REGULATORY

After Delay, CSIMC Recommends Listing of Ilaris for Treatment of CAPS

November 21, 2011
Novartis Pharma’s Ilaris (canakinumab), a treatment for cryopyrin-associated period syndrome (CAPS) whose NHI price listing was delayed by the Central Social Insurance Medical Council (CSIMC; Chuikyo) on November 16 due to an insufficient explanation of its clinical efficacy by the…

To read the full story

REGULATORY

By Izuru Ando

A year has passed since the Ministry of Health, Labor and Welfare (MHLW) announced its package strategy to fuel the early commercialization of software as a medical device (SaMD) in November last year. A growing number of drug makers are…

By Philip Carrigan

Remember what it was like back in March, when we all started working from home? There was a distinct change in the air - a sense of freedom and excitement about the novelty of being able to work from home.…

The average ratio of female employees at managerial posts stood at just 12.5% at pharmaceutical companies operating in Japan, a Jiho survey revealed. While foreign drug makers had an average 25.0%, the ratio came to as low as 9.8% for…

By Yoshinori Sagehashi

Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…

Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…

Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…