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  • Merck and Moderna’s cancer vaccine data leak precedes official Phase 3 results release
    Results from the Phase 3 trial of Moderna and Merck’s therapeutic cancer vaccine were made public on Thursday after an earlier leak of the data. The vaccine, called intismeran autogene, is being e…
    Endpoints · 19d agoNeutral↗ source
  • FDA approves GSK hepatitis B drug; EQT to acquire Qiagen for $10.8 billion
    The U.S. Food and Drug Administration has granted approval to GlaxoSmithKline's new hepatitis B therapy, marking a regulatory milestone for the company. Private-equity firm EQT announced a definit…
    raps · 19d agoPositive↗ source
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US Treasury drafts rules to curb American investment in Chinese biotech firms
The Treasury Department has released draft regulations that would impose broad restrictions on U.S. companies and venture capital firms investing in or acquiring drug and biotechnology assets linke…
Endpoints · 19d agoRegulatoryNegative↗ source
  • Pfizer and Valneva report mixed results for Lyme disease vaccine, with one analysis narrowly missing efficacy
    New data on the collaborative Lyme disease vaccine from Pfizer and Valneva were presented, showing divergent outcomes across two key analyses. One analysis met its predefined endpoints, while the o…
    Endpoints · 19d agoNegative readoutNegative↗ source
  • FDA launches Neuroscience Advancement and Innovation Nexus to boost brain disorder drug development
    The U.S. Food and Drug Administration announced a new program called the Neuroscience Advancement and Innovation Nexus (NAIN) aimed at accelerating the development of medical products for brain and…
    fda press · 19d agoRegulatoryPositive↗ source
  • Roche prepares launch of breast cancer pill giredestrant amid patient anticipation
    Roche is gearing up for the launch of its new oral breast cancer therapy, giredestrant. Teresa Graham, head of Roche's pharma unit, said patients are anxiously awaiting the drug. The announcement…
    Endpoints · 19d agoPositive↗ source
  • FDA accepts new submission for Biohaven’s Vyglxia, opening path to approval
    Biohaven announced that the FDA has accepted a refreshed application for its rare disease drug Vyglxia, which targets a nerve‑damaging disorder. Vyglxia is being developed for spinocerebellar atax…
    BioPharma Dive · 19d agoRegulatoryPositive↗ source
  • Compounding pharmacy recalls copycat version of Eli Lilly’s Zepbound amid safety concerns
    Apothecary Pharma, a compounding pharmacy, has voluntarily recalled its compounded tirzepatide product that mimics Eli Lilly's obesity drug Zepbound. The company said it could not guarantee the saf…
    BioPharma Dive · 19d agoCRLNegative↗ source
  • Roche reaffirms sales outlook despite weaker Xolair sales and looming generic competition
    Roche reported third-quarter group sales of 16.1 billion Swiss francs, about $19.6 billion, a 7% increase that beat analysts' consensus estimate of 15.8 billion francs. The beat was helped by a ne…
    BioPharma Dive · 19d agoEarningsNegative↗ source
  • Regulatory update: Hepatitis B hold lifted for Arbutus drug and Ultomiris receives accelerated approval
    A regulatory update notes that the FDA has removed the clinical hold on Arbutus Biopharma's hepatitis B candidate, clearing the path for the company to resume development after a prolonged review.…
    Endpoints · 19d agoRegulatoryPositive↗ source
  • AbbVie reports Phase 3 success for lutikizumab in painful skin disease, eyes FDA filing next year
    AbbVie announced positive Phase 3 trial results for its experimental IL-1α and IL-1β inhibitor lutikizumab, which is being developed to treat a debilitating skin condition. The study reported impr…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Sanofi breaks ground on new 36,000-sq-m insulin plant in Frankfurt
    Sanofi has broken ground on a new insulin manufacturing facility at its Frankfurt site, covering roughly 36,000 square meters. The plant is part of the company’s expansion in Germany and is expect…
    Endpoints · 19d agoNeutral↗ source
  • GLP-1 drugs enter trials to test impact on alcohol and drug cravings
