Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
SanBio’s Sakigake Cell Therapy Finally Filed in Japan for Traumatic Brain Injury
After repeated delays, SanBio’s lead cell therapy candidate SB623, which has grabbed Japan’s sakigake fast-track tag, was finally filed in the country for the improvement of chronic motor deficits from traumatic brain injury (TBI). The company said on March 7…
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
- Approval by January Unlikely for SanBio’s Lead Cell Therapy as Production Review Stalls
October 21, 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
BUSINESS
- Former Takeda CEO Yasuchika Hasegawa Dies at 80
September 11, 2026
- Takeda R&D Chief Plump to Retire in June 2027
September 11, 2026
- Lasker Win “Not the Finish Line” for Chugai Researchers; Next-Gen Drug Advances
September 11, 2026
- Daiichi Sankyo Wins 203 Billion Yen Lawsuit over Fortis Bid
September 11, 2026
- Silchester Emerges as Suzuken’s Top Shareholder with 10.03% Voting Stake
September 11, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…