A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
Even though pharmacy benefit manager (PBM) reforms were dropped from the continuing resolution that was signed into law Dec. 21 to keep the U.S. government fully functional through March 14, the incoming administration and Congress likely will continue to try to rein in the PBMs, which serve as middlemen in the nation’s drug supply chain.
Epirium Bio Inc. has obtained IND clearance from the FDA for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor.
The U.S. FDA approved 10 drugs in November, down from 15 in October, 24 in September and 22 in August. Four new molecular entities were approved by the agency in the month, bringing the year-to-date total to 42.
As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025.
As recently as last month, Lexicon Pharmaceuticals Inc. was holding out hope regarding the NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), with analysts mulling the potential label.
The acquisition of Karuna Therapeutics Inc. by Bristol Myers Squibb Co. (BMS) was announced in December 2023, and closed as the BioEurope Spring meeting was convening in March. Along with the acquisition of Cerevel Therapeutics Inc. by Abbvie Inc., the deal signaled that big pharma companies were ready to get back into the brain diseases space.
With Alhemo (concizumab-mtci) from Novo Nordisk A/S, a third hemophilia drug in the past eight months has been approved by the U.S. FDA. The once-daily injectable prophylaxis is to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with inhibitors.
The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.
The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take judicial deference for granted any longer. Chad Landmon of the D.C. office of Polsinelli told BioWorld that future litigation against the FDA may extend even to sub-regulatory guidance thanks to the outcome in the case of Loper Bright – a scenario in which industry might carve out a few significant wins in the coming year.
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