Searle v. Biocraft
Searle announced that it has been granted a hearing in the New Jersey Federal Court on its claim that Biocraft infringed its Norpace (disopyramidel patent. FDA approved Biocraft's generic version of the antihypertensive in February ("The Pink Sheet" Feb. 25, p. 8).
You may also be interested in...
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Company is confident that data readout from pivotal trial could be ready before the end of 2020.
Cognoa said it will submit its AI-powered digital app for early detection of autism for de novo clearance with the US FDA. See what the company’s senior medical director of clinical adoption said about it here.