Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
SanBio’s Lead Cell Therapy Rides High with FDA’s RMAT Designation for Traumatic Brain Injury
After grabbing Japan’s sakigake fast-track status back in April, SanBio said on September 19 that it has won the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for its lead stem cell therapy SB623 for the treatment of traumatic brain injury…
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 Start Talks with PMDA over Late-Stage Study of SB623 in Ischemic, Hemorrhagic Strokes: COO
September 17, 2020
- Sumitomo Dainippon Pulls Plug on SanBio’s Lead Cell Therapy
December 16, 2019
- Suzuken, SanBio Join Forces for Commercial Distribution of Stem Cell Therapy
August 7, 2019
- SanBio Vows to Create In-House Marketing System in Japan by 2020, Eyes Global Leader by 2025: President
April 22, 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
BUSINESS
- Hisamitsu Sets April 17 Shareholders Meeting to Approve Squeeze-Out
March 16, 2026
- AbbVie Japan Files Rinvoq for Vitiligo
March 16, 2026
- SSP Appoints Yoko Motoshima as New President
March 16, 2026
- PMP Returns Slam Drug Makers' Leading Products, Prazaxa Cut 45%: Jiho Poll
March 13, 2026
- Lilly to Invest Additional 20 Billion Yen in Japan's Seishin Plant
March 13, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…