Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Enhertu Earns EMA Panel OK for HER2 Positive Solid Tumors
Daiichi Sankyo said on May 22 that its HER2-directed antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has gained the blessing of a key European regulatory panel for a label expansion into HER2 positive metastatic solid tumors. Enhertu received a positive…
To read the full story
Related Article
- Enhertu’s Tumor-Agnostic Use Now under EU Review: Daiichi Sankyo
September 12, 2025
- Enhertu Nabs Pan-Tumor Indication in US: Daiichi Sankyo
April 9, 2024
BUSINESS
- Kyorin Starts Pivotal Study of Chronic Cough DTx in Japan
June 12, 2026
- Lotte Biopharma CVC Invests in Swiss ADC Startup
June 12, 2026
- Ono Seeks Velexbru Nod for CNS Involvement of Malignant Lymphoma
June 12, 2026
- Ono Files Opdivo for Anaplastic Thyroid Cancer
June 12, 2026
- Lilly Warns Against Off-Label Use of Mounjaro
June 11, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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…