REGULATORY

BMS’ Second CAR-T Therapy Ide-Cel Up for PAFSC Review on Dec. 6

November 24, 2021
Bristol Myers Squibb’s second CAR-T cell therapy idecabtagene vicleucel (ide-cel) will come up for discussion at a key Japanese health ministry advisory committee on December 6. If given the nod, it will be in line for approval as the country’s…

To read the full story

Related Article

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…