JCR Pharmaceuticals Co. Ltd. has received approval from Germany’s Paul-Ehrlich Institute (PEI) for its clinical trial application (CTA) for JR-441, a blood-brain barrier penetrating form of heparan N-sulfatase developed using JCR’s proprietary J-Brain Cargo technology.
Sensorion SA has submitted a clinical trial application (CTA) for OTOF-GT to the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). Sensorion plans to submit the CTA in Europe in the coming weeks.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and the Gene Therapy Advisory Committee (GTAC) have approved a clinical trial application (CTA) submitted by University College London (UCL) to initiate a phase I/II trial of BGT-OTCD, Bloomsbury Genetic Therapies Ltd.’s liver-targeted AAV-LK03 gene therapy, in pediatric patients with ornithine transcarbamylase deficiency (OTCD).
It is a “landmark moment” in the long-awaited upgrade of the management of clinical research in Europe, but the industry has given a lukewarm welcome to a mandate to submit all clinical trial applications via the EMA’s clinical trials information system, as of Jan. 31.
Transgene SA has received clinical trial application (CTA) approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a phase I trial of TG-6050, a novel oncolytic virus (OV) for intravenous administration in patients with advanced non-small-cell lung cancer (NSCLC). Enrollment is expected to open in the first half of this year.
The EMA will require all new clinical trial applications to be submitted via its clinical trials information system after Jan. 31, 2023, despite pharma companies and other users raising concerns about functionality and technical failures they are experiencing with the system.
Affimed NV has received clearance of a clinical trial application (CTA) by the French National Agency for the Safety of Medicines and Health Products (ANSM) for a phase I study of AFM-28 (AFM28-101) in CD123-positive relapsed or refractory acute myeloid leukemia (AML).
Benevolentai Ltd. has submitted a clinical trial application (CTA) to the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) for BEN-8744, an oral, peripherally restricted, small-molecule phosphodiesterase 10 (PDE10) inhibitor in development as a first-in-class treatment for ulcerative colitis.
