Kite Pharma claims it has filed the first EU application to market a CAR T-cell therapy, and says that being on the European Medicines Agency’s PRIME scheme was helpful when it came to getting answers to the questions it had on the application.
The race to market CAR T-cell therapies in Europe appears to have moved up a gear – as has the European Medicines Agency’s PRIME (priority medicines) scheme – after Kite Pharma claimed it had submitted the first EU marketing authorization application for such a product and had been granted accelerated assessment under PRIME.
Kite’s announcement on July 31 relates to its CAR (chimeric antigen receptor) T-cell therapy axicabtagene ciloleucel for treating lymphomas. As...
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.
NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
