Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Vyvanse Clears MHLW Panel after a Hold; Approval Expected in March
A key health ministry committee gave its blessing to Shionogi’s pediatric ADHD treatment lisdexamfetamine dimesylate, known as Vyvanse overseas, after a temporary hiccup attributable to its stimulant designation, with the nod putting it in line for approval as early as…
To read the full story
Related Article
- Japan Sets 30 Day Prescription Limit for Shionogi’s ADHD Med Vyvanse
May 29, 2020
- MHLW Approves Vyvanse, Biktarvy, Trelegy, Vyndaqel, Dupixent Asthma Use and More
March 27, 2019
- MHLW Panel OKs Pfizer’s Vyndaqel for Sakigake-Designated Use
February 22, 2019
- MHLW Takes Public Comments on Distribution Management Plan for Shionogi’s ADHD Treatment Vyvanse
December 12, 2018
REGULATORY
- 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
- MHLW Orders Label Revisions for Cancer Drugs, Anticoagulant over Bleeding Risk
March 9, 2026
- Japan Health Minister Lauds Approval of iPSC-Based Therapies
March 9, 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…