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https://www.readbyqxmd.com/read/28919200/predictors-of-enhanced-response-with-benralizumab-for-patients-with-severe-asthma-pooled-analysis-of-the-sirocco-and-calima-studies
#1
J Mark FitzGerald, Eugene R Bleecker, Andrew Menzies-Gow, James G Zangrilli, Ian Hirsch, Paul Metcalfe, Paul Newbold, Mitchell Goldman
BACKGROUND: Benralizumab is an anti-eosinophilic, anti-interleukin-5 receptor α monoclonal antibody that has been shown to significantly reduce asthma exacerbations and improve lung function for patients with severe, uncontrolled asthma. We further explored the efficacy of benralizumab for patients with different baseline blood eosinophil thresholds and exacerbation histories. METHODS: This study is a pooled analysis of the results from the randomised, double-blind, placebo-controlled SIROCCO (NCT01928771) and CALIMA (NCT01914757) phase 3 studies...
September 8, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28919061/efficacy-and-safety-of-dapagliflozin-in-patients-with-inadequately-controlled-type-1-diabetes-depict-1-24-week-results-from-a-multicentre-double-blind-phase-3-randomised-controlled-trial
#2
Paresh Dandona, Chantal Mathieu, Moshe Phillip, Lars Hansen, Steven C Griffen, Diethelm Tschöpe, Fredrik Thorén, John Xu, Anna Maria Langkilde
BACKGROUND: Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor approved for the treatment of type 2 diabetes. We aimed to assess the efficacy and safety of dapagliflozin as an add-on to adjustable insulin in patients with inadequately controlled type 1 diabetes. METHODS: DEPICT-1 was a double-blind, randomised, parallel-controlled, three-arm, phase 3, multicentre study done at 143 sites in 17 countries. Eligible patients were aged 18-75 years and had inadequately controlled type 1 diabetes (HbA1c between ≥7·7% and ≤11·0% [≥61·0 mmol/mol and ≤97·0 mmol/mol]) and had been prescribed insulin for at least 12 months before enrolment...
September 13, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28916556/cell-scientist-to-watch-paul-timpson
#3
(no author information available yet)
Paul Timpson received his bachelor's degree from the University of Strathclyde, UK and completed his PhD under the supervision of Margaret Frame at the Beatson Institute for Cancer Research and the University of Glasgow in 2002, working on Src kinases and Rho family GTPases in cancer cell invasion. He then moved to the Garvan Institute of Medical Research in Sydney, Australia to work with Roger Daly on the actin-binding protein cortactin in several cancer models. Paul returned to the Beatson Institute in 2007 with the aid of an AstraZeneca postdoctoral research fellowship...
September 15, 2017: Journal of Cell Science
https://www.readbyqxmd.com/read/28916303/high-throughput-flow-cytometry-for-drug-discovery-principles-applications-and-case-studies
#4
REVIEW
Mei Ding, Karin Kaspersson, David Murray, Catherine Bardelle
Flow cytometry is a technology providing multiparametric analysis of single cells or other suspension particles. High-throughput (HT) flow cytometry has become an attractive screening platform for drug discovery. In this review, we highlight the recent HT flow cytometry applications, and then focus on HT flow cytometry deployment at AstraZeneca (AZ). Practical considerations for successful HT flow cytometry assay development and screening are provided based on experience from four project case studies at AZ...
September 12, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/28885881/durvalumab-after-chemoradiotherapy-in-stage-iii-non-small-cell-lung-cancer
#5
Scott J Antonia, Augusto Villegas, Davey Daniel, David Vicente, Shuji Murakami, Rina Hui, Takashi Yokoi, Alberto Chiappori, Ki H Lee, Maike de Wit, Byoung C Cho, Maryam Bourhaba, Xavier Quantin, Takaaki Tokito, Tarek Mekhail, David Planchard, Young-Chul Kim, Christos S Karapetis, Sandrine Hiret, Gyula Ostoros, Kaoru Kubota, Jhanelle E Gray, Luis Paz-Ares, Javier de Castro Carpeño, Catherine Wadsworth, Giovanni Melillo, Haiyi Jiang, Yifan Huang, Phillip A Dennis, Mustafa Özgüroğlu
Background Most patients with locally advanced, unresectable, non-small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy). This phase 3 study compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy. Methods We randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months...
