BUSINESS
Sakigake: Now and Future (1) - Topical Sirolimus on Track for Application in 2018 for 1st-in-World Indication
The sakigake fast-track review pathway was rolled out on a pilot basis this fiscal year to accelerate patient access to innovative therapies, with the first batch of six products selected in October. If they make it through the review process…
To read the full story
Related Article
- Sakigake: Now and Future (5) - BioCryst’s BCX7353 Would Be Japan’s 1st Drug for Preventing Angioedema Attacks
April 4, 2016
- Sakigake: Now and Future (4) - MSD’s Anti-PD-1 Antibody Gets Sakigake Designation for Gastric Cancer, While Opdivo also Under Development for Same Indication
March 2, 2016
- Sakigake: Now and Future (3) - Astellas’s FLT3 Inhibitor for AML Receives Designation, but Other Companies Trailing
February 19, 2016
- Sakigake: Now and Future (2) - Shionogi Aims to Submit Application for Novel Flu Drug as Early as FY2017
February 12, 2016
BUSINESS
- DMD Gene Therapy Elevidys Hits Japan Market at Record Price
February 20, 2026
- Bayer Eyes Kerendia as Standard Therapy for CKM Syndrome
February 20, 2026
- Enhertu Accepted for EU Review in Post-Neoadjuvant HER2 Breast Cancer
February 20, 2026
- SymBio Receives Grant for Antiviral Brincidofovir
February 20, 2026
- Over 40% of Breast Surgeons Largely Unaware of Clinical Trials: Survey
February 20, 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…





