$SRNE Sorrento Therapeutics is in discussions with the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA) on IND-enabling studies, chemistry, manufacturing and controls, clinical protocol and end-points required to potentially gain accelerated approval. Sorrento will be responsible for development and commercialisation in North America and Europe, while Mabpharm will have rights in the remaining global markets. pharmaceutical-technology.c...
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