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  • 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
  • European regulators approve Fractyl Health's first GLP-1 gene therapy clinical trial
    European regulators have given the green light for Fractyl Health, a biotech near Boston, to begin its first human study of a GLP-1 gene therapy. The therapy aims to provide a one-time treatment t…
    Endpoints · 4mo agoRegulatoryPositive↗ source
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  • Specialized logistics critical for delivering next-generation cell and gene therapies
    The article explains that personalized medicines such as cell and gene therapies are transforming treatment for rare diseases and cancers. Unlike conventional drugs, these therapies are often made…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Biopharma capacity crunch shifts focus to ready-now manufacturing hubs like Middlesex County, NJ
    Demand for biopharma manufacturing, especially cell and gene therapies, is growing faster than the ability to build new GMP-ready facilities, which can take years to complete. To keep pace, compan…
    BioPharma Dive · 4mo agoNeutral↗ 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
  • Optum Rx Announces Transparent Pharmacy Model Set to Launch in 2027
    Optum Rx, a unit of UnitedHealth Group, introduced a new pharmacy benefit model that promises clear fee structures for its customers. The model is designed to give members visibility into the full…
    Endpoints · 4mo agoPositive↗ source
  • Novo Nordisk secures biotech partner for Parkinson's cell therapy as GSK signs hepatitis B drug deal in China
    Novo Nordisk has found a biotech partner to advance its early‑stage Parkinson's disease cell therapy, giving the program a new development home. GSK disclosed a commercial agreement to sell its he…
    Endpoints · 4mo agoDealNeutral↗ 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
  • Endpoints Weekly highlights biotech company models, a quirky startup story, and earnings season updates
    The latest edition of Endpoints Weekly introduces a look at emerging biotech company structures, noting how new models are reshaping the industry. It also features a light‑hearted piece about a st…
    Endpoints · 4mo agoNeutral↗ 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
  • Lilly adds $4.5 billion to Indiana manufacturing to boost weight-loss drug supply
    Eli Lilly & Co. announced an additional $4.5 billion investment in two of its three manufacturing sites in Lebanon, Indiana. The funding is aimed at expanding capacity for both its genetic therapie…
    BioPharma Dive · 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
  • Odyssey Therapeutics raises $279 million in IPO, adds $25 million private sale
    Odyssey Therapeutics, a biotech focused on autoimmune diseases, completed an initial public offering that generated $279 million by selling 15.5 million shares at $18 each. The company also secured…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Trump reportedly plans to dismiss FDA Commissioner Marty Makary
    Multiple media outlets report that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The reports say the decision has not been finalized and could still be…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • WSJ reports Trump plans to fire FDA Commissioner Marty Makary, decision not yet final
    The Wall Street Journal reported that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The report said the administration has not yet made a final decisi…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Daiichi Sankyo writes off $950 million after abandoning ADC manufacturing plan
    Daiichi Sankyo announced it will abandon its planned antibody-drug conjugate (ADC) manufacturing facility. The company said the decision follows a serious over-estimate of third-party demand for AD…
    Endpoints · 4mo agoEarningsNegative↗ source