Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
SanBio’s Akuugo Set for Re-Review on Oct. 16, Shipment Decision Nears
SanBio’s conditionally approved cell therapy Akuugo (vandefitemcel) will be re-reviewed by a Ministry of Health, Labor and Welfare panel on October 16 — a step that could clear the way for the product’s first shipments in Japan. Akuugo was granted…
To read the full story
Related Article
- SanBio Clears Hurdle for Akuugo Shipments, Heads to Reimbursement Talks
December 10, 2025
- SanBio’s Akuugo Nears Shipment with MHLW Panel Backing; Sakigake Tag OK’ed for Bayer Gene Therapies
October 17, 2025
- SanBio Eyes Akuugo Label Expansion Talks with PMDA in FY2026
September 19, 2025
- SanBio Pushes Back Shipment Approval Timeline for Cell Therapy Akuugo
June 26, 2025
- SanBio, Minaris Aim to Expand Global Reach of Akuugo
June 20, 2025
- SanBio Inches Closer to Cell Therapy Shipment with Partial Change Filing
June 13, 2025
- SanBio’s Cell Therapy Akuugo Scores Conditional Approval
August 1, 2024
- SanBio Says Its Lead Cell Therapy Could Be Shipped from 2025 If All Goes Well
June 21, 2024
- SanBio’s Lead Cell Therapy in Line for Conditional Nod but Can’t Be Shipped Until Comparability Is Confirmed
June 20, 2024
- SanBio’s Lead Cell Therapy Up for Review Again on June 19
June 14, 2024
- 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
REGULATORY
- Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
March 6, 2026
- Forxiga Slapped with 36% Price Cut on PMP Return in FY2026 Revision
March 6, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan's Revised Drug Distribution Guidelines Take Effect
March 6, 2026
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…