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  • Ipsen to acquire Memo Therapeutics and its kidney infection candidate
    French drugmaker Ipsen announced a new acquisition, agreeing to buy Memo Therapeutics along with its experimental kidney infection drug. This marks Ipsen's second transaction announced within a wee…
    Endpoints · 1mo agoDealPositive↗ 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
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  • 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
  • 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
  • Sanofi’s Pompe disease enzyme therapy clears Phase 3 in infants, opening US label expansion
    Sanofi announced that its next‑generation enzyme replacement therapy for Pompe disease met its primary endpoints in a registrational Phase 3 trial involving infants with the severe infantile‑onset…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • BeOne’s Brukinsa cuts risk of progression or death by 43% in frontline mantle cell lymphoma Phase 3 trial
    BeOne Medicines reported that its BTK inhibitor Brukinsa achieved a significant benefit in a Phase 3 trial for patients with mantle cell lymphoma who received the drug as first‑line therapy. The s…
    Endpoints · 1mo agoPositive readoutPositive↗ 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
  • House panel launches probe into Bristol Myers and Pfizer's China trial sites
    A congressional committee has opened an inquiry into the use of clinical trial sites in China by Bristol Myers Squibb and Pfizer. The panel is focusing on facilities that the committee chair says…
    Endpoints · 1mo agoRegulatoryNegative↗ 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 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
  • Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problems
    Unicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time. The FDA c…
    Endpoints · 1mo agoCRLNegative↗ source
  • Beeline Medicines secures $126M from Bain Capital, CPPIB and Bristol Myers to expand immunology pipeline
    Beeline Medicines, a spinout from Bristol Myers Squibb, announced it has received an additional $126 million in financing. The new capital comes from existing investors Bain Capital and the Canada…
    Endpoints · 1mo agoDealPositive↗ source