REGULATORY
    Japan Political Parties Push Varied Pharma Policies as Election Campaign Kicks Off
    By Ken Yoshino October 15, 2024
    Japan’s Lower House election campaign officially kicked off on October 15, with voting set to take place on October 27. All main political parties embrace some kind of pharmaceutical measure in their policy pledges, but…

    LATEST

    MHLW to Run Follow-Up Survey on Updated Commercial Guidelines, Solo Distribution
    October 15, 2024
    The Ministry of Health, Labor and Welfare (MHLW) on October 10 presented plans to conduct a follow-up survey on the state of compliance with the revised drug distribution guidelines, covering wholesalers and customer healthcare providers.According…
    Sandoz Japan Gets OK to Add New Manufacturing Site for Anapeine
    October 15, 2024
    Sandoz has obtained the thumbs-up of Japanese regulatory authorities for the addition of a new manufacturing site for some dosage versions of its long-acting local anesthetic Anapeine (ropivacaine), which has been running short due to…
    Lilly CEO Touts Benefits of Early AD Drug Kisunla
    October 15, 2024
    Eli Lilly CEO David Ricks reiterated the benefits of his company’s amyloid beta-directed antibody Kisunla (donanemab) at a Tokyo event on October 11 following the drug’s Japanese approval last month for early Alzheimer’s disease (AD).In…

    COMMENTARY

    Survey Hints LLP New Coverage Rule Could Push Generic Switches for Cancer Drugs, Pediatric Meds
    By Shinya Sato

    Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…

    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…

    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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