The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW Panel OKs AnGes’ Gene Therapy Collategene for Conditional Approval
A key health ministry panel on February 20 gave the thumbs-up to conditional time-limited approval for AnGes’ HGF gene therapy Collategene (beperminogene perplasmid). If all goes well, it will win the official green light as early as next month for…
To read the full story
Related Article
- Payer Chides AnGes’s Course Change on Collategene, Urges Re-Think of System’s Set-Up
July 4, 2024
- AnGes Alters Strategy for Collategene, Halts Japan Sales for Fresh Submission
June 25, 2024
- AnGes Seeks Full Approval for Gene Therapy Collategene in Japan
June 1, 2023
- AnGes Calls off Japan Development of Collategene for Additional Indication
September 8, 2022
- Anges, Mitsubishi Tanabe to Launch Gene Therapy Collategene on Sept. 10
September 5, 2019
- Gene Therapy Collategene Gets 600,000 Yen Price Tag, Peak Sales Put at 1.2 Billion Yen
August 28, 2019
- AnGes Bags Conditional Approval for Collategene Gene Therapy
March 27, 2019
REGULATORY
- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
December 17, 2025
- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
December 16, 2025
- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 2025
- MHLW Council Determines 3 “Drug Loss” Products as High-Need, to Seek Development
December 16, 2025
- LDP Biosimilar Group Submits Request to Finance Minister, Seeks Continued Support
December 16, 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…