(IN BRIEF) The FDA has accepted AstraZeneca’s sBLA for Imfinzi as a perioperative immunotherapy regimen in resectable early‑stage and locally advanced gastric and GEJ cancers, granting Priority Review with a decision expected in Q4 2025. The application leverages MATTERHORN Phase III data … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged 2025 decision, adjuvant, AstraZeneca, breakthrough therapy designation, clinical paradigm shift, durvalumab, early-stage, EFS hazard ratio, event-free survival, FDA priority review, FLOT chemotherapy, gastric cancer, gastroesophageal junction cancer, high unmet need, Imfinzi, Levi Garraway, locally advanced, MATTERHORN Phase III, neoadjuvant, overall survival, Perioperative Immunotherapy, resectable, sBLA, Susan Galbraith
(IN BRIEF) Roche’s ongoing Phase Ib/IIa Brainshuttle™ AD study of trontinemab shows that 91 percent of participants reach amyloid PET negativity, with ARIA‑E rates under 5 percent. The company has outlined Phase III TRONTIER 1 and 2 trials in early symptomatic Alzheimer’s for 2025, plus a planned … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged Alzheimer’s Association International Conference, amyloid plaques, amyloid‑beta monoclonal antibody, ARIA‑E, blood‑based biomarker, blood‑brain barrier, Brainshuttle, centiloids, clinical dementia rating sum of boxes, cognitive decline, diagnostics, early diagnosis, Elecsys pTau217, Levi Garraway, Matt Sause, PET negativity, Phase Ib/IIa, Phase III TRONTIER 1, Phase III TRONTIER 2, preclinical Alzheimer’s, pTau181, pTau217/Ab42 ratio, Roche, sustainability of clinical trials, TRAVELLER, trontinemab
(IN BRIEF) Mindray has received EU MDR Notified Body Certificates for three core surgical products—Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip, and Reusable Electrode Surgical Instruments—awarded by TÜV Rheinland Greater China on July 11, 2025. This certification marks … Read the full press release
Posted in Business, Financial, Germany, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Security & Safety, Technology
Tagged 2025 certifications, Articulating Endoscopic Linear Cutter, CE marking, Chinese medical devices, clinical safety, EU market access, EU MDR, Global Expansion, Hangzhou Mindray Medical Technology, healthcare manufacturing, INNOVATION, ISO 13485, IVDR, MDSAP, medical device certification, Mindray, minimally invasive surgery, Nanjing, partnership, Polymer Ligation Clip, R&D, regulatory compliance, Reusable Electrode Surgical Instruments, Shao Lingyun, Tony Chen, TÜV Rheinland, Wang Wenlong, Wendy Geng, Zhang Haifeng, Zuo Pengfei
(IN BRIEF) GSK has entered into a multi-programme development and licensing agreement with Hengrui Pharma to advance up to 12 innovative therapies, including HRS-9821, a potentially best-in-class PDE3/4 inhibitor currently in clinical trials for COPD. The deal includes $500 million … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AI-era medicine, biopharma partnership, Chronic obstructive pulmonary disease, clinical development, cloud healthcare, COPD treatment, drug innovation, drug pipeline, dry powder inhaler, Frank Jiang, global health, GSK, Hart-Scott-Rodino Act, Hengrui Pharma, HRS-9821, immunology, inflammation, licensing agreement, milestone payments, novel therapeutics, oncology, partnership, PDE3/4 inhibitor, pharmaceutical collaboration, phase I trials, respiratory medicine, Tony Wood
(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) Sanofi has secured European Commission approval for Sarclisa in combination with VRd as an induction treatment for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The decision was based on part one of the GMMG-HD7 … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged autologous stem cell transplant, bortezomib, cancer treatment, clinical trials, dexamethasone, EU approval, front-line therapy, German-speaking Myeloma Multicenter Group, GMMG-HD7, hematologic malignancies, ICARIA-MM, IKEMA, IMROZ, isatuximab, lenalidomide, MRD negativity, Multiple Myeloma, Olivier Nataf, oncology, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(IN BRIEF) The European Commission has approved Fresenius Kabi’s denosumab biosimilars, Conexxence® and Bomyntra®, for all uses of the originator product. These include osteoporosis treatment for postmenopausal women and at-risk men, mitigation of treatment-related bone loss, prevention of skeletal complications … Read the full press release
Posted in Business, Environment, Financial, Germany, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged #FutureFresenius, Biopharma platform, Bomyntra, cancer metastasis to bone, Conexxence, denosumab biosimilar, Europe, European Commission approval, Fresenius, Fresenius Kabi, Fresenius Kabi Deutschland GmbH, giant cell tumor of bone, high-quality biosimilars, osteoporosis, postmenopausal women, registered trademarks, skeletal complications, treatment-related bone loss
