Japan plans to revise its definition of “vaccines of high development priority.” The Ministry of Health, Labor and Welfare’s (MHLW)…
BUSINESS
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
MSD K.K.’s anti-PD-1 antibody pembrolizumab obtained designation under the sakigake fast-track review pathway for an indication of unresectable, advanced or relapsed gastric cancer. Pembrolizumab is an immune checkpoint inhibitor, a new class of drugs that have attracted a great deal…
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
- MSD Going Full Out for Sakigake-Designated Pembrolizumab, Poised to Bolster Oncology Force
March 25, 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
- Sakigake: Now and Future (1) - Topical Sirolimus on Track for Application in 2018 for 1st-in-World Indication
February 4, 2016
BUSINESS
- Nichi-Iko to Start Production Collaboration with Kyowa in FY2025: President
January 29, 2025
- ASKA, Susmed Initiate Clinical Study of PMS Therapeutic App
January 29, 2025
- PeptiDream/RayzeBio’s Peptide-Radionuclide Theranostic Enter Clinic
January 29, 2025
- GSK Files Depemokimab for Asthma and CRSwNP in Japan
January 29, 2025
- KalVista Files HAE Drug Sebetralstat in Japan
January 29, 2025
As CEO of Morunda, I had the privilege of interviewing Bill Schuster, Country Manager of Viatris in South Korea. Our conversation delved into the multifaceted nature of leadership in the healthcare industry, exploring challenges, successes, and the power of authenticity.A…
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…