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 US Review in First-Line HER2 Breast Cancer
Daiichi Sankyo said on September 24 that a combination therapy of its anti-HER2 antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has been accepted for review by the US FDA as a first-line therapy for HER2-positive breast cancer. The combination pairs…
To read the full story
Related Article
- Enhertu Combo Accepted for EU Review in First-Line HER2 Breast Cancer
January 20, 2026
- 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 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
- Fuji Plans July Launch for Japan’s 1st Simponi, Ranmark Biosimilars
May 21, 2026
- Myelofibrosis Med Inrebic to Go on Sale June 1: Recordati Japan
May 21, 2026
- Fujifilm Opens New US Facility, Expands iPSC-Derived Cell Production
May 21, 2026
- BMS, Nikon Pitch Japan-to-Asia Cell Therapy Push, Draw Support at Policy Forum
May 21, 2026
- High-Dose Uptravi Now Available: Nippon Shinyaku
May 21, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…