Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Terumo to End Sale of HeartSheet after Panel’s Thumbs-Down
Terumo is terminating the sale of HeartSheet, autologous skeletal myoblast sheets for heart failure, the company said on July 20, just one day after a key health ministry panel agreed that it is not appropriate to grant full traditional approval…
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
- 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- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August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
- Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
July 22, 2024
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…