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  • Sanofi asks FDA to withdraw teplizumab from fast-track review after internal disagreement
    Sanofi has formally requested that the U.S. Food and Drug Administration remove its type 1 diabetes therapy, teplizumab, from the agency's new speedy review program. The request follows a disagree…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Roche to acquire digital pathology firm PathAI in deal potentially worth over $1B
    Roche plans to offer PathAI’s tools as part of an effort to improve cancer diagnosis and tailored treatment.
    BioPharma Dive · 4mo agoDealNeutral↗ source
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  • FDA reexamines previously rejected rare cancer therapy amid claims of political interference
    The FDA has opened a new review of a treatment for a rare form of cancer that it had turned down a few months earlier. The reconsideration arrives as the agency faces fresh allegations that politi…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • AI-generated fake citations surge, study finds they are polluting scientific literature
    A new study published in The Lancet reports a sharp rise in fabricated citations that do not correspond to real papers, threatening the reliability of the scientific record. The researchers found…
    STAT · 4mo agoNegative↗ source
  • WHO briefs on hantavirus outbreak aboard cruise ship, Spain to allow docking in Canary Islands
    WHO held a press conference Thursday to update on a suspected hantavirus outbreak on the cruise ship MV Hondius. The vessel is expected to dock in Tenerife, Canary Islands, after Spain agreed to t…
    STAT · 4mo agoNeutral↗ source
  • Seaport Therapeutics goes public as obesity drug race heats up and FDA commissioner faces White House scrutiny
    Seaport Therapeutics announced a successful initial public offering, with CEO Daphne Zohar discussing the company’s next steps on the latest Readout LOUD podcast. The episode also highlighted the…
    STAT · 4mo agoNeutral↗ source
  • Study finds researchers become less disruptive as they age, favoring incremental work
    A new study published in Science reports that scientists tend to produce their most disruptive work early in their careers, but shift toward less groundbreaking research as they get older. The ana…
    STAT · 4mo agoNeutral↗ source
  • CDC’s cruise ship health chief Luis Rodríguez retires amid hantavirus outbreak on MV Hondius
    The Centers for Disease Control and Prevention announced that Luis Rodríguez, who has been with the Vessel Sanitation Program since 2010 and its chief since 2023, will retire. His departure comes…
    STAT · 4mo agoNeutral↗ source
  • STAT Health Tech newsletter highlights OpenAI health policy ideas and Dexcom CGM updates
    The latest STAT Health Tech newsletter, edited by Mario Aguilar, offers a roundup of recent technology developments in health care. OpenAI proposes a set of health policy recommendations aimed at…
    STAT · 4mo agoNeutral↗ source
  • STAT+: FDA to reconsider treatment for rare cancer after its surprise rejection
    The companies developing Ebvallo reached an agreement with the FDA to address its main reason for rejecting the drug.
    STAT · 4mo ago↗ source
  • Hospital shootings steadily increased since 2000
    What the FDA has lost, why hantavirus isn't the next pandemic, and more health news from Morning Rounds
    STAT · 4mo ago↗ source
  • STAT+: Next-gen Duchenne drug from Entrada disappoints
    A next-gen Duchenne therapy from Entrada Therapeutics fell short in an early study, as a number of companies race to make improved drugs.
    STAT · 4mo ago↗ source
  • STAT+: Color me skeptical: Drinking gold is not an ALS cure
    In this week's Biotech Scorecard newsletter, Adam Feuerstein takes on the company touting gold microdust suspended in water as an ALS treatment.
    STAT · 4mo ago↗ source
  • STAT+: Angelini Pharma buys Catalyst Pharmaceuticals and its rare disease drugs for $4.1B
    The Italian firm Angelini Pharma is buying Catalyst Pharmaceuticals, the maker of rare disease drugs, for $4.1 billion.
    STAT · 4mo ago↗ source
  • STAT+: What was lost at the FDA
    What was lost at the FDA: A year after DOGE’s cuts, six agency staffers describe the work they never thought they’d leave.
    STAT · 4mo ago↗ source
  • Opinion: Eugene Braunwald, ‘father of modern cardiology,’ told me he had two dreams. One came true
    Legendary cardiologist Eugene Braunwald had two visions for his career. One of them came true.
    STAT · 4mo ago↗ source
  • Cruise ship hantavirus outbreak worries experts, though they discount pandemic fears
    Scientists are worried that hantaviruses haven’t been as well studied as they ought to be, but not that the MV Hondius cruise ship is ground zero for the next pandemic.
    STAT · 4mo ago↗ source
  • STAT+: Oregon hospitals won’t outsource to national physician chain after all
    Faced with stiff local opposition and a possible loss in court, PeaceHealth drops plan to replace Eugene Emergency Physicians with staffing chain ApolloMD.
    STAT · 4mo ago↗ source
  • Trump administration’s drug strategy is at odds with recent actions on funding, policy
    The White House nods to medication-assisted treatment and fentanyl test strips, despite recently placing new limits.
    STAT · 4mo ago↗ source
  • STAT+: Administration report on most favored nation drug pricing raises new details — and questions
    Administration report on most-favored nation drug pricing raises new details — and questions.
    STAT · 4mo ago↗ source
  • STAT+: Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review
    Sanofi has asked the FDA to pull its type 1 diabetes drug out of Commissioner Marty Makary’s new speedy drug review program.
    STAT · 4mo ago↗ source
  • Bayer to buy Perfuse for up to $2.45B, bolstering eye drug pipeline
    Centered around a glaucoma therapy in mid-stage testing, the deal is Bayer’s first drug company acquisition in several years and potentially its largest since it purchased AskBio in 2020.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: Color Health moving deeper into cancer services, complete with virtual ‘tumor boards’
    Color Health, which coordinates cancer screening, is moving into a gap it observed — obtaining and coordinating actual cancer care.
    STAT · 4mo ago↗ source
  • Novo hikes guidance on Wegovy pill’s fast sales start
    In its latest earnings report, the Danish drugmaker said sales and profit should shrink less than the company originally anticipated thanks to strong prescription numbers for its new obesity pill.
    BioPharma Dive · 4mo ago↗ source
  • Why the FDA is authorizing fruit-flavored vapes
    Marty Makary says he was "skeptical initially" about flavored vapes but that age-gating technology could limit their use.
    STAT · 4mo ago↗ source