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13 stories matching this filter · ← front page

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  • Kura Oncology spins out diabetes program into new company with $50M funding and Lilly support
    Kura Oncology, known for its leukemia menin inhibitor Komzifti, announced it is separating its diabetes research into a newly formed company. The new entity will receive $50 million in financing,…
    Endpoints · 2d agoDealPositive↗ source
  • Moonwalk Biosciences raises $70M to advance siRNA obesity therapy
    Moonwalk Biosciences announced it has secured $70 million in financing to move its obesity program into clinical testing. The funding will support development of a small interfering RNA (siRNA) th…
    Endpoints · 3d agoDealPositive↗ source
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fda medwatch67
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Endocrinology & Metabolism493
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  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 11d agoRegulatoryNeutral↗ source
  • FDA considers two new executive posts and approves first-of-its-kind early drug and ketone‑glucose wearable
    The Health and Human Services department is reportedly evaluating the creation of two additional senior positions within the FDA, a step that could increase agency oversight. In recent approvals,…
    raps · 15d agoRegulatoryNeutral↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA advisory panel backs broader use of wellness peptide BPC-157 despite internal concerns
    The FDA advisory committee voted Thursday to recommend loosening restrictions on BPC-157, a peptide popular among health and wellness enthusiasts for muscle repair, injury healing, metabolism suppo…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • FDA CDER appoints veteran GLP-1 reviewer Lisa Yanoff as acting deputy director
    Acting FDA CDER director Michael Davis promoted Lisa Yanoff to the role of acting deputy director of the Center for Drug Evaluation and Research. Yanoff is a long‑time FDA employee with deep exper…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • AstraZeneca’s GLP-1 obesity pill shows 10.5% average weight loss after six months in Phase 2 trial
    AstraZeneca reported data from its Phase 2 study of a GLP-1 based oral obesity treatment. The trial showed participants lost an average of 10.5% of body weight after six months of therapy. The re…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Roche's daily incretin injection shows promise in Phase 2 trial for type 1 diabetes
    Roche reported that its experimental daily incretin injection achieved positive results in a Phase 2 study involving patients with type 1 diabetes. The study, the first mid-stage trial of a GLP-1…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Novo Holdings invests €500 million in Europe-focused fund as Alnylam advances second obesity drug to clinic
    Novo Holdings, the investment arm of the Novo Nordisk Foundation, has committed €500 million to the Scaleup Europe Fund, a vehicle aimed at supporting European biotech scale‑ups. Alnylam Pharmaceu…
    Endpoints · 3mo agoDealPositive↗ source
  • Rezdiffra Beats Wall Street Forecasts as MASH Market Expands
    Rezdiffra, a drug candidate targeting metabolic dysfunction‑associated steatohepatitis (MASH), is outperforming analysts' expectations according to recent commentary. The optimism comes as the mar…
    Endpoints · 4mo agoPositive↗ source
  • GSK signs $1 billion siRNA partnership with China's SiranBio to target obesity
    GSK is expanding its cardiometabolic portfolio by entering a new collaboration with Chinese biotech SiranBio. The agreement is valued at $1 billion in biobucks and focuses on developing siRNA ther…
    Endpoints · 4mo agoDealPositive↗ source
  • Madrigal secures fourth MASH partnership, snapping up Arrowhead drug passed over by J&J
    Madrigal Pharmaceuticals announced its latest collaboration, marking the fourth deal focused on metabolic dysfunction-associated steatohepatitis (MASH) within a ten‑month span. The agreement bring…
    Endpoints · 4mo agoDealPositive↗ source