(IN BRIEF) University of Exeter researchers found that two weeks of twice-daily, nitrate-rich beetroot juice lowered blood pressure in older adults but not in younger ones, likely because of age-specific changes in mouth bacteria. The randomized crossover study—39 participants under … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Science, Technology, United Kingdom
Tagged ageing, BBSRC Industrial Partnership Award, beetroot juice, blood pressure, cardiovascular health, celery, dietary nitrate supplementation, Dr Lee Beniston, Exeter Clinical Trials Unit, fennel, Free Radical Biology and Medicine, kale, Neisseria, NIHR Exeter Clinical Research Facility, nitrate-rich diet, nitric oxide, Older Adults, oral microbiome, Prevotella, Professor Andy Jones, Professor Anni Vanhatalo, rocket, spinach, University of Exeter
(IN BRIEF) A Luxembourg–South Korea–USA consortium has launched the International Health Data Space Initiative (IHDSI) to create a federated, secure and privacy‑compliant platform for cross‑border health data integration, collaborative clinical research and translational innovation. Led by the Luxembourg Institute of … Read the full press release
Posted in Artificial Intelligence (AI), Business, Education, Financial, Government, Healthcare, Industrial, Investment, Luxembourg, Management, Marketing, News, Science, Technology
Tagged AI driven analytics, autonomous platforms, Big Data Analytics, bladder cancer cohort, Cancer, Cipherome, Clinical Working Group, cloud based analytics, CMP IaaS PaaS DevOps AIaaS AIOps, Compass platform, data silos, EHDS, epidemiology, European Health Data Space, feasibility study, federated data connector, Gaia-X, genomics, governance models, health data integration, hyperscale LLM, IHDSI, International Health Data Space Initiative, joint clinical research, Joint Steering Committee, LIH, Luxembourg Institute of Health, multi omics data, National Cancer Center Korea, NAVER Cloud Corporation, NCCK, Okestro, oncology biomarkers, Parkinson’s disease cohort, partnership, patient centric healthcare, precision medicine, precision oncology strategies, privacy-preserving, scalable computing, secure interoperable access, secure virtual environments, strategic alliance, systems biomedicine, Technical Working Group, translational innovation, translational research
(IN BRIEF) TÜV Rheinland Greater China has issued EU MDR Notified Body Certificates to three key Mindray surgical devices—the Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip and Reusable Electrode Surgical Instruments—during a July 11, 2025 ceremony in Nanjing. … Read the full press release
Posted in Business, Germany, Government, Healthcare, Industrial, Investment, Management, Marketing, Media, News, Security & Safety, Technology
Tagged Articulating Endoscopic Linear Cutter, Brazilian INMETRO, carbon of strategic partnership, Chinese medical devices, clinical evaluation, design and development, EU market access, EU Medical Device Regulation, global strategy, Hangzhou Mindray Medical Technology, international collaboration, ISO 13485, IVDR, MDR Notified Body Certificates, MDSAP, medical device testing, Mindray, minimally invasive surgery, partnership, Polymer Ligation Clip, post-market surveillance, Quality Management, regulatory compliance, Reusable Electrode Surgical Instruments, Shao Lingyun, Tony Chen, TÜV Rheinland Greater China, TÜV Rheinland services, Wang Wenlong, Wang Xinbing, Wendy Geng, Zhang Haifeng, Zuo Pengfei
(IN BRIEF) Sanofi has agreed to acquire UK-based Vicebio for $1.15 billion upfront plus up to $450 million in milestones, with closing anticipated in Q4 2025. The deal adds an early-stage bivalent RSV/hMPV vaccine (VXB‑241, in Phase 1 for older adults) and … Read the full press release
Posted in Artificial Intelligence (AI), Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged acquisition, AI-powered biopharma, Daniel Watterson, Emmanuel Hanon, fully liquid combination vaccines, Jean-François Toussaint, Keith Chappell, lower respiratory tract infections, Medicxi, Molecular Clamp technology, non-mRNA vaccine, Older Adults, partnership, Paul Young, pneumonia, prefilled syringes, regulatory approvals, respiratory vaccines pipeline, seasonal surges, Tags: Sanofi, UniQuest, University of Queensland, Vicebio
(IN BRIEF) EssilorLuxottica has signed a definitive agreement to acquire the optical assets of South Korea’s PUcore, including its R&D unit, production facility, and sales office, along with a portfolio of IP related to high index monomer development. The acquisition … Read the full press release
Posted in Apparel, Fashion & Beauty, Business, Environment, Financial, France, Government, Healthcare, Investment, Management, Marketing, News, Technology
