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  • Updated: Merck beats AstraZeneca to approval for first PCSK9 pill
    As in football, so in pharmaceuticals: The English have been beaten. Merck has outpaced AstraZeneca in the race to get the first US approval for an oral form of a particular kind of cholesterol-low…
    Endpoints · 16d ago↗ source
  • STAT+: Amylyx nears pivotal endocrine drug study readout
    Amylyx Pharmaceuticals will soon read out results from a study evaluating a new treatment for a rare endocrine disorder, a pivotal moment for patients and the company.
    STAT · 16d ago↗ source
  • 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.
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fda medwatch18
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Vaccines517
Endocrinology & Metabolism293
Ophthalmology264
Infectious Disease253
Nephrology239
Fierce Biotech · 16d 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.
    Fierce Biotech · 16d 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.
    STAT · 16d 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 · 16d 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 · 16d ago↗ source
  • Spurred by deep cuts and M&A activity, H1 layoffs could oust 14,000+ in biopharma
    Takeda’s cuts will go the deepest, affecting over 4,700 employees. Layoffs tied to M&A activity include BioNTech letting go of around 800 people at CureVac.
    BioSpace · 16d 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 · 16d 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 · 16d 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 · 16d 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 · 17d 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 f…
    Endpoints · 17d 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 witho…
    Endpoints · 17d 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 · 17d 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 · 17d 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 · 17d ago↗ source
  • Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
    After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain.
    BioSpace · 17d 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 · 17d 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 · 17d 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 billion p…
    Endpoints · 17d 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 sha…
    Endpoints · 17d 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 · 17d 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 · 17d 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 · 17d ago↗ source