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 Granted to Takeda’s Narcolepsy Med, Ninlaro, Daiichi Sankyo’s Valemetostat and More
The Ministry of Health, Labor and Welfare (MHLW) said on April 8 that it has granted sakigake fast-track designation, the Japan equivalent of the US FDA’s breakthrough therapy status, to five drugs including two from Takeda Pharmaceutical - TAK-925 and…
To read the full story
Related Article
- Rakuten Medical’s Photoimmunotherapy Filed in Japan, Subject to Conditional Early OK
July 1, 2020
- Rakuten Medical Could File Photoimmunotherapy for Head and Neck Cancer in 2022; COO Says More Indications Eyed
June 12, 2019
- Takeda Calls Off PIII Study of Sakigake-Designated Ninlaro for AL Amyloidosis after Failing to Hit Primary Goal
June 7, 2019
- Sakigake Status Goes to World’s 1st Renal-Function Improving Agent, BBB-Penetrating Hunter Syndrome Med and 4 More Drugs
March 28, 2018
- Sakigake Fast-Track Designation Given to Aducanumab, 4 Other Products
April 24, 2017
- 6 Drugs Get Sakigake Designation for Fast-Track Review
October 27, 2015
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…