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1,374 stories matching this filter · ← front page

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  • US government unveils AI-driven SURPASS program to accelerate clinical trials
    The U.S. Department of Health and Human Services announced that the Advanced Research Projects Agency for Health (ARPA-H) is launching four new initiatives aimed at modernizing clinical trial desig…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Vertex completes $10 billion Crinetics acquisition as Q3 M&A slows
    M&A activity in the pharmaceutical sector cooled in the third quarter, with total deal value just under $30 billion across 22 transactions, according to BioSpace. Vertex Pharmaceuticals completed…
    BioSpace · 1mo agoDealNeutral↗ source
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  • FAIR Act could boost U.S. rare‑disease trial access and restore biotech leadership
    In a recent BioSpace podcast, host Jennifer C. Smith‑Parker talked with Max Bronstein of Aviva Strategies and Teresa Barnes of PF Warriors about a growing problem: U.S. patients are increasingly un…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Merck’s antibody impresses with ‘highly competitive’ data in chronic skin disease
    Merck has revealed detailed data for tulisokibart from a mid-stage trial in hidradenitis suppurativa that analysts say could help carve out a place in a crowded market that already includes AbbVie’…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Biopharma job seekers urged to act quickly in Q4 hiring surge
    Biopharma professionals face a busy fourth‑quarter hiring season, and experts say candidates should submit applications as soon as possible rather than waiting. Angie Allen, managing partner at Ka…
    BioSpace · 1mo agoPositive↗ source
  • Sanofi pays Regeneron $1B upfront to continue search for Dupixent successor
    Sanofi and Regeneron have had a long and “sometimes contentious” partnership, BMO Capital Markets noted, as the companies contend with the looming loss of exclusivity of their blockbuster drug Dupi…
    BioSpace · 1mo ago↗ source
  • Lilly’s EloraTZP combo shows superior weight loss and glucose control, moves to Phase 3
    Eli Lilly reported that its experimental combination, EloraTZP, which pairs an amylin agonist with the approved obesity drug Zepbound, met all primary and secondary goals in a mid‑stage study of ad…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Bristol Myers revises Phase 3 fibrosis trial after liver safety events, including a death
    Bristol Myers Squibb announced a change to its late-stage Phase 3 "Aloft" trial of the experimental pulmonary fibrosis drug admilparant. The amendment adds closer monitoring for liver-related adve…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • FDA begins review of Roche’s experimental multiple sclerosis pill fenebrutinib
    The FDA has accepted Roche's application for fenebrutinib, an experimental oral therapy for multiple sclerosis, and has started a priority review. The review will evaluate the drug in both relapsi…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Atara and Pierre Fabre resubmit Ebvallo cell therapy after second FDA rejection
    Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have filed a new FDA submission for their cell therapy candidate Ebvallo (tabelecleucel), aimed at treating Epstein‑Barr virus‑positive post‑t…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • PhRMA appoints former congressman Eric Cantor as CEO as Pierre Fabre resubmits Ebvallo approval request
    PhRMA announced that former U.S. House member Eric Cantor will become its president and chief executive on Nov 9, taking over from longtime leader Steve Ubl. Cantor served Virginia from 2000 to 201…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Lilly uses indirect data to argue its oral GLP-1 pill may outperform Novo’s semaglutide
    Eli Lilly’s weight‑loss drug Foundayo has seen a slower launch than expected, according to BMO Capital Markets, which noted the product is lagging behind competitors. To bolster its market case, L…
    BioSpace · 1mo agoPositive readoutNeutral↗ source
  • AI chemistry agent gives wrong answer after handling malformed data, highlighting safety concerns in drug research
    An AI chemistry agent called ChemAgent was tasked with checking whether a molecule had a known hepatobiliary side effect. The agent supplied the molecular structure in an invalid format to a speci…
    BioPharma Dive · 1mo agoNegative↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics as uniQure shares tumble on disappointing Huntington’s data
    Summit Therapeutics received a $2 billion all‑stock investment from AstraZeneca aimed at advancing its bispecific antibody ivonescimab through late‑stage trials. The funding is expected to support…
    BioSpace · 1mo agoDealNeutral↗ source
  • Massachusetts offers $40M in tax incentives to spur 1,600+ life-science jobs
    Massachusetts announced $40 million in tax incentives for 38 life‑science companies, targeting the creation of about 1,644 new jobs. Most of the companies-31 of them-will expand outside Boston and…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • BioNTech to shut three German manufacturing sites after failing to secure buyers, risking 1,860 jobs
    BioNTech announced it will close three manufacturing facilities in Germany after an unsuccessful search for buyers. The sites in Idar-Oberstein, Marburg and Tübingen were slated for possible sale,…
    BioSpace · 1mo agoNegative↗ source
  • Bicara CEO Claire Mazumdar to step down, COO Ryan Cohlhepp to assume leadership in 2027
    Claire Mazumdar, who co‑founded Bicara and has served as its chief executive for almost seven years, announced she will step down at the end of the year. She will take parental leave and then move…
    BioSpace · 1mo agoPositive↗ source
  • Women-led biotech M&A drops sharply in 2026, only two major deals recorded so far
    Last year saw an unprecedented wave of women-led biotech transactions, with eleven high‑value deals out of 72 total biopharma mergers in 2025. In 2026 the pace has slowed dramatically, with just…
    BioSpace · 1mo agoDealNegative↗ source
  • Biopharma must incentivize scientists to make early go-no-go decisions
    The article argues that simply urging scientists to think like entrepreneurs is not enough; biopharma firms need to align rewards with that mindset. Because only about one in ten drug candidates t…
    BioSpace · 1mo agoNeutral↗ source
  • Biopharma needs to reward scientists' judgment
    It’s not enough for organizations to want scientists to think like entrepreneurs. They have to incentivize and reward for that behavior.
    BioSpace · 1mo ago↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics to fund Phase 3 trials of ivonescimab
    AstraZeneca has agreed to a $2 billion all‑stock investment in Summit Therapeutics. The deal involves the purchase of preferred shares that can be converted into common stock, but it does not inclu…
    BioSpace · 1mo agoDealPositive↗ source
  • AstraZeneca puts $2 billion into Summit Therapeutics and partners to test ivonescimab with its oncology pipeline
    AstraZeneca announced a $2 billion equity investment in Summit Therapeutics, acquiring roughly 109,000 shares of convertible preferred stock. The deal will give AstraZeneca about a 12% stake in Sum…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Curium gains FDA nod for Bexlutry as it eyes challenge to Novartis radioligand therapies
    Curium recently received FDA approval for its radiopharmaceutical Bexlutry, positioning it as a direct competitor to Novartis’ Lutathera. The biotech is also in discussions with the FDA about fili…
    BioSpace · 1mo agoApprovalNeutral↗ source
  • Beam Therapeutics sues YolTech and Serapha Bio over alleged theft of base editing trade secrets
    Beam Therapeutics has filed a lawsuit in U.S. District Court in Massachusetts accusing Chinese biotech YolTech Therapeutics and its U.S. partner Serapha Bio of using confidential information to dev…
    BioPharma Dive · 1mo agoNegative↗ source