COMMENTARY

Japan Should Hone Emergency Approval Scheme Based on Xocova Example

By Izuru Ando November 28, 2022
While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…

To read the full story

Related Article

COMMENTARY

Is policy intervention necessary for Japanese drug makers reliant on off-patent brand-name medicines? Many members of the health ministry’s key…

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

By Eric Persoff

The advance of cell therapy is one of the most exciting innovations in medical treatment in recent years. These drugs offer potential curative treatments for severe or previously fatal diseases. In this article, I will explain features and challenges in…

By Izuru Ando

The Liberal Democratic Party (LDP) will wrap up its discussions on the FY2023 tax reform plan within a few days. Some provisions of the R&D tax credit system, which allow drug makers to deduct a portion of R&D expenses from…

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…