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 Lead Cell Therapy in Line for Conditional Nod but Can’t Be Shipped Until Comparability Is Confirmed
A health ministry advisory panel agreed on the granting of conditional approval to SanBio’s lead cell therapy candidate following renewed discussions on June 19, but it also decided that the product will be barred from the market until its quality…
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’s Akuugo Set for Re-Review on Oct. 16, Shipment Decision Nears
October 3, 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 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
- MHLW Official Making Rounds to Rally Private Support for Drug Discovery Fund
January 21, 2026
- Cabinet OKs Subsidy to Boost Antibiotic API Stockpiles, Allocates 7.1 Billion Yen from Reserve
January 21, 2026
- PMDA Chief Vows Stronger Support for Drug Discovery, Orphan Designations
January 21, 2026
- AMED, JPMA Poised to Embed Pharma Expertise in Drug Discovery
January 20, 2026
- Japan’s Lower House Poll Set for Feb. 8 after Takaichi Calls Snap Vote
January 20, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
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…