The Japanese pharmaceutical industry, a vital component of global innovation, faces a talent gap that resonates across multinational corporations. While Japan possesses a wealth of highly skilled professionals, a notable communication disparity impedes recruitment and career advancement, particularly in global…
REGULATORY
Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
A Japanese health ministry panel on July 19 gave its thumbs-down to the granting of full traditional approval for Terumo’s HeartSheet, autologous skeletal myoblast sheets for heart failure, due to insufficient efficacy data. The Pharmaceutical Affairs and Food Sanitation Council’s…
To read the full story
Related Article
- Chuikyo Agrees to Vet Conditional Scheme for Regenerative Medicine as Elevidys Gets Approval
May 15, 2025
- Breyanzi Broadens Label for Follicular Lymphoma in Japan: BMS
August 19, 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- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August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
- Terumo to End Sale of HeartSheet after Panel’s Thumbs-Down
July 22, 2024
- Breyanzi’s Label Expansion Up for MHLW Panel Review on July 19
July 8, 2024
- BMS Files Breyanzi in Japan for Expanded Use in Follicular Lymphoma
February 1, 2024
- Japan Grants 1st Conditional Approval to Terumo’s HeartSheet
September 24, 2015
REGULATORY
- Japan OKs Honebuto Paper with Softened Phrasing on CEA, Sign of Change to Social Security Budgeting
June 16, 2025
- MHLW Panel OKs Report on Clinical Trials, Calls for Model Project on FMV Cost Approach
June 13, 2025
- Latest Honebuto Draft Erases “Expansion” of CEA after LDP Pushback
June 12, 2025
- EquMet, Clenafin See Generic Entry in June Listing
June 12, 2025
- Ruling Bloc, Ishin Agree to Discuss Coverage of OTC-Like Drugs
June 12, 2025
Following the launch of two new therapies since last year, Japan has seen fresh moves in drug development for amyotrophic…
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 key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…