Risk Evaluation and Mitigation Strategy (REMS)
Opioid makers face a task that’s partly old, partly new. Besides training docs on their meds' risks, they'd have to include info on rival therapies.
Biogen and AbbVie’s MS drug Zinbryta faces new restrictions in Europe at a time when tough payers and new challengers are roiling the field.
New FDA commissioner Scott Gottlieb laid out some approaches the agency will take to fight high prices.
Generic drugmakers have accused their branded compatriots of using Risk Evaluation and Mitigation Strategies (REMS) to keep them from bringing generics of some meds to market. Now a bipartisan phalanx of Senators wants to give the generic industry a legal tool to fight that maneuver.