REGULATORY
    ICH’s Guidelines Helped Bring NDMA Contamination Problem to Light: NIHS Officials
    January 24, 2020
    Voluntary recalls have continued over the last year following the detection of the carcinogen N-nitrosodimethylamine or NDMA in a number of drugs. These problems were likely to be found by the introduction of the International…

    LATEST

    Japan Approved World’s 1st Topical JAK Inhibitor Delgocitinib, and More
    January 24, 2020
    The Ministry of Health, Labor and Welfare (MHLW) approved an array of new drugs on January 23, including Japan Tobacco’s Corectim Ointment (delgocitinib), the world’s first topical JAK inhibitor, for atopic dermatitis, with their NHI…
    PMDA to Provide Information Free of Charge for Drug Makers to Consider Use of MID-NET Starting in April
    January 24, 2020
    The Pharmaceuticals and Medical Devices Agency (PMDA) will launch in April an initiative to increase the use of the large-scale medical database, dubbed MID-NET, by providing drug makers free of charge, which have yet to…
    Amgen Astellas BioPharma to Become Amgen’s Wholly Owned Subsidiary; Continue Copromotion with Astellas
    January 24, 2020
    Amgen Astellas BioPharma, a joint venture launched in 2013 by US biotech powerhouse Amgen and Astellas Pharma, will become Amgen’s wholly owned subsidiary on April 1, the pair announced jointly on January 23.As per their initial strategic alliance deal sealed…

    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…

    FY2019 H1 Earnings

    8 Japan Majors Log Combined Sales Rise in 1st Half on Shire Buy, Solid Earnings at Home

    Combined sales of eight major Japanese drug makers grew nearly 26% year on year in April-September, pushed up by the acquisition of Shire by Takeda Pharmaceutical. Even excluding the industry leader, though, seven firms still collectively eked out a slight…

    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…

    COMMENTARY

    Unison Capital Shows Rising Presence with Kyowa Deal, PE Fund Potential Catalyst for Industry Shakeup?
    By Reiji Anasako

    Indian generic maker Lupin is casting off Kyowa Pharmaceutical Industry, which it acquired in 2007. Forking over 57.4 billion yen…

    FY2018 Earnings Roundup

    Japanese Drug Makers Beefing Up China Biz amid Regulatory Tailwind
    By Reiji Anasako

    Riding on the back of an improved regulatory environment in China, major Japanese drug makers are moving to expand their businesses in the world’s second largest pharma market. Companies are pumping up their new drug pipelines, while forging solid sales…

    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

    A Peek into the Digital Pharmaceutical Industry
    By Philip Carrigan

    While the digital transformation may only be in its infancy in the pharmaceutical industry, the winds of change are here. It’s only a matter of time until customers and patients demand a higher level of service, experience, and connectivity from…

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