Teva resolved two US Department of Justice civil suits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act by allegedly conspiring to fix the price of three generic drugs and paying Medicare patients’ copays for its multiple sclerosis brand product Copaxone.

The refuse-to-approve decision for i02/Intarcia’s Type 2 diabetes combination product is the latest example of the FDA reaching final negative decisions on challenging regulatory cases.

Pink Sheet reporter and editors discuss the potential fallout if the US FDA’s rare pediatric disease priority review voucher program is allowed to sunset, as well as an upcoming agency advisory committee meeting on potentially banning compounding of the active ingredient in the now-withdrawn pre-term birth prevention drug Makena.

Covis’ preterm birth prevention drug was withdrawn in April 2023. The agency now is considering whether hydroxyprogesterone caproate should be added to the list of products withdrawn or removed from the market after being found to be unsafe or not effective.