Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
BUSINESS
Enhertu Wins 5th China Indication in HER2-Low/Ultralow Breast Cancer
Daiichi Sankyo said on December 25 that Chinese regulatory authorities have approved its antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) for an additional indication of HER2 low or ultralow breast cancer. The label expansion is for chemotherapy-naïve adult patients with…
To read the full story
Related Article
- Enhertu Approved for HER2-Low/Ultralow Breast Cancer in Europe
April 7, 2025
- Enhertu Gets EMA Backing for HER2-Low/Ultralow Breast Cancer
March 4, 2025
- Enhertu Approved for HER2-Low/Ultralow Breast Cancer
January 29, 2025
- Enhertu Filed for HER2 Low or Ultralow Breast Cancer in Japan
October 7, 2024
- Enhertu Gets Priority Review for HER2 Low or Ultralow Breast Cancer in US
October 2, 2024
- Enhertu Bags Breakthrough Therapy Tag for HER2 Low or Ultralow Breast Cancer
August 20, 2024
BUSINESS
- Wholesalers See NHI-Market Price Gap Falling Below 4.8% to New Record Low
October 26, 2026
- Vyepti Could Expand Migraine Treatment Options: Japanese Expert
October 26, 2026
- Otsuka’s IgAN Drug Voyxact Cuts Kidney Event Risk by 97%
October 26, 2026
- NEC’s Neoantigen Therapy Shows Immunogenicity in Early TNBC Trial
October 26, 2026
- Toho Subsidiary Faces Potential Data Leak via External Email Provider
October 26, 2026
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…