Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Otsuka Files NDA for Lupus Nephritis Drug in Japan
Otsuka Pharmaceutical said on November 10 that it has filed a new drug application for its oral immunosuppressant voclosporin for the treatment of lupus nephritis in Japan.A calcineurin inhibitor, voclosporin was developed by Canada’s Aurinia Pharmaceuticals, which received US FDA…
To read the full story
Related Article
- Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
August 28, 2024
- Eisai’s ALS Therapy, Amgen’s TED Drug Up for Review on Aug. 26
August 19, 2024
- Otsuka’s Lupus Nephritis Med Lupkynis Wins European Greenlight
September 21, 2022
- Otsuka Gets EU Panel Backing for Lupus Nephritis Drug
July 25, 2022
BUSINESS
- Moderna Japan Looks Beyond COVID for Next Growth Pillars
June 9, 2026
- Oncolys Targets 300 Hospitals for Telomelysin Rollout
June 9, 2026
- CSL Behring Japan President Yoshida to Step Down
June 8, 2026
- Japan Approves Oncolys’ Telomelysin for Esophageal Cancer
June 8, 2026
- Takeda Swings to Loss after Booking Amitiza Litigation Charge
June 8, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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 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…