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 Grants Orphan Exclusivity for ALS Drug Radicava ORS
Mitsubishi Tanabe Pharma said that the US FDA has awarded seven years of orphan drug exclusivity for its oral suspension version of the ALS therapy Radicava (edaravone), Radicava ORS. The designation was granted on March 28. Radicava ORS is a…
To read the full story
Related Article
- Oral Radicava Approved in Switzerland: Mitsubishi Tanabe
May 12, 2023
- Canada Approves Mitsubishi Tanabe’s Oral Edaravone for ALS
November 10, 2022
- US FDA OKs Mitsubishi Tanabe’s Oral Edaravone for ALS
May 16, 2022
- Mitsubishi Tanabe’s Oral Edaravone Accepted for Swiss Review in ALS
April 26, 2022
- Mitsubishi Tanabe’s Oral Edaravone Accepted for FDA Review in ALS
January 14, 2022
- Mitsubishi Tanabe Eyes US Submission of Oral Edaravone by March-End
December 13, 2021
BUSINESS
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
- Lotte to Step Up CVC Investments to Drive CDMO Synergies
March 10, 2026
- Ipsen to Withdraw Tazverik Overseas over Secondary Cancer Risk
March 10, 2026
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…