REGULATORY
    3 Parties Reach Deal on Economic Plan, Off-Year “Abolition” Not Spelled Out
    By Ken Yoshino November 21, 2024
    The ruling coalition of the Liberal Democratic Party (LDP) and Komeito clinched an agreement with the opposition Democratic Party for the People (DPP) on a draft revision of a new economic package on November 20.…

    LATEST

    Tepezza, Trodelvy, and More Drugs Now Available in Japan; Kisunla Due Out on Nov. 26
    November 21, 2024
    A throng of new medicines hit the Japanese market on November 20 upon their reimbursement listing, including Amgen’s Tepezza (teprotumumab) and Gilead Sciences’ Trodelvy (sacituzumab govitecan). Eli Lilly’s Alzheimer’s therapy Kisunla (donanemab) is set for…
    MM Drug Talquetamab Filed in Japan: J&J
    November 21, 2024
    Janssen Pharmaceutical (J&J) on November 20 filed a new drug application for its investigational multiple myeloma treatment talquetamab in Japan, the company said.Talquetamab is a T-cell redirecting bispecific antibody that binds to the CD3 receptor on the surfaces of T…
    Terumo Puts Brake on Supply of Anapeine Generics
    November 21, 2024
    Only a week after its launch, Terumo’s generic versions of the long-acting local anesthetic agent Anapeine (ropivacaine) are already under restricted shipments.The major medical devices manufacturer launched two generic versions of Anapeine on November 12,…

    COMMENTARY

    With 1/4 of Pharma Backers Losing Seats, It’s Time for Industry to Revamp Lobbying Activities
    By Ken Yoshino

    Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…

    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…

    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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