EMA to allow use of non-EEA authorised comparator in clinical studies; new guidance applicable as of today LONDON, 30-10-2014 — /EuropaWire/ — The European Medicines Agency (EMA) has published its revised overarching guideline on biosimilars. The main change brought by this … Read the full press release
29-8-2013 — /EuropaWire/ — The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. Quality-by-design is a science- and … Read the full press release
Posted in European Union, Government, Healthcare, Pharma & Biotech, Science
Tagged EMA, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, parallel assessment of quality-by-design applications, pharmaceutical industry, science- and risk-based approach, US FDA, US Food and Drug Administration
16-8-2013 — /EuropaWire/ — The European Medicines Agency has published a reflection paper on general issues for consideration regarding the parenteral administration of coated nanomedicines today. The reflection paper describes general issues to consider during the development of nanomedicines that have a coating, including: the effect … Read the full press release
Posted in Government, Healthcare, Law, Pharma & Biotech, Science
Tagged biodistribution, coated nanomedicines issues, Committee for Medicinal Products for Human Use, EMA reflection paper, EMA reflection papers, EMA's view on coated nanomedicines, European Medicines Agency, general issues for consideration regarding coated nanomedicines, interaction of the coating with other molecules in the biological environment, minimise medicines aggregation, nanotechnology, pharmacokinetics, Surface coating
12-7-2013 — /europawire.eu/ — The European Medicines Agency is organising training sessions on the use of the eSubmission Gateway and web client to submit periodic safety update reports (PSURs) subject to the single-assessment procedure. These training sessions are intended for all applicants submitting … Read the full press release
Posted in Education, European Union, Government, Healthcare, Pharma & Biotech, Science, United Kingdom
Tagged eSubmission, European Medicines Agency, PSURs, training, webinar
26-6-2013 — /europawire.eu/ — The European Medicines Agency has released a draft policy on the publication and access to clinical-trial data for a three-month public consultation. Stakeholders have until 30 September 2013 to send their comments on the draft policy to … Read the full press release
Posted in European Union, Government, Healthcare, Pharma & Biotech
Tagged European Medicines Agency
23-4-2013 — /europawire.eu/ — These sorts of new techniques potentially offer exciting possibilities to patients for the treatment of a range of difficult or previously untreatable conditions. Like all treatments, these techniques also come with benefits and risks. Specific rules were introduced … Read the full press release
Posted in European Union, Government, Healthcare, Law, Pharma & Biotech, Society, United Kingdom
Tagged EMA, European Medicines Agency, medicines, patients, Stem cell, Stem cell therapy, Stem cell therapy treatments, therapy, traceability of materials, treatment, treatment protocols, untreatable conditions
London, 23-10-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a recommendation to give marketing authorisation to insulin degludec, a new basal analogue insulin for the treatment of diabetes mellitus in adults. It … Read the full press release
Posted in European Union, Healthcare, Pharma & Biotech, Science, United Kingdom
Tagged CHMP, European Medicines Agency, higher-strength insulin, Tresiba
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