BioSpace

BioSpace
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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. Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water

    3 gg fa

    Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water

    The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.

    23 min
  2. The Golden Triangle and the gaps: Rethinking UK biotech

    25 giu

    The Golden Triangle and the gaps: Rethinking UK biotech

    In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll hear from Hakan Goker, managing director at M Ventures and Maina Bhaman, partner at Sofinnova Partners. We explore the UK biotech ecosystem : from the Golden Triangle’s evolving role to the challenges of scaling companies, unlocking pension capital and staying globally competitive.   Host   Jennifer C. Smith-Parker, Director of Insights, BioSpace   Guests   Hakan Goker, Managing Director, M Ventures Maina Bhaman, Partner, Sofinnova Partners   Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    20 min
  3. AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more

    24 giu

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

    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.

    22 min
  4. From fragile skin to living medicine: Lessons from RDEB

    18 giu

    From fragile skin to living medicine: Lessons from RDEB

    In this episode of Denatured, you'll hear from Mark Lowdell, CSO & co-founder at INmuneBio Inc. and Vishwas Seshadri, CEO & director at Abeona Therapeutics. We examine how recessive dystrophic epidermolysis bullosa serves as a model for cell and gene therapy, and what this ultra-rare disease teaches us about scaling advanced treatments for the future.   Host   Jennifer C. Smith-Parker, Director of Insights, BioSpace   Guests   Mark Lowdell, CSO & Co-Founder, INmuneBio Inc   Vishwas Seshadri, CEO & Director, Abeona Therapeutics   Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    22 min
  5. Moderna’s FDA adcomm, IPO mania, biopharma layoffs, more

    17 giu

    Moderna’s FDA adcomm, IPO mania, biopharma layoffs, more

    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.

    26 min
  6. Portugal, Spain and the new biotech frontier

    10 giu

    Portugal, Spain and the new biotech frontier

    In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you'll hear from Hannah Franklin, associate at Biovance Capital and Pablo Gabriel Cironi Lopez, director of life science investment at Caixa Capital Risc. We examine the rise of Southern Europe’s biotech ecosystem—from Portugal’s efforts to turn strong science into startups to Spain’s growing depth of capital and talent—and what it will take for the region to compete globally. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Hannah Franklin, Associate, Biovance Capital Pablo Gabriel Cironi Lopez, Director, Life Science Investment, Caixa Capital Risc Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    21 min
  7. Lilly tees off with Novo at ADA, GSK’s $10.6B deal, FDA reform continues in Makary’s absence

    10 giu

    Lilly tees off with Novo at ADA, GSK’s $10.6B deal, FDA reform continues in Makary’s absence

    Everything came up roses for Eli Lilly at the American Diabetes Association, as the pharma boasted positive results for its new pill Foundayo and next-gen asset retatrutide—not just for weight loss but also for other indications. Obesity rival Novo Nordisk, meanwhile, held a dinner, during which executives may have convinced analysts that the company is turning a corner after a rough couple of years. Also check out ADA updates from Roche and partner Zealand Pharma, Boehringer Ingleheim, Pfizer (touting results from its Metsera buy), AstraZeneca, Kailera Therapeutics and more. Outside of ADA, the biggest news of the past week came on Tuesday with GSK striking the biggest traditional pharma/biotech M&A of the year so far with its $10.6 billion acquisition of oncology focused Nuvalent Bio. And on Monday, J&J notched a smaller deal, buying out Firefly Bio for $1B. These deals add to continued uptick in M&A seen in biopharma this year, with much of that momentum being driven by Eli Lilly and its GLP-1 cash. At an FDA listening meeting last week on the Commissioner’s National Priority Voucher program, the agency heard multiple calls to pause it. Confusion also still persists around all of the new rare disease pathways, including the new plausible mechanism framework.

    25 min
  8. Rethinking hair loss treatment

    3 giu

    Rethinking hair loss treatment

    In this episode of Denatured, you'll be hearing from Daniel Gil, CEO of Pelage Pharmaceuticals and Francisco Ramírez-Valle, senior vice president of immunology discovery at Eli Lilly. We dive into the long-overlooked hair loss space, exploring why true innovation has lagged, how a regenerative approach aims to reactivate dormant follicles and what early proof-of-concept means for patients. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Daniel Gil, CEO, Pelage Pharmaceuticals Francisco Ramírez-Valle, Senior Vice President, Immunology Discovery, Eli Lilly Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    22 min
Elenco completo (243)

Descrizione

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.

Informazioni

  • Creatore
    BioSpace
  • Anni di attività
    2023 - 2026
  • Puntate
    243
  • Classificazione
    Contenuti adatti a tutti
  • Copyright
    © 2026 BioSpace
  • Sito web del podcast
    BioSpace

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