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

Allele claims Regeneron’s monoclonal antibody cocktail and Pfizer/BioNTech’s COVID-19 vaccine infringe its fluorescent protein patent. Regeneron asks court to toss suit against it, arguing use of protein for FDA submission is protected. A different court denied Pfizer/BioNTech’s motion to dismiss similar suit.

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead. 

After four years of litigation, Pfizer has reached a preliminary settlement over allegations that it devised an “illegal scheme” with Viatris’ Mylan establish a monopoly for the EpiPen autoinjector device.