With at least two potential candidates being touted as potential best-in-class by their sponsors, the oral SERD market is shaping up to be highly competitive. Sanofi has taken an early lead in expanding the scope of its Phase III breast cancer program.

Advisory committee to consider whether two-year delay is clinically meaningful and substantial evidence standard is satisfied; notably, panel input is not requested on an issue that has tripped up BLA review - bridging data that suggest pharmacokinetic differences between the clinical trial and commercial drug products.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

The US regulator is worried about deficiencies in the submission for Provention Bio’s high-profile therapy teplizumab for the prevention of type 1 diabetes that could significantly delay its review.