FDA receives additional marketing application for Janssen ZYTIGA
Janssen-Cilag International NV has also sent a type II variation to the European Medicines Agency (EMA) for approval. The two applications are intended to increase the uses of
Teva Pharmaceuticals International and Polpharma Biologics have signed a global licensing agreement for a proposed biosimilar to Ocrevus (ocrelizumab) to treat multiple sclerosis (MS).
Under the agreement Clarity’s PET based companion diagnostics and radio-immunotherapeutics development program will receive cGMP chemistry manufacturing,scale up and aseptic fill/finish services and analytical support from Dalton Pharma.