In this week's podcast edition of Five Must-Know Things: major Q4 catalysts; Verona’s COPD contender; Alfasigma acquires Intercept; more setbacks for Keytruda/Lenvima combo; and new pressures on China IPOs.

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.