Cargando…

Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency

Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may...

Descripción completa

Detalles Bibliográficos
Autores principales:	Orellana García, Laura Patricia, Ehmann, Falk, Hines, Philip A., Ritzhaupt, Armin, Brand, Angela
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Frontiers Media S.A. 2021
Materias:	Medicine
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8591033/ https://www.ncbi.nlm.nih.gov/pubmed/34790681 http://dx.doi.org/10.3389/fmed.2021.753187

Ejemplares similares

Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency
por: Maliepaard, Marc, et al.
Publicado: (2022)

The European Medicines Agency's approval of new medicines for type 2 diabetes
por: Blind, Eberhard, et al.
Publicado: (2018)

Health horizons: Future trends and technologies from the European Medicines Agency’s horizon scanning collaborations
por: Vignali, Valentina, et al.
Publicado: (2022)

Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy
por: Hines, Philip A., et al.
Publicado: (2020)

Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
por: Bakker, Elisabeth, et al.
Publicado: (2022)

The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach
por: Nicotera, Giuseppe, et al.
Publicado: (2019)

Extension of the European Medicines Agency (EMA) approval of trifluridine/tipiracil for gastric cancer
por: Alsina, Maria, et al.
Publicado: (2019)

Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond
por: Hendrikse, Natalie M., et al.
Publicado: (2022)

Post‐Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004–2014
por: Cherla, Avi, et al.
Publicado: (2022)

Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers
por: Malottki, Kinga, et al.
Publicado: (2014)

Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021
por: Ciani, Oriana, et al.
Publicado: (2023)

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer
por: Stanel, Stefan Cristian, et al.
Publicado: (2017)

Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia
por: Schuessler‐Lenz, Martina, et al.
Publicado: (2019)

Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017–2022
por: Ciani, Oriana, et al.
Publicado: (2023)

Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications
por: Malottki, Kinga, et al.
Publicado: (2011)

Availability, accessibility and delivery to patients of the 28 orphan medicines approved by the European Medicine Agency for hereditary metabolic diseases in the MetabERN network
por: Heard, Jean-Michel, et al.
Publicado: (2020)

The evidence base for psychotropic drugs approved by the European Medicines Agency: a meta-assessment of all European Public Assessment Reports
por: Erhel, Florian, et al.
Publicado: (2020)

Biomarker Qualification at the European Medicines Agency: A Look Under the Hood
por: Berman, Steven, et al.
Publicado: (2022)

The current landscape of the FDA approved companion diagnostics
por: Jørgensen, Jan Trøst
Publicado: (2021)

Availability and Affordability of Drugs With a Conditional Approval by the European Medicines Agency; Comparison of Korea With Other Countries and the Implications
por: Kwon, Hye-Young, et al.
Publicado: (2018)

Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada
por: Lythgoe, Mark P., et al.
Publicado: (2021)

Real-world outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: A retrospective cohort study
por: Boyle, Jemma M., et al.
Publicado: (2021)

Psychopharmacology at the era of EMEA (European Medicines Agency)
por: Pestana, Luis Camara, et al.
Publicado: (2010)

A bacteriophage journey at the European Medicines Agency
por: Debarbieux, Laurent, et al.
Publicado: (2015)

Involvement of the European Medicines Agency in multi-stakeholder regulatory science research projects: experiences of staff members and project coordinators
por: Saesen, Robbe, et al.
Publicado: (2023)

Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan
por: Shimazawa, R, et al.
Publicado: (2014)

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13
por: Davis, Courtney, et al.
Publicado: (2017)

Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency
por: Dekker, Marieke J. H. J., et al.
Publicado: (2021)

A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020
por: Teixeira, Maria Manuel, et al.
Publicado: (2022)

Aligning the Economic Value of Companion Diagnostics and Stratified Medicines
por: Blair, Edward D., et al.
Publicado: (2012)

The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011–2018
por: Schuster Bruce, Catherine, et al.
Publicado: (2019)

The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency
por: Dekker, Marieke J. H. J., et al.
Publicado: (2021)

Review: UK medicines likely to be affected by the proposed European Medicines Agency’s guidelines on phthalates
por: Jamieson, Lisa, et al.
Publicado: (2015)

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications
por: Lenić, Ines, et al.
Publicado: (2019)

COMPANION TO NEONATAL MEDICINE
Publicado: (1982)

The Oxford Companion to Medicine
por: Davies, J. D.
Publicado: (1987)

The Oxford Companion to Medicine
por: Wolstenholme, Gordon
Publicado: (1987)

Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics
por: Twomey, Julianne D., et al.
Publicado: (2021)

European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation
por: Zoeller, R Thomas, et al.
Publicado: (2023)

The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia
por: Rose, Klaus, et al.
Publicado: (2015)

Cannot write session to /tmp/vufind_sessions/sess_ort26fjgu55k5opb5p8lfkji7j