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https://www.readbyqxmd.com/read/29773326/tremelimumab-combined-with-durvalumab-in-patients-with-mesothelioma-nibit-meso-1-an-open-label-non-randomised-phase-2-study
#1
Luana Calabrò, Aldo Morra, Diana Giannarelli, Giovanni Amato, Armida D'Incecco, Alessia Covre, Arthur Lewis, Marlon C Rebelatto, Riccardo Danielli, Maresa Altomonte, Anna Maria Di Giacomo, Michele Maio
BACKGROUND: Tremelimumab, an anti-CTLA4 monoclonal antibody, initially showed good activity when used alone in patients with mesothelioma, but did not improve the overall survival of patients who failed on first-line or second-line chemotherapy compared with placebo in the DETERMINE study. We aimed to investigate the efficacy and safety of first-line or second-line tremelimumab combined with durvalumab, an anti-PD-L1 monoclonal antibody, in patients with malignant mesothelioma. METHODS: In this open-label, non-randomised, phase 2 trial, patients with unresectable pleural or peritoneal mesothelioma received intravenous tremelimumab (1 mg/kg bodyweight) and durvalumab (20 mg/kg bodyweight) every 4 weeks for four doses, followed by maintenance intravenous durvalumab at the same dose and schedule for nine doses...
May 14, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29768149/inhaled-combined-budesonide-formoterol-as-needed-in-mild-asthma
#2
Paul M O'Byrne, J Mark FitzGerald, Eric D Bateman, Peter J Barnes, Nanshan Zhong, Christina Keen, Carin Jorup, Rosa Lamarca, Stefan Ivanov, Helen K Reddel
BACKGROUND: In patients with mild asthma, as-needed use of an inhaled glucocorticoid plus a fast-acting β2 -agonist may be an alternative to conventional treatment strategies. METHODS: We conducted a 52-week, double-blind trial involving patients 12 years of age or older with mild asthma. Patients were randomly assigned to one of three regimens: twice-daily placebo plus terbutaline (0.5 mg) used as needed (terbutaline group), twice-daily placebo plus budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol) used as needed (budesonide-formoterol group), or twice-daily budesonide (200 μg) plus terbutaline used as needed (budesonide maintenance group)...
May 17, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29768147/as-needed-budesonide-formoterol-versus-maintenance-budesonide-in-mild-asthma
#3
Eric D Bateman, Helen K Reddel, Paul M O'Byrne, Peter J Barnes, Nanshan Zhong, Christina Keen, Carin Jorup, Rosa Lamarca, Agnieszka Siwek-Posluszna, J Mark FitzGerald
BACKGROUND: Patients with mild asthma often rely on inhaled short-acting β2 -agonists for symptom relief and have poor adherence to maintenance therapy. Another approach might be for patients to receive a fast-acting reliever plus an inhaled glucocorticoid component on an as-needed basis to address symptoms and exacerbation risk. METHODS: We conducted a 52-week, double-blind, multicenter trial involving patients 12 years of age or older who had mild asthma and were eligible for treatment with regular inhaled glucocorticoids...
May 17, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29766771/five-year-risk-of-stroke-after-tia-or-minor-ischemic-stroke
#4
Pierre Amarenco, Philippa C Lavallée, Linsay Monteiro Tavares, Julien Labreuche, Gregory W Albers, Halim Abboud, Sabrina Anticoli, Heinrich Audebert, Natan M Bornstein, Louis R Caplan, Manuel Correia, Geoffrey A Donnan, José M Ferro, Fernando Gongora-Rivera, Wolfgang Heide, Michael G Hennerici, Peter J Kelly, Michal Král, Hsiu-Fen Lin, Carlos Molina, Jong Moo Park, Francisco Purroy, Peter M Rothwell, Tomas Segura, David Školoudík, P Gabriel Steg, Pierre-Jean Touboul, Shinichiro Uchiyama, Éric Vicaut, Yongjun Wang, Lawrence K S Wong
Background After a transient ischemic attack (TIA) or minor stroke, the long-term risk of stroke and other vascular events is not well known. In this follow-up to a report on 1-year outcomes from a registry of TIA clinics in 21 countries that enrolled 4789 patients with a TIA or minor ischemic stroke from 2009 through 2011, we examined the 5-year risk of stroke and vascular events. Methods We evaluated patients who had had a TIA or minor stroke within 7 days before enrollment in the registry. Among 61 sites that participated in the 1-year outcome study, we selected 42 sites that had follow-up data on more than 50% of their enrolled patients at 5 years...
