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3,104 stories matching this filter · ← front page

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  • 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
  • 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
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  • 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
  • Lawmakers push FDA to close loophole allowing import of counterfeit Eli Lilly obesity drug
    A bipartisan group of U.S. lawmakers is urging the Food and Drug Administration to address a regulatory gap that permits the importation of unapproved versions of retatrutide, an experimental obesi…
    STAT · 19h agoRegulatoryNeutral↗ source
  • BioSpace podcast highlights Q3 job market gains and sharp layoff decline for biopharma talent
    BioSpace Vice President of Marketing Chantal Dresner and content manager Angela Gabriel released a bonus podcast episode reviewing the biopharma job market in the third quarter of 2026. They repor…
    BioSpace · 22h agoPositive↗ 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 · 1d agoDealNeutral↗ source
  • Proposed ACGME rule changes could strip resident doctors of mandatory rest periods
    Arifeen Rahman, a clinical instructor in rhinology at the Medical University of South Carolina, recounts working 90-hour weeks as a junior otolaryngology resident in 2023, often exceeding the ACGME…
    STAT · 1d agoRegulatoryNegative↗ source
  • BioSpace releases Q3 2026 biopharma job market report showing upbeat hiring trends
    BioSpace has published its third quarter 2026 biopharma job market report, which examines hiring activity, workforce cuts and overall employment patterns across the sector. The analysis highlights…
    BioSpace · 1d agoPositive↗ 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 · 1d agoRegulatoryNeutral↗ source
  • New poll gauges U.S. voter attitudes toward transgender sports participation and abortion access
    A recent assessment released by STAT examines how American voters feel about transgender youth competing in school sports and about access to abortion services. The analysis is presented as a concr…
    STAT · 23h agoNeutral↗ 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 · 1d agoPositive↗ source
  • Nursing home cuts resident care while diverting revenue to real estate, state oversight lacking
    A Boston Globe Spotlight investigation found that a nursing home in Taunton, once praised for high quality, has seen a sharp decline in resident care after a new owner took over. The new owner, El…
    STAT · 15h agoNegative↗ source
  • JAMA paper on OpenEvidence highlights clinician use but raises unanswered questions
    A new study published in JAMA examines how clinicians are employing the OpenEvidence platform, an artificial-intelligence-driven tool designed to assist medical decision-making. The authors highli…
    STAT · 21h agoNeutral↗ source
  • Reporter urges audiences to skip new Elizabeth Holmes documentary
    Matthew Herper, a reporter covering medical innovation, recounts his two interviews with Elizabeth Holmes in 2015, at the peak of Theranos hype. The first interview occurred just before John Carre…
    STAT · 20h agoNegative↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 22h agoLayoffsNegative↗ source
  • Roche signs $15 billion ADC partnership with China's Hansoh, offering $400 million upfront
    Roche announced a licensing agreement with Hansoh Pharmaceutical to develop a broad portfolio of antibody-drug conjugates (ADCs).\n\nThe deal includes an upfront cash payment of $400 million and a…
    BioSpace · 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 · 2d 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 · 2d 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 · 2d agoPositive readoutPositive↗ source
  • Sanofi breaks ground on Frankfurt insulin API plant with €400 million German aid
    Sanofi has started construction of a new insulin active pharmaceutical ingredient (API) manufacturing facility at its Frankfurt site in Germany. The plant, covering about 36,000 square meters, is…
    BioSpace · 1d agoDealPositive↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.1 billion, gaining Phase 3 PV siRNA asset
    Merck KGaA announced it will buy Silence Therapeutics for about $1.1 billion, giving the German group a foothold in hematology. Silence, a UK-based RNA specialist, develops short interfering RNA m…
    BioSpace · 1d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic protoporphyria, setting stage for FDA resubmission
    Disc Medicine's bitopertin, being developed for erythropoietic protoporphyria (EPP), a rare blood disorder that causes painful light sensitivity, had its accelerated FDA application rejected in Feb…
    BioSpace · 2d agoPositive readoutPositive↗ source
  • Gilead’s oral ulcerative colitis drug shows significant remission in Phase 2 trial
    Gilead Sciences reported results from a Phase 2 trial of its oral ulcerative colitis drug emvistegrast. In the study, patients took a 200 mg daily dose for 12 weeks and achieved a 23% placebo-adju…
    STAT · 2d 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 · 2d 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 · 2d agoDealNeutral↗ source