Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- MSD Launches RSV Antibody Enflonsia in Japan without NHI Listing
August 24, 2026
- Sumitomo Pharma Eyes Global Position as Adjuvant Supplier
August 24, 2026
- Oncolys’ Oncolytic Virus Telomelysin Hits Japan Market
August 24, 2026
- Sobi’s Still’s Disease Drug Kineret Now Available in Japan
August 24, 2026
- MSD Files Welireg-Keytruda Combo in Japan for Adjuvant RCC
August 24, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…