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 Breakthrough Therapy Tag for 2nd Line Breast Cancer
Daiichi Sankyo and AstraZeneca said on October 4 that the US FDA has granted Breakthrough Therapy designation for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) for the second-line or later treatment of HER2 positive breast cancer. The status was…
To read the full story
Related Article
- Daiichi Sankyo’s Enhertu Beats Kadcyla in 2nd-Line Breast Cancer
August 11, 2021
BUSINESS
- Oral Flu Drugs Prescribed to 2.46 Million in February as Cases Surge Again: Intage
March 17, 2026
- ADDP, Proteros Tie Up to Expand Drug Discovery Support
March 17, 2026
- Personal iPSC Service to Launch with Production Cost in the 10-Million-Yen Range
March 17, 2026
- Olumiant Gains Oral Suspension Formulation in Japan
March 17, 2026
- BMS Japan “On Track” to Double Sales by 2032 as Launch Wave Nears
March 17, 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…