Enforcement Report - Week of April 24, 2024
Lilly to buy injectable drug plant in manufacturing ramp-up
Metsera, a richly funded biotechnology startup, launched Thursday with a portfolio of weight loss drugs the company claims could eventually compete with market-leading medicines from Novo Nordisk and Eli Lilly.
Eli Lilly's weight-loss drug succeeds in trials with sleep apnea patients
INDIANAPOLIS, April 17, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results of the SURMOUNT-OSA phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints. Percentage change in AHI was a key secondary endpoint in both studies. AHI records the number of times a person's breathing shows a restricted or complete block of airflow per hour of sleep and is used to evaluate the severity of obstructive sleep apnea (OSA) and the effectiveness of treatment outcomes. Tirzepatide is the only approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) treatment for chronic weight management, commercialized as Zepbound® in the U.S. and Mounjaro® in some global markets outside the U.S.
A settlement between Eli Lilly and insulin users has collapsed after a federal judge’s ruling that denied class certification for the lawsuit.
Nine months after Eli Lilly’s Prevail Therapeutics reduced the biobucks value of a gene editing deal with Precision Biosciences, the Big Pharma subsidiary has walked away from the partnership entirely.
April 17 (Reuters) - Most doses of Eli Lilly's (LLY.N), opens new tab diabetes drug Mounjaro and weight-loss drug Zepbound would be in limited supply through the second quarter of this year due to increased demand, the U.S. Food and Drug Administration's website showed on Wednesday.
If you thought that Eli Lilly's donanemab could ensure a smooth regulatory flight in the slipstream of Eisai and Biogen, the FDA has other ideas.
INDIANAPOLIS, April 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will announce its first-quarter 2024 financial results on April 30, 2024. Lilly will also conduct a conference call that day with the investment community and media to further detail the company's financial performance.