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.

Mapping the patient journey uncovers a wealth of insights into care, diagnosis and intervention. The onset of advanced analytics tools and sensors now augment the pharma industry’s understanding of the challenges of traversing health care systems. Layering AI into the mapping process not only has the power to provide insights into the current clinical pathway, it can be used to predict and intervene in clinical care.

CDC’s universal recommendation for XBB COVID vaccines means that Novavax’s protein-based vaccine can enter the market immediately upon FDA authorization, but some final questions from the agency are keeping the review going.

The first 10 drugs picked for price negotiation in the US Medicare program will all be unwilling trailblazers. But the position of Abbvie’s Imbruvica stands out as unique in several important ways.