BUSINESS
LTL Pharma Sees “G1” LLP Price Cuts as Business Opportunity: President
By Takashi Ebisawa September 22, 2023
Japan will see the first batch of long-listed products (LLPs) receive the same NHI prices as generics next April under the so-called “G1/G2” rule adopted in 2018. While the rule might seem as a drag…

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September 22, 2023
The Ministry of Economy, Trade and Industry (METI) has selected 23 projects for its funding program aimed at building vaccine production facilities, including one by Moderna Japan. The ministry will put up a total of…
September 22, 2023
An independent safety monitoring committee of the Japanese health ministry on September 20 urged the regulator to take further steps to prevent the off-label use of GLP-1 receptor agonists indicated for type 2 diabetes for aesthetic weight loss.There has been…
September 22, 2023
Viatris Pharmaceuticals Japan said on September 21 that it has filed a new drug application in Japan for its cysteamine eye drops for the treatment of cystine crystal buildup in the cornea of patients with cystinosis.Cystinosis is a hereditary metabolic…
By Ken Yoshino

The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…

As Japan moves into elaborate discussions on the potential reform of its cost-effectiveness assessment (CEA) in FY2024, members of a…

By Yoshinori Sagehashi

The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…

The Japanese government on September 12 approved Moderna’s updated monovalent COVID-19 vaccine directed at the Omicron XBB.1.5 strain, following its…

By Erik Mooren

IntroductionCommercial transformation is a top priority for pharma leaders in Japan and rightfully so. In a market with low single…

By Ken Yoshino

In the run-up to FY2024 budget requests this summer, there were growing hopes in the pharmaceutical industry that the government's de-facto cap on increases in social security spending would finally be lifted. That did not happen, despite strong calls from…

By Yoshinori Sagehashi

The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…

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…

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