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  • 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 · 2h 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 · 8h agoApprovalPositive↗ source
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  • 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 · 3h agoRegulatoryPositive↗ 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 · 3h 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 · 4h 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 · 4h agoPositive readoutPositive↗ source
  • Arcus kidney cancer drug shows stronger potency than Merck's Welireg, boosting shares
    Arcus Biosciences reported follow‑up data from its late‑stage kidney cancer trial that suggest its experimental therapy, casdatifan, may be more potent than Merck's approved drug Welireg. Analysts…
    BioPharma Dive · 4h 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 · 13h agoPositive↗ source
  • Samsung Biologics union vows appeal after court blocks planned strike
    A Seoul court granted Samsung Biologics an order that prevents its labor union from holding a strike that had been scheduled for the company's bio-manufacturing campus. The union, representing con…
    Endpoints · 1h agoNegative↗ source
  • Endpoints AI Day highlights agents, AI slop and biosecurity gaps in pharma
    Endpoints News held its third AI Day, an event dedicated to exploring how artificial intelligence can be applied across drug discovery and development. Speakers, including Nathan Frey of Anthropic…
    Endpoints · 3h agoNeutral↗ source
  • Treasury expected to be harder on China biotech deals in new rules
    The pharma industry is bracing for a more stringent assessment of China deals from the Treasury Department, despite months of work to escape a harsh clampdown on buying new assets there. Endpoints…
    Endpoints · 12m ago↗ source
  • Rapport Therapeutics' epilepsy drug RAP-219 meets primary endpoint in bipolar mania Phase II trial
    Rapport Therapeutics reported that its experimental pill RAP-219, originally developed for epilepsy, was tested in a mid‑stage study of adults with bipolar mania. The trial enrolled roughly 250 par…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • ICER reports two-thirds of new drugs launched 2022-2025 priced well above cost-effectiveness thresholds
    ICER’s latest analysis of launch prices for new prescription medicines shows a sharp rise in net costs between 2022 and 2025. After adjusting for inflation, the median price climbed from $190,000 i…
    BioPharma Dive · 1d agoNegative↗ source
  • Biopharma Sentiment Index climbs to upbeat 105 in Q3 2026, marking strongest optimism in years
    Endpoints Signal released its Q3 2026 Biopharma Sentiment Index, showing a dramatic lift in industry mood. The survey indicates the sector is finally in a positive territory after a four-year downt…
    Endpoints · 1d agoPositive↗ source
  • AstraZeneca teams with Oracle on AI-driven clinical trials as FDA clears Haemonetics vascular closure system
    AstraZeneca announced a collaboration with technology firm Oracle to incorporate artificial intelligence into its clinical trial processes. The partnership aims to use Oracle's cloud and data analy…
    raps · 1d agoApprovalPositive↗ source
  • ICER report finds median launch drug prices jumped 24% between 2022 and 2025
    The Institute for Clinical and Economic Review released a new analysis showing that the median list price of newly launched drugs increased by 24% from 2022 to 2025. The report also notes that net…
    Endpoints · 1d agoNegative↗ source
  • Pfizer halts Phase 2 trial of PF-06835375 in primary immune thrombocytopenia
    Pfizer announced that it is stopping its Phase 2 study of the experimental program PF-06835375, which was being evaluated in patients with primary immune thrombocytopenia, a rare autoimmune blood d…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • Pharma pours billions into bispecifics, ADCs and cell therapies despite limited clinical proof
    The article notes that emerging drug formats such as bispecific antibodies, antibody‑drug conjugates and cell therapies have yet to demonstrate clear clinical success, yet pharmaceutical firms cont…
    BioPharma Dive · 1d agoNeutral↗ source
  • Rapport Therapeutics reports Phase 2 success for J&J-licensed bipolar mania drug
    Rapport Therapeutics announced that its oral investigational drug, which modulates AMPA receptors, has successfully completed a Phase 2 trial in patients with bipolar mania. The study met its prim…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • FDA issues import alert on Olympus endoscopic devices over quality violations
    The U.S. Food and Drug Administration has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The alert applies to…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • Cardinal Health issues updated instructions for Presource kits containing recalled BD Alaris infusion sets
    The FDA CDRH issued an Early Alert to inform the public of a potentially high‑risk device issue involving Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets linked to a re…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 1d agoCRLNegative↗ source
  • FDA issues final guidance on developing and labeling prescription drug apps
    The FDA released its final guidance on Tuesday, outlining how drug sponsors should create, distribute, and label software applications that are used together with prescription medicines. The guida…
    raps · 1d agoRegulatoryPositive↗ source
  • Epic introduces prescription marketplace to let doctors and patients compare drug prices
    Epic, a leading electronic health record provider, announced a new prescription marketplace designed to help physicians and patients see price differences across pharmacies. The platform integrate…
    Endpoints · 1d agoPositive↗ source
  • Astellas teams up with Boston miniprotein startup to explore AI-designed tiny proteins
    Astellas Pharma announced a partnership with a Boston-based startup that specializes in miniproteins, small engineered proteins that can serve as therapeutic agents. The startup leverages artifici…
    Endpoints · 1d agoDealPositive↗ source