Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
EU Panel Backs Kyowa Kirin’s Crysvita for Adult XLH
Kyowa Kirin said on July 27 that its anti-FGF23 monoclonal IgG1 antibody Crysvita (burosumab) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for an indication expansion for the treatment…
To read the full story
Related Article
- Crysvita Approved in Europe for Adult XLH: Kyowa Kirin
October 6, 2020
- Crysvita Accepted for Review in Europe for Additional Adult Use
November 6, 2019
- Kyowa Kirin’s Burosumab Earns Conditional Approval in Europe
February 27, 2018
BUSINESS
- Positive Price Revisions Seen at Several Firms in FY2026 Reform: Poll
March 6, 2026
- Japan Grants First-Ever Approval to iPSC-Based Therapies
March 6, 2026
- Meiji Starts Japan PIII Trial of Rezurock for CLAD
March 6, 2026
- Meiji Rolls Out Rezurock in Taiwan
March 6, 2026
- Toray Out-Licenses Parkinson’s Drug to Immunis
March 6, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…