Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Enhertu Gets 2nd Line Breast Cancer Nod in Europe: Daiichi Sankyo
Daiichi Sankyo said on July 19 that its HER2 directed antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) being codeveloped with AstraZeneca obtained approval in Europe for the earliest lines of treatment for patients with HER2-positive breast cancer. The drug was…
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 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
- Fujifilm Invests in Austria’s Valanx Biotech to Boost ADC Technology
March 13, 2026
- Merck, CDMO Cyto-Facto Join Hands on Cell and Gene Therapy
March 13, 2026
- Anti-PD-1 Agonist Antibody Enters PI in Australia for Autoimmune Diseases: Meiji
March 13, 2026
- Lilly to Invest Additional 20 Billion Yen in Japan's Seishin Plant
March 13, 2026
- Half of Drug Makers Reluctantly Support G1 Rule Overhaul: Jiho Survey
March 12, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…