The U.S. Food and Drug Administration approved Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product, which is indicated to control high blood sugar in adults with Type 2 diabetes as well as adults and pediatric patients with Type 1 diabetes.
The U.S. FDA approved a bone-building drug from Pfenex Inc. to treat osteoporosis in certain patients at high risk for fractures, marking the company’s first commercial product.
The Sumitomo Dainippon-Roivant Alliance encompasses up to 11 biopharmaceutical Vants with more than 25 innovative clinical programs and multiple potential product launches from 2020 to 2022, and access to key elements of Roivant’s proprietary technology platforms including DrugOme and Digital Innovation.
Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration accepted for review the New Drug Application for Talicia (RHB-105) for H. pylori infection.
