In March 2024, BioWorld reported on 261 phase I-III clinical trials updates, showing a 10.6% increase from February's count of 236 and up from January’s 252. However, March’s tally is an 18.2% decline from March 2023’s 319 updates. The average monthly count of phase I-III updates in the first three months of 2024 stood at roughly 277, compared to 305 for all of 2023.
Device recalls may seem an ordinary fact of life, given that some are declared for reasons as innocuous as a change of labeling, but the five device recalls announced by the U.S. FDA April 24 and 25 include one product withdrawal. The recall for the Nimbus series of infusion pumps and administration sets by Infutronix LLC cited instances in which patients were subjected to out-of-specification analgesia flow rates, and the company has seen fit to remove the existing inventory from the market.
Pfizer Inc.’s Beqvez (fidanacogene elaparvovec) won FDA approval for use in adults with hemophilia B, making it the second adeno-associated viral (AAV) vector-based gene therapy available for patients in the U.S., following the late 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec).