(IN BRIEF) In early 2024, Europe’s medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for lung and breast cancer, and AstraZeneca’s Tagrisso for EGFR-mutated lung cancer. Diagnostic advancements … Read the full press release
Posted in Finland, Germany, Healthcare, Insurance, News, Pharma & Biotech, Science, Society, Switzerland, Technology, United Kingdom
Tagged accessible cancer solutions, AstraZeneca, Aviva, BioNTech, breast cancer, breast cancer screening, cancer care, cancer diagnostics, cancer prevention awareness, cancer research, cancer treatment, colorectal cancer, Daiichi Sankyo, datopotamab deruxtecan, Duality Biologics, Eckert & Ziegler, EMA, FDA, genetic risk information, Inspirna, lung cancer, Merck KGaA, multi-cancer early detection, neuroendocrine neoplasms diagnostics, Novartis, ompenaclid, oncology, polygenic risk score, preventive healthcare, Professor Tim Maughan, ReSisTrace methodology, Stage III EGFR-mutated lung cancer, Swiss Re Institute, Tagrisso, treatment-resistant cancer cells, University of Helsinki, University of Liverpool
(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast … Read the full press release
Posted in Business, Education, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Adrian Kemp, AstraZeneca, Daiichi Sankyo, datopotamab deruxtecan, EMA, Ken Takeshita, Lung and Breast Cancer Treatment, Marketing Authorisation, Susan Galbraith
(IN BRIEF) The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have jointly released a comprehensive Artificial Intelligence (AI) workplan outlining their collaborative strategy through 2028. This initiative aims to maximize the benefits of AI for stakeholders … Read the full press release
Posted in Artificial Intelligence (AI), Business, Environment, European Union, Financial, Healthcare, Industrial, Investment, Management, Netherlands, News, Pharma & Biotech, Science, Technology
Tagged 2028 Workplan, artificial-intelligence, EMA, HMAs, Medicines Regulation, partnership, sustainability
(IN BRIEF) Pfizer and BioNTech have received a recommendation for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. The recommendation includes the administration of a single … Read the full press release
Posted in Business, European Union, Germany, Government, Healthcare, Industrial, Management, Marketing, News, Pharma & Biotech, Science
Tagged Albert Bourla, BioNTech, Comirnaty, COVID-19 vaccine, EMA, Omicron XBB.1.5-Adapted, Pfizer, Prof. Ugur Sahin, Tozinameran
(PRESS RELEASE) CAMBRIDGE, 13-Jan-2023 — /EuropaWire/ — AstraZeneca (LSE/STO/Nasdaq: AZN), a British-Swedish multinational pharmaceutical and biotechnology company, has announced that its drug Tezspire (tezepelumab) has been given the green light for self-administration by the European Medicine Agency’s Committee for Medicinal … Read the full press release
Posted in European Union, Healthcare, News, Pharma & Biotech, Science, Sweden, Technology, United Kingdom
Tagged allergic, asthma, asthma biologic, AstraZeneca, convenient pre-filled pen, EMA, eosinophilic, EU approval, Mene Pangalos, Professor Ian Pavord, self-administration, severe asthma patients, tezepelumab, Tezspire, University of Oxford
(COMUNICADO DE PRENSA) CAMBRIDGE, 13-Jan-2023 — /EuropaWire/ — AstraZeneca (LSE/STO/Nasdaq: AZN), una multinacional británica-sueco-farmacéutica y biotecnológica, ha anunciado que su fármaco Tezspire (tezepelumab) ha recibido luz verde para la autoadministración por parte del Comité de Medicamentos de Uso Humano (CHMP) … Read the full press release
Posted in European Union, Healthcare, News, Pharma & Biotech, Science, Sweden, Technology, United Kingdom
Tagged alérgica, aprobación de la UE, asma, asma biológica, AstraZeneca, autoadministración, EMA, eosinofílica, Mene Pangalos, pacientes con asma grave, pluma precargada conveniente, profesor Ian Pavord, tezepelumab, Tezspire, Universidad de Oxford
Zulassungsantrag für die Behandlung von Anämie bei chronischer Nierenerkrankung basierend auf dem klinischen Phase-III-Studienprogramm ASCEND, bestehend aus fünf Studien, die alle ihre co-primären Wirksamkeits- und Sicherheitsendpunkte erreichten Die Zulassung der EMA-Anträge ist der erste große regulatorische Meilenstein für Daprodustat seit … Read the full press release
Posted in Healthcare, Marketing, Pharma & Biotech, United Kingdom
Tagged American Society of Nephrology, Anämie, ASCEND-D, ASCEND-ND, Behandlung von Anämie, chronische Nierenerkrankung, CKD, daprodustat, Dialyse, EMA, Europäische Arzneimittel-Agentur, GlaxoSmithKline, Hämoglobin, HIF-PHI, klinisches Studienprogramm ASCEND Phase III, MAA, Prolylhydroxylase-Hemmer, Zulassungsantrag
Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical trial programme, consisting of five trials that all met their co-primary efficacy and safety endpoints EMA file acceptance is the first major regulatory … Read the full press release
Posted in Healthcare, Marketing, News, Pharma & Biotech, United Kingdom
