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 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- Sakigake Tag to Be Withdrawn for Lisata’s Cell Therapy CLBS12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
- 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…