Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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- Sakigake Tag to Be Withdrawn for Lisata’s Cell Therapy CLBS12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
- Japan to Ease Olanzapine Diabetes Contraindication for Antiemetic Use
July 31, 2026
- Pipe Damage Causes Water Leak at Sawai Plant after Quake: MHLW
July 30, 2026
- MHLW Urges Stable Supply of Drugs after Kumamoto Earthquake
July 30, 2026
- Kumamoto Quake Hits 46 Medical Facilities; No Pharma Damage Yet: MHLW
July 29, 2026
- Japan Shifts Mo-99 Supply Strategy toward Stronger Global Procurement: Panel
July 29, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
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…