entre los protagonistas de la sesión destaca ASML, que continúa marcando nuevos máximos históricos impulsada por la fortaleza de la demanda vinculada a la inteligencia artificial y a los semiconductores avanzados. También analizamos la caída de SoftBank Group tras las dificultades encontradas para estructurar una operación de financiación respaldada por su participación en OpenAI, así como las implicaciones que puede tener para su estrategia inversora en el ámbito tecnológico. Otro de los focos informativos se sitúa en Sanofi, después de que la farmacéutica anunciara la suspensión de un ensayo clínico relacionado con tratamientos para enfermedades autoinmunes, una decisión que ha despertado el interés de los inversores por sus posibles efectos sobre la cartera de productos de la compañía. Además, repasamos la estrategia de mercado en un entorno caracterizado por tipos de interés más elevados, tensiones geopolíticas y un creciente protagonismo de la inteligencia artificial como motor de crecimiento empresarial. Terminamos la hora con el Consultorio de Bolsa, donde Miguel Méndez, analista independiente, responde a las consultas de los oyentes sobre valores nacionales e internacionales, niveles técnicos y oportunidades de inversión.

The Chain: Protein Engineering Podcast
Episode: 86 - PANEL DISCUSSION: Near-Term Challenges for ML/AI in Biotherapeutic R&D

The Chain: Protein Engineering Podcast

Play Episode Listen Later Jun 9, 2026 53:59 Transcription Available


At this year's PEGS Boston, industry experts gathered on a panel to explore how AI and machine learning are deployed in biologics R&D today. Moderated by Peter M. Tessier, Ph.D., Albert M. Mattocks professor of pharmaceutical sciences and chemical engineering at University of Michigan, the panel consisted of Andrew Buchanan, Ph.D., head of discovery at a stealth-mode biotech company; Norbert Furtmann, Ph.D., head of biologics AI and design of large molecules research at Sanofi; Konrad S. Krawczyk, Ph.D., founder and CSO at NaturalAntibody SA; Andrew C.R. Martin, Ph.D., emeritus professor of bioinformatics and computational biology at University College London; Melody Shahsavarian, Ph.D., senior director of data strategy and digital transformation of biotherapeutics discovery research at Eli Lilly & Company; and Bernhardt L. Trout, Ph.D., professor of chemical engineering at Massachusetts Institute of Technology.  Links from this episode:  Pharmaceutical Sciences & Chemical Engineering, University of Michigan University of Michigan Sanofi NaturalAntibody SA Bioinformatics, UCL Biosciences Computational Biology, UCL University College London   Eli Lilly & Company 

ASGCT Podcast Network
Development of a secretable frataxin for Friedrich's ataxia with Dr. Dan DuBreuil

ASGCT Podcast Network

Play Episode Listen Later Jun 4, 2026 19:49


In this episode, recorded on-site at the ASGCT 2026 Annual Meeting, Molecular Therapy Advances Associate Editor-in-Chief Dr. Dan Stone speaks with Dr. Dan DuBreuil of Sanofi. They break down the science behind a recent paper detailing the development of a secretable frataxin, highlighting its potential to improve treatment efficacy for Friedreich’s ataxia. Music: 'Electric Dreams' by Scott Buckley - released under CC-BY 4.0. www.scottbuckley.com.auShow your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

