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  • 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
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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
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 1mo agoApprovalPositive↗ source
  • Ipsen to buy Kartos Therapeutics for $450M, gaining Phase 3 myelofibrosis drug navtemadlin
    French pharmaceutical company Ipsen announced it will acquire California-based Kartos Therapeutics, paying $450 million upfront. The acquisition gives Ipsen control of navtemadlin, an MDM2 inhibito…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • FDA approves Viridian's Lumvoa, positioning it against Amgen's Tepezza in thyroid eye disease
    The Food and Drug Administration has granted approval for Viridian Therapeutics' drug Lumvoa to treat thyroid eye disease, an autoimmune condition that can cause eye pain, bulging and vision proble…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Beeline Medicines raises $126.3M, bringing total Series A funding to $426.3M for immune‑drug development
    Beeline Medicines announced an additional $126.3 million in Series A financing, pushing the total raised to $426.3 million. The capital boost was disclosed on Tuesday and follows an earlier spring…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • NIH's All of Us program taps clinical data-sharing networks to add thousands of EHR records
    The National Institutes of Health's All of Us research program announced a new method for gathering real-world health data by leveraging existing patient data-sharing networks that are typically us…
    STAT · 1mo agoPositive↗ source
  • Anthropic to launch its own drug-development program using Claude Science AI
    Anthropic, an AI company best known for its Claude models, announced it will begin developing its own drug candidates. Executives said the effort is meant to give the firm hands-on experience appl…
    STAT · 1mo agoPositive↗ source
  • Uganda reports Marburg cases, adding to regional Ebola crisis
    Uganda has informed the World Health Organization of a Marburg virus outbreak in its western region, confirming at least one case, with some sources indicating two cases. The emergence of Marburg,…
    STAT · 1mo agoNegative↗ source
  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Investors increase stakes in Bain-backed biotech startup as FDA gene‑therapy chief departs
    Investors are putting more money into a biotech startup backed by private‑equity firm Bain Capital, according to the STAT+ newsletter. Vijay Kumar is leaving his role as acting director of the FDA…
    STAT · 1mo agoDealNeutral↗ source
  • US lawmakers probe Chinese clinical trial sites for potential military links involving major drugmakers
    A bipartisan group of U.S. lawmakers has launched a national‑security investigation into whether several large pharmaceutical companies participated in clinical trials at Chinese sites that may hav…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Trump drug deal with Eli Lilly and Novo Nordisk has loophole allowing higher GLP-1 volumes without price cuts
    The Trump administration negotiated a "grand bargain" with drugmakers that promised lower Medicare and Medicaid prices for GLP‑1 drugs in exchange for higher sales volume. Eli Lilly and Novo Nordi…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Abivax's new ulcerative colitis data eases safety worries, sending shares up 25%
    Abivax released additional data on its experimental ulcerative colitis drug obefazimod. Earlier trial results had shown strong efficacy but raised safety concerns after several cancer cases were r…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Anthropic launches Claude Science AI platform tailored for pharmaceutical research
    Anthropic announced the availability of Claude Science, an AI application built on its large language model and aimed at scientific laboratories and pharmaceutical research. The tool is intended t…
    STAT · 1mo agoPositive↗ source