May 16, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29758944/the-conundrum-of-gsk3-inhibitors-is-it-the-dawn-of-a-new-beginning
#5
Ratan V Bhat, Ulf Andersson, Shalini Andersson, Laurent Knerr, Udo Bauer, Anna Sundgren Andersson
Spanning over three decades of extensive drug discovery research, the efforts to develop a potent and selective GSK3 inhibitor as a therapeutic for the treatment of type 2 diabetes, Alzheimer's disease (AD), bipolar disorders and cancer have been futile. Since its initial discovery in 1980 and subsequent decades of research, one cannot underscore the importance of the target and the promise of a game changing disease modifier. Several pharmaceutical companies, biotech companies, and academic institutions raged in a quest to unravel the biology and discover potent and selective GSK3 inhibitors, some of which went through clinical trials...
May 11, 2018: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/29714612/medical-science-liaisons-in-real-world-evidence-studies-experience-of-astrazeneca-russia
#6
Nikolay Suvorov, Vera Karaseva, Ekaterina Stukalina, Elkhan Sanay, Vera Petrakovskaya, Vladimir Bulatov
There is no doubt that real-world evidence studies have the potential to improve and accelerate the development and delivery of safe and cost-effective innovative medicines to patients as well as influence the way we approach health and health care. Real-world evidence studies are a great challenge in terms of development and conduct, so there should be a good collaboration between the study team and clinical sites at all times, resulting eventually in timely and efficient enrollment. Engaging the sites and key external experts as early as possible during feasibility and routine visits, as well as highlighting the science rationale behind AstraZeneca's portfolio at investigator meetings and during medical science liaison (MSL) interactions, can create a positive impact on physician perception of a particular study and prioritization of patient recruitment in such studies...
January 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29706139/enduring-effects-of-psychological-treatments-for-anxiety-disorders-meta-analysis-of-follow-up-studies
#7
Borwin Bandelow, Anne Sagebiel, Michael Belz, Yvonne Görlich, Sophie Michaelis, Dirk Wedekind
BACKGROUND: It is a widespread opinion that after treatment with psychotherapy, patients with anxiety disorders maintain their gains beyond the active treatment period, whereas patients treated with medication soon experience a relapse after treatment termination.AimsWe aimed to provide evidence on whether enduring effects of psychotherapy differ from control groups. METHOD: We searched 93 randomised controlled studies with 152 study arms of psychological treatment (cognitive-behavioural therapy or other psychotherapies) for panic disorder, generalised anxiety disorder and social anxiety disorder that included follow-up assessments...
April 30, 2018: British Journal of Psychiatry: the Journal of Mental Science
https://www.readbyqxmd.com/read/29614307/lc-ms-ms-reveals-the-formation-of-reactive-ortho-quinone-and-iminium-intermediates-in-saracatinib-metabolism-phase-i-metabolic-profiling
#8
Mohamed W Attwa, Adnan A Kadi, Hany W Darwish, Haitham Alrabiah
Saracatinib (AZD-0530) is a drug under clinical trials that developed by AstraZeneca. It is considered a dual kinase inhibitor, with selective actions as a Src inhibitor and a Bcr-Abl tyrosine-kinase inhibitor. Saracatinib chemical structure contains N-methyl piperazine group and 1,3 benzodioxole group. N-methyl piperazine group that can be bioactivated to form iminium intermediates which can be captured by KCN. 1,3-Benzodioxole group can be bioactivated to form ortho-quinone intermediate that can be conjugated with GSH...
March 31, 2018: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/29602020/mimicking-brain-tissue-binding-in-an-in-vitro-model-of-the-blood-brain-barrier-illustrates-differences-between-in-vitro-and-in-vivo-methods-for-assessing-the-rate-of-brain-penetration
#9
Marjolein Heymans, Emmanuel Sevin, Fabien Gosselet, Stefan Lundquist, Maxime Culot
Assessing the rate of drug delivery to the central nervous system (CNS) in vitro has been used for decades to predict whether CNS drug candidates are likely to attain their pharmacological targets, located within the brain parenchyma, at an effective dose. The predictive value of in vitro blood-brain barrier (BBB) models is therefore frequently assessed by comparing in vitro BBB permeability, usually quoted as the endothelial permeability coefficient (Pe ) or apparent permeability (Papp ), to their rate of BBB permeation measured in vivo, the latter being commonly assessed in rodents...
March 27, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29600850/reflex3d-refined-flexible-alignment-of-molecules-using-shape-and-electrostatics
#10
Thomas Christian Schmidt, David A Cosgrove, Jonas Boström
We present an algorithm, ReFlex3D, for the refinement of flexible molecular alignments based on their three dimensional shape and electrostatic properties. The algorithm is designed to be used with fast conformer generators to refine an initial overlay between two molecules and thus to obtain improved overlaps as judged by an increase in calculated similarity values. ReFlex3D is open-source and built as a python package working in combination with the OEChem Toolkit. As such it can readily be implemented in existing workflows ranging from the selection of compounds from a virtual screening campaign to the construction of similarity based prediction models to estimate binding affinities...
