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1,373 stories matching this filter · ← front page

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  • 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 · 21d 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 · 21d agoRegulatoryNeutral↗ source
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  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 · 21d 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 · 21d 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 · 20d 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 · 20d agoRegulatoryNeutral↗ source
  • BioSpace lists top 12 biopharma employers hiring in July 2026
    BioSpace released a list of the twelve biopharma firms with the most job postings in July 2026. The list includes AbbVie, Regeneron, Amgen, Eli Lilly, Sanofi, Novo Nordisk, Moderna, Insmed, Freder…
    BioSpace · 20d agoNeutral↗ 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 · 20d 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 · 20d 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d agoRegulatoryNeutral↗ source
  • FDA launches nationwide recruitment to broaden scientific and consumer representation on advisory committees
    The U.S. Food and Drug Administration announced a new nationwide effort to recruit qualified experts and consumer representatives for its advisory committees. The agency issued two Federal Register…
    fda press · 21d agoRegulatoryPositive↗ 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 · 21d 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 · 21d agoNegative↗ source