Creative Medical Technology Holdings Inc.'s Immcelz (CELZ-101) has been awarded orphan drug designation by the FDA. Immcelz is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation.
A heads up for the biopharma and med-tech industries: The U.S. government is going beyond warning letters to slap companies for violating the FDA’s good manufacturing practice (GMP) regulations. KVK Research Inc., a U.S.-based generic drug manufacturer, pleaded guilty March 6 to two misdemeanor counts of violating the Federal Food, Drug and Cosmetics Act by introducing adulterated drugs into interstate commerce. As part of the plea, the company agreed to pay a proposed fine and forfeiture amount of $1.5 million.
The biosimilars revolution continues with the U.S. FDA’s approval of the first denosumab biosimilars: Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) from Sandoz Inc. for treating osteoporosis and to prevent bone problems in cancer. The approval puts up a strong challenge to Amgen Inc.’s Prolia, the first biologic for osteoporosis, and Xgeva, for bone cancer.
Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.
The World Trade Organization wrapped up its 13th ministerial conference and, as the saying goes, no news is good news. Life science trade associations in the U.S. lauded the end of the conference without an extension of intellectual property rights waivers for therapies and diagnostics for the COVID-19 pandemic, although this outcome was not entirely surprising.
The U.S. FDA announced several new and updated recalls recently, including a new recall of incubators made by Wipro GE Health Pvt. Ltd., of Bangalore, India, which may be subject to an increased risk that the infant may fall out of the system.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
Taiwan’s Formosa Pharmaceuticals Inc. and Aimmax Therapeutics, Inc. said the U.S. FDA approved APP-13007 (clobetasol propionate ophthalmic suspension 0.05%), a twice-daily corticosteroid eye drop for postoperative eye pain and inflammation.