Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
After 3rd PIII Try, Sumitomo Dainippon Finally Files Latuda for Japan Approval
After two Asian trial flops, Sumitomo Dainippon Pharma said in January that it finally hit PIII goals with its blockbuster atypical antipsychotic Latuda (lurasidone) to yield meaningful results for filing in Japan. Then on July 31, the company made it…
To read the full story
Related Article
- Latuda to Finally Hit Japan Market on June 11
June 5, 2020
- Latuda Succeeds in PIII Schizophrenia Study, Japan NDA Submission Planned by September
January 11, 2019
- Sumitomo Dainippon to Begin Lurasidone PIII within FY2015, 3rd Attempt for Schizophrenia Indication
December 10, 2015
- Sumitomo Dainippon to Take Yet Another Stab at Lurasidone PIII for Schizophrenia
October 29, 2015
- Sumitomo Dainippon Faces Dim Prospects for Lurasidone Filing in Japan
April 27, 2015
- Sumitomo Dainippon Aims to File Lurasidone in Japan in FY2015 following Favorable Asian PIII Study Results
December 26, 2014
BUSINESS
- G1 Reform Will Accelerate LLP Transfers, Fuel Competition: LTL Chief
April 15, 2026
- Daiichi Sankyo’s I-DXd Filed in US for SCLC, Wins Priority Review
April 15, 2026
- Nxera’s Partner Earns Taiwan Approval for Daridorexant
April 15, 2026
- Sanofi Japan Sales Rise 4.5% in 2025 as Dupixent Widens Label
April 15, 2026
- Eylea Biosimilar Supply Curbed amid Originator Disruption
April 14, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…