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  • 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 · 22d 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 · 22d agoPositive readoutPositive↗ source
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  • 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 · 22d agoNeutral↗ source
  • FDA moves to reverse policies of former commissioner Marty Makary
    The Trump administration is actively rolling back decisions made under former FDA commissioner Marty Makary. As the White House weighs a new nominee for the agency, officials have begun revisiting…
    Endpoints · 22d agoRegulatoryNegative↗ 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 · 22d 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 · 22d agoRegulatoryNegative↗ source
  • Former FDA oncology chief calls for agency restructuring after recent staff cuts
    Richard Pazdur, who led the FDA’s Oncology Center of Excellence for more than twenty years, said the agency now faces a "golden opportunity" to restructure its operations. He made the comments aft…
    Endpoints · 22d agoRegulatoryNeutral↗ 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 · 22d 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 · 22d 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 · 22d 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 · 23d 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 · 23d agoRegulatoryNegative↗ source
  • Gilead and Merck to unveil detailed Phase 3 results of once‑weekly oral HIV regimen at AIDS 2026; Dimension Capital launches $800M fund
    Gilead Sciences and Merck announced that they will present detailed results from their Phase 3 trials of a once‑weekly oral HIV treatment regimen at the upcoming AIDS 2026 conference. The data wil…
    Endpoints · 23d agoNeutral↗ source
  • FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study
    The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
    Endpoints · 23d agoRegulatoryNegative↗ source
  • FDA to appoint permanent heads of CBER and CDER alongside new commissioner
    The FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…
    Endpoints · 23d agoRegulatoryNeutral↗ 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 · 23d agoNegative readoutNegative↗ source
  • Agios halts development of next‑generation sickle‑cell drug tebapivat after disappointing mid‑stage trial
    Agios Therapeutics announced it will discontinue development of tebapivat, a next‑generation therapy for sickle cell disease, after the drug failed to demonstrate sufficient efficacy in a Phase 2 t…
    Endpoints · 23d 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 · 23d 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 · 23d agoDealNeutral↗ source
  • Novo Nordisk sues Eli Lilly over allegedly deceptive obesity and diabetes ads
    Novo Nordisk has filed a federal lawsuit against Eli Lilly, accusing the rival of running misleading advertisements for its obesity and diabetes medicines. The company claims Lilly's ads rely on ou…
    STAT · 23d agoRegulatoryNegative↗ source
  • Broad Institute partners with Boston Children’s Hospital and Jackson Lab to launch Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard announced a partnership with Boston Children’s Hospital and the Jackson Laboratory to create a Center for Therapeutic Genetics focused on rare diseases. The…
    Endpoints · 23d agoPositive↗ source
  • Novo Nordisk sues Eli Lilly, alleging deceptive ads that misrepresent GLP-1 drug efficacy
    Novo Nordisk filed a lawsuit in federal court in New Jersey accusing Eli Lilly of running a deceptive advertising campaign. The complaint says Lilly’s ads compare the highest doses of its weight‑l…
    STAT · 23d agoRegulatoryNegative↗ source
  • Rare-disease biotech coalition urges Trump admin to carve out orphan drugs from Medicare price-cut pilots
    Biotech firms formed the Rare Disease Company Coalition and met with the White House Office of Management and Budget to discuss excluding orphan drugs from two Medicare price‑cut pilot programs. T…
    STAT · 23d agoRegulatoryNeutral↗ source
  • Novo Nordisk files lawsuit against Eli Lilly over allegedly deceptive GLP-1 dose ads
    Novo Nordisk has initiated legal action against Eli Lilly in a U.S. court, alleging that Lilly's recent advertisements misrepresent the dosing of GLP-1 obesity treatments. The company says the ads…
    Endpoints · 23d agoNegative↗ source
  • Rare disease drugmakers brace for potential Trump administration price cuts amid GOP push on health‑care fraud
    Rare disease drugmakers are watching the Trump administration closely as proposals emerge that could force lower prices for their specialty therapies. The companies are exploring strategies to miti…
    STAT · 23d agoRegulatoryNeutral↗ source