Amneal Pharmaceuticals

Amneal Pharmaceuticals received FDA approval for Pyridostigmine Bromide Extended-Release Tablets USP 105 mg, a once-daily soman nerve agent pretreatment for U.S. Armed Services and allies, developed using GRANDE® technology.

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The FDA has approved 64 biosimilars, including Steqeyma. Biosimilars are highly similar to FDA-approved reference products with no clinically meaningful differences. Interchangeable biosimilars meet additional requirements, allowing pharmacy-level substitution without prescriber intervention. Examples include biosimilars for Actemra, Avastin, Enbrel, and others, highlighting their safety, effectiveness, and cost-saving potential.

FDA confirms end of Eli Lilly's tirzepatide shortage, contrasting with limited availability of Novo Nordisk's Wegovy. Lilly's assurance of meeting demand could boost market share against Novo. New obesity drugs from Roche, Kailera, and Metsera aim to challenge current market leaders.

Amneal Pharmaceuticals and Metsera collaborate to develop and supply next-gen medicines for obesity and metabolic diseases, leveraging Amneal's global manufacturing and Metsera's ultra-long acting injectables. Amneal will be Metsera's preferred supply partner in developed markets and receive commercialization rights in select emerging markets, planning new facilities in India.

IGM Biosciences shifts to autoimmune research, cutting oncology jobs. Metsera partners with Amneal for obesity drug production. Gritstone Bio explores strategic options. UCB plans a trial comparing Bimzelx to Skyrizi for arthritis treatment.

Amneal and Metsera collaborate to develop and supply new weight loss medicines, leveraging Amneal's manufacturing capabilities and Metsera's innovative therapies, including GLP-1 receptor agonists. The partnership aims to address global obesity and metabolic diseases, with Amneal constructing new facilities in India to support production.

Amneal Pharmaceuticals launches CREXONT®, a new Parkinson's disease treatment, offering extended symptom control with less frequent dosing. The company provides a $25 copay savings program and hosts a symposium at the International Congress of Parkinson's Disease and Movement Disorders. Amneal's financial performance includes a 17% Q2 revenue increase to $702 million, leading to an upward revision of 2024 guidance. The company also received FDA approval for BORUZU and a generic propofol, contributing to its growth and market expansion plans.