Out of 202 Complete Response Letters issued between 2020 and 2024, 150 involved quality/manufacturing issues, according to the regulator’s newly released documents.
Cellular Origins, Cell and Gene Therapy Catapult, and Resolution Therapeutics have been awarded a £1 million grant from the U.K.’s national innovation agency.
The companies plan to combine AbTis’ AbClick linker technology with Lotte’s conjugation manufacturing capabilities at its Syracuse Bio Campus in New York.