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2,718 stories matching this filter · ← front page

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  • Phase II success does not guarantee easy Phase III launch, says Thermo Fisher
    Positive Phase II data often signals the start of Phase III planning, but the transition involves far more than simply adding patients and sites. When a trial expands into new countries, differenc…
    BioPharma Dive · 1h agoNeutral↗ source
  • State incentives can shape site decisions for commercial-stage life sciences firms
    The article advises commercial-stage life-science companies to consider state and local incentives early in expansion planning to improve site selection and preserve capital. Incentives most relev…
    BioPharma Dive · 1h agoNeutral↗ source
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Democrats weigh limits of health-care reforms after midterm win
In the days after their sweeping midterm victories, House and Senate Democrats are debating the scope of possible health-care actions. Party leaders agree on rolling back the Medicaid cuts impleme…
STAT · 2h agoRegulatoryNeutral↗ source
  • Global liver experts agree on definition of acute-on-chronic liver failure
    Liver doctors from many countries have reached a common definition for acute-on-chronic liver failure, a serious complication that occurs when an existing liver disease is suddenly worsened by an a…
    STAT · 2h agoPositive↗ source
  • CVS split into two entities fails to address core issues in pharmacy benefit management
    CVS Health is one of the largest U.S. companies, serving hundreds of millions of Americans and generating about $400 billion in annual revenue. It touches nearly every step of the drug supply chain…
    STAT · 2h agoNegative↗ source
  • Early technical expertise key to tackling complex life-science construction projects
    Life‑science construction projects often present problems that lack obvious solutions, such as retrofitting existing buildings, using unconventional materials, or fitting large process equipment in…
    BioPharma Dive · 1h agoPositive↗ source
  • AI chatbots may help men share emotions, study suggests
    AI chatbots are not therapists, but they can offer a low‑pressure space where men feel less judged when discussing personal concerns. The article follows Luca, who drove across Europe to be with h…
    STAT · 2h agoNeutral↗ source
  • Recent heart-drug trials miss endpoints, raising doubts about AI-driven drug design
    Two large clinical studies presented at the American Heart Association meeting this weekend failed to show any benefit for experimental heart‑attack and stroke therapies, underscoring the difficult…
    STAT · 1d agoNegative readoutNegative↗ source
  • Study finds training bystanders and responders does not boost survival after sudden cardiac arrest
    Sudden cardiac arrest kills about 350,000 people in the United States each year, and only one in ten victims survive. Survival depends heavily on rapid CPR and defibrillation by nearby bystanders o…
    STAT · 13h agoNegative↗ source
  • Biotech Trade Group BIO Sues Over Medicare GLOBE Pricing Pilot
    BIO and two California biotech trade groups have filed a lawsuit in federal court to stop the Medicare GLOBE pilot that would tie US drug prices to those in peer nations. The complaint argues the…
    STAT · 1d agoRegulatoryNegative↗ source
  • 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 · 1d agoNegative readoutNegative↗ source
  • 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 · 1d agoRegulatoryNeutral↗ source
  • Novartis reports nine cancer cases in patients treated with Zolgensma gene therapy
    Novartis disclosed that nine individuals with spinal muscular atrophy who received its gene therapy Zolgensma later developed tumors. Two of the cases showed evidence that the adeno-associated vir…
    BioPharma Dive · 2d agoRegulatoryNegative↗ 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 · 2d 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 · 2d agoRegulatoryNegative↗ 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 · 2d agoRegulatoryNegative↗ source
  • Eli Lilly partners with Hims & Hers to sell Zepbound and Foundayo via telehealth platform
    Eli Lilly announced a partnership with Hims & Hers to make its obesity treatments Zepbound and Foundayo available through the telehealth service. The arrangement lets patients with a prescription…
    BioPharma Dive · 2d agoDealNeutral↗ source
  • Novo Nordisk’s oral Wegovy sales beat forecasts, boosting shares over 5%
    BioPharma Dive’s latest visualization series examines how investors reacted to three drug launches highlighted in recent quarterly earnings. Novo Nordisk reported that its oral Wegovy generated 5.…
    BioPharma Dive · 2d agoPositive readoutPositive↗ 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
  • 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 · 2d agoNeutral↗ 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
  • 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 · 2d 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 · 2d agoPositive↗ source