BUSINESS

SanBio’s Lead Cell Therapy Rides High with FDA’s RMAT Designation for Traumatic Brain Injury

September 20, 2019
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

BUSINESS

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Shinya Sato

Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…

By Philip Carrigan

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,…

By Ken Yoshino

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…