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  • FDA approves AstraZeneca’s baxdrostat for certain patients with hypertension
    One of the key products underpinning AstraZeneca’s goal of hitting $80 billion in revenue by 2030 has been approved by the FDA, the drugmaker said Monday. The blood ...
    Endpoints · 2mo ago↗ source
  • Opinion: ‘Patient autonomy’ has nothing to do with childhood vaccine policies
    Opinion: Vaccine policy it is not a matter of autonomy at all, because infants do not decline vaccination — their parents do.
    STAT · 2mo ago↗ source
  • STAT+: The China question is tearing biotech apart
    China's ascent is forcing U.S. biotech companies and investors to pick a side: Is it an ally or an existential threat?
    STAT · 2mo ago↗ source
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  • Opinion: How to restore credibility to the CDC’s vaccine advisory committee
    Jesse Goodman, former director of CBER and former FDA chief scientist, calls for five critical changes to restore trust in the Advisory Committee on Immunization Practices.
    STAT · 2mo ago↗ source
  • STAT+: U.K. advocacy groups threaten court action over a key provision in the pharma trade deal with the U.S.
    A pair of advocacy groups is threatening legal action unless the U.K. government revokes regulations at the heart of a new pharma trade agreement with the U.S.
    STAT · 2mo ago↗ source
  • In Ebola outbreak, a number of Americans in the Congo believed to have had exposure to suspected cases
    A number of Americans who are in the Congo are believed to have had exposure to suspected cases in the country’s latest Ebola outbreak, sources have told STAT.
    STAT · 2mo ago↗ source
  • When should you get a mammogram? Conflicting advice makes it hard to know
    When should you get a mammogram? Conflicting advice makes it hard to know.
    STAT · 2mo ago↗ source
  • STAT+: The hantavirus outbreak is prompting Covid flashbacks — including the conspiracies
    The deadly outbreak of a rare strain of hantavirus on a cruise has generated echoes of the pandemic era, including conspiracy theories.
    STAT · 2mo ago↗ source
  • STAT+: Sen. Bill Cassidy loses primary as race heads to run-off in win for Trump
    Key health lawmaker Sen. Bill Cassidy will lose his seat, as Louisiana’s Senate primary heads for a runoff between state treasurer John Fleming and Trump-backed Rep. Julia Letlow.
    STAT · 2mo ago↗ source
  • WHO declares Ebola outbreak an international public health emergency
    The WHO said an Ebola outbreak first seen in the Democratic Republic of the Congo was an international public health emergency, underscoring the world's concerns.
    STAT · 2mo ago↗ source
  • Trump blasts ‘disloyal’ Sen. Cassidy while pushing challenger in Louisiana Republican primary
    Bill Cassidy, leader of the Senate committee that oversees health policy, is fighting for his political life in Louisiana's Republican primary on Saturday.
    STAT · 2mo ago↗ source
  • Opinion: The cloudy truth about ‘blue zones’
    “There's been interest in longevity, promoting it, for millennia. But this 25-year campaign really brought it to the forefront,” Eric Topol says of blue zones.
    STAT · 2mo ago↗ source
  • 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↗ source
  • 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