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  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • FDA approves Merck’s oral PCSK9 inhibitor Lipfendra, but cardiologists question its immediate impact
    The FDA has granted approval to enlicitide, marketed by Merck as Lipfendra, marking the first oral PCSK9 inhibitor for lowering blood cholesterol. The drug arrives as new clinical guidelines encou…
    STAT · 3mo agoApprovalNeutral↗ source
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  • Vertex's $10 billion Crinetics buyout draws investor doubts over premium price
    Vertex was the lone bidder in a planned $10 billion acquisition of Crinetics Pharmaceuticals, a California company that focuses on endocrine medicines. Crinetics currently markets a therapy for a…
    BioPharma Dive · 3mo agoDealNegative↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 3mo agoRegulatoryPositive↗ source
  • Trump threatens 200% tariffs on imported generic drugs to force U.S. production
    President Trump announced on Truth Social that generic drugs imported into the United States could face a 100% tariff starting Aug. 1, 2028, rising to 200% three years later. He framed the measure…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Trump announces steep tariffs on imported generic drugs, starting 100% in 2028 and rising to 200% in 2029
    President Donald Trump disclosed a plan to levy heavy tariffs on generic medicines that are imported into the United States. The tariff would be set at 100 percent beginning in August 2028 and woul…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Science Corp's retinal implant gains European approval, eyesight aid for macular degeneration patients
    Science Corporation announced that European regulators have approved its retinal implant for patients with age-related macular degeneration. The device, described as a 'cochlear implant for vision…
    STAT · 3mo agoApprovalPositive↗ source
  • Maui wildfire study proposes new rural health model for disaster recovery
    Researchers Alika Maunakea and Ruben Juarez are leading one of the largest investigations into the long‑term health effects of the 2023 Lahaina wildfires. The study follows more than 20 participant…
    STAT · 3mo agoPositive↗ source
  • Survey Finds 24% of U.S. Workers Stay in Unwanted Jobs to Keep Health Insurance
    A Gallup and West Health survey of more than 2,000 employed adults found that 24% would stay in a job they dislike simply to retain health insurance coverage. The phenomenon, known as job lock, ha…
    STAT · 3mo agoNegative↗ source
  • FDA sends warning letters to Sanofi and Viatris over misleading product claims
    The FDA’s Office of Prescription Drug Promotion issued untitled warning letters to Sanofi and Viatris after reviewing promotional materials that the agency deemed misleading. The letters cite spec…
    raps · 3mo agoRegulatoryNegative↗ source
  • Study finds Merck’s Ervebo may protect against Bundibugyo Ebola strain, prompting calls for DRC testing
    New data from a human study published in the New England Journal of Medicine suggests Merck's Ervebo vaccine, licensed for the Zaire ebolavirus, may also offer protection against the Bundibugyo spe…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Pharma pushes back on China restrictions as AI VC raises $800M and Merck unveils cholesterol pill; Celldex reports trial setback
    Pharma companies are working to ease the impact of broad new restrictions in China, seeking ways to maintain market access amid tighter regulatory scrutiny. An AI‑focused venture capital firm anno…
    STAT · 3mo agoNeutral↗ source
  • Summit Therapeutics' ivonescimab shows improved survival trend in extended follow-up, easing investor doubts
    A new analysis of Summit Therapeutics and Akeso's dual‑acting cancer immunotherapy ivonescimab indicates that the drug's impact on overall survival has grown with longer observation. The extended d…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Hospital AI oversight lagging; senior leaders must take daily responsibility
    AI tools are now common in U.S. hospitals, handling tasks such as drafting clinical notes, flagging sepsis, screening imaging, processing prior authorizations, and responding to patient messages.…
    STAT · 3mo agoNeutral↗ source
  • Study finds rising job dissatisfaction and health‑care access uncertainty among U.S. workers
    A new study shows increasing levels of job dissatisfaction and uncertainty about health‑care access among U.S. workers. The research, funded by AHRQ, surveyed a national sample and found that a gr…
    STAT · 3mo agoNegative↗ source
  • AHRQ cuts $109 million in health services research grants, ending 78 projects early
    AHRQ announced that dozens of health services research grants will stop early, affecting about $109 million still to be spent. The agency said it is reshaping its discretionary award portfolio to…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Nabla executive Alex LeBrun discusses ‘world model’ AI as an alternative to large language models
    Brittany Trang of STAT’s AI Prognosis newsletter interviewed Alex LeBrun, the executive chairman of AI scribe company Nabla, to explore a concept called a “world model.” LeBrun described a world m…
    STAT · 3mo agoNeutral↗ source
  • Argentina’s World Cup defeat offers a cautionary lesson for U.S. hospitals on avoiding complacency
    Opinion writer Basel Tarab, a physician and hospital administrator, reflects on Argentina’s recent World Cup loss as a metaphor for American health‑care systems. He recalls Argentina’s 2022 triump…
    STAT · 3mo agoNeutral↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 3mo agoNeutral↗ source
  • FDA revokes Orange B color additive and proposes to drop Citrus Red No. 2 from food approvals
    The U.S. Food and Drug Administration issued a final order that revokes the authorized use of Orange B as a food color additive. The agency also proposed revoking Citrus Red No. 2, a pigment autho…
    fda press · 3mo agoRegulatoryNeutral↗ source
  • Novartis beats sales expectations as Q2 revenue rises to $14.4B, eyes upcoming study readouts
    Novartis reported a modest rise in second‑quarter sales, lifting its share price after the company posted a 1% increase in net sales to $14.4 billion, surpassing analyst forecasts for a decline. A…
    BioPharma Dive · 3mo agoEarningsPositive↗ source
  • Novo Nordisk sues Eli Lilly over alleged misleading obesity drug ads
    Novo Nordisk filed a lawsuit in a New Jersey federal court accusing Eli Lilly of deceptive advertising for its GLP-1 obesity medicines. The action follows a cease-and-desist request that asked Lil…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Agios halts development of sickle cell drug tebapivat after mid-stage trial failure
    Agios announced it will stop developing tebapivat for sickle cell disease after a mid-stage trial did not meet expectations. The drug, a next-generation pyruvate kinase activator related to the ap…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Broad Institute, Boston Children’s Hospital and Jackson Laboratory launch nonprofit to advance affordable gene therapies for rare diseases
    The Broad Institute, Boston Children’s Hospital and Maine’s Jackson Laboratory announced a new collaboration to develop gene‑based treatments for rare genetic disorders. The three institutions will…
    STAT · 3mo agoDealPositive↗ source
  • Anthropic expands rare disease collaborations as Novo sues Lilly and Agios halts sickle cell drug
    Anthropic, a biotech firm, announced it is expanding its partnership portfolio focused on rare disease therapeutics, deepening collaborations with several companies to advance pipeline candidates.…
    STAT · 3mo agoDealNeutral↗ source