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BioWorld - Thursday, February 26, 2026
Home » Topics » Regulatory » MHLW

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Stem cells

Japan endorses two iPSC drugs for approval under CEA pathway

Feb. 24, 2026
By Marian (YoonJee) Chu
No Comments
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
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Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 24, 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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Stem cells

Japan endorses two iPSC drugs for approval under CEA pathway

Feb. 20, 2026
By Marian (YoonJee) Chu
No Comments
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
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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.
Read More
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