BUSINESS
    SanBio’s Lead Cell Therapy Rides High with FDA’s RMAT Designation for Traumatic Brain Injury
    September 20, 2019
    After grabbing Japan’s sakigake fast-track status back in April, SanBio said on September 19 that it has won the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for its lead stem cell therapy SB623 for the…

    LATEST

    MHLW Asks 15 Makers to Investigate Ranitidine, Nizatidine for Potential Carcinogen Contamination
    September 20, 2019
    Japanese health regulators are following in the footsteps of its counterparts in the US and Europe to review medicines containing ranitidine for their potential contamination with a cancer-causing impurity called N-nitrosodimethylamine (NDMA).On September 17, the Ministry of Health, Labor and…
    JCR Drops Temcell Submission for Epidermolysis Bullosa
    September 20, 2019
    JCR Pharmaceuticals said on September 19 that it has withdrawn its application in Japan for the label expansion of its human mesenchymal stem cell therapy Temcell for the treatment of epidermolysis bullosa (EB) in order to demonstrate its efficacy “with…
    Sakigake Status Withdrawn for Aducanumab: MHLW
    September 20, 2019
    The Ministry of Health, Labor and Welfare (MHLW) removed its sakigake fast-track designation for Biogen’s aducanumab on September 19 after its major PIII flops earlier this year, making it the second such withdrawal, after Keytruda (pembrolizumab) for its gastric cancer…

    INTERVIEW

    Pharma Industry Watered Down Original Proposals for Pricing Overhaul, Corrections Necessary: Kenporen Director
    By Yoshinori Sagehashi

    As Japan gears up for its next drug pricing reform in April 2020, Shoji Kono, director of the National Federation…

    TRENDS

    Sales per Drug Rep Hits Record High in FY2018 as Downsizing Speeds Up
    By Reiji Anasako

    Pharmaceutical sales per rep in Japan, a yardstick for “productivity” at drug makers, reached a record 172 million yen in FY2018, up 20 million yen from five years ago, as companies continue ramping up their job-shedding drive in a bid…

    COMMENTARY

    After Death in First-in-Human Study, MHLW Needs to Release Info. to Alleviate Concerns about Participation in Studies
    By Takashi Ohama

    An adult man who completed the administration of an investigational drug in a Japan PI study conducted by Eisai has died. Whether there was a causal relationship between the drug and the subject’s death remains unclear at the present time,…

    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…

    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

    Practice Makes Perfect - Even in Marketing!
    By Philip Carrigan

    Jascha Heifetz, widely regarded as one of the greatest violinists of all time, was once stopped, on 57th Street in Manhattan, by a pedestrian asking, “Could you tell me how to get to Carnegie Hall?” Heifetz pondered the question for…

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