BUSINESS
    Generic APIs at Crossroads - 3: Gx Society Sets Up Committee for Discussions with Healthcare Providers and API Manufacturers
    By Takashi Ebisawa August 14, 2020
    The Japanese Society of Generic and Biosimilar Medicines established an “API committee” in April as a forum for healthcare providers, API manufacturers, and API trading companies to discuss the various challenges surrounding APIs. Hiroto Yoshiwaka,…

    LATEST

    Think Differently for Post-Pandemic Success
    August 14, 2020
    Japan’s pharmaceutical industry has been in dire need of a shake-up, and as we continue to grapple with the COVID-19 pandemic, one thing is remarkably clear. It’s no longer business as usual, and we’re enjoying a front-row seat to some…
    Generic APIs at Crossroads - 2: Traders’ Group Urges Simpler Regulatory Procedures to Facilitate API Substitution
    August 13, 2020
    Ichiro Fujikawa, chairman of the Japan Pharmaceutical Traders’ Association (JPTA), an organization of importers of APIs and intermediates, calls on the government to simplify regulatory procedures to make it easier for companies to switch to…
    Fujifilm-Sponsored Avigan Trial to Complete Enrollment on Aug. 16
    August 12, 2020
    Fujifilm Toyama Chemical plans to complete the patient enrollment on August 16 for its stalled PIII clinical trial in Japan for its antiviral agent Avigan (favipiravir) for the treatment of COVID-19, a company official said.The Fujifilm group company believes that…

    COMMENTARY

    With Equivocal Honebuto Wording, Off-Year Re-Pricing Debate Delayed Until Year-End
    By Takashi Ohama

    On July 17, Japan’s Cabinet adopted the 2020 Basic Policy on Economic and Fiscal Management and Reform (honebuto). Its initial text suggested the government’s position to carry out its first off-year drug price revision next April as well as its…

    Generic APIs at Crossroads

    Generic APIs at Crossroads - 1: Sawai Quality Chief Says Current Biz Structure Hampers Manufacturing Repatriation
    By Takashi Ebisawa

    Since last year, Japan has seen a number of stock-outs and shortages of generic drugs attributable to API supply disruptions…

    INTERVIEW

    Improper Materials Apparently Decreased after Promotion Guidelines Introduced: Pharmacist
    By Takamitsu Sasai

    Nearly a year after the introduction of the Ministry of Health, Labor and Welfare’s (MHLW) drug promotion guidelines in April…

    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…

    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…

    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

    The Crisis That Ignited a Workplace Revolution
    By Philip Carrigan

    In a change striking to the very core of the traditional Japanese salaryman, “We are seeing the coronavirus ushering in a new way of working… and I think it’s about time,” says Ivan Tselichtchev, Professor of Economics at the Niigata…

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