The U.S. FDA is holding a series of town halls on the use of sterilization methods as alternatives to ethylene oxide (EtO) in response to other federal agency rulemaking, and some of these changes in sterilization methods will not require a new regulatory filing.
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYH-2039, a highly selective methionine adenosyltransferase 2A (MAT2A) inhibitor, for advanced malignant tumors.
The U.S. Court of Appeals for the Third Circuit may have ruled last year that the Department of Health and Human Services doesn’t get to fill in the gaps in the law that created the 340B prescription drug discount program, but some states and lawmakers are coming up with their own workarounds to force drug manufacturers to give the discounts to an unlimited number of contract pharmacies.
At first glance, the number of drugs that received accelerated approval from the U.S. FDA’s Center for Drug Evaluation and Research (CDER) in 2023 was nothing to write home about. Yes, CDER granted nine accelerated approvals last year, up from six in 2022. But the proportion of novel drugs with accelerated approval was 16% both years. And when compared with the 12 drugs in 2020 and the 14 that received accelerated approval in 2021, last year’s crop was a little lackluster. However, a deeper look at the 2023 class of accelerated approvals shows a historic milestone. For the first time since the path was created in 1992, the number of novel biologics getting accelerated approval at CDER outpaced the number of small-molecule drugs.
The U.K. National Institute for Health and Care Excellence (NICE) has released a preliminary health technology assessment for three modules of the Proknow series of software systems by Stockholm-based Elekta AB, which may improve the delivery of radiotherapy services across the U.K. However, NICE indicated it wants to see more evidence regarding the impact of these software modules on radiotherapy treatment plans.
The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
The U.S. FDA approved Orchard Therapeutics plc’s BLA for gene therapy atidarsagene autotemcel, making it the first treatment option for metachromatic leukodystrophy in the U.S. The one-time treatment, branded Lenmeldy, is indicated for children with presymptomatic late infantile, presymptomatic early juvenile or early symptomatic early juvenile disease.
Two sNDAs, one from Bristol Myers Squibb Co. (BMS) and the other from Mirum Pharmaceuticals Inc., have received U.S. FDA approval to further expand their treatment indications.
The U.S. FDA has approved Beigene Co. Ltd.’s Tevimbra (tislelizumab-jsgr) as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that did not include a PD-1 inhibitor. A humanized IgG4 anti-PD-1 monoclonal antibody, tislelizumab is designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
The U.S. FDA’s Oncology Drugs Advisory Committee, in two separate sessions, took up the matters of Carvykti (ciltacabtagene autoleucel) from Johnson & Johnson and the Bristol Myers Squibb Co. product Abecma (idecabtagene vicleucel) – specifically, whether the benefits of each CAR T therapy outweigh the risks in relapsed or refractory multiple myeloma (MM).
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