REGULATORY
    Japan’s Emergency Approval System Comes into Force, Nod Based on Presumed Efficacy
    May 23, 2022
    The Japanese government enforced its emergency approval system on May 20 upon the promulgation of the amended Pharmaceuticals and Medical Devices (PMD) Law, opening the way for regulators to green-light certain drugs and vaccines based on “presumed” efficacy.The amended PMD…

    LATEST

    Japanese Regulators to Accept Online NDA Submissions from July
    May 23, 2022
    The Ministry of Health, Labor and Welfare (MHLW) will begin accepting the online submission of new drug applications (NDAs) as well as other documents related to pharmaceuticals and medical devices, beginning on July 1.The MHLW started accepting online submissions for…
    Healios’ Sakigake Cell Therapy Misses Goal in Ischemic Stroke
    May 23, 2022
    Tokyo-based biotech Healios’ investigational off-the-shelf somatic stem cell therapy MultiStem (HLCM051) failed to meet the primary endpoint in a Japanese PII/III trial for the treatment of ischemic stroke, an indication subject to its sakigake designation.According to topline results obtained from…
    INES-Led Coalition Calls for Patient/Citizen Participation in Healthcare Policymaking
    May 23, 2022
    A project spearheaded by the Institute of New Era Strategy (INES) issued a proposal on May 19 seeking an institutional reform that will allow patients and citizens to take part in developing healthcare policies by establishing positions for them within…

    COMMENTARY

    Foreign Pharma Growing Vocal against Japan’s Pricing Policy, Flags Return of Drug Lag
    By Reiji Anasako

    The Japan presidents of foreign pharma companies are no longer hiding their concerns about the stagnation of drug development in the Japanese market. In their business briefings for 2021, many of them made explicit criticism against what they see as…

    COLUMN

    The Road to Success Is Paved with the Stepping-Stones of Disappointment
    By Philip Carrigan

    The missing ingredient for managers is not their skill, ability, or education. Academic achievements and business success will get runs on the board, to a certain level. However, that is just half of the story.Leaders come in all shapes and…

    FY2022 Drug Maker Employment Survey

    Female Manager Ratio at Japan Drug Makers Finally Hits 10%, Foreign Peers Near 25%: Jiho Poll
    By Reiji Anasako

    The average ratio of females in managerial posts at Japanese drug makers has finally reached a double-digit number, at 10.0%, a Jiho survey found. However, this is still well below a near-25% ratio logged by foreign players operating in the…

    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…

    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…

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