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  • 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
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  • 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
  • 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 · 15d 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 · 15d 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
  • 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
  • Abbott receives FDA clearance for CardioMEMS HF System updates enabling home pressure monitoring via smartphone app
    Abbott announced that the U.S. Food and Drug Administration has cleared updated software for its CardioMEMS HF System. The changes add a patient facing component through the CardioGuide HF mobile a…
    Fierce Biotech · 15d agoApprovalPositive↗ source
  • AstraZeneca opens 570,000-sq-ft Kendall Square R&D hub to boost cancer and biotech research
    AstraZeneca inaugurated a 570,000-square-foot research and development facility in Kendall Square, Cambridge, Massachusetts. The 18-story building will host roughly 2,000 scientists working on chr…
    Fierce Biotech · 15d agoPositive↗ source
  • UK regulator adopts AI framework for medical devices and launches third AI Airlock phase
    The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK government has adopted a set of recommendations on the use of artificial intelligence in medical devices. These…
    raps · 15d agoRegulatoryNeutral↗ source
  • Utah expands AI prescribing sandbox to boost health‑tech innovation
    Utah is positioning itself as a national leader in the use of artificial intelligence for healthcare, according to recent reporting. The state’s Office of AI Policy runs a regulatory sandbox that…
    Endpoints · 14d agoRegulatoryPositive↗ source
  • KymaThera secures $80M Series B to advance oral PI3Kα inhibitor K-1728 as biotech peers raise funds and go public
    KymaThera, a San Diego biotech, announced an $80 million Series B round to fund development of its pan-mutant selective PI3Kα inhibitor, K-1728. The oral candidate is planned to enter Phase 1 clin…
    Endpoints · 15d agoDealPositive↗ source
  • UK regulator adopts AI framework for medical devices, launches next phase of AI sandbox
    The Medicines and Healthcare products Regulatory Agency announced that the UK government has accepted a set of recommendations on using artificial intelligence in medical devices. These recommendat…
    raps · 15d agoRegulatoryPositive↗ source