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    Drug Approval & Reimbursement in 2023

    Japan Approves Multiple Firsts, Leqembi, Arexvy, Leqvio, and More

    Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab).Arexvy became the first…

    COLUMN

    How to Get 4 Qualified Candidates within 4 Weeks
    By Philip Carrigan

    “Time is the scarcest resource, and unless it is managed, nothing else can be managed.” - Peter DruckerSearching for the right candidate takes time… but how much time?The last thing you want is to waste time searching for the wrong…

    Chuikyo on FY2024 Reimbursement Reform

    Chuikyo Rep Grumbles at Too Many Industry Requests, FPMAJ Chief Wants Health Coverage Dabate
    By Yoshinori Sagehashi

    A doctor member of the Central Social Insurance Medical Council (Chuikyo) on September 20 traded barbs with pharma leaders over…

    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…

    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…

    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…