REGULATORY
    First “Post-Nesp” Renal Anemia Med Could Land Japan Approval in September
    August 16, 2019
    Astellas Pharma’s roxadustat could gain Japanese approval as early as September as the first product in the class of drugs called hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors, which are hailed as “post erythropoiesis-stimulating agent (ESA)”…

    LATEST

    Japan’s 1st Forteo Biosimilar Could Get Listed in November
    August 16, 2019
    The biosimilar debut for Eli Lilly’s big-seller osteoporosis drug Forteo (teriparatide) is drawing near as the Japanese health ministry is scheduled to report late this month its plan to approve its first follow-on version filed by Mochida Pharmaceutical. If all…
    AbbVie’s Venetoclax Up for Review on Aug. 23; Tecentriq’s Breast Cancer Use, 2nd Biosimilars Also on Agenda
    August 16, 2019
    AbbVie’s chronic lymphocytic leukemia (CLL) treatment venetoclax will come up for review by a key health ministry advisory panel on August 23. If given the go-ahead, the drug, known as Venclexta and Venclyxto overseas, will gain the official stamp of…
    Japan OKs Zetia Generic, Possibly AG, towards December Listing; No Entry for Lyrica This Time
    August 16, 2019
    The Ministry of Health, Labor and Welfare (MHLW) on August 15 gave the thumbs-up to a slew of generic drugs ahead of the next generic reimbursement listing in December, including what might be an authorized generic (AG) version of MSD/Bayer’s…

    TRENDS

    Chugai Running Offensive/Defensive Play towards EPS Growth Goal, Hemlibra Outpaces Target
    By Reiji Anasako

    Forging ahead with its new three-year business plan, Chugai Pharmaceutical enjoyed rosy earnings in the first half of 2019, bolstered by the outperformance of the Hemlibra (emicizumab) hemophilia drug and its I/O star Tecentriq (atezolizumab). But with a biosimilar onslaught…

    COMMENTARY

    Generic Players Step Up Info Disclosure for Survival in Post-80% Era
    By Tatsuya Otsuka

    Generic drug makers are making greater efforts to disclose more information on their products after years of repeated requests from doctors and medical institutions, which want to better ascertain their quality and stability of their supplies.Ohara Pharmaceutical has been disclosing…

    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…

    INTERVIEW

    As New Era Dawns, Eisai CEO Says Pharma Could Be True Winner of 4th Industrial Revolution
    By Yoshinori Sagehashi

    As Japan heralds the new imperial era of Reiwa, Eisai CEO Haruo Naito sat with Jiho to look back on…

    Upside in Decelerating Gx Arena

    In Authorized Generic Spree, Daiichi Sankyo Espha Focuses More on “Popularization” than “Sales” When It Comes to Cancer AGs
    By Takashi Ebisawa and Tatsuya Otsuka

    Japan’s generic market is hitting a plateau soon. Incentive measures rolled out by the government since 2002 have driven its…

    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

    Failing Isn’t the Issue. What You Do Next Is All that Counts
    By Philip Carrigan

    In 2011 the Japanese pharmaceutical industry was rocked when a whistleblower exposed the falsification of trial data for the drug Diovan, the blockbuster blood pressure drug manufactured by pharma giant Novartis. The ensuing investigation led to the arrest of one…

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