March 30, 2018: Journal of Chemical Information and Modeling
https://www.readbyqxmd.com/read/29578852/economic-burden-of-patients-with-inadequate-response-to-targeted-immunomodulators-for-rheumatoid-arthritis
#11
Vibeke Strand, Namita Tundia, Yan Song, Dendy Macaulay, Mahesh Fuldeore
BACKGROUND: Targeted immunomodulators (TIMs), including biologic disease-modifying antirheumatic drugs (DMARDs) and JAK/STAT inhibitors, are effective therapies for rheumatoid arthritis (RA), but some patients fail to respond or lose response over time. This study estimated the real-world prevalence of RA patients with inadequate responses to an initial TIM (nonresponders) in the United States and assessed their direct and indirect economic burden compared with treatment responders. METHODS: Administrative claims data (January 1999-March 2014) from a large private-insurer database were used, which included work-loss data from a subset of reporting companies...
April 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29551618/long-term-effects-of-discontinuation-from-antipsychotic-maintenance-following-first-episode-schizophrenia-and-related-disorders-a-10-year-follow-up-of-a-randomised-double-blind-trial
#12
Christy L M Hui, William G Honer, Edwin H M Lee, Wing Chung Chang, Sherry K W Chan, Emily S M Chen, Edwin P F Pang, Simon S Y Lui, Dicky W S Chung, Wai Song Yeung, Roger M K Ng, William T L Lo, Peter B Jones, Pak Sham, Eric Y H Chen
BACKGROUND: The long-term consequences of discontinuing antipsychotic medication after successful treatment of first-episode psychosis are not well studied. We assess the relation between early maintenance therapy decisions in first-episode psychosis and the subsequent clinical outcome at 10 years. METHODS: This is a 10 year follow-up study, spanning Sept 5, 2003, to Dec 30, 2014, of a randomised, double-blind trial in seven centres in Hong Kong in which 178 patients with first-episode psychosis with full positive symptom resolution after at least 1 year of antipsychotic treatment were given maintenance treatment (n=89; oral quetiapine 400 mg daily) or early treatment discontinuation (n=89; placebo) for 12 months...
March 15, 2018: Lancet Psychiatry
https://www.readbyqxmd.com/read/29545095/durvalumab-as-third-line-or-later-treatment-for-advanced-non-small-cell-lung-cancer-atlantic-an-open-label-single-arm-phase-2-study
#13
Marina Chiara Garassino, Byoung-Chul Cho, Joo-Hang Kim, Julien Mazières, Johan Vansteenkiste, Hervé Lena, Jesus Corral Jaime, Jhanelle E Gray, John Powderly, Christos Chouaid, Paolo Bidoli, Paul Wheatley-Price, Keunchil Park, Ross A Soo, Yifan Huang, Catherine Wadsworth, Phillip A Dennis, Naiyer A Rizvi
BACKGROUND: Immune checkpoint inhibitors are a new standard of care for patients with advanced non-small-cell lung cancer (NSCLC) without EGFR tyrosine kinase or anaplastic lymphoma kinase (ALK) genetic aberrations (EGFR-/ALK-), but clinical benefit in patients with EGFR mutations or ALK rearrangements (EGFR+/ALK+) has not been shown. We assessed the effect of durvalumab (anti-PD-L1) treatment in three cohorts of patients with NSCLC defined by EGFR/ALK status and tumour expression of PD-L1...
March 12, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29464664/benralizumab-first-global-approval
#14
A Markham
Kyowa Hakko Kirin, AstraZeneca and subsidiaries are developing benralizumab (Fasenra™)-a humanised anti-interleukin-5 receptor alpha chain (IL-5Rα) monoclonal antibody-as a treatment of severe eosinophilic asthma and chronic obstructive pulmonary disease (COPD). Eosinophilia is a characteristic of certain asthma and COPD phenotypes and depletion of eosinophils has demonstrated therapeutic benefit. Benralizumab was recently approved by the US FDA as add-on maintenance therapy for patients with severe asthma who have an eosinophilic phenotype...
March 2018: Drugs
https://www.readbyqxmd.com/read/29440213/does-industry-sponsored-education-foster-overdiagnosis-and-overtreatment-of-depression-osteoporosis-and-over-active-bladder-syndrome-an-australian-cohort-study
#15
Barbara Mintzes, Swestika Swandari, Alice Fabbri, Quinn Grundy, Ray Moynihan, Lisa Bero
OBJECTIVES: To investigate patterns of industry-sponsored educational events that focus on specific health conditions for which there are concerns about overdiagnosis and overtreatment. DESIGN AND SETTING: This retrospective cohort study examines publicly reported industry-sponsored events in Australia from October 2011 to September 2015 for three conditions potentially subject to overdiagnosis and overtreatment: depression, osteoporosis and overactive bladder. We used a database of transparency reports to identify events with a focus on depression, osteoporosis and overactive bladder and compared these with other sponsored events...
