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  • Bexorg receives $28 million ARPA-H grant to extend testing of revived human brain tissue
    Bexorg, a biotech focused on brain research, was awarded $28 million by the U.S. Advanced Research Projects Agency for Health (ARPA-H). The funding will support longer-duration experiments on human…
    Endpoints · 14d agoDealPositive↗ source
  • Nuvig Therapeutics halts Phase 2 trial of NVG-2089 in chronic inflammatory demyelinating polyneuropathy
    Nuvig Therapeutics announced it is terminating one of its two ongoing clinical programs, a Phase 2 study of its candidate NVG-2089. The trial was designed to evaluate NVG-2089 in patients with chr…
    Endpoints · 14d agoCRLNegative↗ source
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  • MimiVax's glioblastoma vaccine falls short of Phase 2b primary endpoint
    MimiVax reported that its investigational vaccine for glioblastoma did not achieve the primary efficacy goal in a Phase 2b trial. The study, more than a decade in development, compared the vaccine…
    Endpoints · 14d agoNegative readoutNegative↗ source
  • Executive candidates need full truth, not a sales pitch, to address company challenges
    The article argues that candidates for senior roles must be given an honest picture of the company's problems rather than a polished sales narrative. It notes that during executive searches, infor…
    BioSpace · 14d agoNeutral↗ source
  • iRegene Therapeutics’s NouvSight001 Cleared for Clinical Trials in the U.S. and China for Retinitis Pigmentosa
    Following its Parkinson’s disease program, iRegene advances another off-the-shelf cell therapy into clinical development in the U.S. and China.
    Fierce Biotech · 14d agoNeutral↗ source
  • Eden Brothers recalls Calabrese broccoli seeds over possible Salmonella contamination
    Eden Brothers LLC announced a recall of its Calabrese broccoli seeds after being informed by its supplier that the product may be contaminated with Salmonella. The recall includes 1‑ounce and 1‑po…
    fda recalls · 13d agoCRLNegative↗ source
  • AbbVie/Genmab’s Epkinly halves progression risk in frontline DLBCL trial
    A Phase 3 study of the bispecific antibody Epkinly combined with standard chemotherapy showed nearly a 50% reduction in the risk of disease progression or death compared with chemotherapy alone in…
    BioPharma Dive · 15d agoPositive readoutPositive↗ source
  • Epkinly shows 51% PFS boost in frontline DLBCL, may become new standard of care
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a substantial gain in progression‑free survival when added to the standard R‑CHOP regimen in newly diagnosed diffuse large…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • AbbVie and Genmab's Epkinly succeeds in late-stage first-line DLBCL trial, challenging Roche's Polivy
    AbbVie and Genmab announced that their T‑cell engager Epkinly met its primary endpoints in a late‑stage study evaluating first‑line treatment for diffuse large B‑cell lymphoma (DLBCL). The trial de…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • MimiVax’s cancer vaccine fails phase 2 glioblastoma study, but CEO still sees data as ‘inspiring’
    MimiVax has reports a phase 2b miss in newly diagnosed glioblastoma patients, but remains positive about a significant survival benefit in a subset of patients 65 years and under.
