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.
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.
Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), has been approved for use in Japan, making it the world’s first and only approved therapy to treat acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick type B disease. Sanofi’s executive vice president and global head of R&D, John Reed, hailed it as a “watershed moment” that was the culmination of 20 years of research.
Regenerative medicine company Sanbio Co. Ltd. submitted its BLA for its lead mesenchymal stem cell-based treatment, SB-623, to Japan’s Ministry of Health, Labour and Welfare for chronic motor deficit due to traumatic brain injury. The application was submitted through Japan’s Sakigake designation system.
Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
Astellas Pharma Inc. and Seagen Inc. received approval through a priority review from Japan's Ministry of Health, Labour and Welfare for Padcev (enfortumab vedotin) to treat radically unresectable urothelial carcinoma that has progressed after chemotherapy. The green light for the antibody-drug conjugate is based on the global phase III EV-301 clinical trial, which included sites in Japan.
Japan’s Ministry of Health, Labour and Welfare approved the Regen-Cov (casirivimab/imdevimab, also known as Ronapreve) antibody cocktail for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
Japan’s Ministry of Health, Labour and Welfare approved the Regen-Cov (casirivimab/imdevimab, also known as Ronapreve) antibody cocktail for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
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