REGULATORY
    Special Mitigation Margin for COVID-19 Up for Debate towards FY2022 Drug Price Revision: MHLW Bureau Chief
    January 15, 2021
    For its first “off-year” re-pricing this April, the government has decided to add 0.8% to the so-called adjustment rate used in its drug price revision formula in order to soften the impact of COVID-19. Now,…

    LATEST

    Kolon Ordered Payment to Mitsubishi Tanabe over Cell Therapy License Deal
    January 15, 2021
    Korea’s Kolon Life Science has been ordered by the International Court of Arbitration to pay 2.63 billion yen plus arbitration costs to Mitsubishi Tanabe Pharma over a dispute around their cell therapy licensing deal, the Japanese company said on January…
    Administrative Penalty on Nichi-Iko Possible by March-End over Recalls
    January 15, 2021
    Toyama prefectural authorities could issue an administrative penalty on Nichi-Iko Pharmaceutical by the end of this fiscal year over a slew of recalls stemming from manufacturing problems at its oral drug plant in the prefecture.“Nichi-Iko…
    MHLW Initiates Discussions on Amendment of Clinical Research Law
    January 15, 2021
    The Ministry of Health, Labor and Welfare (MHLW) has initiated discussions toward revising the Clinical Research Law. The MHLW will hold these discussions through the Health Science Council’s clinical research subcommittee, which will complete its…

    COMMENTARY

    Potential Reimbursement Challenges of Aducanumab Could Usher in Health Insurance Overhaul in Japan
    By Yoshinori Sagehashi

    On December 10, Biogen/Eisai’s controversial Alzheimer’s treatment aducanumab was filed for regulatory approval in Japan. It’s unclear whether Japanese regulators…

    TRENDS

    Top 10 PHARMA JAPAN Articles in 2020

    With a tumultuous year heading towards a close, let us share the 10 most-read stories on PHARMA JAPAN in 2020. With 2020 being a biennial drug price revision year, our global readers apparently had their eyes riveted on which products…

    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…

    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

    Is Your Company Culture Being a Victim of COVID-19?
    By Philip Carrigan

    As we navigate the lingering effects of the global pandemic, one thing is unmistakably clear - change is here. We’ve changed, and so have our companies. The entire workplace has transformed, but it’s not always a change for the better.…

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