BUSINESS
    Ultragenyx Looks to Launch 6 New Products in Japan by 2028-End: CCO
    By Kohei Hori October 17, 2024
    Ultragenyx Pharmaceutical aims to deliver six new products for rare disease patients in Japan by the end of 2028, starting with Dojolvi (triheptanoin), which is already available in the US and other markets for the…

    LATEST

    Doshisha Offshoot Eyes Nationwide Delivery of Cryopreserved Cell Product for Bullous Keratopathy
    October 17, 2024
    ActualEyes, a Kyoto-based biotech startup spun out of Doshisha University, has initiated a Japanese PII trial for a cell product that it hopes will be a game changer for the treatment of bullous keratopathy, a…
    Eisai Alzheimer’s Drug Hits Another Snag, This Time in Australia
    October 17, 2024
    Eisai said on October 17 that Australian regulators have recommended against the approval of its amyloid beta-targeting antibody Leqembi (lecanemab) as a treatment for early Alzheimer’s disease (AD). The company intends to seek a rethink.The…
    MHLW Panel to Review BeiGene’s 1st Drug Candidate in Japan and More on Oct. 30
    October 17, 2024
    Japan’s key health ministry panel will discuss on October 30 whether to endorse the approval of a roster of medicines including BeiGene’s BTK inhibitor zanubrutinib, which if given the final go ahead, will be the…

    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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