UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.
AbbVie reported the company’s fourth-quarter 2021 and full-year financial results on Feb. 2, with worldwide net reviews up 7.4% to $14.89 billion for the quarter. Total revenues for 2021 were $56 billion. The company’s anchor product remains Humira, which will begin to lose exclusivity in 2023.
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.
A U.S. district court ruled in favor of generic drugmaker Mylan NV in a patent dispute over Biogen Inc.’s blockbuster multiple sclerosis drug Tecfidera, sending Biogen’s shares down nearly 6 percent.
In essence, we all want those boots on the ground to drive commercial value. Yet, not every high-priced pair of shoes delivers the desired ROI. Physician access time or practice location, and position of the brand in its life cycle, often make the cost of deploying a traditional field rep undesirable. Yet, many brands benefit from a personal visit to the office.
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.
LEO Pharma Inc announced the U.S. Food and Drug Administration expanded the approved indication for Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. Additionally, the FDA approved Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.
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.