It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in approving biosimilars. Currently, 63 biosimilars have been approved in the U.S., thanks to 18 new approvals in 2024 that stretched the number of biologics referenced by biosimilars from 14 to 17. That’s an all-time record, CDER Director Patrizia Cavazzoni said, as she released the drug center’s annual approval report for 2024.

Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. agreed to pay more than $4 million to resolve False Claims Act allegations that it failed to report potential research misconduct to the NIH and the Department of Health and Human Services’ Office of Research Integrity in grant applications and progress reports.

China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.

With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight.

Continuing a spate of beginning-of-the-year guidance, the U.S. FDA released a draft guidance on developing drugs for optical imaging.

Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy.