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) AstraZeneca reported positive Phase III Bax24 trial results showing that baxdrostat achieved a significant and clinically meaningful reduction in 24-hour ambulatory systolic blood pressure in patients with treatment-resistant hypertension. The once-daily oral therapy was well tolerated and maintained … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged Advancing Toward Regulatory Submission, AHA 2025, aldosterone, aldosterone synthase inhibitor, ambulatory blood pressure, American Heart Association, AstraZeneca, AstraZeneca’s Baxdrostat Achieves Significant Blood Pressure Reduction in Phase III Bax24 Trial, AstraZeneca’s Baxdrostat Achieves Strong Blood Pressure Reduction in Phase III Bax24 Trial for Resistant Hypertension, Bax24, Baxdrostat, Baxdrostat Delivers Significant 24-Hour Blood Pressure Control in Phase III Study, BaxHTN, Bryan Williams, cardiovascular health, Chronic kidney disease, clinical trial, heart failure prevention, Hypertension Treatment, Phase III results, primary aldosteronism, resistant hypertension, rHTN, SBP, Sharon Barr, systolic blood pressure
(IN BRIEF) AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu plus pertuzumab has been accepted for Priority Review by the FDA for the first-line treatment of HER2-positive metastatic breast cancer. The application is supported by data from the … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, AstraZeneca, breakthrough therapy designation, cancer treatment innovation, Daiichi Sankyo, DESTINY-Breast09, Enhertu, Enhertu plus pertuzumab moves closer to first-line approval in HER2-positive metastatic breast cancer after FDA Priority Review acceptance, FDA, FDA grants Priority Review to Enhertu plus pertuzumab for 1st-line HER2-positive metastatic breast cancer following DESTINY-Breast09 success, HER2-positive breast cancer, Ken Takeshita, metastatic breast cancer, oncology, pertuzumab, Priority Review, progression-free survival, Real-Time Oncology Review, Susan Galbraith, THP regimen, trastuzumab deruxtecan
(IN BRIEF) Alfa Laval is hosting ESS Innovation Day 2025 on 19 August in Lund, Sweden, an event that unites research directors from leading companies and universities to explore how neutron science from the European Spallation Source (ESS) can help … Read the full press release
Posted in Business, Energy, Gas & Oil, Financial, Industrial, Infrastructure & Utilities, Investment, Management, Marketing, Media, News, Sweden, Technology
Tagged academia and industry, Alfa Laval, Asker Healthcare, AstraZeneca, Chalmers University, Emma Adlerton, ESS, ESS Innovation Day 2025, European competitiveness, European Spallation Source, Helmut Schober, Hitachi Energy, industrial innovation, Jarla Invest, Julien Gennetier, Laurence Mott, Lund, Mene Pangalos, neutron science, R&D collaboration, sustainability, Sweden, Tetra Pak, Uppsala University
(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) 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) 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) The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) combined with gemcitabine and cisplatin as neoadjuvant therapy, followed by Imfinzi adjuvant monotherapy, for adults with resectable muscle-invasive bladder cancer. This approval is anchored in NIAGARA Phase III trial data … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged adjuvant monotherapy, AstraZeneca, cisplatin, curative intent, Dave Fredrickson, durvalumab, ESMO, European Commission, event-free survival, gemcitabine, Imfinzi, immunotherapy, MIBC, Michiel Van der Heijden, muscle-invasive bladder cancer, neoadjuvant chemotherapy, New England Journal of Medicine, NIAGARA Phase III, NMIBC, overall survival, radical cystectomy
(IN BRIEF) Sanofi has launched early global shipments of Beyfortus (nirsevimab) in anticipation of the 2025–2026 RSV season, enabling healthcare providers to begin immunizations well before the typical onset of infections in November. In collaboration with AstraZeneca, Sanofi has significantly … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged AstraZeneca, Beyfortus, EU label, extended protection, global distribution, hospitalizations, infant immunization, lower respiratory tract disease, monoclonal antibody, newborn care, nirsevimab, pediatric health, public health, real-world studies, respiratory syncytial virus, RSV, RSV season, Sanofi, Thomas Triomphe, Vaccine Innovation, vaccine supply chain
(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, BTK inhibitor, Calquence, chemoimmunotherapy, chronic lymphocytic leukaemia, clinical trial, CLL, Dave Fredrickson, European Commission approval, European Union, fixed-duration regimen, hematologic diseases, hematology, leukemia, obinutuzumab, oncology, progression-free survival, treatment option, venetoclax
(IN BRIEF) The POTOMAC Phase III trial results show that adding Imfinzi to standard BCG induction and maintenance therapy improves disease-free survival (DFS) for patients with high-risk non-muscle-invasive bladder cancer (NMIBC). The combination demonstrated significant benefits over BCG alone, with … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged AstraZeneca, Bacillus Calmette-Guérin, BCG, bladder cancer, cancer treatment, clinical trial, Cristian Massacesi, disease progression, disease-free survival, durvalumab, high-risk bladder cancer, Imfinzi, immunotherapy, Maria De Santis, NMIBC, non-muscle-invasive bladder cancer, Phase III Trial, POTOMAC
