Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
BUSINESS
Daiichi Sankyo’s Datroway Approved in Europe for Breast Cancer
Daiichi Sankyo said on April 8 that its TROP2-directed antibody drug conjugate (ADC) Datroway (datopotamab deruxtecan) is now approved in Europe for the treatment of certain breast cancer patients. The European Commission granted approval to the drug to treat adult…
To read the full story
Related Article
- Datroway Lands EU Approval in 1st-Line TNBC
August 3, 2026
- Datroway Grabs Positive CHMP Opinion in 1st-Line TNBC
June 30, 2026
- FDA Approves Daiichi’s Datroway for EGFR Lung Cancer
June 25, 2025
- Dato-DXd Gets EU Panel Backing for Breast Cancer: Daiichi Sankyo
February 4, 2025
- FDA Approves Daiichi’s New ADC Datroway for Breast Cancer
January 21, 2025
- Daiichi’s Revised Filing for TROP2 ADC Accepted for FDA Review
January 15, 2025
- Daiichi, AZ Pull EU Dato-DXd Filing for Lung Cancer
December 25, 2024
- Daiichi Sankyo’s TROP2 ADC Gets Breakthrough Therapy Tag in US
December 10, 2024
- Daiichi Sankyo Replaces FDA Lung Cancer Filing for TROP2-Directed ADC
November 13, 2024
- New Biomarker Analysis Data Out for Daiichi Sankyo’s TROP2 ADC
September 10, 2024
- Daiichi’s TROP2 ADC Accepted for US FDA Review in Breast Cancer
April 3, 2024
- Daiichi Sankyo’s TROP2 ADC Now under Review for Breast Cancer in Japan
March 15, 2024
- EU Regulators Accept Daiichi Sankyo’s TROP2 ADC for Review in Lung, Breast Cancers
March 5, 2024
- Daiichi Sankyo’s TROP2 ADC Now under US FDA Review for Lung Cancer
February 20, 2024
BUSINESS
- Japan’s 1st Xolair Biosimilar Finally Set for December Launch after Delays
October 23, 2026
- PHP Security Flaws Trigger Website Shutdowns Across Japan Pharma Sector
October 23, 2026
- Enhertu Snares China Approval for HER2 Positive Solid Tumors
October 23, 2026
- Nxera Seeks South Korean Approval for DMD Drug Vamorolone
October 23, 2026
- Vital KSK Warns of Possible Email Address Leak via External Mail Provider
October 23, 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…