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  • Akeso's ivonescimab shows survival advantage over Keytruda in Chinese lung cancer trial
    A new data cut from a study comparing ivonescimab, a bispecific antibody from China-based Akeso, with Merck's Keytruda in patients with non-small cell lung cancer was released. The interim results…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Abivax remains independent despite intense acquisition speculation
    Biotech merger activity is at record levels, yet the French company Abivax, which is developing the ulcerative colitis drug obefazimod, has not been bought. Rumors have floated about a potential $…
    STAT · 2mo agoDealNegative↗ source
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  • Overdose deaths fall sharply in US and abroad, report links decline to naloxone and harm-reduction measures
    A new report highlights a sudden drop in drug overdose deaths after years of consistently high numbers in the United States. The data show that U.S. deaths fell 27% in 2024 and preliminary figures…
    STAT · 2mo agoNeutral↗ source
  • CBER official overturns Replimune melanoma drug rejection; AbbVie reports phase 3 success in multiple myeloma
    A CBER regulator has reversed a prior decision to reject Replimune's experimental melanoma therapy, allowing the program to move forward. AbbVie announced that its multiple myeloma candidate achie…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA’s Biologics Branch Scores Wins Against Unproven Stem Cell Clinics, Says Expert
    Professor Paul Knoepfler, a cell‑biology professor at UC Davis, writes that the FDA’s biologics division has recently taken concrete steps to curb the proliferation of unproven stem‑cell clinics in…
    STAT · 2mo agoRegulatoryPositive↗ source
  • FDA launches TEMPO pilot to let generative AI medical devices reach patients before formal approval
    The Food and Drug Administration has opened a new pilot program called TEMPO that permits certain generative‑AI medical devices to be made available to patients even though they have not received f…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome ed…
    raps · 2mo agoRegulatoryNeutral↗ source
  • New cardiovascular guidelines released for tactical athletes such as EMTs, firefighters and police
    The American College of Cardiology and the American Heart Association issued new cardiovascular guidance aimed at clinicians who treat "tactical athletes," a term that includes emergency responders…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Invivyd appoints chairman Marc Elia as CEO ahead of COVID antibody readout
    Invivyd, an infectious-disease biotech, announced that its chairman Marc Elia will also serve as chief executive officer. Elia, who joined the board in 2022 and helped shape the company's scientif…
    Fierce Biotech · 2mo agoNeutral↗ source
  • OpenEvidence introduces new family of AI models for health tech
    OpenEvidence announced a new family of artificial intelligence models aimed at health technology applications, as reported in STAT's Health Tech newsletter. The announcement highlights the company'…
    STAT · 2mo agoPositive↗ source
  • Fauci warns of public "selective amnesia" on Covid, hints at upcoming book as STAT newsletter covers Trump drug pricing deals
    STAT's twice‑weekly D.C. Diagnosis newsletter continues to blend health policy analysis with behind‑the‑scenes commentary, offering readers insight into current political debates. In a recent inte…
    STAT · 2mo agoNeutral↗ source
  • HHS reverses stance on disability lawsuit amid reports of falling overdose deaths and AI device access
    The Department of Health and Human Services has changed its position on a pending disability lawsuit, signaling a shift in its legal strategy. Data released this year show a sharp decline in U.S.…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Psilocybin prevents chemotherapy-induced neuropathy in mouse study, effects last up to eight months
    Researchers at MD Anderson reported that a single dose of psilocybin given before chemotherapy blocked the development of pain hypersensitivity in mice. The protective effect persisted for up to ei…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • UK government proposes legal amendments to modernize medicines and medical device regulations
    The UK government has introduced a set of legal amendments aimed at updating the framework that governs medicines and medical devices. The changes are intended to streamline approval processes, in…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Pediatricians Offer 'Last Resort' Care for Vaccine-Skeptical Parents
    A small group of pediatricians across six states have created what they call a "practice of last resort" for families hesitant about vaccines. Rather than turning patients away, they focus on liste…
    STAT · 2mo agoNeutral↗ source
  • Former doula turned OB‑GYN calls for better understanding between the two professions
    Debra Eluobaju, a maternal‑fetal medicine fellow who previously worked as a doula, reflects on the gap between doulas and obstetricians. She argues that many conflicts in maternity care stem from s…
    STAT · 2mo agoNeutral↗ source
  • Novartis signs up to $3.2 billion deal with Korea's Alteogen for subcutaneous drug delivery technology
    Novartis has entered an option and license agreement with Korean biotech Alteogen to use its ALT-B4 subcutaneous delivery platform, a partnership that could be worth up to $3.2 billion if all optio…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Ultragenyx's Angelman syndrome drug fails in Phase 3 trial, showing no benefit
    Ultragenyx announced that its experimental therapy GTX-102 for Angelman syndrome did not demonstrate any benefit compared with a sham control in a large Phase 3 trial. The drug had previously show…
    STAT · 2mo agoNegative readoutNegative↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 2mo agoNegative readoutNegative↗ source
  • UniQure files FDA priority review request for Huntington’s gene therapy AMT-130
    UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • H1 partners with Novo Nordisk to build AI-driven data foundation for clinical development
    Clinical trials are becoming more complex and data‑heavy, but decision‑making processes have not kept pace. H1 and Novo Nordisk are collaborating to address this gap. Novo Nordisk’s StudyHub links…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Fortrea acquires Worldwide Clinical Trials' early-phase division for $45 million
    Fortrea announced it will purchase the early-phase services division of Worldwide Clinical Trials for $45 million. The transaction gives Fortrea control of Worldwide's clinical pharmacology unit,…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Novartis to cut about 130 jobs in Switzerland as it reshapes biologics production in Basel
    Novartis announced it will eliminate roughly 130 positions in Switzerland as part of a reorganization of its biologics technical development and manufacturing footprint in Basel. The company plans…
    Fierce Biotech · 2mo agoLayoffsNegative↗ source
  • UniQure submits experimental Huntington's gene therapy to FDA for accelerated review
    UniQure announced that it has filed its experimental gene therapy for Huntington's disease with the U.S. Food and Drug Administration, seeking accelerated approval. The submission follows earlier…
    STAT · 2mo agoRegulatoryNeutral↗ source