(IN BRIEF) The European Medicines Agency (EMA), together with leading European healthcare professional and consumer organisations, has launched the #ItTakesATeam campaign to raise awareness of collective efforts in preventing and managing medicine shortages across the EU. The initiative, co-created with … Read the full press release
Posted in Healthcare, Management, Marketing, Media, News, Pharma & Biotech, United Kingdom
Tagged #ItTakesATeam, awareness campaign, EMA, EMA Unites European Healthcare Partners in #ItTakesATeam Campaign to Tackle Medicine Shortages, Emer Cooke, EU healthcare collaboration, European Association of Hospital Pharmacists, European Association of Nuclear Medicine, European Consumer Organisation, European Medicines Agency, European Paediatric Neurology Society, European Union of General Practitioners, healthcare professionals, Jorge Batista, medicine shortages, medicine supply chain, New EMA Awareness Initiative Highlights Collaborative Efforts Behind Managing Medicine Shortages Across Europe, patient safety, PGEU, public health, regulatory cooperation
Pertussis cases surge: Over 60,000 reported in Europe; infants most at risk. Maternal vaccination expands: Finland, Norway, and UK updated pregnancy vaccine strategies. BioNet advances: Submitted recombinant pertussis vaccine to EMA; secured EU-GMP approval. Nasal vaccine progresses: ILiAD’s BPZE1 granted … Read the full press release
Posted in Denmark, European Union, Finland, France, Germany, Healthcare, Ireland, News, Norway, Pharma & Biotech, Science, United Kingdom
Tagged acellular pertussis vaccine, Adacel, antibody avidity, antigen dose, ASEAN, Bio Farma, BioNet, biotechnology, booster dose, Boostrix-IPV, BPZE1, certification, Chulalongkorn University, clinical trial, compliance, Dario Cresci, dTap, ECDC, EMA, EU-GMP, EU-GMP certification, EU/EEA, Europe Confronts Pertussis Resurgence as Infant Cases Rise Amid Falling Immunity and Vaccination Gaps, Europe Faces Pertussis Resurgence Amid Waning Immunity and Falling Maternal Vaccination Rates, European Medicines Agency, European Union, European Union Good Manufacturing Practice, Europe’s Pertussis Vaccine Market Opens to New Entrants as Demand Rises, From EU-GMP Certification to ASEAN Partnerships BioNet Broadens Its Global Vaccine Strategy, GMP production facilities, GSK, Hanna Nohynek, health policy, HPRA, human challenge trial, hVIVO, ILiAD Biotechnologies, immunization strategy, infant protection, Innovation Passport, Institut Pasteur, intranasal vaccine, Ireland Health Products Regulatory Authority, Lancet Infectious Diseases, maternal vaccination, MHRA, mucosal immunity, outbreak, pandemic recovery, Pertagen®, pertussis, pertussis vaccine, Pertussis Vaccine Manufacturing, pharmaceutical quality, Phase 3, Philippe Guillot-Chêne, pregnancy immunization, public health, recombinant pertussis vaccine, recombinant pertussis vaccines, regulatory approval, Sanofi, Tdap, TdaP combination vaccine, V, vaccine, vaccine blunting, vaccine development, Vaccine Hesitancy, vaccine pipeline, vaccine rollout, vaccine shortage, vaccine supply, vaccine uptake, VacPertagen, whooping cough
BioNet earns EU-GMP certification for its acellular pertussis vaccine, confirming compliance with EU manufacturing and quality standards. Inspection by Ireland’s HPRA supports EMA review of BioNet’s recombinant vaccine candidate VacPertagen. Partnerships expanding: MoU with Indonesia’s Bio Farma to accelerate TdaP … Read the full press release
Posted in European Union, France, Healthcare, Ireland, Pharma & Biotech, Science
Tagged acellular pertussis vaccine, BioNet, BioNet’s EU-GMP Certification Marks Strategic Step Toward EMA Review and Expands Global Vaccine Reach, BioNet’s Manufacturing Accreditation Aligns with Growing International Efforts to Reinforce Pertussis Vaccine Supply, biotechnology, certification, compliance, Dario Cresci, EMA, EU-GMP certification, European Medicines Agency, European Union, European Union Good Manufacturing Practice, From EU-GMP Certification to ASEAN Partnerships BioNet Broadens Its Global Vaccine Strategy, GMP production facilities, HPRA, Ireland Health Products Regulatory Authority, Pertagen®, pertussis, pertussis vaccine, Pertussis Vaccine Manufacturing, pharmaceutical quality, Philippe Guillot-Chêne, recombinant pertussis vaccines, Regulatory Milestone and Research Progress Signal BioNet’s Expanding Role in Next-Generation Vaccine Development, V, vaccine, VacPertagen
(IN BRIEF) BioNet has achieved European Union Good Manufacturing Practice (EU-GMP) certification, a key international standard that validates its facilities and processes for producing high-quality pharmaceuticals. This certification, granted after inspection by Ireland’s Health Products Regulatory Authority (HPRA), allows BioNet … Read the full press release
Posted in European Union, France, Healthcare, Ireland, Pharma & Biotech