Tagged American Society of Nephrology, anaemia, ASCEND Phase III clinical trial programme, ASCEND-D, ASCEND-ND, Chronic kidney disease, CKD, daprodustat, dialysis, EMA, European Medicines Agency, GlaxoSmithKline, haemoglobin, HIF-PHI, MAA, Marketing Authorisation Application, prolyl hydroxylase inhibitor, treatment of anaemia
New arrangement leverages Kuehne+Nagel’s global solutions for pharma & healthcare logistics (PRESS RELEASE) CAMBRIDGE, MA, U.S.A. / SCHINDELLEGI, 7-Jan-2021 — /EuropaWire/ — Global transport and logistics company Kuehne+Nagel announces international supply chain arrangement with Moderna, Inc. (NASDAQ:MRNA), a biotechnology company … Read the full press release
Posted in Healthcare, News, Pharma & Biotech, Switzerland, Technology, Transportation & Logistics
Tagged biotechnology, Covid-19 Vaccine Moderna, Dan Staner, distribution, Dominique Nadelhofer, EMA, European Medicines Agency, Harriet Barham, Kuehne+Nagel, logistics, messenger RNA, Moderna, mRNA, pandemic, pharma hub, QuickSTAT, Robert Coyle, Storage, supply chain, therapeutics, vaccines, Warehousing
(PRESS RELEASE) VALBY, Denmark, 22-Dec-2020 — /EuropaWire/ — Danish international pharmaceutical company, H. Lundbeck A/S (Lundbeck) announces that its marketing authorization application for Vyepti™ (eptinezumab-jjmr) has been accepted by the European Medicines Agency (EMA). The filing seeks approval to introduce … Read the full press release
Posted in Denmark, Healthcare, Marketing, News, Pharma & Biotech
Tagged calcitonin gene-related peptide, CGRP, Dr. Johan Luthman, EMA, eptinezumab-jjmr, European Medicines Agency, H. Lundbeck A/S, humanized monoclonal antibody, Juliane Lenzner, Lundbeck, marketing authorization, migraine, migraine preventive antibody, neurological disease, Palle Holm Olesen, preventative therapy, severe headaches, Vyepti™
(PRESS RELEASE) GENEVA, 26-Mar-2020 — /EuropaWire/ — Inspection, verification, testing and certification company SGS announced it has developed a test method to identify nitrosamine impurities in drug products, raw materials and APIs. In 2018, the presence of the nitrosamine N-nitrosodimethylamine … Read the full press release
(PRESS RELEASE) AMSTERDAM, 16-Jan-2020 — /EuropaWire/ — The European Medicines Agency (EMA) appoints Dr Hilmar Hamann as Head of the Information Management Division. Prior to joining EMA, Dr. Hamann has served as the Director for the Office of Business Informatics … Read the full press release
Posted in Healthcare, Management, Netherlands, News, Pharma & Biotech, Technology
Tagged Agency from the United States Food and Drug Administration, appointment, automation, chemical kinetics, chemist, Dr Hilmar Hamann, EMA, FDA, informatics, Information Management, IT, molecular physics, Pharmaceutical, robotic process, technologies, University of Göttingen
EMA, MHRA and FDA among regulatory agencies participating (PRESS RELEASE) BERLIN, 10-Jun-2019 — /EuropaWire/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in … Read the full press release
Posted in France, Germany, Healthcare, Ireland, Media, Netherlands, News, Pharma & Biotech, Science, Switzerland, United Kingdom
Tagged 4th PDA European Annual Meeting, Amsterdam, automation, Basel, Berlin, biopharmaceuticals, data quality management, data science, digitalization, Dublin, EMA, European Medicines Agency, FDA, Felix G. Rebitschek, Healthcare, HPRA, London, Manufacturing, manufacturing technologies, Max Planck Institute, medicines, MHRA, Paris, PDA, pharmaceuticals, PIC/S, regulators, Virtual Reality, Walter Morris, WHO, Zurich
(PRESS RELEASE) LONDON, 27-Mar-2019 — /EuropaWire/ — The LentiGlobin application for Conditional Marketing Authorization (cMAA) at the EMA from bluebird bio is still in the process of being reviewed by CHMP during their 25-28 March 2019 meeting. An opinion for … Read the full press release
Posted in European Union, Healthcare, Italy, News, Pharma & Biotech, Science
Tagged AVLT, CHMP, cMAA, Dr. Chris Sotirelis, Dr. Michele Lipucci di Paola, EMA, gene therapy, LentiGlobin, Thalassaemia, UKTS
Fresh design and improved features to provide better user experience LONDON, 25-Sep-2018 — /EuropaWire/ — The European Medicines Agency (EMA) will launch a new version of its corporate website (www.ema.europa.eu) on 27 September 2018. The new website will have an improved … Read the full press release
Posted in Internet & Online, Pharma & Biotech, United Kingdom
Tagged EMA, European Medicines Agency, medicines, website
Publication of updated Q+As and practical guidance LONDON, 20-Jun-2018 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to the questions-and-answers … Read the full press release
Posted in European Union, Management, Pharma & Biotech, United Kingdom
Tagged Brexit, EMA, guidance, Pharmaceutical, The European Commission
Workshop with regulators from EU, Japan and US open for registration LONDON, 28-May-2018 — /EuropaWire/ — The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) are co-organising a workshop to discuss the development … Read the full press release
Posted in Education, Healthcare, Pharma & Biotech, Science, Technology, United Kingdom
