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Home » Topics » Asia-Pacific » Japan

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AI-generated illustration of spinal cord

Dewpoint and Mitsubishi ink $480M ALS research collaboration

Dec. 10, 2024
By Tamra Sami
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
Read More
Art concept for hematologic cancer

Takeda bolsters oncology pipeline via $1.3B deal for Keros’ elritercept

Dec. 10, 2024
By Tamra Sami
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland China, Hong Kong and Macau.
Read More
AI-generated illustration of spinal cord
Neurology/psychiatric

Dewpoint and Mitsubishi ink $480M ALS research collaboration

Dec. 10, 2024
By Tamra Sami
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
Read More
AI-generated illustration of spinal cord

Dewpoint and Mitsubishi ink $480M ALS research collaboration

Dec. 6, 2024
By Tamra Sami
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
Read More
Art concept for hematologic cancer

Takeda bolsters oncology pipeline via $1.3B deal for Keros’ elritercept

Dec. 4, 2024
By Tamra Sami
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland China, Hong Kong and Macau.
Read More

Daiichi Sankyo, Astrazeneca submit new BLA for Trop2 lung cancer ADC

Nov. 19, 2024
By Tamra Sami
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
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FDA hands complete response letter to Astellas’ Izervay sNDA

Nov. 19, 2024
By Marian (YoonJee) Chu
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
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Daiichi Sankyo, Astrazeneca submit new BLA for Trop2 lung cancer ADC

Nov. 13, 2024
By Tamra Sami
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
Read More

Report: Drug regulators enabling forced labor in supply chain

Nov. 5, 2024
By Mari Serebrov
Drug regulators around the world have a unique opportunity – and, in some cases, a legal mandate – to remove the taint of forced labor from the biopharma supply chain. But some of them, including the U.S. FDA and Japan’s PMDA, may be turning a blind eye to those responsibilities, according to a recent report from the nonprofit Centers for Advanced Defense Studies.
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PMDA U.S. office in Washington D.C.

Japan PMDA opens second overseas office in Washington

Nov. 5, 2024
By Marian (YoonJee) Chu
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.
Read More
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