REGULATORY

MHLW Panel Backs Orphan Drug Designation for Opdivo for Hodgkin’s Lymphoma

February 29, 2016

- Only subscribers can save articles.
  
  Sign In
  
  Subscribe

A key advisory committee of the Ministry of Health, Labor and Welfare (MHLW) on February 26 supported the designation of four agents including Ono Pharmaceutical’s Opdivo (nivolumab) as orphan drugs. The Pharmaceutical Affairs and Food Sanitation Council’s Second Committee on…

To read the full story

MHLW Advisory Panel Supports Novartis’s Ceritinib, AZ’s Osimertinib
February 29, 2016

REGULATORY

Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
March 6, 2026
Forxiga Slapped with 36% Price Cut on PMP Return in FY2026 Revision
March 6, 2026
Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
Japan's Revised Drug Distribution Guidelines Take Effect
March 6, 2026
Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 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…

COMMENTARY

G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands

By Shinya Sato

Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…

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…