Tagged antibiotics for children, antimicrobial resistance, EMA, FDA, PMDA, workshop
Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release
Close collaboration with new host country as of day one key for successful move LONDON, 09-Nov-2017 — /EuropaWire/ — With less than two weeks to go before EU Member States select a new host city for the European Medicines Agency (EMA) … Read the full press release
Posted in European Union, Healthcare, Management, United Kingdom
Tagged EMA, EU Member States, European Medicines Agency
LONDON, 10-Oct-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use. Excipients refer to everything in a medicine other than the active substance. While most excipients are considered inactive, some can have … Read the full press release
Posted in European Union, Healthcare, Pharma & Biotech, United Kingdom
Tagged EMA, European Medicines Agency
European Medicines Agency and healthcare payer organisations held joint meeting on 19 September LONDON, 29-Sep-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA’s offices … Read the full press release
BRUSSELS, 03-Aug-2017 — /EuropaWire/ — The application procedure to host the two UK-based EU agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA), came to a close at midnight last night, 31 July 2017. The European Commission will … Read the full press release
Posted in Belgium, European Union, Government, United Kingdom
Tagged EBA, EMA, European Commission, President Jean-Claude Juncker, UK-based EU agencies
The European Medicines Agency (EMA) is currently looking for a new location in connection with the UK’s withdrawal from the EU. Sweden has now submitted its official offer to host the EMA. STOCKHOLM, 03-Aug-2017 — /EuropaWire/ — The offer guarantees … Read the full press release
Posted in European Union, Government, Healthcare, Pharma & Biotech, Sweden, United Kingdom
Tagged EMA, Prime Minister Stefan Löfven, Sweden, The European Medicines Agency
LONDON, 03-Apr-2017 — /EuropaWire/ — As a science-driven organisation, the European Medicines Agency (EMA) has developed a framework to formalise, structure and further develop interactions with the academic community in the context of the European medicines regulatory network. The framework … Read the full press release
EMA workshop will discuss role of patients, consumers and healthcare professionals LONDON, 07-Mar-2017 — /EuropaWire/ — How has the concept of personalised medicine evolved globally and in the European Union and what are its regulatory challenges and opportunities? These are some … Read the full press release
Posted in European Union, Healthcare, United Kingdom
Tagged biomedical discoveries, EMA, healthcare professionals, personalised medicines
OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants Priority Review Designation for OCREVUS Biologics License Application (BLA) BASEL, 29-Jun-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced … Read the full press release
Posted in Healthcare, Pharma & Biotech, Switzerland
Tagged EMA, FDA, OCREVUS, Roche, Sandra Horning M.D.
EMA veterinary committee sets objectives to limit risks arising from use of antimicrobials in animals LONDON, 20-11-2015 — /EuropaWire/ — The European Medicines Agency has released for public consultation a new strategy on antimicrobials for 2016-2020 adopted by its Committee … Read the full press release
Deadline to submit expressions of interest to represent civil society at PRAC andCAT to European Commission extended until 18 October LONDON, 1-10-2015 — /EuropaWire/ — The Health and Food Safety Directorate-General of the European Commission has extended the deadline for … Read the full press release
EMA publishes workshop report on requirements for the authorisation of vaccines LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has published today the outcome of a workshop which explored how to ensure the availability of veterinary vaccines in … Read the full press release
Registration now open for a workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) on 28 May 2015 LONDON, 9-4-2015 — /EuropaWire/ — Enpr-EMA will hold its 7th annual workshop on 28 May 2015 at … Read the full press release
LONDON, 13-11-2014 — /EuropaWire/ — GSK today announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag (Revolade™), seeking an additional indication for the treatment of adult patients with severe aplastic anaemia … Read the full press release
Posted in Healthcare, Marketing, Pharma & Biotech, United Kingdom
Tagged eltrombopag (Revolade™), EMA, European Medicines Agency, GSK, severe aplastic anaemia
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
30-7-2013 — /EuropaWire/ — The European Medicines Agency (EMA) has published the ‘First annual report onEudraVigilance for the European Parliament, the Council and the Commission’, which covers the period from 1 January to 31 December 2012. It is the third time the … Read the full press release
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
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