Le Super Daily
Le Grand Comité Édito #6

Le Super Daily

Play Episode Listen Later Jun 3, 2026 54:05


Épisode 1483 : C'est l'épisode 1483 du Super Daily et on en profite pour se faire un comité édito !Pour ce nouvel épisode, toute l'équipe du Super Daily se réunit exceptionnellement autour du micro pour un bilan de milieu d'année totalement décontracté. Avant les grands bouleversements de l'été, Thibault, Camille et Adjan regardent dans le rétro pour vous livrer un savant mix d'infos clés, de coulisses d'agence et de franches rigolades.Des dilemmes impitoyables pour tester votre vision du WebL'équipe se prête au jeu d'un « Tu préfères » cornélien appliqué au marketing digital. Entre la suppression des Reels par Adam Mosseri, la perte dramatique de vos statistiques social media et la gestion de crises de marques majeures, leurs réponses risquent de bousculer vos certitudes et d'animer vos propres débats de bureau.Passage sur les dossiers chauds de l'agence !C'est aussi l'occasion idéale pour plonger dans les dossiers chauds de l'agence Supernatifs. De la production vidéo d'envergure internationale pour Sanofi au lancement de produit majeur pour Tefal, en passant par les coulisses des Nuits de Fourvière, ou les stratégies de pointe pour CLAAS, Lunii, TBS et Valrhona, vous saurez tout sur l'actualité de l'industrie de l'attention !C'était aussi l'occasion d'aborder des choses plus légères ! Cet épisode se clôture sur les trajectoires personnelles de vos animateurs préférés. Entre un événement heureux et objectifs personnels, le timing est parfait pour faire le point avant la rentrée !Installez-vous confortablement, écoutez l'épisode et venez papoter avec nous sur Instagram pour nous donner vos propres réponses !…Retrouvez toutes les notes de l'épisode sur www.lesuperdaily.com ! Le Super Daily est le podcast quotidien sur les réseaux sociaux. Il est fabriqué avec une pluie d'amour par les équipes de Supernatifs. Nous sommes une agence social media basée à Lyon : https://supernatifs.com. Ensemble, nous aidons les entreprises à créer des relations durables et rentables avec leurs audiences. Ensemble, nous inventons, produisons et diffusons des contenus qui engagent vos collaborateurs, vos prospects et vos consommateurs. Hébergé par Acast. Visitez acast.com/privacy pour plus d'informations.

Pharma and BioTech Daily
Moderna-Merck Combo Cuts Melanoma Risk by 49% | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jun 3, 2026 5:15


