Inside FDA’s New Gene and Cell Therapy Guidances

The company’s technology was used to create CAR-T cells that demonstrated the expression of complex CARs in a single DNA donor.

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

The investment will be done over five years and will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple US states.