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https://www.readbyqxmd.com/read/28795581/the-evolution-of-the-pharma-cro-working-relationship-astrazeneca-and-covance
#1
(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
#2
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
#3
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
#4
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...
July 25, 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
#5
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
#6
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...
July 17, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28724523/savolitinib-heads-for-phase-iii-trial-in-prcc
#7
(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
#8
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
#9
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
#10
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
#11
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
#12
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
https://www.readbyqxmd.com/read/28578601/olaparib-for-metastatic-breast-cancer-in-patients-with-a-germline-brca-mutation
#13
Mark Robson, Seock-Ah Im, Elżbieta Senkus, Binghe Xu, Susan M Domchek, Norikazu Masuda, Suzette Delaloge, Wei Li, Nadine Tung, Anne Armstrong, Wenting Wu, Carsten Goessl, Sarah Runswick, Pierfranco Conte
BACKGROUND: Olaparib is an oral poly(adenosine diphosphate-ribose) polymerase inhibitor that has promising antitumor activity in patients with metastatic breast cancer and a germline BRCA mutation. METHODS: We conducted a randomized, open-label, phase 3 trial in which olaparib monotherapy was compared with standard therapy in patients with a germline BRCA mutation and human epidermal growth factor receptor type 2 (HER2)-negative metastatic breast cancer who had received no more than two previous chemotherapy regimens for metastatic disease...
August 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28545978/benralizumab-for-patients-with-mild-to-moderate-persistent-asthma-bise-a-randomised-double-blind-placebo-controlled-phase-3-trial
#14
Gary T Ferguson, J Mark FitzGerald, Eugene R Bleecker, Michel Laviolette, David Bernstein, Craig LaForce, Lyndon Mansfield, Peter Barker, Yanping Wu, Maria Jison, Mitchell Goldman
BACKGROUND: Benralizumab is a humanised, anti-interleukin 5 receptor α monoclonal antibody that directly and rapidly depletes eosinophils, reduces asthma exacerbations, and improves lung function for patients with severe eosinophilic asthma. The objective of this trial was to assess the safety and efficacy of benralizumab for patients with mild to moderate, persistent asthma. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients aged 18-75 years, weighing at least 40 kg, and with a postbronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of at least 12% at screening, from 52 clinical research centres in six countries...
July 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28530840/oral-glucocorticoid-sparing-effect-of-benralizumab-in-severe-asthma
#15
RANDOMIZED CONTROLLED TRIAL
Parameswaran Nair, Sally Wenzel, Klaus F Rabe, Arnaud Bourdin, Njira L Lugogo, Piotr Kuna, Peter Barker, Stephanie Sproule, Sandhia Ponnarambil, Mitchell Goldman
BACKGROUND: Many patients with severe asthma rely on oral glucocorticoids to manage their disease. We investigated whether benralizumab, a monoclonal antibody directed against the alpha subunit of the interleukin-5 receptor that significantly reduces the incidence of asthma exacerbations, was also effective as an oral glucocorticoid-sparing therapy in patients relying on oral glucocorticoids to manage severe asthma associated with eosinophilia. METHODS: In a 28-week randomized, controlled trial, we assessed the effects of benralizumab (at a dose of 30 mg administered subcutaneously either every 4 weeks or every 8 weeks [with the first three doses administered every 4 weeks]) versus placebo on the reduction in the oral glucocorticoid dose while asthma control was maintained in adult patients with severe asthma...
June 22, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28530520/cardiovascular-disease-and-gout-real-world-experience-evaluating-patient-characteristics-treatment-patterns-and-health-care-utilization
#16
Michael H Pillinger, Sripal Bangalore, Alyssa B Klein, Scott Baumgartner, Robert Morlock
BACKGROUND: Gout, hyperuricemia, and cardiovascular disease (CVD) are prevalent conditions in the United States, and while they share common risk factors such as obesity, hypertension, hypercholesterolemia, and type 2 diabetes mellitus, relatively little is known about what patient and disease characteristics may link CVD with hyperuricemia and gout and how the presence of both diseases affects management decisions differently than for patients with gout alone. OBJECTIVE: To identify differences in patient characteristics, patterns of urate-lowering therapy (ULT) use, and gout control in gout patients with and without cardiovascular comorbidity...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28485203/expert-panel-recommendations-for-the-identification-and-management-of-hyperkalemia-and-role-of-patiromer-in-patients-with-chronic-kidney-disease-and-heart-failure
#17
Zubaid Rafique, Matthew R Weir, Macaulay Onuigbo, Bertram Pitt, Richard Lafayette, Javed Butler, Maria Lopes, Carolyn Farnum, W Frank Peacock
Virtual panel meetings were conducted among 7 physicians, all of whom are independent experts, including 3 nephrologists, 2 cardiologists, and 2 emergency medicine physicians (the panel). The panel met with the purpose of discussing the current treatment landscape, treatment challenges, economic impact, and gaps in care for patients with hyperkalemia that is associated with heart failure and chronic kidney disease. The stated goal of the panel discussion was to develop practical solutions in the identification and management of hyperkalemia in this patient population...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28448773/letter-prudent-formulary-management-or-underutilization-of-the-novel-p2y12-receptor-inhibitors-in-patients-with-acute-coronary-syndrome-who-received-percutaneous-coronary-intervention
#18
Ole Hauch
The author is a former employee of AstraZeneca and owns stock in AstraZeneca. The author reports no conflicts of interest related to the subject of this letter.
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28435240/risk-of-pneumonia-with-budesonide-containing-treatments-in-copd-an-individual-patient-level-pooled-analysis-of-interventional-studies
#19
Sally Hollis, Carin Jorup, Dan Lythgoe, Gunnar Martensson, Pontus Regnell, Göran Eckerwall
BACKGROUND: Concerns have been raised that treatment of COPD with inhaled corticosteroids may increase pneumonia risk. Responding to a request from the European Medicines Agency Pharmacovigilance Risk Assessment Committee, a pooled analysis of interventional studies compared pneumonia risk with inhaled budesonide-containing versus non-budesonide-containing treatments and the impact of other clinically relevant factors. METHODS: AstraZeneca-sponsored, parallel-group, double-blind, randomized controlled trials meeting the following criteria were included: >8 weeks' duration; ≥60 patients with COPD; inhaled budesonide treatment arm (budesonide/formoterol or budesonide); and non-budesonide-containing comparator arm (formoterol or placebo)...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28432619/assessment-of-saxagliptin-efficacy-meta-analysis-of-14-phase-2-and-3-clinical-trials
#20
Mikaela Sjöstrand, Cheryl Wei, William Cook, Kristina Johnsson, Pia S Pollack, Christina Stahre, Boaz Hirshberg
INTRODUCTION: This meta-analysis of data from 14 phase 2 and 3, double-blind, randomized, controlled 12- and 24-week studies (N = 4632) summarizes saxagliptin efficacy in patients with type 2 diabetes (T2D) across treatment regimens. METHODS: Patients received saxagliptin 5 mg/d or control as either monotherapy (n = 1196 vs placebo), add-on therapy (n = 2139 vs placebo and n = 514 vs uptitrated sulfonylurea), or initial combination therapy (n = 619 vs control monotherapy)...
June 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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