REGULATORY
MHLW Panel Backs “Sakigake” Influenza Drug; Possibility of Accelerated Approval and Listing Unclear
The Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council, a de-facto decision-making body for marketing approval, recommended approval on February 2 for Shionogi’s influenza type A/B treatment baloxavir marboxil, which has been designated for priority review…
To read the full story
Related Article
- Shionogi’s Single-Dose Flu Med Xofluza Hits Japan Shelves
March 15, 2018
- Xofluza to Join NHI Price List March 14 as Key Panel Gives Expedited OK
March 7, 2018
- Shionogi’s Single-Dose Flu Med Gets Accelerated OK
February 26, 2018
- Japan’s 1st Herceptin Biosimilar Clears MHLW Panel, Now in Line for March Approval for Gastric Cancer
February 5, 2018
- Shionogi’s Sakigake-Designated Flu Med Up for MHLW Panel Review on Feb. 2, Early Listing Possible?
January 23, 2018
REGULATORY
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 2026
- MHLW Official Says US MFN Policy Could Be Taken Up by Chuikyo
May 15, 2026
- Oncolys’ Telomelysin Up for Japan Panel Review on May 21
May 15, 2026
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 2026
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…





