Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Zolgensma Up for Japan Advisory Panel Meeting on Feb. 26, Listing Expected as Early as May
A key Japanese health ministry panel will review whether to recommend approval of Novartis’ spinal muscular atrophy (SMA) gene therapy Zolgensma on February 26, and if it gets the clearance and all goes without a hitch, the typical timeline suggests…
To read the full story
Related Article
- Japan Panel to Review J-TEC’s Cell Product, Zolgensma on Feb. 26; Orphan Status for Luxturna Also Up for Discussion
February 20, 2020
- Zolgensma Not on Roster for Nov. 13 MHLW Panel Review
November 7, 2019
- Zolgensma’s Japan Launch Delayed into 2020 as Sakigake Review Drags On, MHLW Still Eager to Make Decision by Year-End
October 23, 2019
REGULATORY
- Japan Panel Green-Lights Pfizer’s Tukysa, Wider Labels for Tezspire, and More Drugs
January 30, 2026
- MHLW to Ease Uniform Driving Restrictions on Oral Antiepileptics
January 29, 2026
- MHLW Eyes Distribution Rules in Revamped Supply Support Premium: Chuikyo
January 29, 2026
- Entyvio, Rexulti, and Lenvima among 15 More Drugs Picked for IRA Price Talks
January 29, 2026
- Japan’s Lower House Campaign Begins amid Fragmented Political Set-Up
January 28, 2026
Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…