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BioWorld - Tuesday, July 7, 2026
Home » Topics » Regulatory » MHLW

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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.
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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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Conceptual image for brain cancer treatment

Oncolytic virus therapy may soon change glioma care: Bio Japan

Oct. 10, 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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Japanese flag

Japan pledges to become ‘land of drug discovery’: Bio Japan 2024

Oct. 9, 2024
By Marian (YoonJee) Chu
The Japanese government is throwing full weight behind the Bioeconomy Strategy initiative to position Japan’s biopharmaceutical industry as both a key driver of economic growth and global drug discovery hub.
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New Japan drug approvals: cancer, insomnia, Alzheimer’s and more

Oct. 1, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
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New Japan drug approvals: cancer, insomnia, Alzheimer’s and more

Sep. 26, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
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Celltrion president Young ho Yoo and Kukje Pharm President and CEO Nam Tae-Hoon

Celltrion gains Korea approval of Eylea biosimilar

June 4, 2024
By Marian (YoonJee) Chu
Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
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Celltrion president Young ho Yoo and Kukje Pharm President and CEO Nam Tae-Hoon

Celltrion gains Korea approval of Eylea biosimilar

May 30, 2024
By Marian (YoonJee) Chu
Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
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Green approved stamp

Astellas wins first approval of Vyloy in gastric cancer in Japan

April 2, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
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Green approved stamp

Astellas wins first approval of Vyloy in gastric cancer in Japan

March 27, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
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