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of groundbreaking advancements and strategic maneuvers reshaping the landscape of drug development and patient care. In recent news, Moderna and Merck & Co. have reported substantial progress in cancer treatment with their Phase 2b trial results involving Intismeran Autogene combined with Keytruda. This combination therapy, leveraging the innovative mRNA vaccine technology alongside Keytruda, has shown a remarkable 49% reduction in recurrence risk for high-risk melanoma patients. This synergy not only enhances therapeutic options in melanoma but also underscores the transformative potential of mRNA vaccines beyond infectious diseases, suggesting a new frontier for oncology treatments. Bristol Myers Squibb has also made significant strides with its Phase 3 trial results for Izalontamab Brengitecan, an antibody-drug conjugate. This therapy has demonstrated a 40% reduction in death risk among patients with triple-negative breast cancer—an aggressive subtype with historically limited treatment options. The success of this bispecific antibody targeting Trop2 highlights the advancing trend towards precision medicine, where therapies are increasingly tailored to specific genetic and molecular profiles, promising improved patient outcomes. Turning to business developments, Rallybio's merger with Avenzo Therapeutics through a reverse merger transaction marks a notable consolidation trend within the industry. Supported by a $215 million private placement, this merger aims to accelerate drug discovery and development in oncology, emphasizing the importance of strategic collaborations in enhancing therapeutic pipelines. Similarly, MindMaze Therapeutics is streamlining operations post-merger by refocusing on core competencies aligned with broader industry trends towards specialization. Regulatory updates have been equally dynamic. Shionogi's Xocova (Ensitrelvir) has received FDA approval for post-exposure prophylaxis against COVID-19 following successful Phase 3 trials. As a small-molecule protease inhibitor, Xocova enriches the therapeutic arsenal against COVID-19 and reflects ongoing efforts to manage infectious diseases even as the pandemic wanes. Strategic partnerships are further shaping the industry landscape. The collaboration between ASCO and Ryght AI aims to enhance breast cancer trial site selection using artificial intelligence. This initiative signifies a growing trend towards integrating AI and machine learning technologies in clinical trial optimization to streamline processes and improve efficiency—an essential endeavor as trials become more complex and data-driven. Additionally, Sanofi's integration of AI via field agents to enhance efficiencies across business facets highlights how AI adoption is accelerating and promises to reshape drug development processes and patient care strategies significantly. Meanwhile, challenges persist. The FDA's rejection of Cingulate's CTX-1301 due to manufacturing concerns underscores the rigorous regulatory environment that companies navigate. Similarly, Roche's Persevera trial missing its primary endpoint in breast cancer treatment highlights the inherent risks involved in drug development. In scientific advancements, Gilead Sciences has made progress with Livdelzi in treating primary biliary cholangitis (PBC), a rare liver disease. The Phase 3 trial success points to ongoing innovation in rare disease treatments—a critical area for enhancing patient outcomes. On another front, Contraline is advancing its male birth control candidate after securing $92.5 million in funding. This first-in-class topical contraceptive fills a significant gap in male contraceptive options, demonstrating an increasing focus on diversifying reproductive health solutions. In strategic shifts within the industry, Merck is reducing its workforce as part of a broader $3 billion cost-cutting strategy aimed at optimizing operations while investing in innovation and technology. At ASCO 2026, Celcuity shared ambitions to revolutionize breast cancer treatment paradigms through innovative pathway targeting, while GSK introduced a new approach for rare gut cancers—conditions that have seen little advancement over decades. Such initiatives highlight critical roles innovative research plays in oncology. In summary, these developments reflect a vibrant period for the pharmaceutical and biotech sectors characterized by scientific innovation, strategic mergers, regulatory milestones, and ongoing clinical trials that collectively promise to enhance patient care. Emphasis on personalized medicine, expansion of mRNA technology into oncology, and AI-driven efficiencies are poised to redefine approaches across therapeutic domains while navigating stringent regulatory standards and market dynamics that require strategic agility and robust R&D pipelines. Thank you for tuning into Pharma Daily—your source for insightful updates from the world of pharmaceuticals and biotechnology. Stay connected for more groundbreaking news and analysis shaping the future of healthcare.Support the show

ESC TV Today – Your Cardiovascular News
Season 4 - Ep.10: Mitral annular disjunction - The heart in high altitude

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later May 28, 2026 17:22


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.

ESC TV Today – Your Cardiovascular News
Season 4 - Ep10: Extended interview on mitral annular disjunction

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later May 28, 2026 10:43


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.

Grownlearn
AI Is Rewriting Brand Strategy - Former Twinings & Danone Executive Explains

Grownlearn

Play Episode Listen Later May 27, 2026 42:08


How is AI changing the way brands innovate, launch products, understand consumers, and build stronger relationships with their markets? In this episode of Grownlearn, host Zorina Dimitrova speaks with Shantanu Srivastava, a global marketing and innovation leader with more than two decades of experience across major consumer brands including Twinings, Danone, Sanofi, and Reckitt. Shantanu explains how AI is transforming marketing efficiency, product development, consumer research, compliance screening, and brand strategy inside large organizations. He also shares why human judgment remains essential, even as AI tools make innovation faster, cheaper, and more continuous. The conversation also explores the shift from traditional brand storytelling to story doing and story living, with examples from challenger and purpose-led brands such as Oatly, Tony's Chocolonely, Dove, and others. Shantanu also shares his personal transition from corporate brand leadership to entrepreneurship, including his work in health and wellness, lifestyle-related health management, and advisory work with startups and purpose-driven brands. In this episode, we discuss: • How AI is changing marketing and innovation • Why FMCG companies are rethinking consumer-led product development • How AI can reduce time and cost in research, marketing planning, and product launches • Why brand storytelling is evolving into story doing and story living • What startups can learn from global brands — and what big brands can learn from startups • How purpose-led brands create deeper consumer engagement • Why AI-driven innovation still needs human oversight • Shantanu's journey from global brand leadership to health and wellness entrepreneurship This conversation is especially relevant for founders, marketers, brand leaders, innovation teams, FMCG professionals, startup advisors, and anyone interested in the future of AI-driven brand growth.

