ACADEMIA
    Alzheimer’s-Related Guidelines Being Revised to Accommodate Kisunla, Rexulti
    By Shinya Sato November 6, 2024
    A group of Japanese researchers has embarked on work to revise a series of guidelines related to treatments for Alzheimer’s disease (AD) and associated conditions following the arrival of two new therapies in the arena…

    LATEST

    Fujifilm CDMO Unit’s New Bioreactors Now Up and Running in Denmark
    November 6, 2024
    Fujifilm said on November 5 that its CDMO arm Fujifilm Diosynth Biotechnologies has completed its first-phase global manufacturing expansion with six new mammalian cell bioreactors now in operation in Denmark.The company has spent roughly 100…
    Eisai and Taiho VC Firms Certified for AMED Startup Project
    November 6, 2024
    The Japan Agency for Medical Research and Development (AMED) has certified the corporate venture capitals of Eisai and Taiho Pharmaceutical for its funding program aimed at strengthening Japan’s pharma startup ecosystem.The project is designed to address the lack of funding…
    Konica Minolta Unloads Ambry as It Pivots Away from Precision Biz
    November 6, 2024
    Konica Minolta said on November 5 that it is divesting its US subsidiary Ambry Genetics to Tempus AI for roughly US$600 million as part of efforts to augment its revenue base. The deal is scheduled to close in the second…

    COLUMN

    Elevating Leadership: Insights from Japan’s Healthcare Sector
    By Philip Carrigan

    For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…

    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…

    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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