Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Sawai Eyes First-to-File Status for 5 Generics in the US
Japanese generic major Sawai Pharmaceutical is stepping up its drive to branch out overseas, now aiming to seek first-to-file (FTF) status in the US to earn 180-day generic market exclusivity there for five products now being developed for the country.…
To read the full story
Related Article
- Sawai Files Myrbetriq Generic in US, Its 2nd Product after Livalo Copy
September 28, 2016
BUSINESS
- Teijin to Divest Feburic, Bonalon, Other Legacy Brands to LTL
June 18, 2026
- Takeda CEO Pulls in 2.3 Billion Yen in FY2025
June 18, 2026
- Sawai’s Revlimid Generic Gains Additional Lymphoma Indications
June 18, 2026
- Efient AGs Widen Labels to Close Indication Gap
June 18, 2026
- AZ, Kyoto Ink Pact to Promote NCD Prevention, Early Detection
June 18, 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…