REGULATORY

7 Products Including iPS Cell-Derived Product Receive Sakigake Review Status in the Second Round of Designations

March 2, 2017

- Only subscribers can save articles.
  
  Sign In
  
  Subscribe

The Ministry of Health, Labor and Welfare (MHLW) announced seven products in the second round of the designation of products under the categories of regenerative medicine products and medical devices for the sakigake fast-track review system on February 28. The…

To read the full story

3 Regenerative Medicine Products, 2 Medical Devices Designated for Sakigake Review: MHLW
February 15, 2016

REGULATORY

Japan Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
February 20, 2026
Health Minister Signals Early March Approval for iPSC Products
February 20, 2026
Takaichi Urges Public-Private Investment Push in Drug Discovery
February 20, 2026
Two iPSC-Derived Products Now in Line for Conditional Approval
February 20, 2026
PM Takaichi Keeps Cabinet Intact after Lower House Vote
February 18, 2026

Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

COLUMN

The Strategic MSL: Beyond Data Delivery, It’s About Impact

By Philip Carrigan

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…

COMMENTARY

Hisamitsu’s MBO: Is Shareholder Accountability Trust-Building or a Shackle?

By Hayate Horiguchi

Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…