A US Complete Response Letter for SPARC’s paclitaxel product has cast a cloud over the project’s viability, but the company is still hopeful of an FDA approval by the fourth quarter of fiscal 2021. With the delay in commercialization, investment in some prioritized projects might also require external funding or even an exit from other research assets.

Roche will obtain options to license candidates discovered and optimized by Rheos under the collaboration. Jazz acquires US rights to PharmaMar SCLC candidate, while Biogen teams with both Ionis and Catalyst.

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

Evolving regulations and emerging opportunities appear to have put China firmly on the radar of several frontline Indian firms. Sun Pharma is the latest to join those seeking a larger play in the Asian market.