Tagged acellular pertussis vaccine, BioNet, biotechnology, certification, compliance, Dario Cresci, EMA, EU-GMP certification, European Medicines Agency, European Union, European Union Good Manufacturing Practice, GMP production facilities, HPRA, Ireland Health Products Regulatory Authority, Pertagen®, pertussis, pertussis vaccine, Pertussis Vaccine Manufacturing, pharmaceutical quality, Philippe Guillot-Chêne, recombinant pertussis vaccines, vaccine, VacPertagen
(IN BRIEF) GSK announced that its B7-H3-targeted antibody-drug conjugate GSK5764227 (GSK’227) has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of pulmonary neuroendocrine carcinoma, including small-cell lung cancer (SCLC). The designation is supported … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, ARTEMIS-001, B7-H3, breakthrough therapy designation, cancer research, EMA, EMA Grants Orphan Drug Designation to GSK’s B7-H3 Antibody-Drug Conjugate for Pulmonary Neuroendocrine Carcinoma, FDA, GSK, GSK Strengthens Oncology Pipeline With EMA Orphan Drug Status for GSK’227 in Small-Cell Lung Cancer, GSK5764227, GSK’227, immuno-oncology, lung cancer, NEC, ODD, oncology, oncology pipeline, orphan drug designation, PRIME designation, pulmonary neuroendocrine carcinoma, relapsed or refractory, SCLC, Small cell lung cancer, solid tumours, targeted therapy
(IN BRIEF) Roche announced that its Phase III INShore trial evaluating Gazyva/Gazyvaro (obinutuzumab) in children and young adults with idiopathic nephrotic syndrome met its primary endpoint, showing superior sustained remission rates at one year compared to mycophenolate mofetil (MMF). The … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged B cell targeting, Basel, Chronic kidney disease, corticosteroids, EMA, FDA, Gazyva, Gazyva/Gazyvaro Demonstrates Superior Sustained Remission in Children and Young Adults With Idiopathic Nephrotic Syndrome, Gazyvaro, idiopathic nephrotic syndrome, immune-mediated kidney diseases, INS, INShore study, Levi Garraway, lupus nephritis, NOBILITY study, obinutuzumab, pediatric nephrology, phase III clinical trial, proteinuria, REGENCY study, renal disease, Roche, Roche Announces Positive Phase III INShore Results for Gazyva/Gazyvaro in Children and Young Adults With Idiopathic Nephrotic Syndrome, sustained remission, targeted therapy
Europe’s RNA immunotherapy sector is gaining speed with new in vivo CAR-T and mRNA vaccine trials. Germany approved the region’s first in vivo CAR-T study, marking regulatory progress. The UK’s Cancer Vaccine Launch Pad advances personalised mRNA cancer vaccine trials … Read the full press release
Posted in Belgium, Business, Germany, Healthcare, Pharma & Biotech, Science, Technology, United Kingdom
Tagged AstraZeneca, ATMP, autoimmunity, BioNTech, BioNTech’s BNT116, biotechnology, Cancer Vaccine Launch Pad, CAR-T therapy, clinical trials, CREATE Medicines, CureVac, EMA, EU-FAB, Europe, Europe Becomes a Hub for Next-Generation RNA Immunotherapy with Strong Clinical and Industrial Momentum, Europe’s Biotech Sector Accelerates RNA-Based Immunotherapy with Breakthroughs in CAR-T and mRNA Vaccines, Europe’s RNA Immunotherapy Industry Poised for Expansion as BioNTech AstraZeneca and CREATE Medicines Lead Advances, Europe’s RNA Immunotherapy Landscape Expands with First In Vivo CAR-T Trial and Growing mRNA Vaccine Efforts, Europe’s RNA Immunotherapy Pipeline Gains Scale as Regulators and Industry Push for Next-Gen Cancer Treatments, fibrosis, Germany, Imfinzi, immuno-oncology, in vivo CAR-T, INT2104, mRNA Vaccines, multi-lineage immune programming, Myeloid Therapeutics, NHS England, oncology, pharma, RNA immunotherapy, RNA Immunotherapy in Europe: Emerging Trials Strategic Mergers and a Clearer Regulatory Path, RNA Immunotherapy Takes Hold in Europe as BioNTech-CureVac Deal and CREATE Medicines Expansion Signal Maturity, RNA therapeutics, RNA-based therapies, United Kingdom
(IN BRIEF) The European Commission, EMA, and HMA have set new targets to strengthen Europe’s role in clinical research by authorising an additional 500 multinational clinical trials over five years and ensuring that two-thirds of studies begin patient recruitment within … Read the full press release
Posted in European Union, Government, Healthcare, Management, Netherlands, News, Pharma & Biotech, Science, Technology
Tagged ACT EU, Ana Zanoletty, clinical trial ecosystem, Clinical Trials Information System, Clinical Trials Regulation, COMBINE programme, Corinna Hartung, CTIS, CTR, CTR Collaborate, EMA, EMA and partners unveil new clinical trial benchmarks under ACT EU to enhance Europe’s competitiveness in medical research, EU healthcare, EU launches five-year plan to authorise 500 more multinational clinical trials and speed up patient recruitment timelines, Europe competitiveness, European Commission, Heads of Medicines Agencies, HMA, ICH E6 R3, innovative medicines, Marianne Lunzer, MedEthicsEU, medical research, multinational clinical trials, Patient Recruitment
(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
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