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  • 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 · 23d 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 · 23d agoNegative↗ source
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  • Researchers develop tumor "avatar" model that predicts immunotherapy response with 93% accuracy
    Researchers at Elephas Biosciences, in collaboration with academic centers, created an ex vivo tumor "avatar" from patient biopsies to test how tumors respond to immunotherapy. They exposed 124 tu…
    Fierce Biotech · 23d agoPositive readoutPositive↗ 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 · 24d agoApprovalPositive↗ 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 · 24d agoNeutral↗ 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 · 24d agoPositive readoutNeutral↗ source
  • Bristol Myers Squibb leads $237 million Series E for Pathos AI and launches Alzheimer's collaboration
    Bristol Myers Squibb (BMS) headed a financing round that raised $237 million for biotech Pathos AI. The Series E funding will support Pathos AI's development of its AI‑driven platform for drug dis…
    Fierce Biotech · 24d agoDealPositive↗ 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 · 24d 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 · 24d 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 · 24d 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 · 24d agoRegulatoryPositive↗ source
  • Lycia Therapeutics targets $228M IPO to fund food allergy protein degrader programs
    Lycia Therapeutics announced plans for an initial public offering expected to raise about $228 million. The proceeds are intended to support its pipeline of protein degrader therapeutics targeting…
    Fierce Biotech · 24d agoDealNeutral↗ source
  • FDA and UK regulators discuss new frameworks for generative AI oversight
    At the MedTech Conference in Boston, officials from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency met to talk about how to regulate generati…
    raps · 24d agoRegulatoryNeutral↗ source
  • SCRS unveils Eagle Insights Dashboard to benchmark clinical trial site performance
    The Society for Clinical Research Sites introduced a new data intelligence platform called the Eagle Insights Dashboard. The tool provides sponsors and contract research organizations with a compos…
    Fierce Biotech · 24d agoPositive↗ source
  • Roche signs up to $15 billion ADC partnership with China's Hansoh, paying $400 million upfront
    Roche announced a new partnership with Chinese drugmaker Hansoh Pharmaceutical Group focused on antibody‑drug conjugates. The agreement includes an upfront payment of $400 million and the potential…
    BioPharma Dive · 24d agoDealPositive↗ source
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    Fierce Biotech · 25d agoApprovalPositive↗ source
  • Roche signs $15 billion ADC partnership with China's Hansoh Pharma
    Roche has re-entered a partnership with China's Hansoh Pharmaceutical, signing a $15 billion biobucks agreement. The deal covers a broad portfolio of antibody-drug conjugate programs, including tw…
    Fierce Biotech · 25d agoDealPositive↗ source
  • Israeli biotech's inhaled exosome therapy cuts respiratory failure and mortality in ARDS phase 2b trial
    Nano24, an Israeli biotech company, tested its inhaled exosome product EXO‑CD24 in a mid‑stage study involving 90 patients with acute respiratory distress syndrome. The trial compared the therapy,…
    Fierce Biotech · 25d agoPositive readoutPositive↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, adding Phase-2 RNAi drug for polycythemia vera
    Merck KGaA announced it will purchase UK‑based Silence Therapeutics for about $1.3 billion, paying $20 in cash per share, representing a 130 % premium. The deal gives Merck control of an RNA‑inter…
    BioPharma Dive · 24d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic porphyria
    Disc Medicine announced that its experimental therapy bitopertin achieved its primary and secondary goals in a Phase 3 trial for erythropoietic porphyria, a rare condition that makes patients extre…
    BioPharma Dive · 24d agoPositive readoutPositive↗ source
  • Pathos AI partners with BMS and Tempus to use AI for Alzheimer’s drug development
    Pathos AI announced two collaborations aimed at accelerating drug development for neurological disorders, including Alzheimer’s disease. The agreement with Bristol Myers Squibb gives the pharma co…
    Fierce Biotech · 24d agoDealPositive↗ source
  • AbbVie’s combo of Skyrizi and trosunilimab shows higher remission than Skyrizi alone in phase 2 Crohn’s trial
    AbbVie tested a next‑generation Crohn’s disease regimen by randomizing 300 patients with moderate‑to‑severe disease to receive Skyrizi, the α4β7 inhibitor trosunilimab, or the two drugs together (c…
    Fierce Biotech · 25d agoPositive readoutPositive↗ source
  • Lilly reports 79% response rate for FRα-directed ADC in platinum-sensitive ovarian cancer
    Lilly presented phase 1 data on its FRα‑directed antibody‑drug conjugate, sofetabart mipitecan (Sofe-M), combined with bevacizumab in patients whose ovarian cancer had progressed after platinum the…
    Fierce Biotech · 25d agoPositive readoutPositive↗ source
  • Merck acquires Silence Therapeutics for $1.3B; Hansoh Pharma signs $15B deal with Roche
    German Merck announced the acquisition of Silence Therapeutics in a transaction valued at $1.3 billion. In China, Hansoh Pharma disclosed a partnership with Roche that involves a $15 billion drug…
    raps · 25d agoDealNeutral↗ source
  • Eli Lilly teams with Hong Kong's Metis TechBio in up to $1.1 billion AI nanoparticle partnership
    Eli Lilly has entered a partnership with Hong Kong‑based Metis TechBio to access an artificial‑intelligence driven platform for designing lipid nanoparticles that can improve drug delivery. The co…
    Fierce Biotech · 25d agoDealPositive↗ source