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  • 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 · 5h agoApprovalPositive↗ source
  • Roche reports up to 30% shrinkage of chronic MS lesions with fenebrutinib, eyes FDA approval
    Roche has filed for FDA approval of its BTK inhibitor fenebrutinib for both relapsing and primary progressive multiple sclerosis, after the agency accepted the submission. At the MSToronto2026 mee…
    Fierce Biotech · 6h agoPositive readoutPositive↗ source
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  • 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 · 46m 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 · 1h 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 · 1h agoPositive readoutPositive↗ source
  • Astellas partners with AI Proteins on $400M computational drug discovery deal
    Astellas Pharma of Japan has entered a partnership with Boston based AI Proteins to apply its computational design platform to drug discovery. AI Proteins builds miniproteins from scratch using ar…
    Fierce Biotech · 6h agoDealPositive↗ 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 · 9h agoPositive↗ source
  • Biotech reverse mergers surge in 2026, reaching highest level since 2021 as PIPE financing spikes
    Biotech companies are using reverse mergers to re‑enter public markets at a rate not seen since 2021, according to a J.P. Morgan report released in October 2026. In the first nine months of 2026,…
    Fierce Biotech · 12h agoDealPositive↗ source
  • Amid bepirovirsen triumph, GSK quietly scraps trial of next-gen hep B therapy
    GSK may have cemented its hepatitis B credentials with Tuesday’s landmark FDA nod for its “functional cure” bepirovirsen, but the pharma continues to rethink its strategy for next-gen candidates.
    Fierce Biotech · 6h agoRegulatoryNeutral↗ 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 · 23h 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 · 23h 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 · 21h 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
  • Rapport Therapeutics' Phase 2 Bipolar Mania Trial Meets Primary Endpoint, Though Effect Size Below Target
    Rapport Therapeutics reported that its phase 2 study of RAP-219 in bipolar mania met the primary endpoint, showing a statistically significant improvement on the Young Mania Rating Scale (YMRS) at…
    Fierce Biotech · 1d agoPositive readoutNeutral↗ source
  • EY report says MedTech growth driven by commercial leaders, AI and expanding into new care settings
    The latest EY Pulse of the MedTech Industry report looks at the period from 2025 through the first half of 2026. It finds that innovation has spurred more dealmaking and R&D spending, while artific…
    Fierce Biotech · 1d agoPositive↗ source
  • Pfizer halts phase 2 trial of CXCR5 antibody for immune thrombocytopenia
    Pfizer announced it is ending a phase 2 study of its CXCR5-targeting antibody PF-06835375 in patients with primary immune thrombocytopenia (ITP). The decision was described as a business decision a…
    Fierce Biotech · 1d agoCRLNegative↗ 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
  • AstraZeneca partners with Oracle to boost clinical trial patient recruitment using AI
    AstraZeneca announced a collaboration with data-technology firm Oracle to apply artificial-intelligence tools to clinical-trial recruitment. The non-binding agreement will let the partners explore…
    Fierce Biotech · 1d agoDealPositive↗ 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