Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
AnGes Alters Strategy for Collategene, Halts Japan Sales for Fresh Submission
AnGes is changing its development strategy for its HGF gene therapy Collategene (beperminogene perplasmid). The change involves the pulling of its Japanese application currently under review that seeks a conversion from conditional to full approval, which will then be followed…
To read the full story
Related Article
- FIRM Warns Conditional Approval Pricing Change Could Chill Regenerative Medicine R&D
February 3, 2026
- Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
January 15, 2026
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- Chuikyo Urges Stricter Pricing Rules for Conditionally Approved Regenerative Medicines
October 16, 2025
- Chuikyo Agrees to Vet Conditional Scheme for Regenerative Medicine as Elevidys Gets Approval
May 15, 2025
- Mitsubishi Walks Away from Collategene Deal with AnGes
August 26, 2024
- Chuikyo Urges Rethink of Health Coverage for Conditionally Approved Regenerative Medicines
August 9, 2024
- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August
July 26, 2024
- Payer Chides AnGes’s Course Change on Collategene, Urges Re-Think of System’s Set-Up
July 4, 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
- Collategene Generates Only 4 Million Yen in 4 Months
February 5, 2020
- Full Approval in Japan Will Be 1st Goal for Collategene: AnGes Chief
September 11, 2019
- 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
- After Listing Delayed, Collategene Expected to Reach Market by Year-End: AnGes Founder
July 22, 2019
- AnGes Delays Launch of Collategene, “Sale Preparations Will Take More Time”
May 15, 2019
- AnGes Bags Conditional Approval for Collategene Gene Therapy
March 27, 2019
- MHLW Panel OKs AnGes’ Gene Therapy Collategene for Conditional Approval
February 21, 2019
BUSINESS
- Kineret Could Bring Earlier Remission in Still’s Disease: Expert
September 8, 2026
- Shionogi’s Cefiderocol Approved in Australia
September 8, 2026
- Argenx Recalls 1 Lot of Vyvdura as Precaution over Foreign Matter
September 8, 2026
- Japan Ethical Drug Sales Rise 4.8% in July: Crecon
September 8, 2026
- Keytruda Holds Top Spot for 35th Straight Month in August: Encise
September 7, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…