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  • White House conducts final review of three candidates for FDA commissioner
    The White House is completing its final review of candidates to become the next Food and Drug Administration commissioner. The shortlist features Heidi Overton, a current White House adviser; Jeff…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • U.S. officials urge pharma companies to increase domestic production of essential generic drugs
    At a private gathering in the Eisenhower Executive Office Building, senior officials from the Trump administration met with pharmaceutical leaders. Secretary of State Marco Rubio, Health Secretary…
    STAT · 1mo agoRegulatoryNeutral↗ source
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  • Lung transplants boost survival for select stage 4 lung cancer patients, study finds
    Northwestern Medicine surgeons and oncologists performed double lung transplants on a small group of stage 4 lung cancer patients whose disease was confined to the lungs. The JAMA study compared 1…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Novartis announces reduction of 322 jobs at New Jersey facility
    Novartis filed a WARN notice indicating it will eliminate 322 positions at its East Hanover, New Jersey site. The reduction is part of a broader restructuring effort aimed at streamlining operation…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • HHS pushes FDA to formalize public release of rejection letters to drug makers
    HHS announced it is preparing a new FDA regulation that would codify the agency's practice of publishing complete response letters (CRLs) that inform pharmaceutical companies of a drug's rejection.…
    Endpoints · 1mo agoCRLNeutral↗ source
  • ACA insurers seek median 14% premium hike for 2027 as enrollment falls
    Insurers filing with state regulators for 2027 ACA plans are asking for a median premium increase of 14%, according to an analysis of filings in 16 states and the District of Columbia. This would…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Biohaven targets muscle-sparing obesity market to compete with Lilly's GLP-1 drugs
    Biohaven is positioning itself to address obesity by developing treatments that preserve lean muscle, a differentiator from existing GLP-1 therapies. The company sees an opportunity to act as a "s…
    Endpoints · 1mo agoNeutral↗ source
  • Mass General Brigham nurses begin largest strike in Massachusetts over pay and benefits
    Thousands of nurses at Brigham and Women’s Hospital walked off the job on Wednesday, marking the first strike at the Harvard‑affiliated facility and the largest nurses walkout in the state’s histor…
    STAT · 1mo agoNegative↗ source
  • Sanofi proposes to cease negative statements about CSL's flu vaccine amid EU probe
    Sanofi has offered to stop making disparaging comments about CSL's flu vaccine following an investigation launched by the European Commission. The offer comes two weeks after the Commission began p…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • RFK Jr. moves to compile list of Covid-19 vaccine injuries to streamline compensation claims
    Health secretary Robert F. Kennedy Jr. announced plans to create a list of injuries that would be presumed caused by Covid-19 vaccines. The list would allow individuals who suffer from those condi…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Longevity entrepreneur Bryan Johnson reveals he has autoimmune gastritis, a hard-to-diagnose stomach disease
    Bryan Johnson, known for his longevity ventures, announced on X that he has been diagnosed with autoimmune gastritis. The condition is a chronic inflammatory disease where antibodies attack stomac…
    STAT · 1mo agoNeutral↗ source
  • STAT+: Europe will accelerate its review of RevMed’s drug
    Kailera's GLP-1 pill data raises concerns, FDA clears Vera autoimmune therapy, and more biotech news from The Readout
    STAT · 1mo ago↗ source
  • STAT+: Prime Medicine claims victory in dispute over gene-editing technology with Beam Therapeutics
    Prime Medicine said it had won an arbitration dispute against Beam Therapeutics, a clash that had pitted two well-backed gene-editing companies against each other.
    STAT · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Vera kidney drug approval, a U.K. Enhertu pricing deal, and more
    The FDA approved a kidney disease drug from Vera Therapeutics called Trutakna, to treat IgA nephropathy
    STAT · 1mo ago↗ source
  • Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
    An arbitration panel ruled Prime didn’t breach a deal with Beam by developing a rare disease treatment. Elsewhere, European regulators are using a pancreatic cancer drug to test a new framework for…
    BioPharma Dive · 1mo ago↗ source
  • Another big premium hike on the horizon
    FDA's crackdown on online ketamine retailers, unprecedented health care premium hikes, and more health news from Morning Rounds
    STAT · 1mo ago↗ source
  • Sino Biopharm hooks AstraZeneca, GSK for separate respiratory partnerships
    Sino Biopharmaceutical announced drug development and sales pacts with two UK pharma companies on Wednesday. One will see the Hong Kong biotech license an investigational PDE3/4 inhibitor to AstraZ…
    Endpoints · 1mo ago↗ source
  • Satellos gives early look at Duchenne pill in adults ahead of key data in children
    Satellos Bioscience is building its case for a Duchenne muscular dystrophy pill with data in adult patients ahead of a potentially pivotal readout in children later this year. The Canadian biotech’…
    Endpoints · 1mo ago↗ source
  • Opinion: STAT+: What’s the right role for AI in dementia care?
    Three tricky questions about using AI in dementia care.
    STAT · 1mo ago↗ source
  • Opinion: The AI licensure debate is missing the point of licensure
    “AI will reshape medicine. The physicians who answer for the outcome must lead the way it enters patient care," write Afnan R. Tariq and Ami Bhatt.
    STAT · 1mo ago↗ source
  • Are glucose monitors a good thing for 2-year-olds? Experts look at risks, benefits
    The newly approved over-the-counter CGM offers a new approach to tackling childhood obesity but also raises a host of questions.
    STAT · 1mo ago↗ source
  • STAT+: Trump administration pursues more durable changes to science policy after setbacks in court
    The White House has proposed sweeping changes to the bedrock regulation undergirding all federal contracts, empowering the executive branch to direct research, terminate grants, and external scient…
    STAT · 1mo ago↗ source
  • Vertex's Crinetics deal points to big ambitions for cystic fibrosis leader
    Vertex Pharmaceuticals' $10 billion acquisition of an endocrinology startup represents the company’s clearest and boldest step toward the upper echelon of the biopharma industry. Long a biotech suc…
    Endpoints · 1mo ago↗ source
  • Tampa General kicks off legal fight over Lilly's 340B restrictions
    Tampa General Hospital sued Eli Lilly for halting its 340B discounts, kicking off a broader fight over whether pharmaceutical companies can condition drug discounts on new claims data requirements.…
    Endpoints · 1mo ago↗ source
  • Vera's IgAN approval kicks off competition with Otsuka
    Vera Therapeutics’ fusion protein atacicept got an accelerated approval on Tuesday for a chronic autoimmune disease that damages the kidneys. The drug will be marketed as Trutakna for immunoglobuli…
    Endpoints · 1mo ago↗ source