Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Kura/Kyowa Kirin’s AML Drug Inches Closer to FDA Filing on Positive PII Data
Kura Oncology and Kyowa Kirin have unveiled positive topline results from a PII clinical trial for their investigational acute myeloid leukemia (AML) treatment ziftomenib, putting the drug on track for its regulatory submission in the US in the second quarter…
To read the full story
Related Article
- Kura, Kyowa Kirin Land US FDA Approval for AML Med Komzifti
November 17, 2025
- Ziftomenib Given in New AML Cohort in US PI Trial: Kura/Kyowa Kirin
October 3, 2025
- Kura/Kyowa Kirin’s AML Drug Accepted for US FDA Review
June 3, 2025
- Kyowa Kirin, Kura Form Global Collab on Leukemia Drug
November 22, 2024
BUSINESS
- Nippon Kayaku Aims to Lift New Drug Sales Ratio to 30%, Bolsters Oncology Push
February 25, 2026
- Keio Spinoff Taps Nikon as CDMO, Targets 2027 Start for KP8011 Trial
February 25, 2026
- Astellas, Vir Strike Strategic Deal to Advance PSMA-Targeting TCE
February 25, 2026
- Nippon Shinyaku to Take Over UCB’s Fintepla in Japan from April
February 25, 2026
- Opdivo-Yervoy Expands Label for Colorectal Cancer in South Korea
February 25, 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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…