(IN BRIEF) Pfizer and BioNTech have received a positive recommendation from the EMA’s CHMP for their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY® LP.8.1, for individuals aged six months and older. This updated vaccine offers improved immune protection against prevalent SARS-CoV-2 subvariants, … Read the full press release
Posted in Business, Germany, Healthcare, Industrial, News, Pharma & Biotech, Science, Technology
Tagged BioNTech, booster, CHMP, COMIRNATY LP.8.1, COVID-19 vaccine, EMA, EU vaccine rollout, European Commission, immune response, LP.8.1 variant, mRNA technology, mRNA Vaccine, NB.1.8.1 variant, Pandemic Preparedness, pediatric COVID vaccine, Pfizer, public health, SARS-CoV-2, vaccine adaptation, XFG variant
(IN BRIEF) AstraZeneca’s Trixeo Aerosphere has received a positive opinion from the EMA’s CHMP for use with a new propellant that offers a 99.9% reduction in Global Warming Potential compared to traditional formulations. Trixeo becomes the first pressurised metered-dose inhaler … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Ambition Zero Carbon, AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, Breztri, BTK inhibitor, budesonide, Calquence, chemoimmunotherapy, CHMP, chronic lymphocytic leukaemia, climate action in pharma, clinical trial, CLL, COPD, Dave Fredrickson, EMA, environmental sustainability, European approval, European Commission approval, European Union, fixed-duration regimen, formoterol fumarate, Frederik Trinkmann, glycopyrronium, hematologic diseases, hematology, Honeywell, inhalers, leukemia, low GWP, next-generation propellant, obinutuzumab, oncology, pMDI, progression-free survival, Respiratory Care, Ruud Dobber, Susanna Palkonen, Sustainable Healthcare, treatment option, Trixeo Aerosphere, venetoclax
(IN BRIEF) Novo Nordisk has received a positive opinion from the European Medicines Agency’s CHMP recommending label expansion for Alhemo® (concizumab) to include adolescents and adults with haemophilia A and B without inhibitors. Backed by robust data from the explorer8 … Read the full press release
Posted in Business, Denmark, Healthcare, News, Pharma & Biotech, Science, Technology
Tagged Alhemo®, bleeding disorder, CHMP, concizumab, EMA, European Commission, explorer8 trial, Haem-A-QoL, Haemophilia A, haemophilia B, haemophilia treatment, Martin Holst Lange, monoclonal antibody, Novo Nordisk, patient-reported outcomes, pen-injector, SF-36v2, subcutaneous prophylaxis, thrombin production, tissue factor pathway inhibitor
(IN BRIEF) Final overall survival results from AstraZeneca’s FLAURA2 Phase III trial confirm that combining Tagrisso with chemotherapy significantly improves survival for patients with first-line advanced EGFR-mutated NSCLC. The data reinforce Tagrisso as the foundational therapy in this setting, building … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged ADAURA trial, ADAURA2, adjuvant therapy, AstraZeneca, cancer survival, chemotherapy, EGFRm NSCLC, EMA, FDA, FLAURA2 trial, global clinical trial, LAURA trial, lung cancer treatment, NeoADAURA, non-small cell lung cancer, oncology, osimertinib, overall survival, Pasi A. Jänne, pemetrexed, platinum-based treatment, progression-free survival, Susan Galbraith, Tagrisso, targeted therapy
(IN BRIEF) GSK’s marketing authorisation application for linerixibat, an investigational ileal bile acid transporter inhibitor, has been accepted for review by the European Medicines Agency. The submission is supported by GLISTEN Phase III trial data showing that linerixibat rapidly and … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, United Kingdom
Tagged alcohol-related liver disease, bile acid transporter, cholestatic pruritus, chronic hepatitis B, EASL Congress, EMA, European Medicines Agency, FDA, GLISTEN trial, GSK, IBAT inhibitor, itch-related sleep interference, Kaivan Khavandi, linerixibat, Marketing Authorisation Application, MASH, NCT04950127, orphan drug designation, PBC, Phase III, primary biliary cholangitis, UK regulatory review
(IN BRIEF) TotalEnergies and RGE have announced a major renewable energy project in Indonesia, where their joint venture, Singa Renewables, has received a conditional licence from Singapore’s Energy Market Authority (EMA) to import 1 GW of clean power. The project, … Read the full press release
Posted in Business, Energy, Gas & Oil, Environment, Financial, France, Government, Industrial, Infrastructure & Utilities, Investment, Management, Marketing, News, Technology
Tagged ASEAN, Battery Energy Storage System, clean firm power, decarbonization, electricity import, EMA, energy security, energy transition, Helle Kristoffersen, hybrid renewable power plant, Imelda Tanoto, Indonesia, partnership, renewable energy, RGE, Riau Province, Singa Renewables, Singapore, Singapore Energy Market Authority, solar farm, subsea interconnector, sustainability, sustainable development, TotalEnergies
(IN BRIEF) In 2023, a historic initiative saw all 27 EU countries, along with Iceland and Norway, collecting and reporting both sales and usage data on veterinary antimicrobials for the first time. The resulting ESUAvet report details that 98% of … Read the full press release
Posted in Business, European Union, Financial, Government, Healthcare, Iceland, Industrial, Investment, Management, Netherlands, News, Norway, Science, Technology
Tagged 2023, AMEG, Animal Health, antimicrobial resistance, antimicrobials, ASU Platform, breeders, Category B, Category C, Category D, Cattle, chickens, EMA, ESUAvet, ESVAC, EU27, European Union, farmers, feed mills, food-producing animals, Iceland, Norway, penicillins, pharmacies, pigs, public health, retailers, sales data, sulfonamides, tetracyclines, turkeys, usage data, veterinarians, veterinary medicine
(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
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