FDA documents GMP issues at a long-troubled Bloomington, IN, fill-finish facility — formerly owned by Catalent and acquired by Novo Nordisk in late 2024 — according to a Form 483 issued following an April reinspection.
Eight Mintz attorneys analyze the recent Supreme Court decision giving generic drug manufacturers a victory in an induced infringement case.
FDA documents GMP issues at a long-troubled Bloomington, IN, fill-finish facility — formerly owned by Catalent and acquired by Novo Nordisk in late 2024 — according to a Form 483 issued following an April reinspection.
Eight Mintz attorneys analyze the recent Supreme Court decision giving generic drug manufacturers a victory in an induced infringement case.
Gilead and Merck say they have discontinued the KEYNOTE-D46/EVOKE-03 study of Gilead’s Trodelvy and Merck’s Keytruda as a treatment for certain patients with previously untreated metastatic non-small cell lung cancer.
Eli Lilly reports Phase 3 study results showing its oral GLP-1 receptor agonist Foundayo (orforglipron) outperformed Novo Nordisk's oral semaglutide on blood sugar control and weight loss in what the company described as the first head-to-head late-stage Type 2 diabetes trial.
