Amneal Pharmaceuticals

Amneal resubmits NDA for DHE autoinjector for migraine and cluster headache treatment, and receives FDA approval for exenatide, its first generic injectable GLP-1 agonist.

Amneal Pharmaceuticals advances two initiatives: resubmission of a DHE autoinjector NDA for migraine and cluster headache treatment, and FDA approval for exenatide, a GLP-1 agonist for type 2 diabetes. The DHE autoinjector offers at-home, single-dose relief without refrigeration or assembly, targeting severe headaches. Exenatide approval showcases Amneal's innovation in generic injectables.

Amneal Pharmaceuticals resubmits DHE autoinjector NDA to FDA for migraines and cluster headaches, and receives FDA approval for exenatide, its first generic GLP-1 agonist.

Amneal Pharmaceuticals resubmitted a migraine treatment NDA to the FDA and received approval for its diabetes and obesity treatment. The migraine treatment, dihydroergotamine, is a single-dose autoinjector that can be self-administered at home. The FDA review is expected in Q2 2025.

Amneal resubmits DHE autoinjector NDA for migraines and receives FDA approval for exenatide, its first generic GLP-1 agonist.

Metsera, a biotech startup, raised $215 million in Series B financing, led by Wellington Management and Venrock Healthcare Capital Partners, bringing its total funding to over $500 million. The company aims to develop obesity drugs, including a long-acting GLP-1 drug, MET-097i, which showed promising weight loss results in a Phase 1 trial. Metsera also has ongoing trials for an injectable amylin analog and an oral GLP-1 peptide, with potential combinations of therapies. The company has partnered with Amneal Pharmaceuticals for manufacturing.

Amneal Pharmaceuticals reported a 13% increase in Q3 revenue to $702 million, driven by strong performance in generics and specialty products. The company launched CREXONT for Parkinson's disease and partnered with Metsera for obesity treatments, positioning it for growth. Amneal plans to build two new facilities in India and expand its biosimilar portfolio, projecting healthcare distribution revenues to exceed $700 million by 2025 and international expansion to add $50-100 million in revenue by 2027.

The article discusses the importance of SSR (Server-Side Rendering) in modern web development, highlighting its role in improving performance and SEO.

The Global Glioblastoma Multiforme Treatment Market is projected to grow from US$ 2.2 Billion in 2023 to US$ 4.7 Billion by 2033, at a CAGR of 8.1%. Radiation Therapy leads with a 39.2% market share, followed by Bevacizumab in drug classes at 29%. Hospitals dominate end-use with over 47% share. North America leads regionally with 42.3% market share, driven by advanced healthcare. Key players like F. Hoffmann-La Roche Ltd. and recent developments, including Teva's partnership and Pfizer's Crizotinib trials, highlight ongoing advancements and collaborations in GBM treatment.

Panelists at GRx+Biosims 2024 discussed biosimilar device requirements, emphasizing risk analysis, human factors studies, and alternative validation approaches to streamline regulatory approval for interchangeable biosimilars while ensuring patient safety and efficacy.