Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
AnGes Bags Conditional Approval for Collategene Gene Therapy
Osaka-based biotech AnGes said on March 26 that it gained conditional, time-limited approval for what it claims to be the world’s first gene therapy for chronic arterial occlusion. Once launched, it will be marketed and promoted by partner Mitsubishi Tanabe…
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
- MHLW Panel OKs AnGes’ Gene Therapy Collategene for Conditional Approval
February 21, 2019
BUSINESS
- Nippon Kayaku Aims to Lift New Drug Sales Ratio to 30%, Bolsters Oncology Push
February 25, 2026
- Keio Spinoff Taps Nikon as CDMO, Targets 2027 Start for KP8011 Trial
February 25, 2026
- Astellas, Vir Strike Strategic Deal to Advance PSMA-Targeting TCE
February 25, 2026
- Nippon Shinyaku to Take Over UCB’s Fintepla in Japan from April
February 25, 2026
- Opdivo-Yervoy Expands Label for Colorectal Cancer in South Korea
February 25, 2026
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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…