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1,937 stories matching this filter · ← front page

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  • Merck’s anti‑TL1A antibody tulisokibart fails Phase 2b in systemic sclerosis lung disease but succeeds in hidradenitis suppurativa
    Merck reported mixed Phase 2b results for its anti‑TL1A monoclonal antibody tulisokibart, acquired in the 2023 Prometheus Biosciences purchase. In patients with systemic sclerosis‑associated inter…
    BioSpace · 20d agoNegative readoutNeutral↗ source
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 20d agoNegative↗ source
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  • Icon partners with Anthropic to integrate Claude AI into clinical trial planning
    Icon, a contract research organization, announced a multi-year collaboration with Anthropic to bring the Claude AI system into its clinical trial operations. The partnership will combine Anthropic…
    Fierce Biotech · 20d agoDealPositive↗ source
  • UK regulator debates whether AI scribes count as medical devices
    UK regulators are examining whether AI-driven clinical documentation tools, often called AI scribes, should be classified as medical devices under current law. The proposal has generated debate am…
    STAT · 20d agoRegulatoryNeutral↗ source
  • Pfizer adds $2.5 billion to restructuring, targeting $6 billion savings by 2029
    Pfizer announced an additional $2.5 billion in cost reductions as part of its ongoing restructuring program. The new cuts focus on technology and simplification across commercial, R&D and manufact…
    BioSpace · 20d agoNegative↗ source
  • Analysis questions expanded orphan drug exemptions under recent legislation
    Ed Silverman, a Pharmalot columnist, examined a provision in the One Big Beautiful Bill Act that keeps certain orphan drugs out of Medicare price negotiations. The Inflation Reduction Act, which b…
    STAT · 20d agoRegulatoryNegative↗ source
  • Smith & Nephew lowers 2026 sales outlook as US knee implant revenue falls 7%
    Smith & Nephew announced a revision to its 2026 sales outlook, now expecting underlying revenue growth of about 4% versus the prior 6% target. The change follows a second‑quarter report showing re…
    Fierce Biotech · 20d agoEarningsNegative↗ source
  • Pfizer drops two obesity programs, including Metsera-derived GLP-1 candidate, in pipeline cleanout
    Pfizer announced it is removing two clinical‑stage obesity programs as part of its quarterly pipeline cleanout. The first program, MET-224o, is an oral ultra‑long‑acting GLP‑1 receptor agonist tha…
    Fierce Biotech · 20d agoNegative↗ source
  • KKR to acquire medtech maker Integer in $5.7 billion deal
    KKR announced an agreement to take Integer private for approximately $5.7 billion, offering $127 per share in cash to Integer stockholders. Integer, based in Plano, Texas, saw its shares rise abou…
    Fierce Biotech · 20d agoDealNeutral↗ source
  • Kennedy and Oz dismiss Medicaid cut claims, but state officials warn new rules could strip coverage
    Health secretary Robert F. Kennedy Jr. and former Vice President Dan Oz asserted that the administration is not cutting Medicaid, calling the idea a myth during a farm visit in Michigan. State Med…
    STAT · 20d agoRegulatoryNegative↗ source
  • Latigo Biotherapeutics targets non-opioid pain market with $247 M IPO
    Latigo Biotherapeutics announced details of its planned initial public offering, aiming to raise roughly $247 million to advance its pipeline of non-opioid pain treatments. The company intends to…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Pfizer expands cost-cutting program, targeting $1 billion in new savings through 2029
    Pfizer announced it is expanding a cost-cutting initiative first launched in 2023 to further reduce expenses. The new measures are projected to generate about $1 billion in additional savings by 2…
    BioPharma Dive · 20d agoNeutral↗ source
  • As portfolio erodes, BMS stands to gain a lot from rumored AstraZeneca merger
    While both drugmakers face looming patent cliffs, analysts say joining forces could help Bristol Myers Squibb replenish its eroding portfolio—while the strategic case for AstraZeneca seems to be mo…
    BioSpace · 20d agoDealNeutral↗ source
  • Eli Lilly expands early-access program for experimental obesity drug retatrutide
    Eli Lilly announced it will broaden its early-access initiative for retatrutide, an investigational drug targeting obesity. The company said the program will let additional patients apply for the…
    STAT · 20d agoRegulatoryPositive↗ source
  • Aurora Therapeutics halts its custom CRISPR program and cuts staff after competitor Beam moves ahead
    Aurora Therapeutics, a startup developing personalized gene-editing drugs, announced it is abandoning its lead CRISPR program. The decision came just seven months after the company launched, and i…
    STAT · 20d agoLayoffsNegative↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 20d agoRegulatoryNeutral↗ source
  • FDA invites stakeholder input to shape a new Quantitative Medicine Innovation Network
    The FDA announced it is looking for feedback from a broad range of stakeholders to help design a Quantitative Medicine Innovation Network (QMIN). The proposed QMIN would be a cross-sector platform…
    raps · 20d agoRegulatoryNeutral↗ source
  • Lisata Therapeutics cuts 72% of staff after merger with Kuva falls through and files lawsuit
    Lisata Therapeutics announced it is cutting about 72% of its full‑time workforce after a planned merger with Kuva Labs collapsed. The company had 21 full‑time employees at the end of 2025, so roug…
    BioSpace · 19d agoLayoffsNegative↗ source
  • Two Michigan Cyclospora Deaths Reported as Eli Lilly Expands Special Retatrutide Access
    Two people in Michigan have died after contracting cyclospora, a parasitic infection that is rarely fatal but can be severe for those with underlying health conditions. State health officials confi…
    STAT · 20d agoRegulatoryNeutral↗ source
  • Vertex unfazed by competitive IgAN space as FDA verdict looms
    Positive two-year follow-up data for Otsuka Pharmaceuticals’ IgA nephropathy drug Voyxact could support the FDA’s ongoing review of Vertex Pharmaceuticals’ povetacicept, CEO Reshma Kewalramani said…
    BioSpace · 20d agoEarningsNeutral↗ source
  • Patient finds open-source diabetes app improves control despite lack of FDA approval
    Patient has type 1 diabetes for over 30 years and has used FDA-approved pumps and sensors that were upgraded roughly every five years. Over time his glucose control slipped despite the regulated de…
    STAT · 20d agoPositive↗ source
  • Experts debate extra regulation for low-risk digital wellness devices
    Two recent papers published in JAMA have highlighted concerns about low-risk digital health technologies that consumers use. Experts say that even though these tools are considered low-risk, they…
    raps · 20d agoRegulatoryNeutral↗ source
  • Danske Bank reports share sale by APMH Invest under its buyback program
    On August 4, 2026, Danske Bank A/S filed a market‑abuse regulation report detailing a change in share ownership. The filing shows that APMH Invest A/S sold a portion of its Danske Bank shares on a…
    globenewswire health · 20d agoRegulatoryNeutral↗ source
  • Danske Bank discloses managerial transactions per Danish regulator on Aug 4, 2026
    Danske Bank A/S issued a notification on 4 August 2026 regarding transactions made by individuals who hold managerial responsibilities. The disclosure follows the EU Market Abuse Regulation, requi…
    globenewswire health · 20d agoRegulatoryNeutral↗ source
  • New York study questions effectiveness of involuntary outpatient mental health treatment, urges more funding for voluntary services
    A new evaluation of New York's involuntary outpatient treatment program adds to a growing body of research on court‑ordered mental health care. The study examined outcomes for people with serious c…
    STAT · 20d agoNegative↗ source