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…

    LATEST

    METI to Bankroll 95.5 Billion Yen in 23 Projects to Build Vaccine Sites, Moderna Among Them
    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…
    MHLW Panel Members Call for Tightening Advertising Regulations for Off-Label GLP-1 Use
    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…
    Viatris Files Cystinosis Med in Japan
    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…

    MHLW Panel on Generic Industry Structure

    MHLW Proposes Curbing Entries of Generic Makers That Threaten Stable Supplies
    By Ken Yoshino

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

    Chuikyo on FY2024 Reimbursement Reform

    Chuikyo Mixed on Expanding Range of CEA Price Adjustments for Pricey Meds

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

    MHLW Panel on Pharmaceutical Regulations

    Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
    By Yoshinori Sagehashi

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

    Drug Approval & Reimbursement in 2023

    Moderna’s Omicron XBB.1.5 Vaccine Snags Japan Approval

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

    COLUMN

    How Far Has Your Organization Come? Key Lessons Learned from Ongoing Commercial Transformations in Japan
    By Erik Mooren

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

    COMMENTARY

    Hopes to Nix Budget Ceiling Dashed, How Will Industry Get Its Message Across to Govt?
    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…

    MHLW Expert Panel on Comprehensive Policies

    Expert Panel Broadly OKs Draft Report on Pharma Policies, Further Deliberations by Other Forums
    By Yoshinori Sagehashi

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

    Chuikyo on Off-Year Drug Price Revision

    Healthcare Providers Rap Product Coverage of Off-Year Re-Pricing, Payers Hail Threshold: Chuikyo

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

    Jiho Survey: FY2022 Drug Price Revision

    Authorized Generics Likely Speeding Up G1/G2 Price Cuts for Off-Patent Brands: Jiho Tally

    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…

    FY2022 Drug Pricing Reform

    MHLW Unveils New List Prices for FY2022 Revision, 18 Off-Patent APIs Face Early “G1” Cuts

    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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