Real life economics, not functionality, is the standard for determining a relevant antitrust market for distinct versions of a prescription drug, the U.S. Court of Appeals for the Second Circuit said as it schooled a lower court and handed Regeneron Pharmaceuticals Inc. a win in its ongoing litigation with Novartis AG and Vetter Pharma International GmbH over the prefilled syringe market for eye drugs Eylea (aflibercept) and Lucentis (ranibizumab).
Asieris Pharmaceuticals Co. Ltd plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia.
China’s National Medical Products Administration (NMPA) approved Kechow Pharma Inc.’s MEK inhibitor, tunlametinib, for treatment of patients with NRAS-mutated advanced melanoma who were previously treated with PD-1/PD-L1 inhibitors. The Center for Drug Evaluation granted tunlametinib a priority review. The approval marks the first targeted therapy for this patient population and the first product that originated from Kechow, a privately held firm founded in 2014 to develop small-molecule therapeutics against cancer.
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.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).
As widely expected, Madrigal Pharmaceuticals Inc.’s resmetirom picked up the first U.S. FDA approval for treating nonalcoholic steatohepatitis (NASH), an advanced form of nonalcoholic fatty liver disease that has been steadily increasing in global prevalence. Branded Rezdiffra, the liver-directed THR-beta agonist gained accelerated approval for use in conjunction with diet and exercise to treat adults with noncirrhotic NASH with moderate to advanced liver fibrosis, specifically stages F2 and F3.
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