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  • Entrada stock falls on Duchenne data; Wegovy expands access
    Plus, news about BioCryst, GSK and Roche. 🙃 Entrada’s Duchenne drug disappoints: The biotech reported initial data in six patients who received the low dose of its exon 44 skipping drug ...
    Endpoints · 2mo ago↗ source
  • STAT+: More political interference at the FDA?
    A political appointee gets in the way of a Sanofi drug's approval, and more from STAT's D.C. Diagnosis newsletter.
    STAT · 2mo ago↗ source
  • Amgen adds $300M to Puerto Rico budget; Novartis to exit oral drug factory in Germany
    Plus, news about FDA's one-day inspections and BioMADE: 🇵🇷 Amgen pours another $300M into Puerto Rico: The funds will be used to bolster its biologics production in Juncos, which was established ...
    Endpoints · 2mo ago
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  • STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more
    Sanofi asked the FDA to pull teplizumab out of a speedy review voucher program after a political appointee disagreed with staff over its approval
    STAT · 2mo ago↗ source
  • STAT+: FDA revisits a rare cancer treatment it rejected a few months ago
    Secret drug pricing deals, a virtual AI cancer clinic, and other biotech news from The Readout
    STAT · 2mo ago↗ source
  • Atara, Pierre Fabre's cell therapy to get another shot at FDA approval
    There's new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals. US regulators are willing to reconsider using a Phase 3 study as the basis for an a…
    Endpoints · 2mo ago↗ source
  • STAT+: OpenAI’s health policy wishlist, CGM news from Dexcom, and more
    In this edition of STAT Health Tech: A health policy blueprint from OpenAI, CGM updates from Dexcom, and push back against whole body scans.
    STAT · 2mo ago↗ source
  • Pennsylvania sues AI chatbot company for posing as a licensed doctor
    The state of Pennsylvania has sued Character.AI, a startup that lets users chat with different AI-generated personas, for illegally presenting a chatbot as a licensed doctor in the state. This is t…
    Endpoints · 2mo ago↗ 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 · 2mo 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 · 2mo 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 · 2mo ago↗ source
  • Angelini fortifies neurology portfolio with $4.1B buyout of Catalyst
    Angelini Pharma is spending $4.1 billion to buy Catalyst Pharmaceuticals and its trio of FDA-approved treatments for rare neurological diseases. The buyout will add three medicines to Angelini’s po…
    Endpoints · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo ago↗ source
  • Amgen, AbbVie say IRA negotiations impacted Q1 sales
    At least two drugmakers say they’re feeling the impact of the Inflation Reduction Act, after the first drug prices negotiated under the law took effect in January. Amgen and AbbVie reported in thei…
    Endpoints · 2mo ago↗ source
  • Lilly plans new $4.5B manufacturing investment in Indiana
    Eli Lilly is committing to its roots, allocating $4.5 billion for new manufacturing investments across Indiana as drugmakers pledge more US projects. The world’s largest pharma company, headquarter…
    Endpoints · 2mo ago↗ source
  • BeOne culls five cancer programs and an autoimmune Phase 2
    BeOne Medicines has greatly expanded its pipeline over the years, bringing 18 new molecular entities to the fore across 2024 and 2025. But that also means the drugmaker will likely cull more experi…
    Endpoints · 2mo ago↗ source
  • Lonza looks to ride ADC wave with upcoming factory, workforce expansion
    BASEL, Switzerland — Lonza said it wants to own the commercial market for antibody-drug conjugates, with a new manufacturing site set to come online next year and plans to increase its headcount. T…
    Endpoints · 2mo 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 · 2mo 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 · 2mo ago↗ source