BioSpace

BioSpace
  • 4.9 (14)
  • LIFE SCIENCES
  • UPDATED WEEKLY

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.

  1. Inside Germany’s biotech capital infrastructure and innovation engine

    5D AGO

    Inside Germany’s biotech capital infrastructure and innovation engine

    In this episode of Denatured, as part of our series of the European life science investment ecosystem, you'll be hearing from Regina Hodits, managing director at Angelini Ventures and Sofia Ioannidou, VC partner at Andera Life Sciences. They examine Germany’s biotech and life sciences landscape, focusing on the scientific, infrastructure and policy shifts required to enable European companies to scale globally while remaining anchored in Europe. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Regina Hodits, Managing Director, Angelini Ventures Sofia Ioannidou, VC Partner, Andera Life Sciences Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    23 min
  2. FDA’s absent leaders, the millions pharma CEOs make, and pancreatic cancer’s momentum

    6D AGO

    FDA’s absent leaders, the millions pharma CEOs make, and pancreatic cancer’s momentum

    FDA Commissioner Marty Makary officially resigned last week following reports of his ouster. Then, the acting directors for the agency’s two main review units also left their posts, as did the FDA chief of staff and chief AI officer. Domino effect aside, the reaction from the industry has been mostly positive, given Makary’s tumultuous reign. But he might be hard to replace. If it were up to the biotech industry, former longtime oncology regulator and short-lived CDER director Richard Pazdur would take the role. For now, FDA Deputy Commissioner for Food Kyle Diamantas is in charge. Eli Lilly’s David Ricks was the highest paid pharma CEO last year, but J&J’s Joaquín Duato made the most relative to rank-and-file employees, with a median pay ratio of 358 to one. He was on the top of BioSpace’s list last year, too, with a ratio of 293 to 1. Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. This week, Truist Securities went so far as to nominate RevMed as “the next oncology titan,” a title currently held by Merck and its blockbuster cancer drug Keytruda. Safety continues to challenge the gene therapy space, especially in Duchenne muscular dystrophy. Late last week, REGENXBIO announced mixed results from a Phase 3 program—the gene therapy did lead to functional improvements, but two serious adverse events caused the stock to drop 37%. Finally, Amgen’s rare disease drug Tavneos continues to face scrutiny. Last month, the FDA alleged that doctored data were filed to support Tavneos’ initial approval. Now, it’s been linked to 20 deaths in Japan.

    27 min
  3. From MSCs to iPSCs: building the cell therapy future

    MAY 14

    From MSCs to iPSCs: building the cell therapy future

    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.

    20 min
  4. Makary’s out at FDA, Sanofi’s priority voucher issues, top exec pay

    MAY 13

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

    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.

    16 min
  5. Fibrosis, IPF and the search for better therapies

    MAY 7

    Fibrosis, IPF and the search for better therapies

    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.

    18 min
  6. Pfizer, Lilly, more report Q1, FDA names acting CBER director and an ALS awakening

    MAY 6

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

    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.

    23 min
  7. What makes life science angel investment work?

    APR 30

    What makes life science angel investment work?

    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.

    22 min
  8. Q1 earnings take off, Lilly strikes deals, Regeneron notches historic approval, FDA raises questions

    APR 29

    Q1 earnings take off, Lilly strikes deals, Regeneron notches historic approval, FDA raises questions

    First quarter earnings are coming in at a rapid pace, with Sanofi and Novartis defending patents for Dupixent and Lutathera, respectively, and Sanofi welcoming Belén Garijo as CEO. Still to come this week are Eli Lilly, AstraZeneca, Regeneron and many more. Lilly will undoubtedly discuss its recent streak of dealmaking, including a $2.25 billion pact with AI biotech Profluent, plus buyouts of Ajax Therapeutics for up to $2.3 billion and Kelonia Therapeutics for up to $7 billion. Meanwhile, Regeneron earned FDA approval for the highly anticipated gene therapy that will now be known as Otarmeni. The same day the approval came down, Regeneron also struck a deal with the White House. Over at the FDA, the agency has requested—again—that Amgen remove the autoimmune therapy Tavneos from the market. Separately, the FDA has issued three Commissioner’s National Priority Vouchers to unnamed psychedelic drug developers. Finally, who will replace Vinay Prasad, the head of the agency’s Center for Biologics Evaluation and Research (CBER), who departs at the end of April after one year as the biologics chief?

    22 min
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4.9
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About

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.

Information

  • Creator
    BioSpace
  • Years Active
    2023 - 2026
  • Episodes
    232
  • Rating
    Clean
  • Copyright
    © 2026 BioSpace
  • Show Website
    BioSpace

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