Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Approval by January Unlikely for SanBio’s Lead Cell Therapy as Production Review Stalls
SanBio said on October 20 that the company is unlikely to obtain Japanese regulatory approval for its lead cell therapy SB623 during the current fiscal year ending January 2023, due to the longer-than-expected timeline for the production-related review. SB623 was…
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
BUSINESS
- Lotte to Step Up CVC Investments to Drive CDMO Synergies
March 10, 2026
- Ipsen to Withdraw Tazverik Overseas over Secondary Cancer Risk
March 10, 2026
- Minimum Price Hike, Spillover Abolition Win Industry Support in FY2026 Reform: Jiho Poll
March 10, 2026
- Xospata Misses OS Endpoint in PIII Trial in Untreated FLT3-Mutated AML
March 10, 2026
- Enhertu Now under US Review for Post-Neoadjuvant HER2 Breast Cancer
March 10, 2026
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…