Is policy intervention necessary for Japanese drug makers reliant on off-patent brand-name medicines? Many members of the health ministry’s key…
REGULATORY
Japan to Revise Revlimid Risk Management Rule in June; February Generic Approval Eyed
A health ministry safety panel on January 24 approved a plan to revise the “RevMate” risk management program for Revlimid (lenalidomide), a blood cancer drug known to cause birth defects, in June, anticipating the listing of its generic versions as…
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A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
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…
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…