Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a green light Oct. 31 from the FDA as both the first approved biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab).
Phathom Pharmaceuticals Inc. will begin marketing Voquezna (vonoprazan) in December, thanks to the Nov. 1 approval by U.S. regulators, who cleared the potassium-competitive acid blocker at 10-mg and 20-mg doses for all grades of erosive gastroesophageal reflux disease (GERD), maintenance of healing of all grades of the condition and relief of associated heartburn.
As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI.
The U.S. Department of Justice (DOJ) has a unique role in enforcement of medical product communication even though the department shares oversight of medical product promotions with the FDA and the Federal Trade Commission (FTC).
Sibionics Technology Co. Ltd. said it received the CE mark for its continuous glucose monitoring (CGM) system, coined the Sibionics GS1 CGM, helping the company expand its market opportunities beyond China.
The FDA has awarded U.S. orphan drug designation and rare pediatric disease designation to Huidagene Therapeutics Co. Ltd.’s HG-204 (AAV-hfCas13Y-gMECP2), an RNA editing therapy based on CRISPR/Cas13Y, for the treatment of methyl-CpG binding protein 2 (MeCP2) duplication syndrome (MDS).
Had it been asked to, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee would have voted Oct. 31 to recommend approval of Vertex Pharmaceutical Inc. and Crispr Therapeutics AG’s exagamglogene autotemcel, or exa-cel, as a one-time transformative treatment for severe sickle cell disease in individuals 12 and older.
As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has converted its regulatory sandbox for artificial intelligence (AI) into a full-fledged program dubbed the AI-Airlock, described as a regulatory-monitored virtual area in which industry can “generate robust evidence for their advanced technologies.” MHRA said it is focused on ensuring that AI products are available in the U.K. “before they are available anywhere else in the world,” a sign that national economic competitiveness is fostering a regulatory willingness to deal with uncertainty about this class of products.
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