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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 · 18d 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 · 18d 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 · 17d 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 · 17d 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 · 18d 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 · 18d agoPositive↗ 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 18d 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 · 18d agoRegulatoryNeutral↗ 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 · 19d agoApprovalPositive↗ source
  • Rezera files for IPO to fund NLRP3 peripheral artery disease program
    Rezera, which rebranded from NodThera earlier this year, has entered the queue for an initial public offering. The filing, submitted on Wednesday, is intended to raise capital to support the compa…
    Endpoints · 18d agoDealPositive↗ source
  • Treasury to tighten scrutiny of China biotech acquisitions under upcoming rules
    Treasury Secretary Scott Bessent announced on Sept 9 2026 that the Treasury Department will issue new guidance that makes it harder for U.S. pharma companies to complete biotech deals in China. Th…
    Endpoints · 19d agoRegulatoryNegative↗ source
  • CSL appoints former ViiV and GSK veteran Deborah Waterhouse as new CEO
    CSL announced that Deborah Waterhouse will become its chief executive. The appointment follows her departure from GSK, where she spent three decades. Waterhouse most recently led ViiV Healthcare,…
    Endpoints · 19d agoPositive↗ source
  • Alcon buys Neurotech for $550 million upfront
    Alcon, the Swiss eye‑care company, announced it has completed the acquisition of Neurotech Pharmaceuticals. The transaction includes an upfront cash payment of $550 million, with the possibility o…
    Endpoints · 19d agoDealNeutral↗ source
  • Roivant's autoimmune drug brepocitinib succeeds in two pivotal trials, paving way for 2027 filing
    Roivant Sciences said its autoimmune drug brepocitinib met primary goals in two pivotal studies. The trials, which evaluated the drug in separate autoimmune indications, showed statistically signi…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Lilly advances retatrutide toward sleep-apnea market
    Eli Lilly is moving its triple-agonist drug retatrutide closer to a potential launch for sleep-apnea. The company, which expects to introduce the drug for obesity next year, is now gathering data i…
    Endpoints · 19d agoPositive↗ source
  • China biotech RiboX reports first human data for circular RNA therapies
    China biotech company RiboX has disclosed its initial human data on circular RNA therapeutics, marking the first clinical readout for this emerging platform. The study represents a milestone for t…
    Endpoints · 18d agoNeutral↗ source