(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) 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) Novartis has announced that its Phase III PSMAddition trial of Pluvicto™ in combination with standard of care (SoC) has met its primary endpoint, showing a significant benefit in radiographic progression-free survival (rPFS) and a positive trend in overall … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged androgen receptor pathway inhibitors, cancer research, clinical trials, FDA approval, FDA regulatory review, metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, mHSPC, Novartis, Novartis oncology, overall survival, Phase III PSMAddition, Pluvicto, progression-free survival, prostate cancer, prostate cancer treatment, PSMA-positive, radioligand therapy, treatment options
(IN BRIEF) GSK has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma. The approval follows positive results from the DREAMM-7 and DREAMM-8 phase III trials, … Read the full press release
Posted in Business, Environment, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged anti-BCMA, antibody-drug conjugate, Blenrep, bortezomib, chemotherapy, clinical efficacy, clinical trials, DREAMM-7, DREAMM-8, global markets, GSK, Japan approval, Multiple Myeloma, oncology, orphan drug designation, overall survival, partnership, PDUFA, pomalidomide, progression-free survival, regulatory approval, sustainability, treatment options
(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) Researchers at the Institute of Cancer Research in London have identified genetic markers that predict a significant survival benefit from combining ipatasertib with abiraterone in treating metastatic castration-resistant prostate cancer. In the phase III IPATential150 trial, patients whose … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Science, Technology, United Kingdom
Tagged abiraterone, AKT inhibitor, biomarkers, clinical trial, genetic markers, Institute of Cancer Research London, ipatasertib, IPATential150 trial, metastatic castration-resistant prostate cancer mCRPC, overall survival, personalized medicine, PIK3CA/AKT1/PTEN pathway, Professor Johann de Bono, PTEN gene, Roche, sequencing techniques, synthetic lethality, targeted therapy, UK patients
(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) Sarclisa, an anti-CD38 treatment developed by Sanofi, has been approved in China for treating adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least one prior therapy. The approval is based on the … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged anti-CD38 antibody, autologous stem cell transplant, bortezomib, CACA, Category I Recommendation, Chinese Anti-Cancer Association, Chinese Society of Clinical Oncology, clinical data, CSCO, dexamethasone, Global Head of Oncology, ICARIA-MM phase 3 study, innovative regulatory pathways, innovative therapies, IsaFiRsT real-world study, Lecheng Pilot Program, lenalidomide, local authorities, medical community, National Medical Products Administration, newly diagnosed multiple myeloma, NMPA, Olivier Nataf, overall response rate, overall survival, Pd, pomalidomide, R/R MM, real-world evidence, regulatory submission, relapsed or refractory multiple myeloma, RWE, Sanofi, Sanofi in China, Sarclisa
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