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  • Kailera and Hengrui’s GLP-1/GIP candidate ribupatide cuts weight up to 20% and restores menstrual cycles in Phase 2 PMOS trial
    Kailera Therapeutics and Hengrui Pharma reported positive results from a Phase 2 study of their weekly injectable GLP-1/GIP dual agonist, ribupatide, in women with polyendocrine metabolic ovarian s…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Regeneron explores pairing its obesity drug with lipid-lowering therapy to differentiate in crowded GLP-1 market
    The pipeline of GLP-1 based medicines is delivering increasingly strong weight-loss results, prompting many companies to seek ways to stand out as the market fills. Regeneron said it is looking at…
    Endpoints · 1mo agoPositive↗ source
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  • Moderna appoints former executive Juan Andres as COO as Neurocrine reshuffles leadership; Pharming CEO steps down after board dispute
    Juan Andres, a former Moderna executive, will return from retirement to assume the role of chief operating officer on Oct. 5. His deep familiarity with the company is seen as valuable as Moderna ad…
    Endpoints · 1mo agoNeutral↗ source
  • Summit Therapeutics partners with AstraZeneca and Daiichi Sankyo on cancer trial; Eccogene hits $50 million milestone
    Summit Therapeutics announced a partnership with AstraZeneca and Daiichi Sankyo to evaluate its Trop-2‑directed antibody‑drug conjugate in a clinical trial. The collaboration will involve joint de…
    Endpoints · 1mo agoDealPositive↗ source
  • Novartis bets up to $7.8B for an mRNA-encoded T cell engager from China’s Abogen
    Novartis is licensing an mRNA-based therapy designed to produce a CD3xCD19 T cell engager inside the body. Abogen Biosciences says the in vivo approach could reduce the likelihood of dangerous cyto…
    BioSpace · 1mo ago↗ source
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 1mo agoApprovalPositive↗ source
  • Sanofi to pay $1 billion upfront to expand antibody partnership with Regeneron
    Sanofi announced it will provide Regeneron with a $1 billion upfront payment to broaden their existing antibody collaboration. The agreement is timed as the patent protection for Dupixent, the joi…
    Endpoints · 1mo agoDealNeutral↗ source
  • Eli Lilly, Novo, AbbVie and Boehringer showcase new obesity drug data at European meeting
    The European Association for the Study of Diabetes held its annual meeting in Milan, drawing obesity and metabolic disease experts and providing a platform for drugmakers to present emerging weight…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Sanofi, Regeneron expand partnership with $1 billion deal to develop next-generation Dupixent-like antibodies
    Sanofi and Regeneron announced they have broadened their long‑standing alliance, adding a $1 billion upfront payment to fund joint work on new immune‑modulating drugs. The revised agreement calls…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Pfizer's experimental eczema drug tilrekimig shows strong skin clearance in Phase 2 trial
    Pfizer reported that its three‑pronged antibody, tilrekimig, met the primary endpoint of its Phase 2 study in patients with moderate to severe atopic dermatitis. After 16 weeks, a significantly hig…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • BMS flags liver injury cases, including a death, in Phase 3 trial of pulmonary fibrosis drug admilparant
    Bristol Myers Squibb has amended the protocol for its Phase 3 pulmonary fibrosis study of admilparant after reporting several liver injury events, one of which resulted in a patient death. The comp…
    BioSpace · 1mo agoNegative↗ source
  • Devoted Health secures $1.2 billion in new funding to fuel senior member growth
    Devoted Health, a Medicare Advantage insurer and medical group, announced a fresh capital injection of nearly $1.2 billion. The financing round includes a $555 million Series G investment along wi…
    Endpoints · 1mo agoDealPositive↗ source
  • Lilly ends partnership with Foghorn after lead cancer drug fails efficacy tests
    Lilly announced it is ending its collaboration with Foghorn Therapeutics after the biotech's lead cancer candidate, FHD-909, did not meet efficacy benchmarks in testing. The decision halts the join…
    BioPharma Dive · 1mo agoNegative↗ source
  • United Therapeutics wins Delaware court case; BMS secures pediatric approval for Camzyos
    United Therapeutics secured a legal victory in a federal court in Delaware, with the judge ruling in the company's favor. The decision marks a notable win for the biotech firm, though the specific…
    Endpoints · 1mo agoApprovalNeutral↗ source
  • HHS launches funding programs to accelerate U.S. clinical trials amid rising Chinese competition
    HHS announced new initiatives aimed at speeding up clinical trial development in the United States. The department introduced a five-year program called "Surpass" that seeks proposals from teams wi…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • Foghorn Therapeutics cuts 40% of workforce after ending Lilly oncology partnership
    Foghorn Therapeutics and Eli Lilly announced the end of their 2021 oncology collaboration. The partnership had focused on developing and commercializing cancer treatments. Following the terminatio…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • FDA issues warning letter to Fresenius Kabi over famotidine injection contamination
    FDA inspectors spent three weeks at Fresenius Kabi's plant in Melrose Park, Illinois, and issued a warning letter after finding manufacturing deviations linked to patient adverse events. The issue…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Zealand Pharma shares fall as Boehringer Ingelheim partnership weight-loss drug shows modest 9.8% loss in Phase 3
    Zealand Pharma and its partner Boehringer Ingelheim reported that their glucagon/GLP-1 dual agonist survodutide met the primary endpoints in the Phase 3 SYNCHRONIZE-2 trial, but the magnitude of we…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Eli Lilly ends partnership with Foghorn Therapeutics, prompting 40% staff cut at biotech
    Eli Lilly announced it is withdrawing from its collaboration with Foghorn Therapeutics on a synthetic lethality drug program. Following the pullback, Foghorn said it will cut roughly 40% of its wo…
    Endpoints · 1mo agoDealNegative↗ source
  • US government unveils AI-driven SURPASS program to accelerate clinical trials
    The U.S. Department of Health and Human Services announced that the Advanced Research Projects Agency for Health (ARPA-H) is launching four new initiatives aimed at modernizing clinical trial desig…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Regeneron antibody restores muscle loss in patients after stopping Wegovy, mid-stage data show
    Regeneron presented new mid-stage data at the European Association for the Study of Diabetes (EASD) meeting in Milan showing its investigational antibody can help patients with obesity recover musc…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Vertex completes $10 billion Crinetics acquisition as Q3 M&A slows
    M&A activity in the pharmaceutical sector cooled in the third quarter, with total deal value just under $30 billion across 22 transactions, according to BioSpace. Vertex Pharmaceuticals completed…
    BioSpace · 1mo agoDealNeutral↗ source
  • Kallyope rebrands as TriGemX Bio, secures $94M to fund Phase 3 migraine trial
    Kallyope, a New York City drug developer, announced it is changing its name to TriGemX Bio as it narrows its pipeline to migraine. The rebrand follows a recent partnership with Novo on an obesity…
    Endpoints · 1mo agoDealPositive↗ source
  • FAIR Act could boost U.S. rare‑disease trial access and restore biotech leadership
    In a recent BioSpace podcast, host Jennifer C. Smith‑Parker talked with Max Bronstein of Aviva Strategies and Teresa Barnes of PF Warriors about a growing problem: U.S. patients are increasingly un…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Boehringer's obesity drug shows up to 9.8% weight loss in diabetes patients but lags behind competitors
    Boehringer Ingelheim presented data at the European Association for the Study of Diabetes (EASD) meeting in Milan, showing its lead obesity candidate achieved up to 9.8% weight reduction in a late-…
    Endpoints · 1mo agoNegative readoutNeutral↗ source