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  • STAT+: CMS signals intent to revamp how it pays for clinical software and AI
    CMS wants to build a standardized payment structure for clinical software and AI that factors in their impact on patient outcomes.
    STAT · 14d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 14d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.
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raps · 14d ago
↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 14d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any…
    raps · 14d ago↗ source
  • Khong Guan Corporation Issues Expanded Recall of Glutinous Rice Balls With Black Sesame Filling to Include Black & White Glutinous Rice Balls With Black Sesame Filling Due to Undeclared Peanuts
    Khong Guan Corporation (Union City, CA) is recalling specific lots of “Glutinous Rice Balls with Black Sesame Filling” and “Black & White Glutinous Rice Balls with Black Sesame Filling” in their re…
    fda recalls · 14d ago↗ source
  • Graham’s death from aortic dissection raises questions about preventing the rare disorder
    When the body’s most important blood vessel tears from the inside, it’s a medical emergency that can be years in the making.
    STAT · 14d ago↗ source
  • Graham’s death from aortic dissection raises questions about preventing the rare disorder
    When the body’s most important blood vessel tears from the inside, it’s a medical emergency that can be years in the making.
    STAT · 14d ago↗ source
  • FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
    The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasi…
    fda press · 15d ago↗ source
  • STAT+: At key hearing, Kennedy’s ouster of former CDC director looms over nominee to replace her
    Erica Schwartz and Sean Kaufman navigated tough questions about vaccines, political independence, and pushing back on RFK Jr.
    STAT · 15d 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.
    STAT · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d ago↗ source