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  • Federal judge halts Colorado price cap on Amgen's Enbrel drug
    A U.S. district judge issued an injunction that stops the Colorado Prescription Drug Affordability Board from imposing a payment limit on Enbrel, a high-volume biologic sold by Amgen. The court fou…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Former FDA AI regulator says biopharma is misreading agency's guidance, leading to overly cautious approaches
    Tala Fakhouri, who wrote AI policy at the FDA, left the agency last summer and now serves as chief AI and regulatory strategy officer at contract research organization Parexel. She says biopharma…
    STAT · 1mo agoRegulatoryNegative↗ source
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  • Genetix, formerly Bluebird Bio, claims rapid turnaround and aims to treat 1,000 sickle-cell patients annually by 2030
    David Meek completed a distressed buyout of Bluebird Bio last year and has rebranded the company as Genetix. He says the transaction rescued the firm from the brink of bankruptcy and set it on a pa…
    STAT · 1mo agoDealPositive↗ source
  • Elevance Health sues CMS, claiming $115 million loss from disputed Medicare Advantage star rating recalculation
    Elevance Health filed a lawsuit in the U.S. District Court for the Southern District of Georgia, alleging that the Centers for Medicare & Medicaid Services (CMS) recalculated its Medicare Advantage…
    STAT · 1mo agoRegulatoryNegative↗ source
  • CDC leadership accused of stifling vaccine effectiveness studies and reshaping advisory committee role
    Ben Lopman, a professor of epidemiology and global health at Emory University, wrote an opinion piece warning that CDC leadership is trying to manufacture a scientific debate about vaccines where n…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Protillion Biosciences appoints Robert Hollingsworth as chief scientific officer
    Protillion Biosciences announced the hiring of Robert Hollingsworth as its new chief scientific officer. Hollingsworth joins Protillion after serving as chief scientific officer at Shoreline Therap…
    STAT · 1mo agoNeutral↗ source
  • Loss of Colorado Rep. Diana DeGette removes a knowledgeable voice for biopharma in Congress
    Colorado Democratic Rep. Diana DeGette was defeated in her primary, ending her service in the U.S. House of Representatives. DeGette was widely recognized for her deep understanding of biopharma p…
    STAT · 1mo agoNegative↗ source
  • Teen use of AI mental-health chatbots jumps 40% in a year, experts call for safety rules
    A recent study published in JAMA Pediatrics found that the proportion of adolescents turning to AI chatbots for mental-health advice rose from roughly one in eight to one in five within a single ye…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Heat waves become more frequent and intense, raising health risks for Americans as presidential fitness test returns
    Recent data show that heat waves across the United States are occurring more often, lasting longer, and reaching higher temperatures, which experts say could increase health problems such as heat e…
    STAT · 1mo agoNeutral↗ source
  • Presidential fitness test returns as a modest push for youth activity, experts caution limits
    The health secretary reintroduced a presidential fitness test as part of a campaign to boost youth health and address rising sedentary habits. Experts say the test is a positive step but not a com…
    STAT · 1mo agoNeutral↗ source
  • FDA approves Orca Bio's T-cell therapy to lower graft-versus-host disease risk in blood cancer transplants
    The FDA gave its nod to Orca Bio's personalized T-cell therapy, Tregzi, aimed at patients with blood cancers undergoing stem cell transplants. The therapy is designed to cut the chance of chronic…
    STAT · 1mo agoApprovalPositive↗ source
  • Study finds statins and blood-pressure meds bring middle-aged obese adults' heart risk markers in line with normal-weight peers
    A new 25-year observational study published in The Lancet shows that adults over 40 with obesity have blood‑pressure and cholesterol levels comparable to those of normal‑weight individuals. Resear…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Ipsen to acquire Swiss biotech Memo Therapeutics in up to €800 million deal for BK virus drug
    Ipsen announced it will purchase Memo Therapeutics, a Swiss biotech, in a transaction valued at up to about €800 million. The agreement provides Memo investors with €200 million upfront and potent…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Abivax shares jump 40% after Phase 3 data show no excess cancer risk for ulcerative colitis drug
    Abivax reported new safety data from its Phase 3 trial of obefazimod in ulcerative colitis. The data indicated malignancy rates among trial participants were comparable to background rates observed…
    BioPharma Dive · 1mo agoPositive↗ source
  • Ebola and Marburg outbreaks highlight need for pathogen-agnostic diagnostics
    The authors describe a current Bundibugyo Ebola outbreak affecting the Democratic Republic of Congo and Uganda, which has resulted in more than 1,300 confirmed cases and over 375 deaths. While the…
    STAT · 1mo agoNegative↗ source
  • BridgeBio secures up to $1 billion in preferred equity as United Therapeutics invests $140 million to acquire Thymmune
    BridgeBio Pharma announced that Sixth Street Partners and HealthCare Royalty will provide up to $1 billion in preferred equity to support its upcoming product launches. The financing is structured…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Biotech Scorecard Q3 Highlights Upcoming Trial Readouts from Amylyx and Biogen
    STAT’s quarterly biotech scorecard lists fifteen events that could move biotech stocks, focusing on trial readouts and other milestones. Amylyx Pharmaceuticals reported results from its Phase 3 LU…
    STAT · 1mo agoNeutral↗ source
  • Researchers claim creation of first fully synthetic cell, launch public benefit corporation to share technology
    Researchers at the University of Minnesota reported in a preprint that they have built what they call a synthetic cell, dubbed "SpudCell," which they suggest may be the first of its kind. The team…
    STAT · 1mo agoPositive↗ source
  • Anthropic launches Claude Science AI tool for pharma research labs
    Anthropic announced the availability of Claude Science, an application that tailors its large language model for use in scientific laboratories and pharmaceutical research operations. The tool is…
    STAT · 1mo agoPositive↗ source
  • STAT+: More signs that GLP-1s may help with peripheral artery disease
    Anthropic will begin developing drugs, BridgeBio pockets a billion, and more biotech news from The Readout
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • FDA permits Zyn nicotine pouches to be marketed as safer than cigarettes
    The U.S. Food and Drug Administration announced that Zyn's nicotine pouches can be advertised as a safer alternative to traditional cigarettes. The decision reflects the agency's view that the pouc…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Maryland Governor Calls for Investment in Young Men’s Mental Health to Combat Rising Suicide and Loneliness
    Maryland Governor Wes Moore wrote an opinion urging states to shift how they address young men’s mental health, arguing they should be seen as people to invest in rather than problems to fix. He n…
    STAT · 1mo agoPositive↗ source
  • Alcohol industry fights declining demand by intensifying behind-the-scenes lobbying, says STAT+
    Recent data show that U.S. alcohol consumption is falling, creating a challenging market for producers. In response, companies have stepped up lobbying efforts aimed at lawmakers, nonprofit events…
    STAT · 1mo agoNegative↗ source
  • Anthropic’s Claude Science signals AI firms are taking health research seriously
    Brittany Trang, a health‑tech reporter, notes that Anthropic’s new Claude Science model shows major AI developers are turning toward genuine scientific work rather than only high‑profile demos. Th…
    STAT · 1mo agoPositive↗ source