Generic association advocates enforcement action against companies that use REMS to block generics while PhRMA disputes claims of REMS abuse and citizen petition delay tactics.
In what has been a busy year of innovators and generic companies sparring over how to foster a more competitive marketplace, the Association for Accessible Medicines (AAM) and the Pharmaceutical Research and Manufacturers of America (PhRMA) renewed their rivalry on the issue in comments to the US FDA.
The groups submitted recommendations to an FDA docket opened in connection with the agency's July public meeting on administering the...
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.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
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.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
