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3,525 stories matching this filter · ← front page

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  • Novo Nordisk’s anti-inflammatory drug ziltivekimab fails to cut heart events, but cardiologists still eye inflammation pathway
    Novo Nordisk reported that its experimental monoclonal antibody ziltivekimab lowered interleukin‑6 levels in the ZEUS trial but did not reduce heart attacks, strokes or cardiovascular deaths compar…
    STAT · 2d agoNegative readoutNegative↗ source
  • Democrats Take House, Raising Questions for Biopharma Policy
    Democrats secured control of Congress in a wave election held on Tuesday, shifting the political balance in Washington. The change is expected to influence the regulatory landscape for the biophar…
    Endpoints · 2d agoRegulatoryNeutral↗ source
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  • New studies highlight hurdles in lowering blood pressure after stroke or in diabetes patients
    Researchers presented three new studies at the American Heart Association scientific sessions that examined how to lower blood pressure in patients who have had a stroke or who live with type 2 dia…
    STAT · 1d agoNegative readoutNeutral↗ source
  • STAT+: Failure of Novartis Lp(a) drug raises questions about cardiovascular strategy
    Medical mystery at the AHA conference: A Novartis drug lowered a risk marker for cardiovascular disease but did not lower chance of heart attack or stroke.
    STAT · 2d agoRegulatoryNeutral↗ source
  • Harvard scientist George Church quits AI startup Radical, alleging partner stole his credit
    George Church, a prominent Harvard researcher known for advising biotech and synthetic biology ventures, has stepped down from his role at the artificial‑intelligence startup Radical. In a public…
    Endpoints · 2d agoNegative↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 3d agoApprovalPositive↗ source
  • Democrats’ Midterm Win Promises Medicaid Reversal and ACA Subsidy Restoration for Hospitals
    The November midterm election gave Democrats control of both the House and Senate, a result analysts describe as a landslide. The shift is expected to create a more favorable environment for hospit…
    STAT · 3d agoRegulatoryPositive↗ source
  • New evidence links AAV gene therapies to tumor risk, raising safety concerns
    Recent cases reported this year provide strong evidence that adeno-associated viruses (AAVs), the vectors used to deliver therapeutic genes, can trigger tumor formation. The findings settle a two‑d…
    STAT · 3d agoRegulatoryNegative↗ source
  • Amgen's Repatha shows reduced heart attack risk while Satellos alters Duchenne trial endpoint
    Satellos Bioscience announced a change to the primary endpoint of its ongoing Duchenne muscular dystrophy trial of the investigational small‑molecule forazapadin, shifting focus to a measure of mus…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • Novartis reports seven tumor cases in children treated with Zolgensma
    Novartis has disclosed that seven children who received its gene therapy Zolgensma for spinal muscular atrophy were later found to have tumors. The company said the cases were identified during po…
    STAT · 3d agoRegulatoryNegative↗ source
  • States sue Trump administration to halt Medicaid work-requirement rollout
    Four states filed a lawsuit in the U.S. District Court in Oregon challenging the Trump administration's Medicaid work-requirement changes. The complaint alleges the overhaul would cause sovereign,…
    STAT · 2d agoRegulatoryNegative↗ source
  • Newly elected scientists aim to restore health equity programs cut by Trump administration
    Two newly elected officials with scientific credentials, Michigan Senator-elect Abdul El-Sayed, an epidemiologist, and Georgia Rep-elect Jasmine Clark, a microbiologist, are preparing to join Congr…
    STAT · 2d agoPositive↗ source
  • Immunocore reports early data showing 70% two-year survival with brenetafusp/Kimmtrak combo in uveal melanoma
    Immunocore presented early clinical data on its bispecific T-cell engager combination brenetafusp and Kimmtrak in patients with uveal melanoma. The analysis, based on a subset of patients, indicat…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • Amgen’s Repatha linked to fewer heart attacks while Novartis reports seven new tumor cases in Zolgensma patients
    Amgen reported that its cholesterol‑lowering drug Repatha was associated with a lower incidence of heart attacks in a recent analysis. The data suggest the therapy may provide cardiovascular benefi…
    STAT · 3d agoNeutral↗ source
  • Moderna posts first profit in two years, driven by Covid-19 vaccine sales, as it refocuses on cancer vaccines
    Moderna reported a modest profit for the quarter, marking its first earnings surplus in two years. The turnaround was driven primarily by continued sales of its international Covid-19 vaccine portf…
    Endpoints · 3d agoEarningsPositive↗ source
  • Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertainty
    A panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on va…
    raps · 3d agoRegulatoryNeutral↗ source
  • Sarepta halts enrollment in confirmatory Phase 3 trial of Elevidys gene therapy for Duchenne muscular dystrophy
    Sarepta Therapeutics announced it will no longer enroll additional patients in the Phase 3 confirmatory study of its gene therapy Elevidys for Duchenne muscular dystrophy. The trial was intended t…
    Endpoints · 3d agoCRLNegative↗ source
  • Podcast examines Democrats' midterm win and concerns over a costly, questionable fertility genetic procedure
    Stat's weekly biotech podcast "The Readout LOUD" released an episode featuring Washington correspondent Daniel Payne to discuss how the Democrats' sweeping midterm victory could shape drug pricing…
    STAT · 3d agoNeutral↗ source
  • MetaVia appoints Sarah Browne as chief medical officer
    MetaVia announced the hiring of Sarah Browne as its new chief medical officer. Browne previously worked as a clinical development consultant for Souffle Therapeutics and before that served as vice…
    STAT · 3d agoPositive↗ source
  • Eugia US recalls specific lot of vancomycin injection after glass particle found in vials
    Eugia US LLC, formerly Auro Medics Pharma, announced a voluntary nationwide recall of the vancomycin hydrochloride injection (1.25 g per 30 mL vial) for lot number 3VM26026A. The recall was trigge…
    fda recalls · 3d agoCRLNegative↗ source
  • Former MAHA official Calley Means blames White House for yielding to industry pressure
    Calley Means, a leader of the Make America Healthy Again (MAHA) group and former senior official in the Trump administration, announced his resignation and criticized the White House for being sway…
    STAT · 2d agoNegative↗ source
  • Novo and Pfizer appoint new CFOs while Alnylam sees departure of its chief commercial officer
    Novo announced the appointment of a new chief financial officer as part of its effort to improve financial leadership. The hire follows earlier reports that the company is seeking to turn a corner…
    Endpoints · 3d agoNeutral↗ source
  • Medical records often miss women's health experiences, limiting AI's potential
    Ann Hirsch and Jennifer Silva argue that artificial intelligence cannot reach its full promise in women's health until medical records capture the complete picture of patients' lives. They cite a r…
    STAT · 3d agoNegative↗ source
  • Medicare delays controversial remote patient monitoring ban to 2029, opening window for provider pushback
    Medicare regulators advanced a plan to prohibit hospitals and other providers from using third‑party companies for remote patient monitoring (RPM) services, despite strong opposition from health‑te…
    STAT · 3d agoRegulatoryNeutral↗ source
  • Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA work
    At the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
    raps · 3d agoRegulatoryNeutral↗ source