REGULATORY
    MHLW Sets Volume Thresholds for Drug Orders to Resolve Generic Shortages
    January 28, 2022
    Late last year, Japan’s health ministry urged drug makers to lift their shipment restrictions for medicines deemed to be in sufficient supply at least by a certain parameter to iron out generic supply issues. Now,…

    LATEST

    Fujifilm to Buy Atara’s Cell Therapy Manufacturing Facility in US
    January 28, 2022
    Fujifilm said on January 27 that it will acquire a cell therapy manufacturing facility in California from US biotech startup Atara Biotherapeutics for some US$100 million, a move that marks its full-scale entry into the cell therapy CDMO business.Atara, which…
    Otsuka Partners with VR Solution Firm to Offer Social Skills Training for Mental Health
    January 28, 2022
    Otsuka Pharmaceutical said on January 27 that it has signed a deal with Tokyo-based virtual reality (VR) solution developer Jolly Good for codevelopment and exclusive sales in Japan of a social skills training (SST) platform utilizing VR.The joint business aims…
    MHLW Council Deems Public Knowledge-Based Filings Acceptable for 8 Fertility Treatment Indications
    January 28, 2022
    A health ministry panel agreed on January 26 that applications based on information in the public domain would be acceptable for seven APIs including metformin for eight infertility treatment indications. With this decision, public knowledge-based…

    COMMENTARY

    Significance and Challenges around Proposed Emergency Approval Scheme, Eyes on Diet Debate
    By Tatsuya Otsuka

    A bill to amend the Pharmaceutical and Medical Devices (PMD) Law is expected to be submitted to the ordinary session of the Diet this year, which was convened on January 17 for a 150-day run. The proposed amendment is for…

    TRENDS

    15 APIs with 10 Billion Yen-Plus Peak Sales Outlooks Listed in 2021: Jiho Tally

    A total of 15 new drugs (APIs) joined the NHI price list in 2021 with peak sales forecasts topping at 10 billion yen, many of them in the area of orphan diseases and with few mega launches, according to a…

    FY2022 Drug Pricing Reform

    Chuikyo OKs FY2022 Drug Pricing Reform Outline; Spillover Exclusion, Mega Seller Rule

    Japan’s all-important reimbursement policy panel on December 22 approved an outline of the next drug pricing reform scheduled for April 2022, which embraces plans to reward innovative new indications and introduce a grace period for so-called “spillover” re-pricing.The reform outline…

    COLUMN

    4 Things You Can Do to Overcome Zoom Overload
    By Philip Carrigan

    Remember what it was like back in March, when we all started working from home? There was a distinct change in the air - a sense of freedom and excitement about the novelty of being able to work from home.…

    INTERVIEW

    From Treatment to Prevention, Top Expert on AD Research, Aducanumab and Its Implications - 2
    By Yoshinori Sagehashi

    Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…

    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…

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