Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Vyjuvek Gel, 1st Topical Gene Therapy, Poised for Approval in Japan
A Japanese health ministry panel on July 7 endorsed the approval of Vyjuvek Gel (beremagene geperpavec), a topical gene therapy developed by US upstart Krystal Biotech, for the treatment of dystrophic epidermolysis bullosa (DEB), a rare genetic skin disorder. If…
To read the full story
Related Article
- Krystal Launches Japan’s First DEB Therapy Vyjuvek Gel
October 22, 2025
- Listing OK’ed for Krystal’s Vyjuvek Gel, Japan’s First Topical Gene Therapy
October 16, 2025
- Japan to Apply Drug Pricing Rules for Krystal Gene Therapy: Chuikyo
August 28, 2025
- Krystal Biotech Snags Japan Nod for Vyjuvek as 1st Topical Gene Therapy
July 29, 2025
REGULATORY
- Update: DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
February 13, 2026
- MHLW Orders Label Revisions for Vyxeos, Inlyta, Imbruvica, and More Drugs
February 13, 2026
- MHLW Orders Label Revisions for Sulfite-Containing Medical Products
February 13, 2026
- PMDA Urges Proper Use of Colchicine, Advises against High-Dose Administration
February 12, 2026
- PMDA to Offer Priority Consultations for Overseas Startups
February 12, 2026
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
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…