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  • Vera Therapeutics' Trutakna shows kidney function stabilization and lower death risk in Phase 3 IgAN trial
    Vera Therapeutics reported that its drug Trutakna met its primary goals in a two‑year Phase 3 study of patients with IgA nephropathy. The therapy stabilized kidney function and lowered the risk of…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Fourth measles death reported in Pennsylvania, all victims unvaccinated
    Pennsylvania health officials reported a fourth measles-associated death in the state, involving an 18-year-old from Mifflin County. The death was caused by acute disseminated encephalomyelitis, a…
    STAT · 1mo agoNegative↗ source
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  • Medicare AI prior-authorization pilot plagued by rollout glitches, causing care delays
    Documents obtained through a Freedom of Information Act lawsuit reveal that the Medicare program using artificial intelligence for prior authorization was launched hastily and suffered numerous tec…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Medicare expands ACCESS pilot to cover more chronic conditions with outcome-based payments
    Medicare's ACCESS model, a pilot that pays technology providers for managing chronic diseases, is being broadened. Initially covering diabetes, hypertension, chronic musculoskeletal pain, depressi…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA opens pilot program to speed human testing of new drugs
    The Food and Drug Administration announced it is accepting applications for a pilot under Operation TrialBlazer aimed at reducing the time before drug candidates can start human trials. The initia…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30
    The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • New documents expose flaws in Medicare’s rushed AI prior-authorization pilot
    New internal documents have highlighted serious shortcomings in Medicare’s recently launched AI-driven prior‑authorization pilot, which was rolled out faster than anticipated. The pilot, designed…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Exercise and echocardiograms helped keep astronauts’ hearts stable during six-month spaceflight, study finds
    A team of international researchers examined 13 astronauts who spent six months aboard the International Space Station. The crew underwent regular onboard echocardiograms to monitor heart size and…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Legend Biotech appoints former Novartis executive as CEO while Vera pursues full approval for kidney drug
    Legend Biotech announced that Ingrid Zhang, a former Novartis executive, will take over as chief executive officer, replacing Ying Huang who stepped down in July. Vera reported that its recently l…
    STAT · 1mo agoNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about a GSK deal for a drug from China, job losses in the U.S., and more
    GSK has continued its drive to bulk up its pipeline, taking global rights to a multiple myeloma treatment developed in China
    STAT · 1mo agoDealNeutral↗ source
  • NIH now allows businesses to apply for its research funding
    The National Institutes of Health announced that companies are eligible to submit grant applications, expanding the pool of potential research partners. This change aims to foster collaboration bet…
    STAT · 1mo agoRegulatoryPositive↗ source
  • States urged to apply tobacco-settlement lessons to Meta’s $18 billion payout
    Susan Morrisey, former head of Colorado’s tobacco‑control coalition, reflects on how the 1998 tobacco settlement was debated and allocated among competing interests in the state. She recalls that…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • RFK Jr. to keynote Children’s Health Defense event as hospitals criticize GOP rural health fund
    Robert F. Kennedy Jr. is slated to deliver the keynote address at a Children’s Health Defense gathering, marking a return to the anti-vaccine activism that defined his recent public profile. Hospi…
    STAT · 1mo agoNeutral↗ source
  • Danone USA recalls So Delicious Dairy Free Salted Caramel Cluster frozen dessert pints over possible foreign material
    Danone USA announced a voluntary recall of its So Delicious Dairy Free Salted Caramel Cluster non-dairy frozen dessert pints. The recall applies to pints with best‑by dates on or before April 3, 2…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Gias Foods recalls bettergoods Italian Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of two lots of its bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated a potential contamination with Listeria monocytog…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • Judge blocks Trump administration's plan to cap visas for grad students and postdocs
    A federal judge issued a preliminary injunction on Monday, stopping the Trump administration's plan to limit the length of visas used by graduate students and postdoctoral researchers. The Departm…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Abbott to pay $385 million to settle claims over 2022 baby-formula plant shutdown
    Abbott Laboratories agreed to a $385 million settlement related to the 2022 shutdown of its Sturgis, Michigan baby-formula plant, the largest in the United States. The plant’s problems triggered a…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • A&P Creations recalls X10 supplement after discovering undeclared Viagra and Cialis ingredients
    A&P Creations LLC announced a voluntary recall of its X10 Natural Enhancement Supplement after testing revealed the presence of sildenafil and tadalafil, the active ingredients in prescription drug…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • GSK presents promising late-stage lung cancer data from two investigational drugs
    GSK highlighted late-stage results for two of its lung cancer candidates, reporting encouraging efficacy signals that could advance the programs toward regulatory review. The company shared the da…
    STAT · 1mo agoPositive readoutNeutral↗ source
  • AstraZeneca's breast cancer drug camizestrant fails pivotal first-line trial
    AstraZeneca announced that its investigational breast cancer drug camizestrant did not meet primary endpoints in a pivotal Phase 3 trial evaluating it as a first-line treatment for advanced disease…
    STAT · 1mo agoNegative readoutNegative↗ source
  • Definium’s LSD therapy cuts anxiety scores in second late-stage trial
    Definium Therapeutics reported that its LSD-based drug DT120 reduced anxiety symptoms in a second late-stage study. In the 12-week trial, patients receiving a 100-microgram dose saw an average 9.8…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Pennsylvania reports third measles death this year, a 40-year-old woman in Jefferson County
    Pennsylvania officials confirmed a third measles-related death in the state this year, involving a 40-year-old woman in Jefferson County. Coroner Greg Furlong said the death was measles-related bu…
    STAT · 1mo agoNegative↗ source
  • Third measles-related death reported in Pennsylvania amid ongoing outbreak
    A 40-year-old woman in Pennsylvania died from complications related to measles, marking the third measles-related fatality in the state in recent weeks. The death was confirmed by Jefferson County…
    STAT · 1mo agoNegative↗ source
  • Novo Nordisk rebrands as "Novo" to signal renewed focus amid slipping market share
    Novo Nordisk announced it will drop "Nordisk" from its name, adopting the shorter brand "Novo" along with a new slogan "Lasting Health Starts Now" as part of a cultural shift. The company says the…
    STAT · 1mo agoNegative↗ source
  • Hospital leaders say GOP's $50 billion rural health fund falls far short of Medicaid cuts
    Republican lawmakers added a $50 billion Rural Health Transformation Fund to the tax‑cut legislation, aiming to help hospitals cope with planned Medicaid cuts. The fund represents only about 5 % o…
    STAT · 1mo agoRegulatoryNegative↗ source