Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Orphan Status for Otsuka’s Sakigake-Designated Product, and 4 Other Cell and Gene Therapies Endorsed
A Japanese expert panel backed the awarding of orphan drug status for Otsuka Pharmaceutical’s gene therapy TBI-1301 for the treatment of synovial sarcoma, and four other regenerative medicine products by holding discussions in a round-robin method, the health ministry said…
To read the full story
REGULATORY
- Chuikyo OKs Listing of J&J’s Rybrofaz, Peak Sales Seen at 43.8 Billion Yen
March 12, 2026
- Truqap Price Cut Set at 10.7% from June under CEA Scheme
March 12, 2026
- Council Floats 9.6% Growth Target for Japan’s On-Patent Drug Market
March 11, 2026
- MHLW Approves Towa Generics for Revolade, Vimpat
March 11, 2026
- Panel Clears Zolgensma Intrathecal Form to Expand Use in Older SMA Patients
March 10, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…