The difficulties in rolling out the EU’s Medical Device Regulation are well known, but the attendant delays continue to exert ripple effects in other markets. The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has formally extended the time frame for acceptance of existing CE marked devices into the U.K. market, another demonstration of the ongoing turmoil associated with the herky-jerky deployment of the MDR.
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Argenx, Biomarin, Drug Farm, Madrigal, Merus, Scisparc, Unicycive, Zai Lab.
Xuanzhu Biopharmaceutical Co. Ltd., a subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., received marketing approval in mainland China for its anaprozole sodium enteric-coated tablet as a treatment of duodenal ulcer.
Two separate insider trading tips involving a biopharma acquisition and trial results for Pfizer Inc.’s COVID-19 antiviral, Paxlovid, allegedly netted millions of dollars in “ill-gotten” trading profits, according to U.S. SEC complaints announced June 29.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arup Laboratories, Feops, USMI.
The U.K. Competition and Markets Authority (CMA) has declared its opposition to a proposed merger between Cochlear Ltd. And Oticon Medical A/S, two of the prime movers in the bone conduction implant space.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ausper, Bristol Myers Squibb, Can-Fite, Celltrans, Endo, Genenta, Geron, Harbour Biomed, Ipsen, Italfarmaco, Paladin Labs, Recce.
Becoming the first gene therapy approved for hemophilia A, Roctavian (valoctocogene roxaparvovec) finally received the U.S. FDA’s blessing on June 29, after developer Biomarin Pharmaceutical Inc. spent nearly three years working to address issues raised in a 2020 complete response letter. The approval came a day prior to the June 30 PDUFA date.
Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes.
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