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BioWorld - Saturday, December 20, 2025
Home » Topics » Regulatory » MHLW

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Japan to create centralized pandemic response agency akin to the US CDC

July 5, 2022
By Tamra Sami
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare.
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Japan to create centralized pandemic response agency akin to the US CDC

July 1, 2022
By Tamra Sami
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare.
Read More
Person holding stomach in pain

Taiho picks up nod for Jeselhy to treat gastrointestinal stromal tumors in Japan

June 28, 2022
By Doris Yu
Japan’s Ministry of Health, Labour and Welfare has given Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. the green light for its oral heat shock protein 90 (HSP90) inhibitor Jeselhy (pimitespib) to treat gastrointestinal stromal tumors (GIST) that have progressed after chemotherapy. The company will soon commercialize the drug in Japan.
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Taiho picks up nod for Jeselhy to treat gastrointestinal stromal tumors in Japan

June 27, 2022
By Doris Yu
Japan’s Ministry of Health, Labour and Welfare has given Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. the green light for its oral heat shock protein 90 (HSP90) inhibitor Jeselhy (pimitespib) to treat gastrointestinal stromal tumors (GIST) that have progressed after chemotherapy. The company will soon commercialize the drug in Japan.
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Japanese money and medicine

Japan’s annual drug price reforms result in less predictability for pharma market

April 19, 2022
By Tamra Sami
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
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Japanese money and medicine

Japan’s annual drug price reforms result in less predictability for pharma market

April 18, 2022
By Tamra Sami
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
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Japan rolls out higher than average 32 approvals in March to close out fiscal year

April 5, 2022
By Gina Lee
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.
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Japan rolls out higher than average 32 approvals in March to close out fiscal year

April 4, 2022
By Gina Lee
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.
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Green approved stamp

Sanofi’s Xenpozyme becomes first therapy approved for rare progressive genetic disorder ASMD

March 29, 2022
By David Ho
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.
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Keita Mori, CEO, Sanbio

Japan’s Sanbio submits BLA for brain injury regenerative therapy under Sakigake designation system

March 29, 2022
By Tamra Sami
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.
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