Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…
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
- Public-Private Pharma Talks Expand to Domestic R&D, Manufacturing Investment
November 2, 2026
- Japan’s Healthcare Spending Hits Record 48.8 Trillion Yen in FY2024
November 2, 2026
- PMDA Renews Warning on Off-Label GLP-1 Use amid Adverse Event Reports
November 2, 2026
- PMDA Halts Medical Device Application Platform after Unauthorized Access
October 30, 2026
- Drug Makers Can Refuse Diabetes Drug Supply over Improper Prescribing: JFTC
October 30, 2026
The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Japan’s pharmaceutical industry asked the ruling Liberal Democratic Party (LDP) on October 29 to boost the country’s drug supply security…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…