Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Filing for SanBio’s Sakigake Cell Therapy for TBI Likely to Be Delayed
SanBio said on December 15 that the regulatory submission for its lead regenerative cell medicine SB623 in Japan for the treatment of chronic traumatic brain injury (TBI) is likely to be delayed. The company has aimed for its filing by…
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
- SanBio to Start Talks with PMDA over Late-Stage Study of SB623 in Ischemic, Hemorrhagic Strokes: COO
September 17, 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
- Japan Pharma Workforce Up Slightly; Generic Firms Drive Gains over 5 Years
April 10, 2026
- Zenyaku, Chugai to End Rituxan Co-Promotion in September
April 10, 2026
- Effexor’s GAD Nod Seen Boosting Diagnosis, Treatment in Japan: Expert
April 10, 2026
- MSD Japan Eyes Up to 8 Approvals, 8-Plus Filings under New Chief
April 10, 2026
- Pfizer Japan Files Tukysa Label Expansion in Breast, Biliary Tract Cancers
April 9, 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…