All Advanced therapy medicinal product articles

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    Innovating and harmonising access and requirements amid the global regulatory challenges of biologics


    This article provides an overview of the regulatory challenges of biologics facing the biopharmaceutical industry, focusing on the need for global regulatory harmonisation. These challenges are central to ensuring the safety, efficacy and accessibility of biologic therapies for patients worldwide. To navigate these regulatory challenges, a collaborative effort will be ...

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    Regulating Vaxzevria

    Vol. 20 #4
    Hosted by Alan Booth, managing editor of Regulatory Rapporteur, this episode of RegRapPod  is an extended conversation with authors Priti Shah and Anna Litsiou following on from their article in the April issue [Vol. 20 #4]Priti and Anna share insights around the regulatory process of AstraZeneca’s COVID-19 vaccine - Vaxzevria.

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    Industry news

    Gene therapy gives hope to patients with ‘butterfly skin’


    FDA approves first gene therapy to treat dystrophic epidermolysis
    bullosa patients – a condition sometimes called ‘butterfly skin’.

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    Gene therapy: regional assessment comparison


    Axicabtagene ciloleucel (tradename YESCARTA) is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets CD19 and is approved for the treatment of aggressive, relapsed or refractory forms of B-cell non-Hodgkins lymphoma (NHL). The active substance is composed of a patient’s cells that have undergone ex vivo modification, which causes ...

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    Global regulatory frameworks for the development of gene therapy products


    Gene therapies have the potential to revolutionise the global healthcare system. Some of these products may offer curative benefits to patients with devastating conditions. This continuing professional development (CPD) supplement provides an overview of the regulatory framework for the development of gene therapy products in key markets.