BioSpace

BioSpace
  • 0,0 (0)
  • SCIENCE DE LA VIE
  • CHAQUE SEMAINE

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

    -11 H

    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
  2. What makes life science angel investment work?

    -6 J

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

    29 AVR.

    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
  4. The next era of diabetes management

    23 AVR.

    The next era of diabetes management

    In this episode of Denatured, you'll be hearing from Dr. Sarah Howell, CEO at Arecor Therapeutics and Dr. Wendy S. Lane, clinical endocrinologist and diabetologist. We examine how increasingly connected and tailored diabetes technologies are reframing the field’s central opportunity around minimizing the day-to-day demands of managing the condition.

    22 min
  5. Trump’s psychedelics push, Lilly’s up to $7B CAR T deal, Replimune’s saga and Denali’s big win

    22 AVR.

    Trump’s psychedelics push, Lilly’s up to $7B CAR T deal, Replimune’s saga and Denali’s big win

    After entering the CAR T arena in February, Eli Lilly jumped onto the in vivo bandwagon, penning a deal worth up to $7 billion for Kelonia Therapeutics and its gene therapy delivery tech iGPS. Meanwhile, Belgium-based UCB scooped up Neurona Therapeutics for $650 million upfront and up to $500 million in milestone payments. On the policy front, President Donald Trump signed a new executive order that analysts believe could help psychedelic therapies become the “key next wave” of mental health therapies. The EO instructs the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to “appropriate psychedelic drugs” that have secured breakthrough designation, a move that could cut review timelines from 10-12 months to 1-2 months for these therapies. Elsewhere, the FDA’s rebuff of Replimune’s advanced melanoma drug RP1 continues to make waves, with CEO Sushil Patel slamming the agency for failing to exercise flexibility, while experts have lamented the regulator’s inconsistency. On the business side, Kailera managed to break biopharma’s all-time IPO record, raising $625 million last week. The new all-time high prompted BioSpace to take a look back at other historic IPOs in the industry, with mRNA heavyweight Moderna’s 2018 debut falling into second place. BioSpace also spoke with Denali Therapeutics CEO Ryan Watts about the company’s long-awaited FDA approval for Hunter syndrome drug Avlayah. “It was the greatest professional moment of my life,” Watts said during an event put on by Utah’s biotech community hub, BioHive.

    26 min
  6. Funding the Future of European Biotech

    16 AVR.

    Funding the Future of European Biotech

    In this episode of Denatured, you'll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partner, Venture Investments at Novo Holdings. We debate whether Europe’s world-class science can be matched by a truly integrated venture ecosystem—and what it would take, in practice, to get there. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Edoardo Negroni, Co-Founder & Managing Partner, AurorA-TT Naveed Siddiqi, Senior Partner, Venture Investments, Novo Holdings Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    20 min
  7. J&J targets $100B revenue, Replimune rebuffed again and a “Revolution” in pancreatic cancer

    15 AVR.

    J&J targets $100B revenue, Replimune rebuffed again and a “Revolution” in pancreatic cancer

    Johnson & Johnson kicked off Q1 earnings season with a “modest” beat, raking in $24.1 billion in sales as it targets $100 billion in revenue in 2026. J&J, as always, is the first to report results from a first quarter that has seen a wave of deals across biopharma; this M&A rush is expected to headline investor calls as more companies, including Novo Nordisk and Eli Lilly, report their Q1 results in the coming days. Meanwhile, IPOs are also on an upswing, with Kailera Therapeutics eyeing a raise that could reach as high as $533 million.   On the regulatory front, Replimune failed for a second time to secure approval for its advanced melanoma therapy RP1, as the FDA held its ground, requesting a Phase 3 trial that CEO Sushil Patel indicated in a statement last week “will not be viable.” This comes as analysts say the FDA’s new policy of making complete response letters public is increasing accountability.   Along with transparency, another key theme for the FDA this year has been its promise to be flexible, particularly when it comes to therapies for rare diseases. While BioSpace has closely covered the myriad cases where the agency has appeared to reverse its guidance to sponsors, two companies—Rezolute & CERo Therapeutics—lauded recent interactions with the FDA, calling reviewers “collaborative” and “curious.”   Finally, heading into the American Association for Cancer Research’s annual meeting this weekend, several companies—including Revolution Medicines, Allogene and IDEAYA Biosciences and Servier—got a jump start, reporting positive data in a number of indications. Revolution’s report was especially seminal. The company’s therapy, daraxonrasib, doubled survival in pancreatic cancer—a disease that has just a 13% survival rate five years after diagnosis.

    18 min
  8. Bonus: Q1 2026 Job Market Update

    14 AVR.

    Bonus: Q1 2026 Job Market Update

    Listen to BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss 2026 job market performance so far, sharing the latest BioSpace data. They touch on positive signs they saw between January and March, including a reduced number of layoffs, and what this year might have in store for those seeking employment in 2026.

    9 min
Tout afficher (227)

À propos

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.

Informations

  • Création
    BioSpace
  • Années d’activité
    2023 - 2026
  • Épisodes
    227
  • Classification
    Tous publics
  • Copyright
    © 2026 BioSpace
  • Site web de l’émission
    BioSpace

Vous aimeriez peut‑être aussi