PhRMA calls for FDA to address unique needs of biosimilar review program
PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.
PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.
Novartis has outlined plans to drive down the cost of producing its siRNA therapy, Leqvio, to support use in larger patient populations.
CDMO AGC Biologics has acquired a commercial manufacturing facility in Longmont, Colorado: giving it significant additional capacity and space to expand its global end-to-end cell and gene therapy offering.