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2,339 stories matching this filter · ← front page

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  • 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 · 3h agoPositive↗ 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 · 2h agoNegative readoutNegative↗ source
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  • FDA releases final guidance on prescription-drug companion apps and software
    FDA issued final guidance that creates a clear framework for how drug makers can develop, distribute and label mobile applications that accompany prescription medicines. The document answers three…
    fda press · 4h agoRegulatoryNeutral↗ 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 · 5h 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 · 7h agoPositive readoutNeutral↗ 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 · 13h 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 · 14h agoDealPositive↗ 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 · 1h 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 · 5h agoDealPositive↗ 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 · 9h agoDealNeutral↗ source
  • FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
    Today, the U.S. Food and Drug Administration approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy pa…
    fda press · 1h ago↗ source
  • Industry at a ‘turning point’ with growth dominated by commercial leaders: EY report
    A new report has found that in 2025 through the first half of 2026, innovation increased dealmaking and R&D investment, AI heavily influenced the future of value creation, and that industry growth…
    Fierce Biotech · 12h ago↗ source
  • Hospital Glucose Meter Removal: Nova Biomedical Removes StatStrip Glucose Hospital Meter Systems
    Software update for StatStrip Glucose Hospital Meter Systems due to the potential for glucose results to be assigned to the incorrect patient.
    fda medwatch · 13h ago↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, expanding siRNA portfolio
    Merck KGaA, the German science and technology conglomerate, announced an agreement to purchase UK‑based Silence Therapeutics. The deal is valued at about $1.3 billion and gives Merck access to Sil…
    Endpoints · 1d agoDealPositive↗ source
  • Roche signs $400 million upfront deal with China's Hansoh, potential $15 billion partnership
    Roche announced a major collaboration with Chinese biotech Hansoh, committing $400 million upfront. The agreement gives Roche access to Hansoh's drug discovery platform and aims to co-develop cand…
    Endpoints · 1d 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 · 1d 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 · 1d 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 · 1d agoPositive readoutPositive↗ source
  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 1d agoApprovalPositive↗ source
  • Gilead to launch Phase 3 trial of oral α4β7 inhibitor after promising Phase 2 ulcerative colitis results
    Gilead Sciences announced plans to begin Phase 3 trials next year for its oral α4β7 integrin inhibitor aimed at treating ulcerative colitis. The move follows a Phase 2 dose‑finding study that repo…
    Endpoints · 1d agoPositive readoutPositive↗ 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 · 1d 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 · 1d agoDealNeutral↗ source
  • Antheia secures $80 million conditional loan from DOD to expand U.S. generic drug manufacturing
    Antheia, a biosynthesis manufacturer, has been awarded a conditional loan of $80 million from the U.S. Department of Defense. The funding is aimed at onshoring the company’s generic drug productio…
    Endpoints · 22h agoDealPositive↗ source
  • EyePoint's Phase 3 trial fails, prompting 53% staff cuts; Lilly signs China drug delivery partnership
    EyePoint, a Watertown, Massachusetts biotech, reported that its experimental therapy did not meet primary endpoints in a Phase 3 study, marking a setback for the company. Following the trial failu…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • Disc Medicine's rare sun-sensitivity drug meets all endpoints in Phase 3 trial
    Disc Medicine announced that its experimental therapy for a rare condition that makes sun exposure painful has completed a Phase 3 study. The trial reported success on every primary and secondary…
    Endpoints · 1d agoPositive readoutPositive↗ source