FDA's curb on overseas cell processing to hit smaller cell and gene therapy companies: GlobalData - Express Pharma

FDA's curb on overseas cell processing to hit smaller cell and gene therapy companies: GlobalData - Express Pharma

The FDA now bars new clinical trials that send US patients’ live cells overseas, including to China, for gene editing and return infusion, a move tied to two executive orders. While the scope and impact are unclear, smaller cell and gene therapy companies that rely on foreign manufacturing may be hardest hit. Regulators haven’t specified how many trials are affected, though therapies like chimeric antigen receptor T-cell (CAR-T), which sometimes…

FDA crackdown on overseas cell processing to hit smaller cell and gene therapy companies, says GlobalData - GlobalData

The FDA now bars new clinical trials that send US patients’ live cells overseas, including to China, for gene editing and return infusion, a move tied to two executive orders. While the scope and impact are unclear, smaller cell and gene therapy companies that rely on foreign manufacturing may be hardest hit. Regulators haven’t specified how many trials are affected, though therapies like chimeric antigen receptor T-cell (CAR-T), which sometimes…