Entrada Therapeutics Inc. has received authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and research ethics committee to initiate a phase I/II study of ENTR-601-45 for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 45 skipping.
The U.K. Medicines and Health Care Products Regulatory Agency reported a pilot program for the use of RWE in regulatory decision making, which is largely directed toward drug products.
The U.K. is continuing to shape up regulation, adding reform of its accelerated drug approval process and its draft guidance on personalized mRNA cancer vaccines to new clinical trial regulations that will come into force early in 2026. The Innovative Licensing and Access Pathway has been relaunched following a review of the industry’s experience of the scheme since its introduction in January 2021, and it will be open for applications from next month.
