Amneal Pharmaceuticals received the green light from the U.S. Food and Drug Administration for bevacizumab-maly, a biosimilar to Roche/Genentech’s Avastin. The biosimilar approval marks the second for Amneal during 2022.
Boehringer Ingelheim announced the company’s intention to pump €25 billion ($27 billion) into its R&D pipeline over the next five years.
The U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.
The U.S. Food and Drug Administration approved Gilead Company Kite’s Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Merck announced that the company will lay off 170 people from Cambridge, Massachusetts-based Acceleron Pharma, which was acquired during November 2021 for about $11.5 billion.
The U.S. Food and Drug Administration approved a 2 mg dose of Novo Nordisk’s Ozempic (semaglutide) injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated along with diet and exercise to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.
After producing vaccines and treatments for acute COVID-19 in record time, researchers and drugmakers are turning to finding a cure for long COVID, a more elusive target marked by hundreds of different symptoms afflicting millions of people.
A federal judge in Delaware tossed out a lawsuit by Roche company Genentech accusing Novartis’ Sandoz division of patent infringement. In this case, the patent was related to Genentech’s Esbriet (pirfenidone), which is used to treat idiopathic pulmonary fibrosis.
AstraZeneca said on March 24 the company’s drug Imfinzi, along with chemoradiotherapy, failed to achieve the main goal of improving survival in patients with locally advanced cervical cancer without the disease worsening.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
