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BioWorld - Tuesday, April 21, 2026
Home » Topics » Regulatory » MHLW

MHLW
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Japan’s MHLW approves raft of new drugs

Sep. 30, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare (MHLW) approved a slew of new drugs in the last week of September, including Japan’s first sustained release GIP/GLP-1 receptor agonist for type 2 diabetes from Eli Lilly and Co. and Mitsubishi Tanabe Pharma Corp.; a self-administered injectable drug for rheumatoid arthritis from Eisai Co. Ltd. and Nippon Medac Co. Ltd.; a CAR T from Legend Biotech Corp. and Janssen Pharmaceutical KK; and two drugs from Astrazeneca plc, one in asthma and the other in pediatric plexiform neurofibromas in neurofibromatosis type 1.
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Digital 3-D illustration of Japan's flag, light effects

Japan approves Daiichi Sankyo’s Ezharmia for refractory T-cell leukemia, lymphoma

Sep. 27, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
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Japan approves Daiichi Sankyo’s Ezharmia for refractory T-cell leukemia, lymphoma

Sep. 26, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
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Digital 3-D illustration of Japan's flag, light effects

J-Tec’s autologous cultured cartilage receives full MHLW approval after 7 years

July 19, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
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J-Tec’s autologous cultured cartilage receives full MHLW approval after 7 years

July 19, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. 
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J-Tec’s autologous cultured cartilage receives full MHLW approval after 7 years

July 18, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
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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.
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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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