Results 1 to 10 of about 8,763,994 (119)

Potency assays and biomarkers for cell-based advanced therapy medicinal products

Frontiers in Immunology, 2023
Advanced Therapy Medicinal Products (ATMPs) based on somatic cells expanded in vitro, with or without genetic modification, is a rapidly growing area of drug development, even more so following the marketing approval of several such products.
C. Capelli, Carolina Cuofano, C. Pavoni, S. Frigerio, D. Lisini, S. Nava, Michele Quaroni, Valentina Colombo, Francesco Galli, Svetlana Bezukladova, P. Panina-Bordignon, G. Gaipa, P. Comoli, G. Cossu, G. Martino, A. Biondi, M. Introna, J. Golay   +17 more
semanticscholar   +1 more source

Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries

Frontiers in Pharmacology, 2023
Introduction: Advanced Therapy Medicinal Products are a type of therapies that, in some cases, hold great potential for patients without an effective current therapeutic approach but they also present multiple challenges to payers.
J. C. Rejón-Parrilla, J. Espín, Sarah Garner, Stanislav Kniazkov, David Epstein   +4 more
semanticscholar   +1 more source

Advanced therapy medicinal products in China: Regulation and development

MedComm, 2023
Advanced therapy medicinal products (ATMPs) have shown dramatic efficacy in addressing serious diseases over the past decade. With the acceleration and deepening of China's drug regulatory reforms, the country sees a continuous introduction of policies ...
Jia-Qi Lu, Longchang Xu, Wei-Che Wei, Wu He   +3 more
semanticscholar   +1 more source

Human umbilical cord-derived mesenchymal stem/stromal cells: a promising candidate for the development of advanced therapy medicinal products

Stem cell research & therapeutics, 2021
Umbilical cord-derived mesenchymal stem/stromal cells (UC-MSCs) emerge as a perspective for therapeutic use in immune and inflammatory diseases. Indeed, immunomodulatory and anti-inflammatory properties, associated to fewer ethical, availability, and ...
M. Mebarki, Camille Abadie, J. Larghero, A. Cras   +3 more
semanticscholar   +1 more source

Identification of inadequate responders to advanced therapy among commercially-insured adult patients with Crohn’s disease and ulcerative colitis in the United States

BMC Gastroenterology, 2023
Background The purpose of this analysis was to assess the frequency of inadequate response over 1 year from advanced therapy initiation among patients with Crohn’s disease (CD) or ulcerative colitis (UC) in the United States using a claims-based ...
T. Gibble, A. Naegeli, M. Grabner, K. Isenberg, M. Shan, Chia-Chen Teng, J. Curtis   +6 more
semanticscholar   +1 more source

A pipeline analysis of advanced therapy medicinal products.

Drug Discovery Today, 2023
Advanced therapy medicinal products (ATMPs) are innovative biological products categorised as either gene, somatic cell, tissue-engineered or combined therapies. As of March 2022, 12 ATMPs are marketed in the EU and UK.
Georgina Wilkins, Kate Lanyi, Alex Inskip, O. Ogunbayo, Petra Brhilkova, Dawn Craig   +5 more
semanticscholar   +1 more source

The incidence of remission and indicators of inadequate response to advanced therapy in patients with ulcerative colitis: results from medical charts in the United Kingdom

Current Medical Research and Opinion, 2023
Objective A considerable proportion of patients with moderate-to-severe ulcerative colitis (UC) treated with advanced therapies do not achieve remission, even after 1 year of treatment, and suboptimal response to advanced therapies is frequently observed
J. Lindsay, N. Picker, D. Kromer, M. Smyth, H. Patel   +4 more
semanticscholar   +1 more source

The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001

Bone Marrow Transplantation, 2022
In February 2021, the ‘Advanced Therapy Medicinal Product’ (ATMP) ARI-0001 (CART19-BE-01), developed at Hospital Clínic de Barcelona (Spain), received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) under the ‘hospital ...
E. Trias, M. Juan, Á. Urbano-Ispizua, G. Calvo   +3 more
semanticscholar   +1 more source

Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

Frontiers in Medicine, 2022
Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-engineered therapies have demonstrated enormous therapeutic benefits. However, their development is complex to be managed efficiently within currently existing regulatory ...
Maja Pizevska, J. Kaeda, Enrico Fritsche, H. Elazaly, P. Reinke, L. Amini   +5 more
semanticscholar   +1 more source

Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products.

Cytotherapy, 2022
Hospital exemption (HE) is a regulated pathway that allows the use of advanced therapy medicinal products (ATMPs) within the European Union (EU) under restrictive conditions overseen by national medicine agencies.
N. Cuende, R. Ciccocioppo, M. Forte, J. Galipeau, L. Ikonomou, B. Levine, A. Srivastava, Patricia J. Zettler   +7 more
semanticscholar   +1 more source