September 8, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28877011/tezepelumab-in-adults-with-uncontrolled-asthma
#6
Jonathan Corren, Jane R Parnes, Liangwei Wang, May Mo, Stephanie L Roseti, Janet M Griffiths, René van der Merwe
BACKGROUND: In some patients with moderate-to-severe asthma, particularly those with noneosinophilic inflammation, the disease remains uncontrolled. This trial evaluated the efficacy and safety of tezepelumab (AMG 157/MEDI9929), a human monoclonal antibody specific for the epithelial-cell-derived cytokine thymic stromal lymphopoietin (TSLP), in patients whose asthma remained uncontrolled despite treatment with long-acting beta-agonists and medium-to-high doses of inhaled glucocorticoids...
September 7, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28866800/chronologic-age-at-hospitalization-for-respiratory-syncytial-virus-among-preterm-and-term-infants-in-the-united-states
#7
Rohan C Parikh, Kimmie K McLaurin, Andrea V Margulis, Josephine Mauskopf, Christopher S Ambrose, Melissa Pavilack, Sean D Candrilli
INTRODUCTION: Respiratory syncytial virus (RSV) is the leading cause of hospitalization among infants in the United States, and the risk for RSV hospitalizations is greater for infants born preterm. Recent studies in preterm and term infants have shown that RSV hospitalization rates vary considerably depending on infant chronologic age. This study sought to aggregate the data available from published literature and from nationally representative databases of US infant hospitalizations to generate a composite description of the effect of young chronologic age on RSV hospitalizations among US preterm and term infants by individual month of age...
September 2, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/28851537/use-of-a-collaborative-tool-to-simplify-the-outsourcing-of-preclinical-safety-studies-an-insight-into-the-astrazeneca-charles-river-laboratories-strategic-relationship
#8
Frederic D C Martin, Amanda Benjamin, Ruth MacLean, David M Hollinshead, Claire Landqvist
In 2012, AstraZeneca entered into a strategic relationship with Charles River Laboratories whereby preclinical safety packages comprising safety pharmacology, toxicology, formulation analysis, in vivo ADME, bioanalysis and pharmacokinetics studies are outsourced. New processes were put in place to ensure seamless workflows with the aim of accelerating the delivery of new medicines to patients. Here, we describe in more detail the AstraZeneca preclinical safety outsourcing model and the way in which a collaborative tool has helped to translate the processes in AstraZeneca and Charles River Laboratories into simpler integrated workflows that are efficient and visible across the two companies...
August 26, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/28795581/the-evolution-of-the-pharma-cro-working-relationship-astrazeneca-and-covance
#9
(no author information available yet)
Christopher Bailey (AstraZeneca) and Lee Goodwin (Covance) speak to Sankeetha Nadarajah (Managing Commissioning Editor, Bioanalysis) about the evolution of the Pharma-CRO working relationship between AstraZeneca and Covance.
August 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28781064/cardiovascular-mortality-and-morbidity-in-patients-with-type-2-diabetes-following-initiation-of-sodium-glucose-co-transporter-2-inhibitors-versus-other-glucose-lowering-drugs-cvd-real-nordic-a-multinational-observational-analysis
#10
Kåre I Birkeland, Marit E Jørgensen, Bendix Carstensen, Frederik Persson, Hanne L Gulseth, Marcus Thuresson, Peter Fenici, David Nathanson, Thomas Nyström, Jan W Eriksson, Johan Bodegård, Anna Norhammar
BACKGROUND: In patients with type 2 diabetes and a high cardiovascular risk profile, the sodium-glucose co-transporter-2 (SGLT2) inhibitors empagliflozin and canagliflozin have been shown to lower cardiovascular morbidity and mortality. Using real-world data from clinical practice, we aimed to compare cardiovascular mortality and morbidity in new users of SGLT2 inhibitors versus new users of other glucose-lowering drugs, in a population with a broad cardiovascular risk profile. METHODS: CVD-REAL Nordic was an observational analysis of individual patient-level data from the Prescribed Drug Registers, Cause of Death Registers, and National Patient Registers in Denmark, Norway, and Sweden...
