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 (3) - Astellas’s FLT3 Inhibitor for AML Receives Designation, but Other Companies Trailing
ASP2215 (gilteritinib), a selective FLT3/AXL inhibitor Astellas Pharma is developing as a treatment for relapsed or treatment-resistant acute myeloid leukemia (AML), obtained designation under the sakigake fast-track review pathway. It was selected because of its novel mechanism of action and…
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 (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
- Sumitomo Pharma CEO Hails Appointment of Parent Firm’s New President
February 5, 2025
- Astellas to Revamp Management in April, Consolidate R&D Functions
February 5, 2025
- Astellas to File Japan NDA for Izervay This Month
February 5, 2025
- Ono Axes ONO-2910 Peripheral Neuropathy Program and More
February 4, 2025
- Mochida President Hails Govt Initiatives to Drive Biosimilar Uptake
February 4, 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…