Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Curiteva, Theranica Bio-Electronics.
Building on capabilities developed during the COVID-19 pandemic, the U.K. Health Security Agency’s Vaccine Development and Evaluation Centre hit the ground running.
Calling it a “landmark judgment,” the U.K.’s Competition and Markets Authority welcomed the Competition Appeal Tribunal’s Aug. 8 unanimous decision upholding an £84 million (US$107 million) fine levied against London-based Advanz Pharma Corp. for excessive drug pricing.
A logjam of clinical trial applications that has bult up at the U.K. Medicines and Healthcare products Agency (MHRA) is deterring companies from conducting studies in the U.K., according to the Bioindustry Association.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease.
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Ascentage, Biocity, Biogen, Huidagene, Impact, Iveric, Jacobio, MBX, NS, Rhythm, Viatris.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pentax Medical, Qiagen.
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