Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
US FDA Withholds Approval for Injectafer Due to Manufacturing Facility Issues: Daiichi Sankyo
Daiichi Sankyo announced on July 26 that its US subsidiary Luitpold Pharmaceuticals, Inc. has received a Complete Response Letter from the US FDA for the treatment of iron deficiency anemia Injectafer (ferric carboxymaltose injection) for which a new drug application…
To read the full story
BUSINESS
- Pharma Earnings Season Kicks Off; Off-Year Impact, Overseas Trends in Focus
April 24, 2026
- Gilead Files Trodelvy-Keytruda Combo for 1L TNBC in Japan
April 24, 2026
- Co-Promotions Dominate in Oncology, Diabetes Alliances: Fuji Keizai
April 24, 2026
- Medii, Pediatric Neurology Society Build System to Support Elevidys Use
April 24, 2026
- Oncolys’ OBP-301 Wins US Fast Track Designation
April 24, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…