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  • Colombian court upholds compulsory license for HIV drug, affirming legal framework
    The Court of Justice of the Andean Community ruled that Colombia's issuance of a compulsory license for an HIV medicine two years ago was lawful. The tribunal said the government had a valid publi…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Medicare falls short on projected Alzheimer’s drug costs as fewer seniors use Leqembi
    Bob Herman reports that Medicare's earlier estimate that the new Alzheimer's therapy Leqembi would cost the program $3.5 billion in 2025 has proved far too high. The agency's actuaries based the fo…
    STAT · 4mo agoRegulatoryNegative↗ source
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  • FDA policy lets some flavored vapes stay on shelves without full approval, raising expert concerns
    The Food and Drug Administration announced a new guidance that allows certain flavored e-cigarettes and nicotine pouches to remain on the market even though they have not received full authorizatio…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Astellas therapy brings new hope to rare disease patients amid broader biotech challenges
    A new Astellas treatment is being highlighted as a source of optimism for a community affected by a rare disease, after a period of setbacks in the program. The article also notes a revived gene t…
    STAT · 4mo agoPositive↗ source
  • Medicare uptake of newly approved Alzheimer’s drugs Leqembi and Kisunla falls short of expectations
    Medicare is seeing much lower use of the two Alzheimer’s treatments that received FDA approval earlier this year. The drugs, Leqembi and Kisunla, were expected to generate notable spending for Med…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Experts call for licensing framework as Utah pauses AI chatbot prescription program
    Alon Bergman, an assistant professor of medical ethics at the University of Pennsylvania, argues that AI-driven medical tools need a licensing system. He points to Utah’s recent pilot with the AI c…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Medicare cuts projected spending on new Alzheimer’s drugs as uptake remains low
    Medicare is spending far less on the recently approved Alzheimer’s treatments Leqembi and Kisunla than officials had anticipated. The Centers for Medicare and Medicaid Services said the agency does…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Providers and insurers vie to influence upcoming No Surprises Act arbitration rule
    The federal government is preparing to release a final rule that will reshape the arbitration process under the No Surprises Act. Health care providers and insurers are both scrambling to have thei…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • President Trump says government may consider approving certain forms of kratom-derived 7-OH
    President Trump suggested the federal government could move to approve some forms of 7-OH, an opioid derived from the kratom plant. 7-OH, short for 7-hydroxymitragynine, occurs naturally in kratom…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • FDA commissioner Marty Makary faces possible dismissal amid political pressure, while new insights link menstrual cycles to mental health
    Theresa Gaffney’s Morning Rounds newsletter highlighted a growing body of research that connects menstrual cycle patterns with fluctuations in mental health, underscoring the importance of gender‑s…
    STAT · 4mo agoNeutral↗ source
  • AI dependence mirrors addiction, warns psychiatrist, sparking debate on hidden costs
    Jonathan Avery, vice chair for addiction psychiatry at Weill Cornell Medicine, reflects on his podcast about addiction and the mixed feedback he receives. In a recent episode he interviewed NYU ne…
    STAT · 4mo agoNeutral↗ source
  • Dermatophilosis identified in clusters of European gay men, a mild livestock skin disease
    Researchers in France and Spain have diagnosed several men who have sex with men with dermatophilosis, a bacterial skin infection normally seen in livestock. The cases occurred without any known c…
    STAT · 4mo agoNeutral↗ source
  • Experts criticize CDC's limited role as hantavirus outbreak spreads on cruise ship
    Health officials are dealing with a hantavirus outbreak affecting passengers on a cruise ship, and the World Health Organization has taken the lead in coordinating the response. The U.S. Centers fo…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Dr. Glaucomflecken urges national focus on medicine’s corporatization in First Opinion podcast
    The First Opinion podcast featured an interview with ophthalmologist and comedian Will Flanary, better known as Dr. Glaucomflecken. He discussed his views on the growing corporatization of medicine…
    STAT · 4mo agoNeutral↗ source
  • Opinion piece questions bioethical basis of RFK Jr’s alleged raccoon penis collection
    An opinion article highlights a claim that Robert F. Kennedy Jr. once removed the penis of a dead raccoon in 2001. The allegation was first reported in a recent biography and cited during a congres…
    STAT · 4mo agoNegative↗ source
  • Roche to acquire PathAI for $750 million to boost AI pathology
    Roche announced it will acquire Boston based PathAI for an upfront payment of $750 million. The acquisition follows a partnership that began in 2021 and is intended to speed the use of artificial i…
    STAT · 4mo agoDealPositive↗ source
  • Former FDA officials and pharma groups weigh in as Supreme Court considers mifepristone regulation
    The Supreme Court is expected to act on a case involving the abortion pill mifepristone after a pause on a federal appeals court order that halted mail‑order distribution. The decision could resha…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Medicare’s new RAPID coverage pathway speeds adult device access, but pediatric devices still lag
    The Centers for Medicare and Medicaid Services and the FDA introduced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. The new process promises Medicare natio…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Capricor sues Japanese partner over botched Duchenne therapy launch and pricing concerns
    Capricor Therapeutics has filed a lawsuit against its Japanese collaborator Nippon Shinyaku and its subsidiary NS Pharma. The biotech alleges the partners mishandled preparations for the launch of…
    STAT · 4mo agoNegative↗ source
  • Trump reportedly moves to dismiss FDA Commissioner Marty Makary
    President Trump is said to have approved a plan to remove FDA Commissioner Marty Makany, according to several news outlets. The proposed ouster would add to recent turnover in the agency’s senior l…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Capricor sues Nippon Shinyaku over delayed Duchenne drug rollout and pricing formula flaw
    Capricor Therapeutics has filed a lawsuit in New Jersey alleging that Nippon Shinyaku and its US subsidiary NS Pharma have failed to execute agreed upon marketing plans for the company's Duchenne m…
    STAT · 4mo agoRegulatoryNegative↗ source
  • FDA proposes stripping gender references from regulations, prompting research concerns
    The U.S. Food and Drug Administration has issued a proposal to eliminate references to gender in its regulatory language. The change is intended to modernize the rules but has drawn attention from…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Aging scientific workforce grapples with rising fabricated citations as hantavirus cruise ship outbreak drags on
    A new analysis highlights that an increasingly senior scientific workforce is coinciding with a surge in fabricated citations across medical journals, raising concerns about research integrity. Th…
    STAT · 4mo agoNeutral↗ source
  • Six former FDA officials explain why they left the agency during the Trump era
    STAT's weekly video series STATus Report recently featured a road-trip edition in which reporter Lizzy Lawrence traveled to the Washington suburbs to talk with former FDA staff. The interviews inc…
    STAT · 4mo agoNeutral↗ source
  • Spain prepares to isolate over 140 cruise passengers amid hantavirus outbreak
    Spanish authorities are ready to receive more than 140 passengers and crew from a cruise ship flagged with a hantavirus outbreak as it approaches Tenerife. The vessel is expected to dock on Sunday…
    STAT · 4mo agoNegative↗ source