BioSpace

BioSpace
BioSpace
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230 épisodes

  • BioSpace

    From MSCs to iPSCs: building the cell therapy future

    14/05/2026 | 20 min
    In this episode of Denatured, you'll be hearing from Miguel Forte, president of the International Society for Cell and Gene Therapy (ISCT), and John Ellis, co-founder & CEO of Trenchant Bios, speaking live from the ISCT annual meeting. We dive into mesenchymal stem cells and induced pluripotent stem cells, exploring the science behind them, the manufacturing challenges, and the potential for scalable, engineered next-generation therapies.

    Host
    Jennifer C. Smith-Parker, Director of Insights, BioSpace

    Guests
    Jon Ellis, Co-founder & CEO, Trenchant Bio
    Miguel Forte, President, International Society for Cell & Gene Therapy

    Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
  • BioSpace

    Makary’s out at FDA, Sanofi’s priority voucher issues, top exec pay

    13/05/2026 | 15 min
    Moments after recording this episode of The Weekly, FDA Commissioner Marty Makary announced his resignation. Reports first circulated last Friday that President Donald Trump had signed off on his ouster. The president initially denied this account, originally from The Wall Street Journal, on Saturday morning, but appears to have now confirmed the plan.
     
    This confusion underscores a key theme in Robert F. Kennedy Jr.’s health department: lack of transparency and clear communication. Makary’s exit also highlights the high level of senior leadership turnover across the Department of Health and Human Services. With Makary is on his way out, the FDA will reportedly be helmed by an acting commissioner, Kyle Diamantas. This would also be fitting for an agency whose two key review divisions—the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER)—are currently led by temporary directors.
     
    Meanwhile, one of Makary’s key initiatives, the Commissioner’s National Priority Review (CNPV) program, hit a snag last week as Sanofi has reportedly requested that the FDA remove its diabetes prevention drug Tzield from the scheme. This comes after acting CDER director Tracy Beth Høeg apparently intervened in the drug’s review.
     
    And in the business realm, BioSpace kicks off our annual compensation report. Who made the most money in 2025? Was it Eli Lilly’s David Ricks or Johnson & Johnson’s Joaquin Duato? Read BioPharm Executive to find out. Not subscribed? Sign up here for all of BioSpace’s insightful newsletters.
  • BioSpace

    Fibrosis, IPF and the search for better therapies

    07/05/2026 | 18 min
    In this episode of Denatured, you'll be hearing from Georg Vo Beiske, CEO of Tribune Therapeutics and Jonas Hallén, co-founder & Chief Medical Officer of Calluna Pharma. We dive into IPF and fibrosis challenges, unpacking treatment hurdles, emerging targets, unmet needs and expansion paths beyond the lung.

    Host
    Jennifer C. Smith-Parker, Director of Insights, BioSpace

    Guests
    Georg Vo Beiske, CEO, Tribune Therapeutics
    Jonas Hallén, Co-Founder & CMO, Calluna Pharma

    Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
  • BioSpace

    Pfizer, Lilly, more report Q1, FDA names acting CBER director and an ALS awakening

    06/05/2026 | 22 min
    First quarter earnings continue to roll in, with Pfizer, Eli Lilly, Amgen and more reporting in the past week. While Pfizer beat consensus estimates, it wasn’t enough for analysts, who had greater expectations for the New York pharma. Analysts were more than satisfied with Lilly’s 56% revenue increase, though the company itself appeared to want more—a feat executives believe it could have achieved had it not lowered prices on many of its medicines. Meanwhile, a host of small– to-medium biotechs are beginning to report, with analysts focused squarely on key near-term catalysts. 

    On the regulatory beat, the FDA tapped Katherine Szarama as a temporary replacement for outgoing Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, whose controversial reign over the biologics division ended April 30. And the FDA held its first advisory committee meeting in nine months, for two AstraZeneca cancer drug applications, which former regulator Harpreet Singh said was missing the “Pazdur moment,” after stalwart oncology leader Richard Pazdur left the agency last November.

    Over in R&D, an optimistic story is unfolding in a treatment space that has endured much heartache over the past few years: ALS. In the past week, QurAlis and Corcept Therapeutics both reported positive mid-stage data for their respective candidates, with QurAlis’ QRL-201 eliciting an up to 50% in decrease progression, and Corcept reporting a two-year survival advantage for patients talking its dazucorilant.

    Finally, in BioPharm Executive this week, senior BioSpace editor Annalee Armstrong sits down with biotech founders to discuss the challenges of being a founder today.
  • BioSpace

    What makes life science angel investment work?

    30/04/2026 | 21 min
    In this episode of Denatured, you'll be hearing from Yaniv Sneor, founder of the Mid Atlantic Bio Angels and Alex Pederson, an investor at Mid Atlantic Bio Angels and partner at Alloy Bio Consulting. We discuss why a life sciences-only angel group matters, how they evaluate opportunities, and the importance of strong teams, capital efficiency and a realistic path to exit.

    Host
    Jennifer C. Smith-Parker, Director of Insights, BioSpace
    Guests
    Yaniv Sneor, Founder, Mid Atlantic Bio Angels
    Alex Pederson, Investor, Mid Atlantic Bio Angels & Partner, Alloy Bio Consulting
    Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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À propos de BioSpace
Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.
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