Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
AZ Files Forxiga for Expanded Use in Type 1 Diabetes in Japan
AstraZeneca said on May 21 that it has filed an application in Japan for the SGLT2 inhibitor Forxiga (dapagliflozin) seeking expanded use to include an adjunct treatment to insulin in adult type 1 diabetes patients. The filing came on the…
To read the full story
BUSINESS
- 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
- Minimum Price Hike, Spillover Abolition Win Industry Support in FY2026 Reform: Jiho Poll
March 10, 2026
- Xospata Misses OS Endpoint in PIII Trial in Untreated FLT3-Mutated AML
March 10, 2026
- Enhertu Now under US Review for Post-Neoadjuvant HER2 Breast Cancer
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…