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
- Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
March 6, 2026
- Forxiga Slapped with 36% Price Cut on PMP Return in FY2026 Revision
March 6, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan's Revised Drug Distribution Guidelines Take Effect
March 6, 2026
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





