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FDA
Ebvallo, which Pierre Fabre Pharmaceuticals and Atara Biotherapeutics are proposing to treat a posttransplant complication, joins a wave of rejected or discouraged therapies on which the FDA has reversed previous guidance after the exit of former Commissioner Marty Makary.
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IPO
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
Last year, 11 major M&A deals were signed with women-led biotechs. The industry is nowhere near on track to meet that bar for 2026.
Strange and bittersweet. That’s how Claire Mazumdar describes her plan to step down from the top spot at Bicara, a biotech she helped form, and head out on parental leave before transitioning into a new role.
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Follow along as BioSpace tracks job cuts and restructuring initiatives.
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Read our takes on the biggest stories happening in the industry.
Big Pharma needs more—not fewer—bold bets on rare and difficult diseases after Novartis’ efforts to invest in muscular dystrophy and ALS hit major roadblocks this month.
THE LATEST
FDA
Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease.
The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2 study of AMT-130 underestimates disease progression.
Roche’s anti-myostatin therapy emugrobart is unlikely to elicit meaningful weight loss, according to an interim mid-stage analysis, prompting the pharma to return the asset rights to its subsidiary Chugai Pharmaceutical.
The all-stock deal gives Summit Therapeutics enough money to see through Phase 3 trials for the PD-1/VEGF bispecific ivonescimab—but keeps the asset fully in-house without giving up licensing rights.
Investors looking for more transformative business development at Novo will have to wait, but a new partnership with China’s Hengrui Pharma adds a new weekly oral option to the Danish pharma’s early pipeline.
To successfully challenge Novartis on two planned fronts, Curium will need to overcome the unique challenges posed by radiopharmaceutical supply to get products to patients and win market share.
Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results.
The approval of Mirum Pharmaceuticals’ ALK2 inhibitor for fibrodysplasia ossificans progressiva on Friday adds a third option for patients who had long been without any treatments, joining Regeneron’s recently approved Pasatru and Ipsen’s Sohonos.
Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda’s patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2 billion.
What drives meaningful employee engagement in today’s life sciences workplace? This BioSpace report explores the factors that shape how employees feel about their organizations and what employers can do to create workplaces where talent wants to stay and thrive.