Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Sakigake Status Goes to World’s 1st Renal-Function Improving Agent, BBB-Penetrating Hunter Syndrome Med and 4 More Drugs
The MHLW said on March 27 that it has granted sakigake fast-track designation, a Japan version of the US FDA’s breakthrough therapy status, to six drugs including what is hoped to be the world’s first renal function-improving agent. The six…
To read the full story
Related Article
- Sakigake Tag to Be Withdrawn for Lisata’s Cell Therapy CLBS12
June 27, 2024
- Sakigake Status Granted to Takeda’s Narcolepsy Med, Ninlaro, Daiichi Sankyo’s Valemetostat and More
April 9, 2019
- 3rd Batch of Sakigake Drugs to Be Announced Soon: MHLW Official
March 15, 2018
- 3rd Round of Sakigake Invitations Begin
October 6, 2017
- 3rd Sakigake Invitation for Drugs Slated for This Autumn: MHLW
June 2, 2017
REGULATORY
- DPP Calls for End to Off-Year Drug Price Cuts, Chuikyo Reform
June 15, 2026
- Pharma Wages Multi-Front Lobbying amid Push for Leaner Honebuto
June 12, 2026
- Many Approved AGs Remain Unlisted Despite Final Pre-Reform Opportunity
June 12, 2026
- iPark CEO Calls for National AI Drug Discovery Platform at LDP Hearing
June 12, 2026
- MHLW Official Urges Proper IRB Selection under New GCP Rules
June 12, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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…