European Medicines Agency (EMA) News Channel
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. The European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is biological medicine that is highly similar in all essential aspects to a 'reference' biological medicine already authorised. A disease is considered rare if fewer than five in 10,000 people have it. Around 30 million people in the European Union (EU) suffer from a debilitating rare disease, which means one in 17 people. Finding effective treatment for these rare diseases is a huge challenge. The European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU). Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) are advanced therapies for blood cancer. They belong to a new generation of personalised cancer immunotherapies that are based on collecting and modifying patients' own immune cells to treat their cancer. The European Commission has launched a call for expressions of interest for civil society representatives to join the Management Board of the European Medicines Agency (EMA), as well as the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). This is an opportunity for civil society representatives to participate in EMA’s activities. The European Medicines Agency (EMA) has published today its first report summarising the Agency's actions carried out by two of its committees in 2016 and 2017 - the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) - to support the implementation of the so-called 3Rs principles for more ethical use of animals in medicine testing across the European Union (EU). The European Commission’s Directorate-General for Health and Food Safety has launched a call for expressions of interest to represent patient organisations in the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP). The call aims to fill three positions for COMP members nominated by the European Commission to represent patient organisations. 