EU Fast Track Sought For Epidermolysis Bullosa Gene Therapy & Bispecific RRMM Drug
Janssen and Krystal Biotech will soon learn whether the European Medicines Agency considers their respective products to be of potential major public health interest, particularly from the point of view of therapeutic innovation.
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1 June Marks Historic Day For Patent Protection In Europe
The forthcoming unitary patent system and Unified Patent Court promise to make applying for patents in Europe and litigating infringements simpler and less costly for applicants.
EU CHMP Opinions And MAA Updates
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 EU, and updates on EU marketing authorization changes recommended by the CHMP.