(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) EMA proposes Comirnaty Omicron XBB.1.5 vaccine for ages 6 months+, tailored to combat Omicron XBB.1.5 variant. One dose suffices for ages 5+, while kids 6 months to 4 years may need 1 or 3 doses based on prior … Read the full press release
Not intended for U.S. and UK Media (IN BRIEF) The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended darolutamide, an oral androgen receptor inhibitor, for marketing authorization in the European Union as a treatment for patients … Read the full press release
Posted in European Union, Germany, Healthcare, News, Pharma & Biotech
Tagged ADT, androgen deprivation therapy, Bayer, CHMP, Christine Roth, darolutamide, docetaxel, European Commission, European Medicines Agency, inhibitor, metastatic hormone-sensitive prostate cancer, mHSP, nmCRPC, Nubeqa™, Prof. Bertrand Tombal, prostate cancer
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) VEVEY, 14-Oct-2020 — /EuropaWire/ — Nestlé has successfully closed the acquisition of biopharmaceutical company, Aimmune Therapeutics, Inc. (Nasdaq: AIMT). The company which specializes in developing and bringing new treatments to people with potentially life-threatening food allergies joins Nestlé … Read the full press release
Posted in Investment, Management, News, Pharma & Biotech, Science, Switzerland
Tagged acquisition, Aimmune Therapeutics, allergic reactions, allergies, AlMab7195, anaphylaxis, Andrew Oxtoby, Arachis hypogaea, asthma, EM, Eosinophilic Gastrointestinal Disease, European Medicines Agency, FDA, Greg Behar, monoclonal antibody, Nestlé, Nestlé Health Science, NHSc, oral immunotherapy, PALFORZIA®, Peanut Allergen Powder-dnfp, Pharmaceutical, science-bassed nutritional solutions, Swiss Agency for Therapeutic Products, SwissMedic, treating peanut allergy
(PRESS RELEASE) BERLIN, 14-Aug-2019 — /EuropaWire/ — The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have been invited to speak at the 2019 PDA Europe Biomanufacturing Conference, 3-4 September 2019 in Munich, Germany. The following health … Read the full press release
Posted in Denmark, France, Germany, Healthcare, Italy, Media, Netherlands, News, Pharma & Biotech, Science, Spain, Sweden, United Kingdom
Tagged Accelerated Access, biopharmaceuticals, Continuous Manufacturing, Danish Medicines Agency, Dolores Hernan, Dutch Medicines Evaluation Board, European Directorate for the Quality of Medicines & Healthcare (EDQM), European Medicines Agency, GMP, Gwenael Cirefice, Manufacturing, Martjin van der Plas, Mats Welin, medicines, Nanna Kruse, PDA, Regulation, Swedish Medicines Agency
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
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
Medicine to be voluntarily withdrawn from the market by the company LONDON, 06-Mar-2018 — /EuropaWire/ — The European Medicines Agency (EMA) has started an urgent review of the multiple sclerosis medicine Zinbryta (daclizumab) following 7 cases of serious inflammatory brain disorders … 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
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
Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for all indications included in the reference product’s label Sandoz’ submission includes data from multiple clinical trials with over 800 patients … Read the full press release
Posted in European Union, Germany, Healthcare, Pharma & Biotech, Switzerland
Tagged European Medicines Agency, MabThera®, Roche, Sandoz
LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder. CAZ … Read the full press release
Companies encouraged to submit expressions of interest LONDON, 23-4-2015 — /EuropaWire/ — The deadline for submitting expressions of interest to participate in the information-sharing initiative for generics has been extended to give more time to companies to submit their applications. … 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
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