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BioWorld - Thursday, February 19, 2026
Home » Topics » Regulatory » MHLW

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Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 11, 2026
By Marian (YoonJee) Chu
No Comments

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.


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K-Sure Chairman and President Jang Young-jin Ryu (right) with KPTA Chairman Ryu Hyung-seon at the MOU signing

Korea pharma group to support exports, Korea-Japan-China trade

Sep. 2, 2025
By Marian (YoonJee) Chu
No Comments
The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. to support South Korean companies exporting biopharmaceutical materials overseas.
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K-Sure Chairman and President Jang Young-jin Ryu (right) with KPTA Chairman Ryu Hyung-seon at the MOU signing

Korea pharma group to support exports, Korea-Japan-China trade

Aug. 29, 2025
By Marian (YoonJee) Chu
No Comments
The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. to support South Korean companies exporting biopharmaceutical materials overseas.
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Concept art for adeno-associated viral-based gene therapy.

JCR’s third deal with Alexion gives rights to AAV capsids

July 15, 2025
By Marian (YoonJee) Chu
No Comments
Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs.
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Concept art for adeno-associated viral-based gene therapy.

JCR’s third deal with Alexion gives rights to AAV capsids

July 9, 2025
By Marian (YoonJee) Chu
No Comments
Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs.
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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.
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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.
Read More
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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