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9 stories matching this filter · ← front page

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  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 4d agoNeutral↗ source
  • Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
    The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
    BioSpace · 9d agoApprovalPositive↗ source
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fda medwatch59
fda press38
856
Ophthalmology488
Pain463
Endocrinology & Metabolism457
Infectious Disease436
  • Enveda’s oral obesity pill shows strong GI safety in Phase 1, paving way for trials in patients off GLP-1 drugs
    Enveda reported that its Phase 1 study of the oral obesity candidate ENV-308 demonstrated an exceptional gastrointestinal safety profile in healthy volunteers. The topline data, released on August…
    BioSpace · 18d agoPositive readoutPositive↗ source
  • Amylyx reports promising GLP-1 blocker results while Summit faces survival setbacks and Definium shows anxiety therapy benefit
    Amylyx said its investigational GLP-1 blocker avexitide cut the combined rate of level 2 and level 3 hypoglycemic events by about 55% in patients with post‑bariatric hypoglycemia, beating analyst e…
    BioSpace · 18d agoNeutral↗ source
  • Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemia
    Amylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass s…
    BioSpace · 19d agoRegulatoryPositive↗ source
  • Eli Lilly posts $23 B Q2 revenue, beats forecasts as Foundayo lags behind Novo's oral GLP-1
    Eli Lilly reported second‑quarter revenue of $23 billion, a 48% increase from the prior year and well above analysts' expectations. The strong top‑line helped the company deliver a sizable earnings…
    BioSpace · 1mo agoEarningsNeutral↗ source
  • Biologics surge drives CMOs and CDMOs to boost sterile fill-finish and prefilled syringe capacity
    Biologics, biosimilars and GLP-1 therapies are increasing demand for sterile injectable products, prompting contract manufacturers to expand capacity. CMOs and CDMOs are adding fill-finish, lyophi…
    BioSpace · 1mo agoPositive↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Samsung Biologics proposes $1.8B acquisition of PolyPeptide to enter fast-growing obesity peptide market
    Samsung Biologics, a South Korean contract development and manufacturing organization, announced an offer to acquire Swiss CDMO PolyPeptide for CHF 1.46 billion (about $1.8 billion). PolyPeptide s…
    BioSpace · 1mo agoDealPositive↗ source