Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
EU Regulators Accept Enhertu for Accelerated Review for HER2-Positive Breast Cancer
Daiichi Sankyo said on July 7 that European regulators have accepted its marketing authorization application for Enhertu (trastuzumab deruxtecan) for the treatment of HER2-positive breast cancer. It was granted an accelerated assessment status, it said. In the drug’s first submission…
To read the full story
Related Article
- Enhertu Wins EU Approval for HER2 Low Breast Cancer
January 27, 2023
- 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
- 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
BUSINESS
- GNI Targets Above-Industry Growth in Japan after Ayumi Buyout
July 3, 2026
- Sawai Prevails in ALS Drug Contract Appeal against Neugen
July 3, 2026
- Insilico, Takeda Ink AI Drug Discovery Deal Worth Up to US$600 Million
July 3, 2026
- Otsuka’s Voyxact Shows Two-Year Kidney Benefit in PIII IgAN Trial
July 3, 2026
- PeptiDream, NCC Start FIH Study of CLDN18.2 Radiopharmaceutical
July 3, 2026
The number of newly listed generic drugs in Japan has fallen sharply over the past decade, reflecting structural changes in…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…