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BioWorld - Friday, April 17, 2026
Home » Topics » Regulatory » MHLW

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Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 18, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
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Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 14, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
Read More
Yen currency symbols spilling out of drug capsule

Drug pricing scheme in Japan gets more confusing

Feb. 4, 2025
By Tamra Sami
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.
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Yen currency symbols spilling out of drug capsule

Drug pricing scheme in Japan gets more confusing

Feb. 3, 2025
By Tamra Sami
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.
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3D rendering of drug linked to antibody

Japan approves Daiichi Sankyo’s Trop-2 ADC for breast cancer

Dec. 31, 2024
By Tamra Sami
Daiichi Sankyo Co. Ltd.’s trophoblast cell surface antigen 2 (Trop2)-directed antibody-drug conjugate (ADC), datopotamab deruxtecan (dato-dxd), has been approved in Japan for treating adults with hormone receptor (HR)-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
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PMDA U.S. office in Washington D.C.

Japan PMDA opens second overseas office in Washington

Nov. 5, 2024
By Marian (YoonJee) Chu
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) set up its second overseas regulatory office in Washington, four months after the drug and med-tech regulator opened its first Asia base in Bangkok, Thailand, in July 2024.
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Stem cells

Japan mulls ways to boost cell, gene therapy approvals

Oct. 23, 2024
By Marian (YoonJee) Chu
The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals.
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Stem cells

Japan mulls ways to boost cell, gene therapy approvals

Oct. 22, 2024
By Marian (YoonJee) Chu
The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals.
Read More
Stem cells

Japan mulls ways to boost cell, gene therapy approvals

Oct. 21, 2024
By Marian (YoonJee) Chu
The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals.
Read More
Conceptual image for brain cancer treatment

Oncolytic virus therapy may soon change glioma care: Bio Japan

Oct. 15, 2024
By Marian (YoonJee) Chu
Virus is associated with sickness, but oncolytic virus therapies, which harness viruses to attack and kill cancer cells, may soon change the standard of treatment for cancer, including those long deemed uncurable like malignant glioma.
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