Stakeholders differ on whether the rapid growth in spending is to be expected, given the realities in health care and specialty drug costs, or that the data underscores the need for oversight and reform of the 340B program.

Securing a place on the European Medicines Agency’s priority medicines scheme is not easy, but some companies have managed to make the grade more than once.

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.