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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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo ago↗ source
  • FDA hold puts Aardvark Prader-Willi drug in limbo
    The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.
    BioPharma Dive · 3mo ago↗ source
  • Supreme Court preserves access to abortion pill by mail
    The ruling maintains access to the drug while litigation continues. Mifepristone can still be prescribed at pharmacies or by mail without requiring in-person visits.
    BioPharma Dive · 3mo 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 · 3mo ago↗ source
  • Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers
    Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted i…
    BioPharma Dive · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo ago↗ source
  • India’s pharma industry is going global. But can it catch up to China?
    A record Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way of India becoming an R&D powerhouse.
    BioPharma Dive · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo ago↗ source