Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
SanBio to Start Talks with PMDA over Late-Stage Study of SB623 in Ischemic, Hemorrhagic Strokes: COO
SanBio is now poised to get its lead cell therapy candidate SB623 moved forward for the treatment of chronic strokes in Japan after a closer look into data from a failed US trial showed promise in a smaller group of…
To read the full story
Related Article
- SanBio to Submit Additional Data to Obtain Approval for Lead Cell Therapy
March 27, 2024
- Japan Shelves Decision on SanBio’s Lead Cell Therapy on Quality Concerns
March 26, 2024
- SanBio Chief Baffled by Planned Advisory Session over Lead Cell Therapy
March 21, 2024
- Japan Panel to Discuss Fate of SanBio’s Sakigake Cell Therapy amid Stalled Review
March 19, 2024
- SanBio’s Sakigake Cell Therapy Finally Filed in Japan for Traumatic Brain Injury
March 8, 2022
- Filing for SanBio’s Sakigake Cell Therapy for TBI Likely to Be Delayed
December 16, 2020
- SanBio to Focus on Cell Therapy SB623 for Brain Injury, Stroke, Seeking Licensees for Other Indications
July 16, 2020
- Sumitomo Dainippon Pulls Plug on SanBio’s Lead Cell Therapy
December 16, 2019
- SanBio’s Lead Cell Therapy Rides High with FDA’s RMAT Designation for Traumatic Brain Injury
September 20, 2019
- SanBio to Move Ahead with SB623 Development in Stroke after PII Miss: President
March 26, 2019
- SanBio Vows to Continue Development of Stem Cell Therapy SB623 despite Setback: President
February 25, 2019
- Stem Cell Therapy SB623 Misses Key Target in US PIIb Study for Stroke: SanBio, Sumitomo Dainippon
January 30, 2019
- Sumitomo Dainippon, SanBio to Jointly Develop Cell Therapy Agent for Chronic Stroke in North America
September 30, 2014
BUSINESS
- Positive Price Revisions Seen at Several Firms in FY2026 Reform: Poll
March 6, 2026
- Japan Grants First-Ever Approval to iPSC-Based Therapies
March 6, 2026
- Meiji Starts Japan PIII Trial of Rezurock for CLAD
March 6, 2026
- Meiji Rolls Out Rezurock in Taiwan
March 6, 2026
- Toray Out-Licenses Parkinson’s Drug to Immunis
March 6, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…