Japan Shelves Decision on SanBio’s Lead Cell Therapy on Quality Concerns
To read the full story
Related Article
- SanBio’s Akuugo Nears Shipment with MHLW Panel Backing; Sakigake Tag OK’ed for Bayer Gene Therapies
October 17, 2025
- SanBio’s Akuugo Set for Re-Review on Oct. 16, Shipment Decision Nears
October 3, 2025
- SanBio Eyes Akuugo Label Expansion Talks with PMDA in FY2026
September 19, 2025
- SanBio Pushes Back Shipment Approval Timeline for Cell Therapy Akuugo
June 26, 2025
- SanBio, Minaris Aim to Expand Global Reach of Akuugo
June 20, 2025
- SanBio Inches Closer to Cell Therapy Shipment with Partial Change Filing
June 13, 2025
- SanBio’s Cell Therapy Akuugo Scores Conditional Approval
August 1, 2024
- SanBio Says Its Lead Cell Therapy Could Be Shipped from 2025 If All Goes Well
June 21, 2024
- SanBio’s Lead Cell Therapy in Line for Conditional Nod but Can’t Be Shipped Until Comparability Is Confirmed
June 20, 2024
- SanBio’s Lead Cell Therapy Up for Review Again on June 19
June 14, 2024
- SanBio to Submit Additional Data to Obtain Approval for Lead Cell Therapy
March 27, 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
- Approval by January Unlikely for SanBio’s Lead Cell Therapy as Production Review Stalls
October 21, 2022
- 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
- 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
REGULATORY
- Nipro-Samsung Alliance Nears First Approval in Japan with Stelara Biosimilar
November 14, 2025
- Japan Panel to Review KalVista’s Oral HAE Drug, GSK’s Asthma Med, and More on Nov. 27
November 14, 2025
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- Industry Opposes Deeper CEA Price Cuts for “Cost-Increase” Products
November 13, 2025
- Pharma, Wholesalers Urge Drug Pricing Overhaul to Address Inflation: LDP Hearing
November 13, 2025
In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…





