Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Sanofi Seeks Dupixent Label Expansion into CSU in Japan
Sanofi said on March 31 that it has filed its anti-IL-4/IL-13 antibody Dupixent (dupilumab) for an additional indication of chronic spontaneous urticaria (CSU) in Japan. The submission is supported by data from a global PIII program, called CUPID. The trial,…
To read the full story
Related Article
- Opdivo, Olumiant, Dupixent Now in Line for Label Expansions
February 6, 2024
- Label Expansion for Opdivo, Olumiant, Dupixent Up for PAFSC Review on Feb. 5
January 23, 2024
BUSINESS
- Shionogi/F2G’s Novel Antifungal Makes Mark, New Option in Resistant Cases
June 19, 2026
- Axcelead Joins Lilly’s TuneLab AI Drug Discovery Platform
June 19, 2026
- Create BioVentures Sets Sail as Drug Discovery Bridge Builder
June 19, 2026
- Merck Japan Expands Fertility Benefits, Raises Lifetime Cap to 18 Million Yen
June 19, 2026
- Santen CEO Paid 251 Million Yen in FY2025, COO Joins Disclosure List
June 19, 2026
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…