Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Orphan Status Granted to Fenfluramine, Asciminib, Vosoritide
The Ministry of Health, Labor and Welfare (MHLW) on August 24 newly granted orphan drug designation to three APIs including Zogenix Japan’s fenfluramine. Fenfluramine was given the status for the proposed indication of epileptic seizures associated with Dravet syndrome. The…
To read the full story
REGULATORY
- Pharma Seeks Inflation-Liked Price Hikes, Freeze on Patent-Period Cuts for 2027 Revision
August 27, 2026
- Kisunla Braced for NHI Price Cut after CEA; Leqembi Method to Apply
August 27, 2026
- Xcopri, Leqembi SC Now in Line for Japan Approval with Panel Backing
August 27, 2026
- MHLW Seeks Record 36.6 Trillion Yen for FY2027, Puts AI in Focus
August 27, 2026
- Generic Re-Pricing Relief Reaches Just 1 in 10 Unprofitable Products: JGA
August 27, 2026
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…