BUSINESS
    25 Japan Drug Makers See 50% Growth in Operating Profit on FX, Unprofitability Re-Pricing
    By Kohei Hori, Hayate Horiguchi, and Mayu Narita November 20, 2024
    The combined operating profit of 25 Japanese pharma companies surged nearly 50% over the year in the first half of FY2024 as global players enjoyed a currency tailwind while domestic-oriented firms got a boost from…

    LATEST

    Otsuka Plans US Filing of IgA Nephropathy Drug in H1 2025
    November 20, 2024
    Otsuka Pharmaceutical said on November 19 that it will file for US approval of the investigational monoclonal antibody sibeprenlimab for the treatment of adults with IgA nephropathy between January and June of 2025.An interim analysis…
    DPP Leader Poised to Urge 4 Ministers to Abolish Off-Year Revisions
    November 20, 2024
    The opposition Democratic Party for the People (DPP) is set to lean on four relevant Cabinet ministers to abandon “off-year” drug price revisions even if no clear mention is made on such abolishment in the…
    FDA Turns Down Label Update for Izervay, Astellas Eyes Re-Filing
    November 20, 2024
    Astellas Pharma said on November 19 that the US FDA has declined to approve a label update that the company sought for its complement C5 inhibitor Izervay (avacincaptad pegol) to include favorable two-year clinical trial…

    COMMENTARY

    With 1/4 of Pharma Backers Losing Seats, It’s Time for Industry to Revamp Lobbying Activities
    By Ken Yoshino

    Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…

    COLUMN

    Elevating Leadership: Insights from Japan’s Healthcare Sector
    By Philip Carrigan

    For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…

    MHLW Panel on Generic Industry Structure

    MHLW Panel Draws Up Plans for Generic Industry Shakeup in Final Report

    A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

    MHLW Panel on Pharmaceutical Regulations

    Japan Set to Push Central IRBs for Clinical Trials, Avoid Customary All-Case PMS

    A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…

    Drug Approval & Reimbursement in 2023

    Japan Approves Label Expansions for Rexulti, Rituxan, and More

    The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…

    Chuikyo on FY2024 Reimbursement Reform

    Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap

    Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

    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…

    NEWS CATEGORY

    REGULATORY

    BUSINESS

    ORGANIZATION

    ACADEMIA