BUSINESS
    Daiichi Sankyo Files Yescarta, Second CAR-T Therapy in Japan
    March 30, 2020
    Daiichi Sankyo said on March 30 that it has filed its CAR-T cell therapy axicabtagene ciloleucel, known as Yescarta overseas, in Japan for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma and…

    LATEST

    Japan Hammers Out New 5-Year Health, Medical Strategy
    March 30, 2020
    The Japanese Cabinet on March 27 approved a new five-year health and medical strategy from FY2020, which will begin next month, calling for new initiatives to spur research and development and measures to address the novel coronavirus disease COVID-19.“We have…
    New Stable Supply Panel Wants to Define “Key Drugs” by This Summer
    March 30, 2020
    A new panel of experts on stable drug supplies started discussions on March 27, hoping to draw up a report by this summer that will set out the definition of “key drugs” not only in…
    PMDA Asking Companies to Seek Advice for Trial Rescheduling
    March 30, 2020
    The Pharmaceuticals and Medical Devices Agency (PMDA) is calling on pharmaceutical companies to seek its advice for possible delays and rescheduling for their clinical studies or trial plans due to the coronavirus pandemic.The call comes as the virus outbreak is…

    Post-Promotion Guidelines

    Post-Promotion Guidelines - 1: Drug Makers Struggling to Establish Non-Sales Criteria for Rep Performance Review
    By Takamitsu Sasai

    Drug reps today are facing an increasingly strong imperative to depart from traditional promotional activities simply aimed at getting doctors’ prescriptions. For these reps to shift to communications focusing on proper drug use, the key will be their performance reviews.…

    COMMENTARY

    Lenvima Heading into Megablockbuster Territory, Will Merck Tie-Up Help It Top Combined Aricept/Pariet Sales?
    By Reiji Anasako

    Eisai is aiming to notch up a compound annual growth rate (CAGR) of 20% over FY2020-2025 under its five-year business plan. The primary driver will certainly be Lenvima (lenvatinib), a fast-growing cancer drug that has earned an up-to-US$5.76 billion alliance…

    INTERVIEW

    Improper Materials Apparently Decreased after Promotion Guidelines Introduced: Pharmacist
    By Takamitsu Sasai

    Nearly a year after the introduction of the Ministry of Health, Labor and Welfare’s (MHLW) drug promotion guidelines in April…

    Impact of Oligonucleotides

    Impact of Oligonucleotides - 3: Advances in Modified Oligo Technologies Pave Way for Innovative Drug Arrivals
    By Takashi Ebisawa

    Advancements in modified oligonucleotide technologies has been the key driver behind a spate of approvals in the oligonucleotide therapeutics space…

    FY2020 Drug Pricing Reform

    Japan Panel Hammers Out FY2020 Drug Pricing Reform

    Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…

    Reimbursement Listing in 2018-2019

    Japan’s First Biosimilars of Avastin, Nesp, Forteo Receive Listing

    The Ministry of Health, Labor and Welfare (MHLW) on November 27 added to the NHI price list Japan’s first biosimilars of Avastin (bevacizumab), Nesp (darbepoetin alfa), and Forteo (teriparatide). The NHI prices of first biosimilars are set at 70% of…

    TRENDS

    51 Drugs Listed in 2019 with Total Peak Sales Forecast of 370 Billion Yen, Many for Orphan Diseases

    A total of 51 new drugs joined the NHI price list in 2019, which are expected to generate combined peak sales of 373 billion yen, according to Jiho’s tally of data submitted to a key reimbursement policy panel. The relatively…

    My Viewpoint on CEA

    Ensuring Patient Access Was MHLW’s Top Priority for CEA Scheme: Policy Planning Director
    By Yoshinori Sagehashi

    Some seven years in the making, Japan’s Ministry of Health, Labor and Welfare (MHLW) finally rolled out a cost-effectiveness assessment…

    HTA Debates in 2018-2019

    Japan to Roll Out Cost-Effectiveness Assessment Scheme in April

    Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…

    COLUMN

    Smart Strategies for Building Your Dream Team
    By Philip Carrigan

    Look into the heart of every successful company, the businesses that have made a real impact on the world, and you’ll notice they all share a common trait.The people. But not just any people, as Jim Collins famously said…“People are…

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