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New live biotherapeutics will require regulatory and scientific innovation: the importance of a defined regulatory framework

New live biotherapeutics will require regulatory and scientific innovation: the importance of a defined regulatory framework

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Live Biotherapeutics developers will need to incorporate gold-standard pharmaceutical development techniques and approaches in order to reach market and patients in need The Pharmabiotic Research Institute (PRI), Europe’s only regulatory expertise centre for the development of microbiome-based drug products, has announced the publication of a review titled “Live biotherapeutic products: the importance of a defined […]

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Live Biotherapeutic Products and Safety Assessment

Live Biotherapeutic Products and Safety Assessment

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Live Biotherapeutic Products – a new regulatory approach for the safety assessment of a specific category of biological medicinal products NARBONNE, France – An article has been published in Frontiers in Medicine: Regulatory Science section, which proposes a new set of recommendations for addressing the various regulatory and technical challenges when assessing the safety of […]

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Addressing the Unique Challenges of Live Biotherapeutic Products when Designing Clinical Trials

Addressing the Unique Challenges of Live Biotherapeutic Products when Designing Clinical Trials

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Written by Kristina Campbell – This article originally appeared in the online publication The Microbiome Times Many individuals living with chronic disease—whether it’s asthma, allergies, atopic dermatitis, type 2 diabetes, or another condition—readily confirm their therapeutic options leave a lot to be desired. Even if an existing drug product deals adequately with their symptoms, it often […]

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IMM-ETG: A New European Initiative for Intestinal Microbiome Medicinal Products

IMM-ETG: A New European Initiative for Intestinal Microbiome Medicinal Products

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“Caelus Health, EnteroBiotix, Ferring Pharmaceuticals, and MaaT Pharma, in coordination with the Pharmabiotic Research Institute (PRI), are working in collaboration within the ‘Intestinal Microbiome-based Medicines European Task Group (IMM-ETG)’ to propose a harmonised, pan-European, regulatory approach to intestinal microbiome whole ecosystem[1]-based therapeutics” Monday, 20 May 2019 – Caelus Health, EnteroBiotix, Ferring Pharmaceuticals, and MaaT Pharma […]

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