Unithroid Misappropriated Trade Secrets Claims Against FDA Reinstated
This article was originally published in The Pink Sheet Daily
Federal appeals court rules Jerome Stevens properly alleged an independent injury resulting from FDA’s disclosure of trade secrets and confidential information relating to the Unithroid (levothyroxine) NDA.
You may also be interested in...
Scheduling the event suggests FDA is re-evaluating its position on the interchangeability of the drug class. Announcement of the May 23 meeting comes nearly one year after the agency approved a number of equivalence claims for levothyroxine sodium products.
Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.