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- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August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
- Incyte Looks to More Than Double International Business by 2030: CEO
March 18, 2026
- Stella Pharma Files Steboronine for Recurrent Meningioma
March 18, 2026
- SymBio Enrolls First Patient in US for PIII BCV Trial in Adenovirus Infection
March 18, 2026
- Oral Flu Drugs Prescribed to 2.46 Million in February as Cases Surge Again: Intage
March 17, 2026
- ADDP, Proteros Tie Up to Expand Drug Discovery Support
March 17, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…
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…