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  • FDA acting chief walks back Makary's practice of policymaking through journals
    The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face…
    Endpoints · 11d ago↗ source
  • Senate committee questions CDC pick on political interference over vaccines
    Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday. The CDC has been wit…
    Endpoints · 11d ago↗ source
  • STAT+: New study untangles how Epstein-Barr viral infection triggers immune response in multiple sclerosis
    A new study claims to have uncovered how Epstein-Barr virus launches immune responses seen in people with multiple sclerosis. 
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STAT · 11d ago
↗ source
  • STAT+: Improvements in Alzheimer’s testing could make diagnostics more accessible, informative
    Alzheimer's research is moving in new directions, finding ways to make testing much more accessible, and offering more nuanced results.
    STAT · 11d ago↗ source
  • Cassidy grills Trump nominee on past vaccine comments in heated exchange
    Sean Kaufman, Trump's pick for a key pandemic preparedness role, has questioned vaccines and criticized the CDC.
    STAT · 11d ago↗ source
  • STAT+: Bipartisan lawmakers want to require U.S. to probe reliance on foreign-made drugs, ingredients
    A trio of bipartisan lawmakers reintroduced a bill requiring the FTC and Treasury to investigate whether the U.S. relies too heavily on foreign countries as part of its pharmaceutical supply…
    STAT · 12d ago↗ source
  • STAT+: Elevance plots a Medicaid retreat as costs remain high
    Elevance Health, the country’s second-biggest health insurer, said it plans to further shrink its Medicaid portfolio in the coming year, just as states roll out work requirements.
    STAT · 12d ago↗ source
  • J&J restructures pharma manufacturing footprint at cost of up to $750M
    Johnson & Johnson is anticipating as much as $750 million in costs to restructure its pharmaceutical supply chain and exit factories, moves that are coming as it pushes ahead with its $55 billi…
    Endpoints · 12d ago↗ source
  • Eli Lilly invests in Oura to support patients on GLP-1 drugs
    Eli Lilly on Wednesday made an equity investment in wearable ring startup Oura as the drugmaker looks for ways to support patients taking its GLP-1 medications. An Oura spokesperson declined to s…
    Endpoints · 12d ago↗ source
  • STAT+: The whistleblower, The Lab, and the fine print
    In this AI Prognosis news roundup: Mayo's AI whistleblower, Sutter Health's reply to lawsuit over Abridge scribe, and more.
    STAT · 12d ago↗ source
  • STAT+: Glenmark to pay $29.6 million to settle price-fixing allegations in long-running battle with states
    Glenmark Pharmaceuticals agreed to pay $29.6 million to settle price-fixing allegations in a long-running battle with dozens of states.
    STAT · 12d ago↗ source
  • Celcuity gains FDA approval for closely watched breast cancer drug
    <figure><div><img src="https://imgproxy.divecdn.com/f5a4VRDXQg-SwH2yBDKHbtLeyVHpX8cemnSbe-t-6xU/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjI3NzEwNDk4X0F5Q…
    BioPharma Dive · 12d ago↗ source
  • STAT+: In a major policy shift, Medicare proposes to ban vendors from providing remote monitoring services
    Medicare is proposing to ban vendors from providing remote patient monitoring services on behalf of doctors.
    STAT · 12d ago↗ source
  • Merck ADC, in China study, shows potential to replace chemo in lung cancer
    <figure><div><img src="https://imgproxy.divecdn.com/lM3CYabLlmazQYt-COfrxYzxdsO20VnU3PS1vfCq2lE/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjEwOTMxMjkxXzEua…
    BioPharma Dive · 12d ago↗ source
  • Braveheart, Attovia join next wave of biotech IPOs
    <figure><div><img src="https://imgproxy.divecdn.com/Z8dYUynyAGfRpaERds4uqJPo8FGtQPXgqxIr2sImOmo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDUxMTE2NzE0LmpwZ…
    BioPharma Dive · 12d ago↗ source
  • Nobel Laureate Jennifer Doudna enters AI protein design arena
    Jennifer Doudna, Ph.D., the Nobel Laureate best known for co-inventing the CRISPR system that has become the foundation for gene-editing, is dipping her toes into a new, buzzy field: AI-powered pro…
    Fierce Biotech · 12d ago↗ source
  • Why early de-risking is redefining the path to IND
    Lonza explains why early de-risking has become a strategic imperative for biotech teams working to reach IND with confidence.
    Fierce Biotech · 12d ago↗ source
  • Radiopharma maker AdvanCell hauls in $315M for Pluvicto challenger
    AdvanCell raised a $315 million Series D to study a lead-based prostate cancer agent and shore up its US manufacturing of the radioactive treatment. The round marks one of the largest yet for a r…
    Endpoints · 12d ago↗ source
  • STAT+: Celcuity’s breast cancer drug approved, its first
    FDA's new CBER chief promises normalcy, an weight loss drug without GLP-1s, and more biotech news from The Readout
    STAT · 12d ago↗ source
  • Understanding Agentic AI in Clinical Development
    Earlier this year, my colleague Matt Harrington suggested that clinical leaders should stop asking whether their organizations have an “AI strategy”, not because strategy doesn’t matter, but becaus…
    Fierce Biotech · 12d ago↗ source
  • Deaths from coronary artery disease have fallen, but more progress is within reach
    Managing risk factors is the key to further progress in reducing deaths from coronary artery disease, a new study finds.
    STAT · 12d ago↗ source
  • J&J touts Icotyde prescriptions, but not sales, in first full quarter
    Johnson & Johnson teased some details on Wednesday morning about how the launch of its expected blockbuster Icotyde performed in the second quarter. Without disclosing how much revenue the pl…
    Endpoints · 12d ago↗ source
  • More health workers strike as Ebola cases in Congo exceed 2,000, including 754 deaths
    The number of confirmed cases of Ebola in Congo has reached 2,011, including 754 deaths, making it the the fastest-growing outbreak on record, authorities say.
    STAT · 12d ago↗ source
  • J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 12d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Biogen Alzheimer’s drug, skyrocketing 340B drug sales, and more
    An Alzheimer’s drug from Biogen slowed cognitive decline in a mid-stage trial at roughly comparable rates as approved medicines
    STAT · 12d ago↗ source