    GLP-1 drugs, first approved for diabetes and later for obesity, have sparked interest for broader therapeutic uses. Researchers are now launching large clinical trials to evaluate whether these ag…
    Endpoints · 19d agoNeutral↗ source
  • Georgiamune to ship preclinical solid tumor drug to Menarini in deal up to $1.1 billion
    Georgiamune, a small biotech based in Maryland, announced that it will supply its preclinical solid tumor candidate to Menarini, a family‑owned pharmaceutical company in Italy. The agreement is st…
    Endpoints · 19d agoDealNeutral↗ source
  • Roche touts strong Phase 3 track record while trimming pipeline amid peer setbacks
    Roche's chief executive Thomas Schinecker highlighted the company's high success rate in Phase 3 trials, positioning it as a competitive advantage. The comment accompanied an announcement that Roc…
    Endpoints · 19d agoPositive↗ source
  • FDA issues warning letters to Baxter and Olympus over GMP and QSR violations
    The U.S. Food and Drug Administration sent formal warning letters to Baxter International and Olympus Medical Systems. The letters allege that both companies failed to meet required good manufactu…
    raps · 19d agoRegulatoryNegative↗ source
  • AMA chief urges regulators to keep pace with emerging AI-driven medical care
    The American Medical Association’s chief executive highlighted the rapid progress toward autonomous, AI‑based medical treatments and warned that regulatory frameworks are lagging behind. He emphasi…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • Healthcare groups and tech firms debate FDA evidence requirements for generative AI medical devices
    Healthcare stakeholders are questioning how much clinical evidence the FDA should demand before clearing generative AI-enabled medical devices. The debate centers on balancing innovation speed with…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • Redesign Health merges with ARC Global in $2B deal to help hospitals build startups
    Health tech venture firm Redesign Health is merging with ARC Global, the innovation arm of Sheba Medical Center, to help hospitals in different countries develop and sell software. The new company…
    Endpoints · 19d agoDealNeutral↗ source
  • EMA opens consultation on platform trial methodology; MHRA to recognize CE-marked devices indefinitely
    The European Medicines Agency is launching a public consultation to gather feedback on the methodological aspects of confirmatory platform clinical trials. The agency seeks input from researchers,…
    raps · 19d agoRegulatoryNeutral↗ source
  • Natural Grocers recalls 2‑pound organic mung beans over possible glass contamination
    Vitamin Cottage Natural Food Markets, Inc. in Lakewood, Colorado announced a recall of Natural Grocers brand organic 2‑pound mung beans because of potential glass contamination. The recall follows…
    fda recalls · 19d agoRegulatoryNegative↗ source
  • WinCo Foods recalls hoagie rolls after undisclosed sesame ingredient
    WinCo Foods of Boise, Idaho announced a recall of its brand hoagie rolls because sesame was not listed on the label. The rolls, identified by UPC 2-70552-00649-2 and bearing best-by dates from Sep…
    fda recalls · 19d agoCRLNeutral↗ source
  • GSK and Ionis receive FDA nod for Hibsago, a potential functional cure for chronic hepatitis B
    The U.S. Food and Drug Administration has cleared Hibsago, a collaborative product of GSK and Ionis, as the first therapy of its kind aimed at chronic hepatitis B. The medicine is to be added to s…
    BioPharma Dive · 20d agoApprovalPositive↗ source
  • GSK and Ionis receive FDA nod for hepatitis B therapy promising functional cure
    GSK and Ionis announced that the U.S. Food and Drug Administration has approved their hepatitis B drug bepirovirsen, now marketed as Hibsago. The therapy is intended for chronic hepatitis B patien…
    Endpoints · 20d agoApprovalPositive↗ source
  • Roivant's brepocitinib shows strong Phase 3 results, paving way for uveitis indication
    Roivant subsidiary Priovant Therapeutics announced positive Phase 3 data for its anti‑inflammatory drug brepocitinib in patients with non‑infectious uveitis, an eye disease that can cause blindness…
    BioPharma Dive · 20d agoRegulatoryPositive↗ source