(IN BRIEF) Positive results from the Phase III KALOS and LOGOS trials show that AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) significantly improves lung function in patients with uncontrolled asthma, compared to dual-combination ICS/LABA therapy. The trials demonstrate the potential of Breztri … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged Alberto Papi, asthma, AstraZeneca, BioPharmaceuticals R&D, Breztri Aerosphere, budesonide/glycopyrronium/formoterol, chronic respiratory disease, clinical trials, COPD, global asthma statistics, ICS/LABA, KALOS, LOGOS, lung function, Phase III, regulatory authorities, Sharon Barr, triple-combination therapy
(IN BRIEF) At ESCMID Global 2025 in Vienna, AstraZeneca will present a comprehensive data package from its Vaccines & Immune Therapies portfolio, featuring 13 abstracts across oral and poster presentations. The Company aims to demonstrate its progress in developing innovative … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged AstraZeneca, AZD6563, Benjamin Moutier, bronchiectasis, COVID-19, ESCMID Global 2025, Fluenz, FluMist, hMPV, immunizations, infectious diseases, Klebsiella pneumoniae, monoclonal antibodies, mRNA, MRSA, preclinical data, Pseudomonas aeruginosa, Real-World Data, respiratory viral infections, RSV, serious bacterial infections, Staphylococcus aureus, Vaccines & Immune Therapies, variant-agnostic threshold, Vienna
(IN BRIEF) The MATTERHORN Phase III trial has demonstrated that a perioperative regimen combining AstraZeneca’s Imfinzi (durvalumab) with FLOT chemotherapy significantly improves event-free survival in patients with resectable gastric and gastroesophageal junction cancers compared to standard chemotherapy alone. Interim findings … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged adjuvant, AstraZeneca, clinical trial, Cristian Massacesi, durvalumab, early-stage, EFS, event-free survival, FLOT chemotherapy, gastric cancer, gastroesophageal junction, GEJ cancers, global, Imfinzi, immunotherapy, locally advanced, MATTERHORN, Memorial Sloan Kettering, neoadjuvant, OS, overall survival, pathologic complete response, PCR, Phase III Trial, randomized, resectable, safety profile, tumor regression, Yelena Y. Janjigian
(IN BRIEF) The Conference Forum has announced the 9th annual Patients as Partners® Europe event, scheduled for May 20-21, 2025, at the Royal National Hotel in London. This event offers a platform for pharma R&D and patient advocacy to discuss … Read the full press release
Posted in France, Healthcare, Marketing, Pharma & Biotech, Science, Switzerland, United Kingdom
Tagged Alfred Samuels, AstraZeneca, Azafaros, Beyza Klein, Biotech, Biotechnology Conference, Boehringer Ingelheim, Bre Bugbee-Barrett, Catherine Coulouvrat MD, Chiesi Farmaceutici SpA, clinical development, clinical operations, clinical research, clinical research enterprise, clinical trial, clinical trials, Conference Forum, decentralized clinical trials, Gisela Linthorst, GSK, Harry Verbunt, HTA/Regulatory requirements, Johnson & Johnson Innovative Medicine, Lea-Isabelle Proulx PhD, life post-cancer diagnosis, Marisa Minetti, Medicine Development, Patient Advocacy, patient engagement, patient engagement in drug development, patient experience, Patient Recruitment, Patient Retention, Patients as Partners, Patients as Partners Europe, Peter DiBiaso, pharma, Pharmaceutical Conference, Regeneron, research and development, Roche, Royal National Hotel, Sanofi, Temi Olonisakin MD, The Conference Forum, Valerie Bowling
(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) AstraZeneca’s Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval is based on … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged acalabrutinib, AstraZeneca, autologous hematopoietic stem cell transplantation, bendamustine, blood cancers, Bruton’s tyrosine kinase, BTK inhibitor, Calquence, chemoimmunotherapy, COVID-19, Dave Fredrickson, ECHO Phase III trial, FDA, global regulatory review, international markets, Lymphoma Research Foundation, mantle cell lymphoma, MCL, Meghan Gutierrez, Michael Wang, oncology, PFS, progression-free survival, Project Orbis, regulatory submission, rituximab, safety profile, U.S. approval
(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged advanced NSCLC, antibody-drug conjugate, AstraZeneca, Biologics License Application, BLA, breakthrough therapy designation, Daiichi Sankyo, datopotamab deruxtecan, drug approval, EGFR-mutated, EGFR-tyrosine kinase inhibitors, FDA, metastatic NSCLC, non-small cell lung cancer, NSCLC, objective response rate, oncology, partnership, Phase III Trials, Priority Review, safety profile, systemic therapies, TROP2-directed, TROPION-Lung01, TROPION-Lung05, TROPION-Lung14, TROPION-Lung15
(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has been granted Priority Review by the FDA for the treatment of muscle-invasive bladder cancer (MIBC), potentially becoming the first perioperative immunotherapy in this curative-intent setting. Supported by results from the NIAGARA Phase III trial, … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AstraZeneca, bladder cancer, FDA, Imfinzi, Perioperative Immunotherapy, safety, Susan Galbraith
(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the EU for treating adult patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) with EGFR mutations who have not experienced disease progression after platinum-based chemoradiation therapy. This … 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 Adrian Kemp, AstraZeneca, Dr. Manuel Cobo, safety, Susan Galbraith, Tagrisso, therapy, Unresectable EGFR-Mutated Lung Cancer
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