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Latest News & Analysis
Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.
When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.
Sage will end development for dalzanemdor after it failed in a Phase II Huntington’s disease trial, leaving the company with one commercial drug and three early-stage assets.
The company announced results of the TANDEM study combining the CETP inhibitor with ezetimibe, following successful monotherapy trial data announced in July
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