Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Acer, Alnylam, Ascletis, Blade, Cansino, Curis, Immunitybio, Immunocore, Janssen, Junshi, JW, Kite, Nobelpharma, Precigen, Regeneron, Roche, Sanofi.
Japan’s Ministry of Health, Labour and Welfare finished the first quarter – and Japan’s fiscal year – with a bang, handing out 32 approvals in the month of March. It marked a massive jump from previous months, which saw 13 products approved in February 2022 and 12 in January 2022. A total of nine products were approved in December 2021.
A patient’s death has prompted the FDA to place a partial clinical hold on Curis Inc.’s phase I/IIa study of emavusertib in leukemia. The patient, who had relapsed or refractory acute myeloid leukemia, experienced several conditions. One of them was rhabdomyolysis, a dose-limiting toxicity of emavusertib. Rhabdomyolysis is a breakdown of muscle fibers in the blood.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biolytical Laboratories, Feops, GE Healthcare.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Finch, Merck & Co., Reata, Valenzabio, Y-mabs.
Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.
With FDA clearance of its Endoscreener that uses artificial intelligence (AI) to detect polyps during coloscopy procedures, Wision AI Ltd. is expanding its product portfolio to include colorectal histopathology tools.
With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CTL Amedica, Radiaction.
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