European Medicines Agency

(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 →

(IN BRIEF) AstraZeneca is set to present data on its Vaccines and Immune Therapies portfolio at the European Congress of Clinical Microbiology & Infectious Diseases. Among the data to be presented will be details on the progress of AstraZeneca’s Vaccines … 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 →

Ad hoc announcement pursuant to Art. 53 LR (PRESS RELEASE) BASEL, 19-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, announced that their combination treatment … Read the full press release →

(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 →

(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 →

(PRESS RELEASE) BASEL, 12-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, has announced that the European Commission has approved Xofluza (baloxavir marboxil), a … Read the full press release →

(COMUNICADO DE PRENSA) BASEL, 12-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), un pionero mundial en productos farmacéuticos y diagnóstico centrado en el avance de la ciencia para mejorar la vida de las personas, ha anunciado que la … Read the full press release →

(PRESS RELEASE) LONDON, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON: GSK), a British multinational science-led healthcare company, has announced the third major regulatory milestone for its daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of … Read the full press release →

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 →

(PRESS RELEASE) CAMBRIDGE, 16-Feb-2022 — /EuropaWire/ — AstraZeneca (LON: AZN), a British-Swedish multinational pharmaceutical and biotechnology company, has announced an European Union (EU) approval for its Saphnelo (anifrolumab) medicine as an add-on therapy for the treatment of adult patients with … Read the full press release →

In the YOSEMITE and RHINE studies in diabetic macular edema, at least 60% of eligible Vabysmo patients could extend treatment to every four months at two years, compared to 50% at year one Almost 80% of eligible Vabysmo patients could extend treatment to every … Read the full press release →

New data show pre-symptomatic babies with spinal muscular atrophy (SMA) treated with Evrysdi maintained the ability to swallow Evrysdi has demonstrated consistent clinically meaningful efficacy in adults, children, and babies two months and older and is now approved in 58 countries worldwide Further … Read the full press release →

(PRESS RELEASE) PARIS, 20-Jul-2021 — /EuropaWire/ — Sanofi (EPA: SAN), a global biopharmaceutical company focused on human health, has announced fexinidazole approval by the US Food and Drug Administration (FDA) as the first all-oral treatment for both stages of the … Read the full press release →

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 →

(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 →

(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 →

(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 →

(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 →

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 →