Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Nasal Steroid Used as “Reference Drug” for Xolair in Special Re-Pricing
The application of a new special rule for “indication re-pricing” to Novartis’ anti-IgE antibody Xolair (omalizumab), which was approved for the treatment of pollen allergy in December, was decided by referring to a nasal steroid that carries an allergic rhinitis…
To read the full story
Related Article
- Xolair Faces 37.3% Price Slash, Keytruda 20.9% in April: MHLW
March 5, 2020
- Xolair’s Re-Pricing Decided, but Regulators and Novartis Were at Odds over Patient Projections
March 2, 2020
- Japan’s Special Re-Pricing Rules to Hit 17 Drugs in April; Potentially Big Slash for Keytruda, Lixiana
January 22, 2020
REGULATORY
- 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
- Japan Approves MSD’s HIV Combo Idvynso
March 9, 2026
- MHLW Updates Elective Care LLP List; Target Products Down Sharply to 776
March 9, 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…