Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Argenx Seeks Label Expansion for Vyvdura in Japan
Argenx Japan said on April 25 that it has filed Vyvdura (efgartigimod alfa + vorhyaluronidase alfa), a treatment for generalized myasthenia gravis (gMG), for an additional indication of chronic inflammatory demyelinating polyneuropathy (CIDP). The submission rides on the back of…
To read the full story
Related Article
- Qalsody, Zepbound, Zeposia Inch Closer to Japan Approval with Panel OK
December 3, 2024
- Qalsody, Zepbound, Zeposia Up for Advisory Panel Review on Dec. 2
November 19, 2024
BUSINESS
- Novo Targets Double-Digit Growth in Japan in 2026, Obesity Access Key
February 12, 2026
- Takeda’s Narcolepsy Drug Accepted for US FDA Review
February 12, 2026
- FDA Rejects Regenxbio/Nippon Shinyaku’s MPS II Gene Therapy
February 12, 2026
- Celltrion to Launch Japan’s First Actemra Biosimilar in Late April
February 12, 2026
- MFN Policy Could Affect Business Outside US: Kyowa Kirin CEO
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…