Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Enhertu Combo Accepted for EU Review in First-Line HER2 Breast Cancer
Daiichi Sankyo said on January 19 that EU regulators have accepted for review an application to expand the use of its antibody drug conjugate Enhertu (trastuzumab deruxtecan) in combination with pertuzumab as a first-line treatment for HER2 positive breast cancer.…
To read the full story
Related Article
- Enhertu Combo Wins US FDA Nod in 1st-Line HER2 Breast Cancer
December 17, 2025
- Enhertu Combo Filed for First-Line HER2 Breast Cancer in Japan
October 8, 2025
- Enhertu Combo Accepted for US Review in First-Line HER2 Breast Cancer
September 25, 2025
- Enhertu Combo Gets Breakthrough Tag for First-Line HER2 Breast Cancer
July 22, 2025
- Enhertu Hits Mark in 1st Line Breast Cancer with PIII Trial Win
April 22, 2025
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…