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  • 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
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 20d agoApprovalPositive↗ source
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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
  • 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
  • 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 · 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
  • 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
  • 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
  • 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
  • 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
  • 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 · 21d agoDealNeutral↗ source
  • FDA seeks new advisory committee members, signaling renewed focus on external expertise
    The FDA announced it is inviting subject‑matter experts and consumer representatives to serve on its advisory committees. The call follows a period when the advisory committees had a reduced role…
    raps · 21d agoRegulatoryNeutral↗ 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 · 21d 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 · 21d agoNegative↗ source