Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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
- Regeneron Lines Up 5 Late-Stage Assets for Japan: Commercial Head
December 11, 2025
- Linepharma to Rebrand as Nordic Pharma Japan from 2026
December 11, 2025
- Espha/Bayer Unit Add Pediatric Indication to Xarelto AG
December 11, 2025
- Enhertu’s PIII Ovarian Cancer Trial Kicks Off for 1st-Line Maintenance Therapy
December 11, 2025
- Pfizer Files Hympavzi for Hemophilia with Inhibitors
December 11, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…