Keryx Reaches Special Protocol Assessment Agreement With FDA
Keryx Biopharmaceuticals has reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a phase 3 clinical program for Zerenex (ferric citrate).
Teva Pharmaceuticals International and Polpharma Biologics have signed a global licensing agreement for a proposed biosimilar to Ocrevus (ocrelizumab) to treat multiple sclerosis (MS).