As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
REGULATORY
PMDA Reviewing Safety Risks for Carvykti, Keytruda, Tecentriq, and More
The Pharmaceuticals and Medical Devices Agency (PMDA) is looking into new side effect risks for Janssen Pharmaceutical’s CAR-T cell therapy Carvykti (ciltacabtagene autoleucel), as well as PD-1/PD-L1 agents and other drugs, flagging possible label changes in the near future. According…
To read the full story
Related Article
- MHLW Orders Label Revisions for Keytruda, Tecentriq, and More
January 11, 2024
REGULATORY
- LDP, Ishin Start Framing Copay Models for OTC-Like Drugs: Bilateral Talks
November 25, 2025
- Label Updated for Gazyva and Imbruvica: PMDA
November 25, 2025
- Japan Finalizes Economic Package Positioning Pharma as “Core Industry”
November 25, 2025
- Local Legislators Urge Routine HPV Shots for Males as LDP Group Renews Push
November 25, 2025
- Japan to Launch Panel Next Year to Discuss Third-Party Access to Vaccination Database
November 25, 2025
Japan is set to tighten reimbursement rules for regenerative medicine products granted conditional, time-limited approval, with Central Social Insurance Medical…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…
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…