REGULATORY
    MOF Intent on Expanding Scope of Off-Year Revision in 2025: Budget Examiner
    By Takashi Ebisawa September 6, 2024
    The Ministry of Finance (MOF) considers the implementation of the FY2025 “off-year” drug price revision as a given and is poised to extend its product coverage and rules to be applied, new budget examiner Shiro…

    LATEST

    PMDA-Led Inspections Will Help Straighten Up Generic Makers: MHLW Councilor
    September 6, 2024
    The Pharmaceuticals and Medical Devices Agency (PMDA) taking over the authority to implement certain GMP inspections from prefectural governments is expected to help boost the quality of generics at large, says a top health ministry…
    Axcelead DDP, Lilly Ink Research Collaboration Pact
    September 6, 2024
    Axcelead Drug Discovery Partners said on September 5 that it has signed a strategic research collaboration agreement with Eli Lilly for multiple drug discovery programs.The deal was sealed on August 30. The collaboration period and…
    Trodelvy Up for Japan Panel Review on Sept. 12, Meiji COVID Jab on Agenda Too
    September 6, 2024
    A key Japanese health ministry panel will discuss on September 12 whether to recommend approval for Gilead Sciences’ antibody drug conjugate (ADC) sacituzumab govitecan, otherwise known as Trodelvy in the US and Europe.The Pharmaceutical Affairs…

    COLUMN

    Why LinkedIn Isn’t Effective in Japan
    By Philip Carrigan

    In the Western world, LinkedIn is a staple for many recruitment professionals. It has proven to be a powerful tool for networking, talent sourcing and job postings. But in Japan, people don’t use LinkedIn very much.Here’s why LinkedIn isn’t popular…

    COMMENTARY

    Japan’s Drug-Loss Landscape Is Transforming Driven by Private Sector
    By Kohei Hori and Yoshinori Sagehashi

    An increasing number of companies in Japan are showing an eagerness to snatch up “drug loss” assets. As of this…

    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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