IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.

The latest drug development news and highlights from our US FDA Performance Tracker.

The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.