AstraZeneca today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapagliflozin) in patients with type-2 diabetes (T2D) to include cardiovascular (CV) outcomes data from the Phase III DECLARE-TIMI 58 trial.
AstraZeneca today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to add a self-administration option for Fasenra (benralizumab) and a new delivery method as a pre-filled, single-use auto-injector (the Fasenra pen) to the medicine’s product information in the European Union.
AstraZeneca today announced positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options for patients.
AstraZeneca today announced that Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD).
AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced that Lynparza (olaparib) has been approved in Japan as a maintenance treatment after 1st-line chemotherapy in patients with BRCA-mutated (BRCAm) advanced ovarian cancer, as detected by an approved companion diagnostic test.
AstraZeneca today announced that Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in Japan as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD).
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer.
AstraZeneca today announced detailed results from the interim analysis of the Phase III ASCEND trial at the European Hematology Association (EHA) Annual Congress in Amsterdam, showing Calquence (acalabrutinib) significantly prolonged the time patients live without disease progression in relapsed or refractory chronic lymphocytic leukaemia (CLL).
AstraZeneca today presented positive results from the Phase IIIb DIALIZE trial which investigated the efficacy and safety of Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia in patients with end-stage renal disease (ESRD) on haemodialysis.
Första resultat från observationsstudien CaReMe, baserad på registerdata från bland annat Sverige under åren 2007 till 2016, presenterades vid den amerikanska diabeteskongressen, ADA, den 9 juni. Studien har följt 645 180 personer med typ 2-diabetes som inte tidigare haft etablerad hjärt-kärlsjukdom.
AstraZeneca today announced positive results from the Phase III ELEVATE-TN trialof Calquence (acalabrutinib) in patients with previously-untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.1This is the second Calquence pivotal trial in CLL to meet its primary endpoint early, following the positive results of the ASCEND trial, announced in May.
AstraZeneca and MSD Inc., Kenilworth, N.J., US today presented full results from the Phase III SOLO3 trial which compared Lynparza (olaparib) with physician’s choice of chemotherapy in the treatment of patients with germline BRCA1/2-mutated (gBRCAm)advanced ovarian cancer who had received two or more prior lines of chemotherapy.
AstraZeneca has presented three-year overall survival (OS) results from the Phase III PACIFIC trial of Imfinzi (durvalumab) in unresectable, Stage III non-small cell lung cancer (NSCLC) during the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced detailed results from the Phase III POLO trial at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US (Abs #LBA4).Results are today also published in The New England Journal of Medicine (NEJM).
New data from Novel START, an open-label trial designed to reflect real-world practice, has demonstrated the effectiveness of Symbicort Turbuhaler (budesonide/formoterol) as a potential anti-inflammatory reliever in mild asthma.1
New data from the Symbicort Turbuhaler (budesonide/formoterol) Novel START trial is among 73 AstraZeneca abstracts accepted for oral or poster presentation at the American Thoracic Society (ATS) 2019 International Conference,17-22 May in Dallas, US.
AstraZeneca will present new research across an industry-leading Oncology portfolio, including data for its transformational cancer medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 31 May to 4 June 2019.
AstraZeneca today announced top-line results from the pooled cardiovascular (CV) safety analyses of the global Phase III programme for roxadustat, a first-in-class hypoxia-inducible-factor prolyl hydroxylase inhibitor (HIF-PHI).
AstraZeneca and Daiichi Sankyo Company, Limited today announced positive top-line results for the pivotal Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201). The HER2-targeting antibody drug conjugate (ADC) and potential new medicine was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.
AstraZeneca today announced positive results from the Phase III ASCEND trialof Calquence in previously-treated patients with chronic lymphocytic leukaemia. Results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Calquence monotherapy compared to a combination regimen of rituximab plus physician’s choice of idelalisib or bendamustine.