Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Daiichi Sankyo/Kite’s CAR-T Cell Therapy Scoops Up Orphan Status for B-Cell Lymphoma
Daiichi Sankyo said on October 3 that the CAR-T therapy axicabtagene ciloleucel (development code: KTE-C19) has earned orphan drug status in Japan for the treatment of certain types of B-cell lymphoma. The drug received the orphan status for the treatment…
To read the full story
BUSINESS
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
- Lotte to Step Up CVC Investments to Drive CDMO Synergies
March 10, 2026
- Ipsen to Withdraw Tazverik Overseas over Secondary Cancer Risk
March 10, 2026
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…