Tagged 2025 acquisition, EssilorLuxottica, Francesco Milleri, high index lenses, intellectual property, lens innovation, lens manufacturing, monomers, ophthalmic lenses, optical materials, partnership, Paul du Saillant, production facility, PUcore, R&D acquisition, Republic of Korea, South Korea, sustainability, sustainability in optics, sustainable sourcing, upstream integration
(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) Sanofi has completed its purchase of Blueprint Medicines, acquiring the approved systemic mastocytosis therapy Ayvakit/Ayvakyt (avapritinib), along with two pipeline candidates: elenestinib (a KIT D816V inhibitor in Phase 2/3 HARBOR, NCT04910685) and BLU‑808 (a wild‑type KIT inhibitor). The $129.00‑per‑share … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged $129.00 per share, avapritinib, Ayvakit, Ayvakyt, Blueprint Medicines, BLU‑808, contingent rights, elenestinib, GIST, HARBOR, KIT inhibitor, MERGER, NASDAQ delisting, NCT04910685, partnership, PDGFRA D842V, Sanofi, SM, sustainability, systemic mastocytosis, tender offer
(IN BRIEF) The EIB has extended a €20 million venture debt facility to Solynta, a Dutch biotech firm specializing in true potato seeds, under the InvestEU initiative. This funding will accelerate Solynta’s hybrid breeding research, which replaces bulky, perishable tubers with … Read the full press release
Posted in Agriculture, Banks, Business, Environment, Financial, Food & Beverage, Government, Healthcare, Industrial, Investment, Luxembourg, Management, Marketing, Netherlands, News, Pharma & Biotech, Technology
Tagged climate resilience, disease resistance, EIB, European Investment Bank, food security, Gelsomina Vigliotti, hybrid breeding, InvestEU, Klasja van de Ridder, late blight, non‑GMO, partnership, Peter Poortinga, Solynta, sustainability, true potato seeds, United Nations Sustainable Development Goals, venture debt
(IN BRIEF) Novartis has appointed Mukul Mehta as CFO and Executive Committee member effective March 16, 2026. He will replace long‑time CFO Harry Kirsch, who retires on March 15, 2026, after 22 years at the company. Kirsch oversaw major strategic … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged 22-year career, Alcon spinoff, appointment, business planning and analysis, CFO appointment, digital finance, ECN, Executive Committee, focused medicines strategy, global finance leadership, GSK divestiture, Harry Kirsch, INSEAD, Jamnalal Bajaj Institute of Management Studies, leadership, March 16 2026, Mukul Mehta, Novartis, retirement, Roche divestiture, Sandoz spinoff, TAX, Vas Narasimhan
(IN BRIEF) Towards, backed by the University of Exeter, has opened its first therapy hub on a Leeds high street, offering immediate, no‑wait options for online and face‑to‑face sessions. The Leeds site kicks off a broader UK rollout staffed by … Read the full press release
Posted in Business, Education, Financial, Government, Healthcare, Industrial, Infrastructure & Utilities, Internet & Online, Investment, Management, Marketing, News, Science, Technology, United Kingdom
Tagged applied psychological practice, Catherine Gallop, Cedar Create, financial support, high‑street healthcare, in‑person therapy, Leeds therapy hub, mental health access, no waiting lists, online therapy, partnership, practical learning, Sarah Bateup, therapist training, Tim Rideout, Towards, Towards Academy, UK therapist shortage, University of Exeter
(IN BRIEF) A collaborative study by the University of Bristol, Medical Detection Dogs, and the University of Manchester found that two trained dogs can detect Parkinson’s disease from sebum skin swabs with up to 80% sensitivity and 98% specificity. In … Read the full press release
Posted in Business, Education, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Science, Technology, United Kingdom
Tagged biomarker, Bumper, canine detection, Claire Guest, double‑blind trial, Medical Detection Dogs, Nicola Rooney, non‑invasive diagnostics, Parkinson's disease, partnership, Pd, Peanut, Perdita Barran, sebum swabs, sensitivity 80%, specificity 98%, University of Bristol, University of Manchester
EuropaWire (EW) is the first truly pan-European and leading press release distribution and newswire service for Europe and the European Union working towards consolidating Europe’s voice on the global newswire and media scene. The newswire service comes with advanced submission forms, flexible pricing and PR budgeting, granular targeting, nearly uncapped reach across countries, markets, verticals, industries, audiences, languages, etc., translation and localisation for greater local PR impact, in-depth distribution reporting, metrics and insights including measured PR reach, reads, engagements, impact, etc., no cap on words, images and multimedia to go along with your release, among others. Your press releases will be seen among the releases of Europe’s biggest and most prominent companies, brands and institutions. Here you can learn more about EuropaWire’s mission, achievements, services, etc.
HOW TO GET STARTED?