Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
BUSINESS
Dato-DXd Gets EU Panel Backing for Breast Cancer: Daiichi Sankyo
Daiichi Sankyo said on January 31 that its anti-TROP2 antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) has been recommended for regulatory approval in the EU for the treatment of certain breast cancer patients. The European Medicines Agency’s (EMA) Committee for…
To read the full story
Related Article
- FDA Approves Daiichi’s Datroway for EGFR Lung Cancer
June 25, 2025
- Daiichi Sankyo’s Datroway Approved in Europe for Breast Cancer
April 9, 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
- Oncolys Files Telomelysin in Japan, Eyes API Manufacturing Expansion in Asia
December 16, 2025
- Eisai Flags Nitrosamine Found in Merislon, Says Supply to Continue
December 16, 2025
- Mochida to Bring in Morning Sickness Drug from Canada’s Duchesnay
December 16, 2025
- Global PIII Trial Halted for Arcus-Partnered TIGIT Drug: Taiho
December 16, 2025
- Vyvdura Now Available in Prefilled Syringe: Argenx Japan
December 16, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…