REGULATORY
    Orlistat in Line for Approval as Japan’s 1st Nonprescription Obesity Drug after 4-Year Review
    By Tatsuya Otsuka November 29, 2022
    A health ministry panel on November 28 cleared what is now set to be the first nonprescription obesity treatment in Japan. The drug is expected to gain the official stamp of approval at the end…

    LATEST

    KM Biologics to File COVID Jab in Japan Spring 2023: Official
    November 29, 2022
    KM Biologics plans to file its inactivated COVID-19 vaccine KD-414 in Japan in the April-June quarter of 2023, a company official revealed at an academic symposium on November 27.KD-414 is currently being investigated in a PIII study in Japan and…
    Obesity Society to Highlight Proper Use of Semaglutide If Label Expanded
    November 29, 2022
    The Japan Society for the Study of Obesity (JASSO) plans to put out recommendations to ensure the appropriate use of Novo Nordisk Pharma’s GLP-1 agent semaglutide, which is pending approval for obesity in Japan, once…
    Limit Coverage of Off-Year Re-Pricing to Drugs with Large-than-Average Price Gap: LDP Proposal
    November 29, 2022
    A project team of the ruling Liberal Democratic Party (LDP) aiming to foster Japan’s strengths in drug discovery will call on the health minister to limit the coverage of next year’s “off-year” price revision to…

    COMMENTARY

    Japan Should Hone Emergency Approval Scheme Based on Xocova Example
    By Izuru Ando

    While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…

    COLUMN

    The Pros and Cons of Working from Home in 2022
    By Philip Carrigan

    As the year 2022 draws to a close, what are managers thinking at the world’s leading pharmaceutical companies and medical device companies? We surveyed 86 managers at these companies to find out what’s on their minds.For many managers, a common…

    Chuikyo on Off-Year Drug Price Revision

    Chuikyo Reps Tussle over Product Coverage Threshold for Off-Year Price Revision

    A Japanese reimbursement policy panel on November 16 saw a continued scuffle between members representing healthcare providers and payers over…

    MHLW Expert Panel on Comprehensive Measures for Pharmaceuticals

    Deloitte Proposes Pricing Schemes to Encourage Consolidation of Generic Makers

    Deloitte Tohmatsu Consulting proposed three drug pricing schemes designed to trigger the consolidation of generic makers on October 27, offering…

    Jiho Survey: FY2022 Drug Price Revision

    Authorized Generics Likely Speeding Up G1/G2 Price Cuts for Off-Patent Brands: Jiho Tally

    Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…

    FY2022 Drug Pricing Reform

    MHLW Unveils New List Prices for FY2022 Revision, 18 Off-Patent APIs Face Early “G1” Cuts

    Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…

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