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  • Opinion: Marty Makary misunderstood something fundamental about the FDA
    “The norm-shattering masks a more fundamental misunderstanding of how administrative power can bring about lasting change,” writes Joshua Sharfstein.
    STAT · 2mo ago↗ source
  • Makary resigns; Biogen reports Alzheimer’s data; and more
    Welcome back to Endpoints Weekly. The biggest news this week was Marty Makary’s resignation from his role as FDA Commissioner. The announcement came days after reports emerged that President Donald…
    Endpoints · 2mo ago↗ source
  • STAT+: FDA leadership shakeup widens following Makary’s departure
    The acting director of the FDA’s drug center, Tracy Beth Høeg, is leaving the agency. The news come days after Commissioner Marty Makary handed in his resignation.
    STAT · 2mo ago
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  • CDER chief Høeg fired from FDA as other top roles turn over
    The leader of the FDA's drug division, Tracy Beth Høeg, is expected to depart, as part of a broad shakeup at the top of the agency after the exit of now-former Commissioner Marty Makary, according ...
    Endpoints · 2mo ago↗ source
  • Biopharma M&A maintains strength even as large deals wane
    Biopharma's deals landscape could hardly be better, as large companies take a multi-pronged approach to withstand an avalanche of major patent expiries. But there’s one notable missing piece: megad…
    Endpoints · 2mo ago↗ source
  • STAT+: Takeda will pay $13.6 million to settle allegations it paid kickbacks to doctors
    Takeda Pharmaceuticals agreed to pay $13.6 million to settle allegations that it paid kickbacks to doctors to prescribe an antidepressant.
    STAT · 2mo ago↗ source
  • Amgen expands crackdown on what it says is misuse of 340B program
    Amgen is expanding its claims data requirements for pharmacies dispensing its drugs under the 340B federal drug discount program. The company said the new policy addresses what it claims is fraud a…
    Endpoints · 2mo ago↗ source
  • STAT+: Up and down the ladder: The latest comings and goings
    From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
    STAT · 2mo ago↗ source
  • Candel reports prostate cancer drug's long-term data ahead of FDA filing
    Candel Therapeutics produced long-term follow-up data that may bolster the case for its prostate cancer drug that's heading to the FDA for marketing approval later this year. The company followed u…
    Endpoints · 2mo ago↗ source
  • Post-Hoc Live: Makary's out at FDA and what comes next
    Marty Makary resigned as FDA commissioner on Tuesday after a turbulent tenure at the head of the agency. Makary was scheduled to sit down with senior reporter Max Bayer this week at ...
    Endpoints · 2mo ago↗ source
  • Opinion: First hantavirus, now Ebola: What two outbreaks reveal about global preparedness
    “Preparedness is not built during a crisis press conference or after a pathogen has already crossed borders,” writes Krutika Kuppalli.
    STAT · 2mo ago↗ source
  • Aardvark's next move after clinical hold; Alumis' verdict on Acelyrin asset
    Plus, news about Tenaya’s TN-401 and Taiho’s Inqovi. 📉 Aardvark to unblind rare disease trial following clinical hold: The FDA has placed a full clinical hold on the company's candidate for ...
    Endpoints · 2mo ago↗ source
  • A new Ebola outbreak is confirmed in a remote Congo province, with 65 deaths recorded
    A new Ebola outbreak has been confirmed in Congo’s remote Ituri province, with 246 suspected cases and 65 deaths recorded so far.
    STAT · 2mo ago↗ source
  • STAT+: A political contest in the U.K. could shake up drug pricing
    Makary and Cassidy's fates, U.S. pressures Germany to pay more for drugs, and other health news
    STAT · 2mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about U.S. pressuring Germany on drug prices, FDA upheaval and biotech clinical trials, and more
    In today's Pharmalittle roundup: U.S. pressuring Germany on drug prices, FDA upheaval and biotech clinical trials, and much more.
    STAT · 2mo ago↗ source
  • Opinion: Telehealth abortion with mifepristone continues, with backup plans still in place
    Restricting telehealth prescribing of mifepristone wouldn't spell the end of telehealth medication abortion, writes OB-GYN Christine Henneberg.
    STAT · 2mo ago↗ source
  • Mail-order abortion pills are legal (for now)
    Africa CDC declares Ebola outbreak in DRC, the violent fallout from Trump’s cuts to foreign aid, and more health news
    STAT · 2mo ago↗ source
  • M&A isn’t just for big pharma. Mid-size companies are stepping up deal hunts
    In what is shaping up to be one of the most active years for biopharma M&A on record, a different-looking set of buyers is going shopping. Mid-cap American drugmakers, family-owned pharma groups, f…
    Endpoints · 2mo ago↗ source
  • Andrea Pfeifer ends 23-year reign at AC Immune; Acadia's top R&D exec announces retirement
    AC Immune will be searching for a new CEO for the first time, as the company announced this week that Andrea Pfeifer plans to retire after 23 years at the helm. ...
    Endpoints · 2mo ago↗ source
  • #ASGCT26: A Zillow-like marketplace for abandoned gene therapies goes live
    BOSTON — Two nonprofit organizations have devised a plan to help abandoned cell and gene therapies find a new home. On Thursday, the American Society of Gene & Cell Therapy (ASGCT) and the Orphan T…
    Endpoints · 2mo ago↗ source
  • Opinion: I’m 73. I wish my pills wouldn’t keep changing colors and shapes
    Pharmaceutical companies, generic manufacturers, and pharmacists should be more careful about changing how pills look.
    STAT · 2mo ago↗ source
  • Why isn’t alcohol seen as a public health emergency?
    Why isn't alcohol seen as a public health emergency? Alex Hogan talks to STAT's Isabella Cueto and Lev Facher about their new series on this week's STATus Report.
    STAT · 2mo ago↗ source
  • Opinion: Tributes to Craig Venter and the genomics race are missing something important
    A race, two rivals, a photo finish? Former National Human Genome Research Institute archivist explains what Craig Venter tributes are missing.
    STAT · 2mo ago↗ source
  • STAT+: Top U.S. officials pressured Germany to pay more for prescription drugs
    It's a key piece of Trump's effort to secure lower drug prices for U.S. patients.
    STAT · 2mo ago↗ source
  • DOJ accuses Yale and UCLA medical schools of discriminating against white and Asian applicants
    The Justice Department sent a letter to Yale School of Medicine on Thursday, alleging it was illegally discriminating against applicants who are not Black or Hispanic.
    STAT · 2mo ago↗ source