Getting on the best reimbursement pathway in the US will be vital for the UK company as it moves closer to approval and taking on the established players in the chronic obstructive pulmonary disease arena.

After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

As FDA clears new COVID vaccines, the Regeneron deal is a reminder of the politics of drug pricing. Sen. Sanders touts the agreement, which attaches product price caps to funding for clinical development, and he allows the confirmation effort for the NIH director nominee to proceed.

In a new wave of crackdowns on compliance in the pharma sector in China, 10 medical meetings have been cancelled in short order, while sector-wide stock prices have plunged and 100 hospital officials placed under investigation, shocking the industry.