In Cleveland and Moscow, researchers found freshly-manufactured T-cells showed faster reduction of tumor burden than cryopreserved cells, but uncertainty remains about what the clearance process for the technology will be at the US FDA.
In what the authors call the first study of its kind, a team of researchers at the non-profit Caring Cross have successfully used point-of-care manufacturing technology to create T-cells to treat patients with B-cell malignancies – specifically, children with acute lymphocytic leukemia and adults with non-Hodgkin lymphoma.
The study, published on 10 December in Nature Communications, describes how researchers were able to manufacture CAR19 T-cells in as...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
