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BioWorld - Thursday, February 26, 2026
Home » Topics » Asia-Pacific » Japan

Japan
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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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Hands holding tablet and glass of water

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

March 12, 2024
By Marian (YoonJee) Chu
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.
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Brain with handshake and cityscape

New schizophrenia target draws Boehringer in €755M Sosei deal

March 12, 2024
By Jennifer Boggs
Sosei Group Corp. is getting €25 million (US$27.3 million) up front in a global collaboration and option-to-license deal with Boehringer Ingelheim GmbH aimed at developing GPR52 agonists, a new target for schizophrenia designed to potentially address positive, negative and cognitive symptoms at the same time.
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Brain with handshake and cityscape

New schizophrenia target draws Boehringer in €755M Sosei deal

March 11, 2024
By Jennifer Boggs
Sosei Group Corp. is getting €25 million (US$27.3 million) up front in a global collaboration and option-to-license deal with Boehringer Ingelheim GmbH aimed at developing GPR52 agonists, a new target for schizophrenia designed to potentially address positive, negative and cognitive symptoms at the same time.
Read More
Hands holding tablet and glass of water

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

March 6, 2024
By Marian (YoonJee) Chu
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.
Read More

Takeda, Biological E. partner to widen global access to Qdenga

March 5, 2024
By Tamra Sami
In a move to widen global access to its Qdenga dengue vaccine, Takeda Pharmaceutical Co. Ltd. is partnering with India’s Biological E. Ltd. to manufacture Qdenga (TAK-003).
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EMA validates two filings for Daiichi-Astrazeneca’s ADC

March 5, 2024
By Marian (YoonJee) Chu
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
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EMA validates two filings for Daiichi-Astrazeneca’s ADC

March 4, 2024
By Marian (YoonJee) Chu
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
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Boston Scientific Corporation AGENT Drug Coated Balloon

FDA approves ‘needle-moving’ Boston Scientific’s Agent balloon

March 1, 2024
By Annette Boyle
On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.
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Takeda, Biological E. partner to widen global access to Qdenga

Feb. 28, 2024
By Tamra Sami
In a move to widen global access to its Qdenga dengue vaccine, Takeda Pharmaceutical Co. Ltd. is partnering with India’s Biological E. Ltd. to manufacture Qdenga (TAK-003).
Read More
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