Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Approves Sanofi’s PD-1 Inhibitor, Teikoku’s Donepezil Tape and More
Japan’s health ministry approved a throng of new medicines and indications on December 23 including Sanofi’s PD-1 inhibitor Libtayo (cemiplimab) for the treatment of cervical cancer and Teikoku Seiyaku’s tape formulation of donepezil for Alzheimer’s. Libtayo gained the nod to…
To read the full story
Related Article
- Sanofi Launches PD-1 Inhibitor Libtayo in Japan
March 31, 2023
- Chuikyo OKs Listing of Mounjaro, Libtayo, Imjudo; 30 Billion-Plus Peak Sales for Lilly Med
March 9, 2023
- Sanofi’s Cemiplimab Backed for Approval, Third PD-1 Inhibitor in Japan
November 29, 2022
- MHLW Panel Endorses Teikoku’s Donepezil Tape for Alzheimer’s and More Drugs
November 28, 2022
REGULATORY
- AstraZeneca’s Oral SERD, MSD RSV Antibody Up for Japan Panel Review on May 25
May 12, 2026
- Daiichi Sankyo Wins Japan Approval for MMR Vaccine Mimrit
May 12, 2026
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…