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  • Takeda’s zasocitinib proves ‘top-notch’ for difficult-to-treat psoriasis in phase 3 update
    Takeda has unveiled more data from its phase 3 trials of zasocitinib, demonstrating that the once-daily pill was able to clear or almost clear scalp psoriasis in 75% of patients.
    Fierce Biotech · 9d ago↗ source
  • Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial
    A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.<br>
    Fierce Biotech · 9d ago↗ source
  • Opinion: The growing fang-to-pharmacy pipeline
    “Some of the most powerful medicines we will ever find are already here, carried in the fangs, stingers, and saliva of creatures we’ve been taught to fear,” writes Steve Midway.
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STAT · 9d ago
↗ source
  • Opinion: Medicaid and SNAP cuts are exacerbating the intertwined problems of hunger and mental illness
    “No one built a psychiatric unit to solve hunger,” writes clinical dietician Cole Hanson. But patients come anyway.
    STAT · 9d ago↗ source
  • 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 · 9d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 9d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    <p>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.</p>
    raps · 9d ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    <p>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…
    raps · 9d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    <p>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 a…
    raps · 9d 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 · 10d 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 · 10d 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 · 10d ago↗ source
  • 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d ago↗ source