Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Enhertu Wins EU Approval for HER2 Low Breast Cancer
Daiichi Sankyo and AstraZeneca said on January 26 that their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) is now approved in Europe for HER2 low metastatic breast cancer. This triggers a milestone payment of US$150 million from the UK firm.…
To read the full story
Related Article
- Enhertu Nabs EU Nod for Second-Line Gastric Cancer, CHMP OK for HER2 Low Breast Cancer
December 20, 2022
- Enhertu Gets EU Panel Backing for Second-Line Gastric Cancer
November 15, 2022
- Enhertu Gets 2nd Line Breast Cancer Nod in Europe: Daiichi Sankyo
July 20, 2022
- EMA Starts Enhertu Review for HER2 Low Breast Cancer
June 23, 2022
- Enhertu Delivers Stellar PIII Data in HER2 Low Breast Cancer
June 7, 2022
- Enhertu Hits PFS, OS Goals in HER2 Low Breast Cancer
February 22, 2022
- Enhertu Application Accepted in Europe for 2nd Line Gastric Cancer: Daiichi Sankyo/AZ
November 5, 2021
- Enhertu Approved for Breast Cancer in Europe: Daiichi Sankyo/AZ
January 21, 2021
- Enhertu Gets CHMP Backing for HER2-Positive Breast Cancer
December 15, 2020
- EU Regulators Accept Enhertu for Accelerated Review for HER2-Positive Breast Cancer
July 8, 2020
BUSINESS
- Half of Drug Makers Reluctantly Support G1 Rule Overhaul: Jiho Survey
March 12, 2026
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…
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…