REGULATORY
    Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
    By Takashi Ebisawa October 4, 2024
    A Japanese health ministry panel on October 3 endorsed a list of seven proposals related to regulatory reviews towards the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. At the centerpiece of the…

    LATEST

    Kyowa Kirin Drops Japan Filing for Lumicef for Systemic Sclerosis
    October 4, 2024
    Kyowa Kirin said on October 3 that it has withdrawn an application seeking Japanese regulatory approval for Lumicef (brodalumab), an anti-interleukin-17 (IL-17) receptor A antibody, for an additional indication of systemic sclerosis.In a release, the…
    Daiichi Sankyo Espha to Launch Plaquenil AG in December
    October 4, 2024
    Daiichi Sankyo Espha said on October 3 that it will roll out an authorized generic (AG) of Sanofi’s lupus erythematosus treatment Plaquenil (hydroxychloroquine sulfate) in December upon its reimbursement listing.The company had received approval for a first generic version of…
    Amitiza Claims Tripple Gold in August HP Rep Promotion Rankings: Intage
    October 4, 2024
    Viatris Pharmaceuticals Japan’s chronic constipation drug Amitiza (lubiprostone) left the biggest impression on hospital doctors by sales reps detailing activities in August, according to a monthly Intage survey.Intage’s “Impact Track” detailing track survey asks some 4,000 GPs/hospital doctors about the…

    COLUMN

    6 Tips for Motivating and Engaging Current Employees
    By Philip Carrigan

    It’s easy to spot motivated and engaged employees. They are more productive, they go the extra mile, and they display a sense of ownership in their work.But how do you replicate this culture throughout your organization? How do you encourage…

    COMMENTARY

    LLP Info Might Become Inaccessible If New Coverage Rule Speeds Up Exit
    By Takashi Ebisawa

    Long-listed products (LLPs) in Japan will be subject to a new health coverage scheme starting this October. This is expected…

    MHLW Panel on Generic Industry Structure

    MHLW Panel Draws Up Plans for Generic Industry Shakeup in Final Report

    A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

    MHLW Panel on Pharmaceutical Regulations

    Japan Set to Push Central IRBs for Clinical Trials, Avoid Customary All-Case PMS

    A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…

    Drug Approval & Reimbursement in 2023

    Japan Approves Label Expansions for Rexulti, Rituxan, and More

    The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…

    Chuikyo on FY2024 Reimbursement Reform

    Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap

    Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

    MHLW Expert Panel on Comprehensive Policies

    Expert Panel Broadly OKs Draft Report on Pharma Policies, Further Deliberations by Other Forums
    By Yoshinori Sagehashi

    The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…

    Chuikyo on Off-Year Drug Price Revision

    Healthcare Providers Rap Product Coverage of Off-Year Re-Pricing, Payers Hail Threshold: Chuikyo

    A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…

    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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