(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval as a monotherapy to treat limited-stage small cell lung cancer (LS-SCLC) in patients whose disease … Read the full press release
Posted in Business, European Union, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged ADRIATIC Phase III trial, AstraZeneca, CHMP, disease progression, durvalumab, EMA, European Medicines Agency, hazard ratio, Imfinzi, immunotherapy, limited-stage small cell lung cancer, LS-SCLC, monotherapy, overall survival, platinum-based chemoradiation therapy, progression-free survival, regulatory review, safety profile, Small cell lung cancer, Suresh Senan, survival outcomes, Susan Galbraith, The New England Journal of Medicine, treatment approval
(IN BRIEF) GSK has announced that the European Medicines Agency (EMA) has accepted its regulatory application for a prefilled syringe presentation of Shingrix, its recombinant zoster vaccine (RZV) for preventing shingles. This new presentation simplifies administration for healthcare providers by … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, United Kingdom
Tagged adult immunisation, adult vaccination, EMA, European Medicines Agency, European Union, FDA, GSK, healthcare professionals, herpes zoster, herpes zoster prevention, liquid adjuvant, lyophilised antigen, post-herpetic neuralgia, post-herpetic neuralgia prevention, Prefilled Syringe, Recombinant Zoster Vaccine, reconstitution, regulatory application, RZV, Shingles, Shingrix, submission, U.S. FDA, vaccination, vaccine
(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
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