February 13, 2018: BMJ Open
https://www.readbyqxmd.com/read/29383980/optimizing-anti-vegf-treatment-outcomes-for-patients-with-neovascular-age-related-macular-degeneration
#16
Charles C Wykoff, W Lloyd Clark, Jared S Nielsen, Joel V Brill, Laurence S Greene, Cherilyn L Heggen
BACKGROUND: The introduction of anti-vascular endothelial growth factor (anti-VEGF) drugs to ophthalmology has revolutionized the treatment of neovascular age-related macular degeneration (nAMD). Despite this significant progress, gaps and challenges persist in the diagnosis of nAMD, initiation of treatment, and management of frequent intravitreal injections. Thus, nAMD remains a leading cause of blindness in the United States. OBJECTIVE: To present current knowledge, evidence, and expert perspectives on anti-VEGF therapies in nAMD to support managed care professionals and providers in decision making and collaborative strategies to overcome barriers to optimize anti-VEGF treatment outcomes among nAMD patients...
February 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29348681/impact-of-a-five-dimensional-framework-on-r-d-productivity-at-astrazeneca
#17
REVIEW
Paul Morgan, Dean G Brown, Simon Lennard, Mark J Anderton, J Carl Barrett, Ulf Eriksson, Mark Fidock, Bengt Hamrén, Anthony Johnson, Ruth E March, James Matcham, Jerome Mettetal, David J Nicholls, Stefan Platz, Steve Rees, Michael A Snowden, Menelas N Pangalos
In 2011, AstraZeneca embarked on a major revision of its research and development (R&D) strategy with the aim of improving R&D productivity, which was below industry averages in 2005-2010. A cornerstone of the revised strategy was to focus decision-making on five technical determinants (the right target, right tissue, right safety, right patient and right commercial potential). In this article, we describe the progress made using this '5R framework' in the hope that our experience could be useful to other companies tackling R&D productivity issues...
March 2018: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/29344794/ticagrelor-for-secondary-prevention-of-atherothrombotic-events-after-myocardial-infarction-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#18
REVIEW
Xavier G L V Pouwels, Robert Wolff, Bram L T Ramaekers, Anoukh Van Giessen, Shona Lang, Steve Ryder, Gill Worthy, Steven Duffy, Nigel Armstrong, Jos Kleijnen, Manuela A Joore
The National Institute for Health and Care Excellence (NICE) invited AstraZeneca, the manufacturer of ticagrelor (Brilique® ), to submit evidence on the clinical and cost effectiveness of ticagrelor 60 mg twice daily (BID) in combination with low-dose aspirin [acetylsalicylic acid (ASA)] compared with ASA only for secondary prevention of atherothrombotic events in patients with a history of myocardial infarction (MI) and who are at increased risk of atherothrombotic events. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Maastricht University Medical Centre+, was commissioned as the evidence review group (ERG)...
January 18, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29331313/predictors-of-exacerbation-risk-and-response-to-budesonide-in-patients-with-chronic-obstructive-pulmonary-disease-a-post-hoc-analysis-of-three-randomised-trials
#19
Mona Bafadhel, Stefan Peterson, Miguel A De Blas, Peter M Calverley, Stephen I Rennard, Kai Richter, Malin Fagerås
BACKGROUND: The peripheral blood eosinophil count might help identify those patients with chronic obstructive pulmonary disease (COPD) who will experience fewer exacerbations when taking inhaled corticosteroids (ICS). Previous post-hoc analyses have proposed eosinophil cutoffs that are both arbitrary and limited in evaluating complex interactions of treatment response. We modelled eosinophil count as a continuous variable to determine the characteristics that determine both exacerbation risk and clinical response to ICS in patients with COPD...
February 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29325512/an-industry-update-the-latest-developments-in-therapeutic-delivery
#20
Oliver C Steinbach
The present industry update covers the period 1 October-31 October 2017, with information sourced from company press releases, regulatory and patent agencies as well as scientific literature. While the corporate news in October was traditionally dominated by the announcement of the third quarter results, with most of them showing market and revenue growth but also an increasing number of initial public offerings after years of slower financial development, we also saw trends continuing toward an increasing number of convergences of drugs with nanotechnology, devices and 21st century information technology...
February 2018: Therapeutic Delivery
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