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  • 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
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  • 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
  • 92Bio revives experimental T cell engager previously handed to Amgen
    92Bio, a small California biotech, announced it is bringing back an experimental T‑cell engager it originally created before transferring the program to Amgen. The company said the candidate will…
    Endpoints · 1mo agoNeutral↗ 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
  • 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
  • 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
  • FDA picks seven firms, including Eli Lilly and Fujifilm, for PreCheck pilot to speed factory inspections
    The FDA announced that it has selected seven companies to join the inaugural PreCheck pilot, a program designed to accelerate the review of manufacturing facilities. The cohort includes large drug…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • AbbVie and Genmab's Epkinly shows positive combo results, moving toward label expansion in DLBCL
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a successful outcome when tested together with a commonly used cancer therapy. The data indicate that the combination was…
    Endpoints · 1mo agoPositive readoutPositive↗ 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
  • Sarepta receives FDA decision deadline for exon-skipping therapies, appoints Anna Protopapas as Flare CEO
    The U.S. Food and Drug Administration has set a deadline for a decision on Sarepta Therapeutics' exon‑skipping drug program, with the agency expected to rule by the end of February. The timing is…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA reviewers recommend against adding seven peptides to bulk drug list for compounding
    FDA reviewers have advised that seven widely used peptides should not be added to the FDA's bulk drug substance list for compounding. Their recommendation comes before an upcoming advisory committe…
    Endpoints · 1mo agoRegulatoryNegative↗ 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
  • Abivax reports ulcerative colitis trial cancer rates align with expectations
    Abivax released new data from its Phase 3 trial of an ulcerative colitis candidate. The data show that the number of cancer cases observed was within the range normally expected for ulcerative col…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Biotech firms raise record funds in 2026, with $2.1 bn round for Isomorphic Labs
    After a few slow years, the biotech financing landscape is showing signs of recovery, though investors remain cautious about where they place capital. A recent PharmaVoice reader poll found that 2…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Anthropic launches Claude Science, AI platform aimed at bioscience and drug discovery
    Anthropic, known for its Claude Code AI coding assistant, announced a new product called Claude Science aimed at the life‑science sector. The platform is designed to help biopharma researchers wit…
    Endpoints · 1mo agoPositive↗ source
  • Health tech executives grow confident in AI, survey shows sharp shift in attitudes
    A yearly survey conducted by Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan Mangini reveals that confidence in using artificial intelligence within healthcare has risen sharply over t…
    Endpoints · 1mo agoPositive↗ source
  • Rep. Tom Kean Jr. Discloses Depression Diagnosis After Four-Month Congressional Absence
    Rep. Tom Kean Jr., a Republican congressman from New Jersey, announced on the House floor that he has been receiving treatment for depression, which explains his unexplained four-month absence from…
    STAT · 1mo agoNeutral↗ source
  • FDA acting director of cell and gene therapies Vijay Kumar to depart his post
    Vijay Kumar, who has been serving as the acting director of the Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products, announced he will leave his position. In an inte…
    Endpoints · 1mo agoNeutral↗ source
  • STAT+: All of Us tests a new approach to collect real-world data for research
    The NIH All of Us Research Program has secured thousands of electronic medical records through an innovative use of patient data-sharing networks
    STAT · 1mo ago↗ source
  • Top FDA gene and cell therapy regulator to step down
    Following Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.
    BioPharma Dive · 1mo ago↗ source