Erytech submits MAA to European Medicines Agency for GRASPA
The MAA for GRASPA, ERYTECH’s lead product, consisting of asparaginase encapsulated in red blood cells, is based on the positive findings of the pivotal GRASPALL 2009-06 Phase 2/3
ProBio has entered into an exclusive worldwide licensing agreement with South Korean biotechnology firm AbTis to develop and commercialise an early-stage therapeutic antibody asset.
The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality