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    Will Zolgensma Delay Spur Revision of Sakigake Designation System?
    By Takashi Ohama

    The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…

    Post-Promotion Guidelines

    Post-Promotion Guidelines - 2: Takeda Evaluating “Non-Sales” Factors through Quality Conversations with Bosses
    By Takamitsu Sasai

    When Jiho surveyed drug makers on the non-sales criteria they use to evaluate reps’ performance, it received a variety of…

    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…