Michelle Tarver, the acting director of the U.S. FDA’s device center appeared on a Sept. 24 webinar to discuss her priorities for the agency going forward, one of which is global health equity.
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
When the U.S. FTC filed suit Sept. 20 against the country’s three largest pharmacy benefit managers over their alleged use of rebates to artificially inflate U.S. insulin prices, it also put the three big insulin makers, and other drug manufacturers, on notice that they could be next.
August saw the U.S. FDA approve 22 drugs, an increase from July's 17 but fewer than the 28 approved in June. This brings the 2024 monthly average to just over 19 approvals, outpacing last year's average of 16 per month, as well as the 12.5 per month seen in 2022 and 17 per month in both 2021 and 2020.
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence.
The U.S. Court of Appeals for the Fifth Circuit revived the Pharmaceutical Research and Manufacturers of America’s (PhRMA) constitutional challenge to the Medicare price negotiations, sending it back to a federal court in Texas for a do-over.
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
The U.S. FDA wrapped up the pilot version of the Accreditation Scheme for Conformity Assessment (ASCA) and reported the formation of a permanent ASCA program, which has been seven years in the making.
Azon Medical LLC, a supplier of medical products such as durable medical equipment, is on the hook for slightly more than $1 million for promoting the P-Stim device as eligible for Medicare coverage.
Innate Pharma SA has obtained IND clearance from the FDA for IPH-4502, its novel and differentiated topoisomerase I inhibitor antibody-drug conjugate (ADC) conjugated to exatecan targeting Nectin-4 in solid tumors. In nonclinical models, IPH-45 was well tolerated and showed antitumor efficacy in vitro and in vivo.
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