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  • FDA device center outlines FY 2027 guidance plan, targeting AI-enabled devices and change-control plans
    On Oct 1, the FDA’s Center for Devices and Radiological Health announced its guidance agenda for fiscal year 2027. The top priority is finalizing guidance for artificial intelligence-enabled medic…
    raps · 19d agoRegulatoryNeutral↗ source
  • Novartis bets up to $7.8B for an mRNA-encoded T cell engager from China’s Abogen
    Novartis is licensing an mRNA-based therapy designed to produce a CD3xCD19 T cell engager inside the body. Abogen Biosciences says the in vivo approach could reduce the likelihood of dangerous cyto…
    BioSpace · 19d ago↗ source
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Sanofi to pay $1 billion upfront to expand antibody partnership with Regeneron
Sanofi announced it will provide Regeneron with a $1 billion upfront payment to broaden their existing antibody collaboration. The agreement is timed as the patent protection for Dupixent, the joi…
Endpoints · 20d agoDealNeutral↗ source
  • Eli Lilly, Novo, AbbVie and Boehringer showcase new obesity drug data at European meeting
    The European Association for the Study of Diabetes held its annual meeting in Milan, drawing obesity and metabolic disease experts and providing a platform for drugmakers to present emerging weight…
    BioPharma Dive · 20d agoPositive readoutPositive↗ source
  • Sanofi, Regeneron expand partnership with $1 billion deal to develop next-generation Dupixent-like antibodies
    Sanofi and Regeneron announced they have broadened their long‑standing alliance, adding a $1 billion upfront payment to fund joint work on new immune‑modulating drugs. The revised agreement calls…
    BioPharma Dive · 20d agoDealPositive↗ source
  • Pfizer's experimental eczema drug tilrekimig shows strong skin clearance in Phase 2 trial
    Pfizer reported that its three‑pronged antibody, tilrekimig, met the primary endpoint of its Phase 2 study in patients with moderate to severe atopic dermatitis. After 16 weeks, a significantly hig…
    BioPharma Dive · 20d agoPositive readoutPositive↗ source
  • BMS flags liver injury cases, including a death, in Phase 3 trial of pulmonary fibrosis drug admilparant
    Bristol Myers Squibb has amended the protocol for its Phase 3 pulmonary fibrosis study of admilparant after reporting several liver injury events, one of which resulted in a patient death. The comp…
    BioSpace · 20d agoNegative↗ source
  • Devoted Health secures $1.2 billion in new funding to fuel senior member growth
    Devoted Health, a Medicare Advantage insurer and medical group, announced a fresh capital injection of nearly $1.2 billion. The financing round includes a $555 million Series G investment along wi…
    Endpoints · 20d agoDealPositive↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    On Oct 1, 2026 the U.S. Department of Health and Human Services announced a new initiative under the Advanced Research Projects Agency for Health. The initiative, named the Simulation-augmented, R…
    raps · 20d agoRegulatoryNeutral↗ source
  • EU Council adopts new pharma package to modernize drug legislation
    The Council of the European Union has approved a comprehensive "pharma package" of rules aimed at updating the regulatory framework for medicines across the bloc. The new legislation seeks to stre…
    raps · 20d agoRegulatoryNeutral↗ source
  • Lilly ends partnership with Foghorn after lead cancer drug fails efficacy tests
    Lilly announced it is ending its collaboration with Foghorn Therapeutics after the biotech's lead cancer candidate, FHD-909, did not meet efficacy benchmarks in testing. The decision halts the join…
    BioPharma Dive · 20d agoNegative↗ source
  • United Therapeutics wins Delaware court case; BMS secures pediatric approval for Camzyos
    United Therapeutics secured a legal victory in a federal court in Delaware, with the judge ruling in the company's favor. The decision marks a notable win for the biotech firm, though the specific…
    Endpoints · 20d agoApprovalNeutral↗ source
  • HHS launches funding programs to accelerate U.S. clinical trials amid rising Chinese competition
    HHS announced new initiatives aimed at speeding up clinical trial development in the United States. The department introduced a five-year program called "Surpass" that seeks proposals from teams wi…
    BioPharma Dive · 20d agoRegulatoryPositive↗ source
  • Foghorn Therapeutics cuts 40% of workforce after ending Lilly oncology partnership
    Foghorn Therapeutics and Eli Lilly announced the end of their 2021 oncology collaboration. The partnership had focused on developing and commercializing cancer treatments. Following the terminatio…
    BioSpace · 20d agoLayoffsNegative↗ source
  • FDA issues warning letter to Fresenius Kabi over famotidine injection contamination
    FDA inspectors spent three weeks at Fresenius Kabi's plant in Melrose Park, Illinois, and issued a warning letter after finding manufacturing deviations linked to patient adverse events. The issue…
    BioSpace · 20d agoRegulatoryNegative↗ source
  • Zealand Pharma shares fall as Boehringer Ingelheim partnership weight-loss drug shows modest 9.8% loss in Phase 3
    Zealand Pharma and its partner Boehringer Ingelheim reported that their glucagon/GLP-1 dual agonist survodutide met the primary endpoints in the Phase 3 SYNCHRONIZE-2 trial, but the magnitude of we…
    BioSpace · 20d agoNegative readoutNegative↗ source
  • Eli Lilly ends partnership with Foghorn Therapeutics, prompting 40% staff cut at biotech
    Eli Lilly announced it is withdrawing from its collaboration with Foghorn Therapeutics on a synthetic lethality drug program. Following the pullback, Foghorn said it will cut roughly 40% of its wo…
    Endpoints · 20d agoDealNegative↗ source
  • 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 · 20d agoRegulatoryPositive↗ source
  • Regeneron antibody restores muscle loss in patients after stopping Wegovy, mid-stage data show
    Regeneron presented new mid-stage data at the European Association for the Study of Diabetes (EASD) meeting in Milan showing its investigational antibody can help patients with obesity recover musc…
    Endpoints · 20d agoPositive readoutPositive↗ 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 · 20d agoDealNeutral↗ source
  • Kallyope rebrands as TriGemX Bio, secures $94M to fund Phase 3 migraine trial
    Kallyope, a New York City drug developer, announced it is changing its name to TriGemX Bio as it narrows its pipeline to migraine. The rebrand follows a recent partnership with Novo on an obesity…
    Endpoints · 20d agoDealPositive↗ source
  • 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 · 20d agoRegulatoryPositive↗ source
  • Boehringer's obesity drug shows up to 9.8% weight loss in diabetes patients but lags behind competitors
    Boehringer Ingelheim presented data at the European Association for the Study of Diabetes (EASD) meeting in Milan, showing its lead obesity candidate achieved up to 9.8% weight reduction in a late-…
    Endpoints · 20d agoNegative readoutNeutral↗ source
  • ICMRA urges cut to animal testing while HHS launches ARPA-H SURPASS program to accelerate clinical trials
    International Coalition of Medicines Regulatory Authorities released a joint statement urging drug makers and national control labs to cut back on animal testing throughout a medicine’s development…
    raps · 20d agoRegulatoryNeutral↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    The U.S. Department of Health and Human Services announced a new initiative under ARPA-H called the Simulation‑augmented, Real‑time Platform Adaptive Seamless Trials (SURPASS) program. SURPASS is…
    raps · 20d agoRegulatoryPositive↗ source