August 3, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28762755/astrazeneca-and-covance-laboratories-clinical-bioanalysis-alliance-an-evolutionary-outsourcing-model
#11
Cecilia Arfvidsson, Paul Severin, Victoria Holmes, Richard Mitchell, Christopher Bailey, Stephanie Cape, Yan Li, Tammy Harter
The AstraZeneca and Covance Laboratories Clinical Bioanalysis Alliance (CBioA) was launched in 2011 after a period of global economic recession. In this challenging environment, AstraZeneca elected to move to a full and centralized outsourcing model that could optimize the number of people supporting bioanalytical work and reduce the analytical cost. This paper describes the key aspects of CBioA, the innovative operational model implemented, and our ways of ensuring this was much more than simply a cost reduction exercise...
August 1, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28754483/olaparib-tablets-as-maintenance-therapy-in-patients-with-platinum-sensitive-relapsed-ovarian-cancer-and-a-brca1-2-mutation-solo2-engot-ov21-a-double-blind-randomised-placebo-controlled-phase-3-trial
#12
Eric Pujade-Lauraine, Jonathan A Ledermann, Frédéric Selle, Val Gebski, Richard T Penson, Amit M Oza, Jacob Korach, Tomasz Huzarski, Andrés Poveda, Sandro Pignata, Michael Friedlander, Nicoletta Colombo, Philipp Harter, Keiichi Fujiwara, Isabelle Ray-Coquard, Susana Banerjee, Joyce Liu, Elizabeth S Lowe, Ralph Bloomfield, Patricia Pautier
BACKGROUND: Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib. METHODS: This international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy...
September 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28737992/temporal-trends-in-use-of-biologic-dmards-for-rheumatoid-arthritis-in-the-united-states-a-cohort-study-of-publicly-and-privately-insured-patients
#13
Rishi J Desai, Daniel H Solomon, Yinzhu Jin, Jun Liu, Seoyoung C Kim
BACKGROUND: Ten biologic disease-modifying antirheumatic drugs (bDMARDs) are available as treatment for rheumatoid arthritis (RA), but relatively little is known about population-level time trends in the use of these agents. OBJECTIVE: To describe time trends in the use of bDMARDs in RA patients with private or public insurance in the United States. METHODS: Claims data from private (Optum Clinformatics, 2004-2015) and public (Medicaid Analytic eXtract [MAX], 2000-2010) insurance programs were used...
August 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28729154/tremelimumab-as-second-line-or-third-line-treatment-in-relapsed-malignant-mesothelioma-determine-a-multicentre-international-randomised-double-blind-placebo-controlled-phase-2b-trial
#14
Michele Maio, Arnaud Scherpereel, Luana Calabrò, Joachim Aerts, Susana Cedres Perez, Alessandra Bearz, Kristiaan Nackaerts, Dean A Fennell, Dariusz Kowalski, Anne S Tsao, Paul Taylor, Federica Grosso, Scott J Antonia, Anna K Nowak, Maria Taboada, Martina Puglisi, Paul K Stockman, Hedy L Kindler
BACKGROUND: New therapeutic strategies for malignant mesothelioma are urgently needed. In the DETERMINE study, we investigated the effects of the cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody tremelimumab in patients with previously treated advanced malignant mesothelioma. METHODS: DETERMINE was a double-blind, placebo-controlled, phase 2b trial done at 105 study centres across 19 countries in patients with unresectable pleural or peritoneal malignant mesothelioma who had progressed after one or two previous systemic treatments for advanced disease...
September 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28724523/savolitinib-heads-for-phase-iii-trial-in-prcc
#15
(no author information available yet)
A phase II trial of savolitinib, a MET inhibitor, found that the drug induced partial responses in some patients with papillary renal cell carcinoma and was well tolerated, prompting drug makers Chi-Med and AstraZeneca to launch a phase III study.
