FDA says Teva’s argument to court about dire impact of potential glatiramer ANDAs does not match its statements to investors.
Exasperated at Teva Pharmaceutical Industries Ltd.’s latest attempt to block approval of ANDAs for generic Copaxone (glatiramer), FDA told a district court that it should decline Teva’s “remarkable invitation” to determine whether an application should be approved before the agency decides to do so.
In a May 12 filing, FDA asked the court to toss Teva’s suit against the agency, which seeks...
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
