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    Generic Makers Reorganizing Manufacturing Sites; Leveraging Their Strengths to Survive
    By Tatsuya Otsuka

    A reorganization of manufacturing sites is currently underway in the generic drug industry. With the generic drug share approaching 80% on a volume basis and NHI prices in decline, companies are looking for ways to grow and survive.In July, Nichi-Iko…

    Generic APIs at Crossroads

    Generic APIs at Crossroads - 4: Professor Calls for Monitoring Drugs Liable to Be in Short Supply, Drawing Up Lists of Substitutes
    By Takashi Ebisawa

    Measures focusing on risk management should be necessary to prevent disruptions in API supplies, Prof. Hiroyuki Sakamaki of Kanagawa University…

    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

    Let’s Be Grateful for the Chaos of the Year That Was
    By Philip Carrigan

    As I skied the slopes of Hakuba in January, I never would have imagined the world would be in a complete lockdown just a few months later. There’s no question this has been an incredibly challenging year, but there’s good…