    Fierce Biotech · 15d agoNegative readoutNegative↗ source
  • Forbion raises €2.3 billion with Lilly backing, launches largest Dutch VC fund to back ~30 life-science firms
    Forbion, a Netherlands-based life-science investor, announced it has closed two new funds totaling €2.3 billion ($2.6 billion), the largest capital raise in Dutch venture-capital history. The fund…
    Endpoints · 15d agoDealPositive↗ source
  • GE HealthCare to buy Sofie Biosciences for $945 million, boosting U.S. PET radiopharma capacity
    GE HealthCare announced it will acquire Sofie Biosciences for $945 million in cash, aiming to broaden its radiopharmaceutical manufacturing and distribution in the United States. Sofie Biosciences…
    BioPharma Dive · 15d agoDealPositive↗ source
  • Forbion raises record €2.3 billion to back 30 European biotech firms
    Forbion Capital Partners announced it has closed two new funds, the Growth Opportunities Fund IV and Ventures Fund VIII, together raising €2.3 billion, a record for the European life‑sciences ventu…
    Fierce Biotech · 15d agoDealPositive↗ source
  • TRex Bio targets $111M IPO as Retension and Lycia also prepare public listings
    TRex Bio, backed by Eli Lilly, filed with the SEC to raise about $111.3 million by offering 8.3 million shares priced between $14 and $16. If the midpoint price is achieved, the company expects net…
    Fierce Biotech · 15d agoDealNeutral↗ source
  • UK regulator to shift from one-off checks to continuous monitoring of AI medical devices
    The UK’s Medicines and Healthcare products Regulatory Agency announced a new policy that will require continuous monitoring of AI‑driven medical devices, replacing the current one‑time review model…
    Fierce Biotech · 15d agoRegulatoryPositive↗ source
  • Caribou Biosciences halts pipeline and announces major workforce cut
    Caribou Biosciences, a Bay Area biotech that develops off-the-shelf CAR-T cell therapies, said it will stop all clinical development and begin a substantial workforce reduction. The company, which…
    Fierce Biotech · 14d agoLayoffsNegative↗ source
  • Forbion raises $2.6 billion for two European biotech venture funds
    Forbion announced it has secured 2.3 billion euros ($2.6 billion) across two new venture funds, its largest raise to date. The funds, called Forbion Growth Opportunities IV and Forbion Ventures Fu…
    BioPharma Dive · 14d agoDealPositive↗ source
  • ArriVent shares tumble as lung cancer trial of furmonertinib misses primary goal
    ArriVent BioPharma reported that its late-stage study of furmonertinib in patients with EGFR exon 20 insertion-mutated non-small cell lung cancer did not achieve its primary endpoint. The trial, w…
    BioPharma Dive · 15d agoNegative readoutNegative↗ source
  • AstraZeneca opens 570,000-sq-ft R&D campus in Cambridge, targeting 2,000 staff
    AstraZeneca inaugurated a new research and development building in Cambridge, Massachusetts on Monday. The facility spans 570,000 square feet and is expected to house about 2,000 employees once fu…
    Endpoints · 15d agoPositive↗ source
  • ArriVent's lead lung cancer drug firmonertinib fails Phase 3 trial, shares plunge
    ArriVent BioPharma announced that its flagship EGFR inhibitor, firmonertinib, did not meet primary endpoints in a late-stage Phase 3 study for lung cancer. The trial results were released on Octobe…
    Endpoints · 15d agoNegative readoutNegative↗ source
  • Compliance worries keep AI adoption in drug manufacturing low, survey finds
    A new survey of more than 400 research and manufacturing professionals shows that over 90% of drugmakers have not committed to expanding AI use in regulated drug production. While AI is widely em…
    BioSpace · 15d agoRegulatoryNegative↗ source
  • AI investments in healthcare delivering returns faster than executives anticipated
    A new report from Bessemer Venture Partners finds that artificial-intelligence projects in health-care are delivering benefits more quickly than industry leaders expected. The survey highlights th…
    Endpoints · 15d agoPositive↗ source
  • ArriVent’s phase 3 EGFR inhibitor trial misses primary endpoint, shares plunge 57%
    ArriVent BioPharma reported results from its phase 3 Furvent trial, which evaluated firmonertinib, a brain-penetrant EGFR inhibitor, in patients with exon 20 insertion-mutated non-small cell lung c…
    Fierce Biotech · 15d agoNegative readoutNegative↗ source
  • Kairos pushes prostate cancer drug ENV-105 into earlier treatment line after promising mid-phase data
    Kairos Pharma announced a change to its phase 2 trial of ENV-105, a prostate cancer candidate, moving it to an earlier line of therapy. The modified protocol will enroll patients whose PSA rises a…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Lycia Therapeutics files for IPO to fund antibody degrader platform
    Lycia Therapeutics, a protein‑degradation startup built on research from Nobel laureate Carolyn Bertozzi, announced it has filed for an initial public offering. The filing is intended to raise cap…
    Endpoints · 15d agoDealNeutral↗ source