MHLW

Japan approves first iPSC therapy for Parkinson’s disease

Tue, 10 Mar 2026 12:00:00 -0400

Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.

Japan approves first iPSC therapy for Parkinson’s disease

Fri, 06 Mar 2026 12:00:00 -0500

Japan endorses two iPSC drugs for approval under CEA pathway

Tue, 24 Feb 2026 11:00:00 -0500

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.

Takeda’s oral narcolepsy drug steps closer to FDA approval

Tue, 24 Feb 2026 11:00:00 -0500

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.

Japan endorses two iPSC drugs for approval under CEA pathway

Fri, 20 Feb 2026 12:00:00 -0500

Takeda’s oral narcolepsy drug steps closer to FDA approval

Wed, 11 Feb 2026 12:00:00 -0500

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

Tue, 02 Sep 2025 11:00:00 -0400

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.

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

Fri, 29 Aug 2025 11:00:00 -0400

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

Tue, 15 Jul 2025 11:00:00 -0400

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.

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

Wed, 09 Jul 2025 11:00:00 -0400

Healios posts more upbeat data on Multistem cell therapy for ARDS

Tue, 18 Mar 2025 11:00:00 -0400

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.

Healios posts more upbeat data on Multistem cell therapy for ARDS

Fri, 14 Mar 2025 11:00:00 -0400

Drug pricing scheme in Japan gets more confusing

Tue, 04 Feb 2025 12:00:00 -0500

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.

Drug pricing scheme in Japan gets more confusing

Mon, 03 Feb 2025 12:00:00 -0500

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

Tue, 31 Dec 2024 12:00:00 -0500

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.

Japan PMDA opens second overseas office in Washington

Tue, 05 Nov 2024 12:00:00 -0500

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.

Japan mulls ways to boost cell, gene therapy approvals

Wed, 23 Oct 2024 12:00:00 -0400

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.

Japan mulls ways to boost cell, gene therapy approvals

Tue, 22 Oct 2024 12:00:00 -0400

Japan mulls ways to boost cell, gene therapy approvals

Mon, 21 Oct 2024 12:00:00 -0400

Oncolytic virus therapy may soon change glioma care: Bio Japan

Tue, 15 Oct 2024 12:00:00 -0400

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.

Oncolytic virus therapy may soon change glioma care: Bio Japan

Thu, 10 Oct 2024 12:00:00 -0400

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

Wed, 09 Oct 2024 12:00:00 -0400

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.

New Japan drug approvals: cancer, insomnia, Alzheimer’s and more

Tue, 01 Oct 2024 12:00:00 -0400

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.

New Japan drug approvals: cancer, insomnia, Alzheimer’s and more

Thu, 26 Sep 2024 12:00:00 -0400

Celltrion gains Korea approval of Eylea biosimilar

Tue, 04 Jun 2024 12:00:00 -0400

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.

Celltrion gains Korea approval of Eylea biosimilar

Thu, 30 May 2024 12:00:00 -0400

Astellas wins first approval of Vyloy in gastric cancer in Japan

Tue, 02 Apr 2024 12:00:00 -0400

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.

Astellas wins first approval of Vyloy in gastric cancer in Japan

Wed, 27 Mar 2024 12:00:00 -0400

Shionogi’s oral COVID-19 antiviral wins full approval in Japan

Tue, 12 Mar 2024 12:00:00 -0400

Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.

Shionogi’s oral COVID-19 antiviral wins full approval in Japan

Wed, 06 Mar 2024 12:00:00 -0500