July 19, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28720658/ticagrelor-versus-aspirin-in-acute-embolic-stroke-of-undetermined-source
#16
Pierre Amarenco, Gregory W Albers, Hans Denison, J Donald Easton, Scott R Evans, Peter Held, Michael D Hill, Jenny Jonasson, Scott E Kasner, Per Ladenvall, Kazuo Minematsu, Carlos A Molina, Yongjun Wang, K S Lawrence Wong, S Claiborne Johnston
BACKGROUND AND PURPOSE: Ticagrelor is an effective antiplatelet therapy among patients with atherosclerotic disease and, therefore, could be more effective than aspirin in preventing recurrent stroke and cardiovascular events among patients with embolic stroke of unknown source (ESUS), which includes patients with ipsilateral stenosis <50% and aortic arch atherosclerosis. METHODS: We randomized 13 199 patients with a noncardioembolic, nonsevere ischemic stroke or high-risk transient ischemic attack to ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily for days 2-90) or aspirin (300 mg on day 1 followed by 100 mg daily for days 2-90) within 24 hours of symptom onset...
July 18, 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28716794/incidence-of-live-attenuated-influenza-vaccine-administration-beyond-expiry-date-in-children-and-adolescents-aged-2-17-years-in-the-uk-a-population-based-cohort-study
#17
Herve Caspard, Robert P Wise, Amy Steffey, Robert S Brody
OBJECTIVES: To estimate the proportion of live-attenuated influenza vaccine (LAIV) doses administered beyond expiry date in children and adolescents during influenza seasons 2013-2014 and 2014-2015 in the UK. DESIGN: This was a retrospective cohort study. Two cohorts of children and adolescents who received LAIV from 1 September 2013 to 31 March 2014 and from 1 September 2014 to 31 March 2015 and aged 2-17 years at time of LAIV administration were identified from the Clinical Practice Research Datalink (CPRD)...
July 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28670474/on-the-bridge-over-the-translational-valley-of-death-interview-with-per-i-arvidsson
#18
Per I Arvidsson
Per I Arvidsson speaks to Francesca Lake, Managing Editor: Per received his PhD in organic chemistry from Gothenburg University (Sweden) in 1999, where he continued as a lecturer for a short time. Following 2 years at the ETH Zurich (Switzerland) as a postdoctoral fellow, he went on to establish an independent research group at the Department of Biochemistry and Organic Chemistry at Uppsala University (Sweden). In 2006, he joined AstraZeneca R&D Södertälje (Sweden). After 1-year in-house training for future leaders in drug discovery and development, he became team leader in Medicinal Chemistry in 2007...
June 2017: Future Science OA
https://www.readbyqxmd.com/read/28643244/durvalumab-first-global-approval
#19
Yahiya Y Syed
Intravenous durvalumab (Imfinzi™; AstraZeneca) is a fully human monoclonal antibody that blocks programmed cell death ligand-1 binding to its receptors (PD-1 and CD80), resulting in enhanced T-cell responses against cancer cells. The US FDA has granted durvalumab accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy...
August 2017: Drugs
https://www.readbyqxmd.com/read/28583396/a-novel-endpoint-for-exacerbations-in-asthma-to-accelerate-clinical-development-a-post-hoc-analysis-of-randomised-controlled-trials
#20
Anne L Fuhlbrigge, Thomas Bengtsson, Stefan Peterson, Alexandra Jauhiainen, Göran Eriksson, Carla A Da Silva, Anthony Johnson, Tariq Sethi, Nicholas Locantore, Ruth Tal-Singer, Malin Fagerås
BACKGROUND: Occurrence of severe asthma exacerbations are the cornerstone of the evaluation of asthma management, but severe asthma exacerbations are rare events. Therefore, trials that assess drug efficacy on exacerbations are done late in clinical development programmes. We aimed to establish an endpoint capturing clinically relevant deteriorations (diary events) that, when combined with severe exacerbations, create a composite outcome (CompEx). CompEx needs to strongly mirror results seen with the severe exacerbation-validated outcome, to allow the design of clinical trials of shorter duration and that include fewer patients than trials assessing severe exacerbations...
July 2017: Lancet Respiratory Medicine
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