Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
BUSINESS
Enhertu Gets Priority Review for HER2 Low or Ultralow Breast Cancer in US
Daiichi Sankyo said on October 1 that the US FDA has accepted for review Enhertu (trastuzumab deruxtecan), an antibody drug conjugate (ADC) being jointly developed with AstraZeneca, for certain patients with HER2 low or ultralow breast cancer. The FDA granted…
To read the full story
Related Article
- Enhertu Approved for HER2-Low/Ultralow Breast Cancer in Europe
April 7, 2025
- Enhertu Gets EMA Backing for HER2-Low/Ultralow Breast Cancer
March 4, 2025
- Enhertu Approved for HER2-Low/Ultralow Breast Cancer
January 29, 2025
- Enhertu Filed for HER2 Low or Ultralow Breast Cancer in Japan
October 7, 2024
- Enhertu Bags Breakthrough Therapy Tag for HER2 Low or Ultralow Breast Cancer
August 20, 2024
BUSINESS
- Limited Sites, Bed Capacity Seen as Key Hurdles to Radioligand Therapy Uptake: Urologist
December 8, 2025
- Retevmo Now Available in Tablet Form: Lilly Japan
December 8, 2025
- Japan Ethical Drug Sales Rise 5.9% in October: Crecon
December 8, 2025
- Takeda Closes Innovent Oncology Deal, Bags Rights to 2 Late-Stage Assets
December 8, 2025
- Santen to Market Bayer’s Eylea Bio-AG; Launch Date Still Undisclosed
December 8, 2025
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
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…