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  • 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
  • Utah health AI pilots face regulatory uncertainty as FDA scrutiny looms
    Utah has launched an AI sandbox that allows health-focused artificial-intelligence projects to be tested in real-world settings. The initiative aims to accelerate innovation while monitoring safety…
    STAT · 14d agoRegulatoryNeutral↗ source
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  • WHO issues first global guidelines on childhood and adolescent obesity
    The World Health Organization has released its inaugural set of guidelines aimed at tackling the rapid increase in obesity among children and adolescents. The agency notes that in 2024, about 170 m…
    STAT · 14d agoRegulatoryNeutral↗ source
  • 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
  • ER visits by foreign-born patients fall sharply after increased ICE raids in Los Angeles
    A new study of three Los Angeles emergency rooms found that visits by people born outside the United States dropped sharply after a rise in ICE immigration raids last year. The researchers linked…
    STAT · 14d agoNegative↗ 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
  • Democrats court new Make America Healthy Again voters with food and environmental proposals
    Democrats are reaching out to a new constituency called the Make America Healthy Again (MAHA) voters as the 2026 midterm elections approach. Party leaders have met with MAHA activists, discussed c…
    STAT · 14d agoNeutral↗ source
  • Life insurers deem active-surveillance prostate cancer 'untreated' and deny term coverage, says patient
    Howard Wolinsky, a medical journalist, recounts that after his term life policy expired, eight insurers rejected his application because they considered his prostate cancer, managed by active surve…
    STAT · 14d agoNegative↗ 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
  • 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
  • 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
  • AstraZeneca launches $1 billion R&D hub in Boston’s Kendall Square
    AstraZeneca opened a new research and development site in Kendall Square, Boston, marking a $1 billion investment in the U.S. biotech corridor. The Boston location underscores the company’s commit…
    STAT · 15d agoNeutral↗ source
  • U.S. government launches first federally funded ibogaine trials for opioid addiction and PTSD
    The Trump administration announced the start of the United States' first government‑funded clinical trials of ibogaine, a psychedelic compound being investigated for its potential to treat opioid u…
    STAT · 15d agoRegulatoryPositive↗ 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
  • Experts warn FDA against approving Grail’s ineffective multicancer blood test
    Physician and cancer‑screening researcher H. Gilbert Welch argues that the FDA should not greenlight Grail’s multicancer blood test, noting the company’s trial of 140,000 participants used a weak s…
    STAT · 15d agoRegulatoryNegative↗ 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