Medical Sales U with Dave Sterrett
E55 | How Pharmaceutical Reps Make Over $200,000: The Numbers Nobody Is Talking About

Medical Sales U with Dave Sterrett

Play Episode Listen Later May 18, 2026 34:51


Think the real money in medical sales is only in the Operating Room? Think again.Discover how specialty Pharma and Oncology reps are quietly earning $200K - $300K+ without ever stepping into a scrub suit. In this episode, Dave Sterrett, founder of Medical Sales U and former #1 national rep at Sanofi and Virtuox, breaks down the exact numbers behind the most misunderstood — and lucrative — side of the industry: Specialty Pharma and Oncology Diagnostics.Stop listening to the "device youtuber" that says Pharma is just dropping off samples. We're diving into the high-level clinical selling required to dominate oncology and precision medicine. TOPICSThe Income Reality: Why the "floor" for our members starts at a $95,000 base salary.The Career Ladder: A step-by-step breakdown from entry-level ($110k) to Oncology ($230k+ base).Beyond the Salary: The "hidden" wealth in RSUs, ESPPs, and expense accounts that add $50k+ in value.The Interview Secret: Why smart people fail the "Clinical Conversation" and how to fix it.Work-Life Balance: Why veteran Device reps are leaving the OR for the flexibility of Pharma. CHAPTERS0:00 - The Case for Pharma & Diagnostics2:15 - My Journey: Turning a Territory Around5:45 - Debunking the "Pharma is Easy" Myth10:30 - The Salary Floor: $95k - $125k Base15:10 - The Oncology Tier: $150k - $230k Base20:45 - The Truth About OR Burnout28:30 - How to Master the Clinical Conversation35:00 - Building Generational Wealth with Equity Ready to break into medical sales and secure your first $95k+ base offer?Join Medical Sales U: medicalsalesu.com/Every Monday night, we coach you live to land the job.

Learnings from Leaders: the P&G Alumni Podcast
Katya Lobynko, Danone IT & Data Director

Learnings from Leaders: the P&G Alumni Podcast

Play Episode Listen Later May 17, 2026 36:02


“Every new technology has a hype cycle, so your use case and business rationale must stay the North Star. No flashy AI solution replaces fixing your foundations, processes, and underlying business challenges first.”Katya Lobynko is IT & Data Director at Danone and a digital transformation leader with 15+ years of experience across FMCG and pharma in EMEA and Asia, with expertise spanning commercial operations, data & analytics, conversational AI, and emerging technologies. Before Danone, she spent several years at Sanofi leading innovation and emerging technology initiatives, including helping build the company's conversational AI capability. Katya began her career at Procter & Gamble as a Project Delivery Manager for Europe, the Middle East, and Africa, leading global media planning transformation initiatives for the world's largest advertiser, before earning her MBA through the Asia School of Business, a partnership with MIT Sloan School of Management and the Central Bank of Malaysia. Originally from the Russian Far East and now based in Paris after years living and working across Asia and Europe, Katya brings a deeply international, people-centered perspective to conversations about digital transformation, AI, international careers, and women in tech.This conversation is hosted by podcast co-founder and P&G Alum Drew Tarvin, Founder & CEO of Humor That Works. Drew spent six years at P&G leading IT + brand initiatives before turning his background in engineering, improv, and stand-up comedy into a career helping organizations use humor to improve leadership, communication, and workplace culture. He's the author of Humor That Works and his TEDx talk on "the Skill of Humor" has been viewed more than 16 million times.