REGULATORY

Paper Retraction Won’t Impact Zolgensma Japan Approval, Data Deleted from Label

December 13, 2022
Japanese approval for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) will remain intact despite the recent retraction of a 2010 paper featuring animal study data on the treatment, with regulators upholding their assessment for efficacy and safety. The Ministry of Health,…

To read the full story

REGULATORY

By Philip Carrigan

As the post-pandemic world of work continues to evolve, so do recruiters’ strategies and tools for finding and engaging top talent. In 2023, we are seeing these seven trends:1. Employer branding is becoming an increasingly important factor in the recruitment…

By Sakura Kono

Novo Nordisk’s weight-loss medication Wegovy (semaglutide) was approved in Japan in March. While it skipped the May round of reimbursement listing, physicians eagerly await the arrival of what would be the first new obesity drug in three decades. Other companies…

By Tatsuya Otsuka

Japan’s health ministry on April 27 presented an outline of a report to be compiled next month by its key…

A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…

Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…

Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…