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https://www.readbyqxmd.com/read/29048985/commentary-impact-of-meningococcal-group-b-omv-vaccines-beyond-their-brief
#1
Helen Petousis-Harris
Meningococcal group B outer membrane vesicle vaccines have been used widely in Cuba, New Zealand, and Brazil. They are immunogenic and initially assessed largely by their ability to induce serum bactericidal activity. Measures of efficacy indicate good protection against homologous strains in older children and adults. Effectiveness appears broader than predicted by immunogenicity and efficacy studies. The recent discovery that meningococcal group B OMVs may protect against the related Neisseria species N.gonorrhoeae suggests more to these interesting antigen collections than meets the eye...
October 19, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29039115/genome-editing-technologies-in-adoptive-t-cell-immunotherapy-for-cancer
#2
REVIEW
Nathan Singh, Junwei Shi, Carl H June, Marco Ruella
PURPOSE OF REVIEW: In this review, we discuss the most recent developments in gene-editing technology and discuss their application to adoptive T cell immunotherapy. RECENT FINDINGS: Engineered T cell therapies targeting cancer antigens have demonstrated significant efficacy in specific patient populations. Most impressively, CD19-directed chimeric antigen receptor T cells (CART19) have led to impressive responses in patients with B-cell leukemia and lymphoma. CTL019, or KYMRIAH™ (tisagenlecleucel), a CD19 CAR T cell product developed by Novartis and the University of Pennsylvania, was recently approved for clinical use by the Food and Drug Administration, representing a landmark in the application of adoptive T cell therapies...
October 16, 2017: Current Hematologic Malignancy Reports
https://www.readbyqxmd.com/read/29037984/effect-of-maf-amplification-on-treatment-outcomes-with-adjuvant-zoledronic-acid-in-early-breast-cancer-a-secondary-analysis-of-the-international-open-label-randomised-controlled-phase-3-azure-big-01-04-trial
#3
Robert Coleman, Andrew Hall, Joan Albanell, Andrew Hanby, Richard Bell, David Cameron, David Dodwell, Helen Marshall, Joël Jean-Mairet, Juan-Carlos Tercero, Federico Rojo, Walter Gregory, Roger R Gomis
BACKGROUND: Adjuvant use of bisphosphonates can reduce the incidence of bone metastases in early breast cancer. Recurrence and survival seem to be improved only in postmenopausal patients, but the underlying mechanisms remain unclear. We investigated whether MAF amplification (a biomarker for bone metastasis) in primary tumours could predict the treatment outcomes of adjuvant zoledronic acid. METHODS: The study population included patients enrolled in the international, open-label, randomised, controlled, phase 3 AZURE trial at eligible UK sites who had stage II or III breast cancer and who gave consent for use of their primary tumour samples...
October 13, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29032078/efficacy-and-safety-of-once-monthly-pasireotide-in-cushing-s-disease-a-12-month-clinical-trial
#4
André Lacroix, Feng Gu, Wilson Gallardo, Rosario Pivonello, Yerong Yu, Przemysław Witek, Marco Boscaro, Roberto Salvatori, Masanobu Yamada, Libuse Tauchmanova, Michael Roughton, Shoba Ravichandran, Stephan Petersenn, Beverly M K Biller, John Newell-Price
BACKGROUND: Cushing's disease is a rare debilitating endocrine disorder for which few prospective interventional studies have been done. We report results of the first phase 3 trial assessing long-acting intramuscular pasireotide in patients with Cushing's disease. METHODS: In this phase 3 clinical trial we recruited patients aged 18 years or older with persistent, recurrent, or de-novo (non-surgical candidates) Cushing's disease who had a mean urinary free cortisol (mUFC) concentration (from three 24 h samples) of 1·5-5·0 times the upper limit of normal (ULN), a normal or greater than normal morning plasma adrenocorticotropic hormone concentration, and a pituitary source of Cushing's syndrome, from 57 sites across 19 countries...
October 12, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29023215/cost-effectiveness-analysis-of-monthly-zoledronic-acid-zoledronic-acid-every-3-months-and-monthly-denosumab-in-women-with-breast-cancer-and-skeletal-metastases-calgb-70604-alliance
#5
Charles L Shapiro, James P Moriarty, Stacie Dusetzina, Andrew L Himelstein, Jared C Foster, Stephen S Grubbs, Paul J Novotny, Bijan J Borah
Purpose Skeletal-related events (SREs) such as pathologic fracture, spinal cord compression, or the necessity for radiation or surgery to bone metastasis cause considerable morbidity, decrements in quality of life, and costs to the health care system. The results of a recent large randomized trial (Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology [CALGB/Alliance 70604]) showed that zoledronic acid (ZA) every 3 months was noninferior to monthly ZA in reducing the risks of SREs. We sought to determine the cost-effectiveness (CE) of monthly ZA, ZA every 3 months, and monthly denosumab in women with breast cancer and skeletal metastases...
October 12, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29020007/novartis-trial-validates-inflammasome-as-chronic-disease-driver
#6
Cormac Sheridan
No abstract text is available yet for this article.
October 11, 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/29019079/pharmacotherapy-choice-is-associated-with-2-year-mortality-for-patients-with-heart-failure-and-reduced-ejection-fraction
#7
Nancy M Albert, Dana A Drzayich Antol, Richard W DeClue, Adrianne Waldman Casebeer, Yong Li, Stephen Stemkowski, Chun-Lan Chang
INTRODUCTION: Factors associated with mortality for patients with heart failure and reduced ejection fraction (HFrEF) are known; however, the association between initial pharmacotherapy (IPT) and mortality is unclear in real-world settings. METHODS: Using a retrospective design and claims database, 14,359 Medicare patients with HFrEF from August 2010 to July 2015 were identified. Index date was first HF claim. IPT was mono- or combo-angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), beta-blocker (BB), hydralazine-nitrate (HN), and aldosterone antagonist (AA) within 1 year post-index...
October 10, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29019038/utilisation-and-safety-of-deferasirox-results-from-an-observational-cohort-study-in-england
#8
Vicki Osborne, Miranda Davies, Deborah Layton, Saad A W Shakir
INTRODUCTION: Deferasirox (EXJADE(®), Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood transfusions for various chronic anaemias and some non-transfusion dependant anaemias. OBJECTIVE: The aim of this study was to examine the utilisation and safety of deferasirox used in general practice in England. METHOD: A single exposure observational cohort study design was used...
October 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29019023/challenges-associated-with-estimating-utility-in-wet-age-related-macular-degeneration-a-novel-regression-analysis-to-capture-the-bilateral-nature-of-the-disease
#9
Robert Hodgson, Timothy Reason, David Trueman, Rose Wickstead, Jeanette Kusel, Adam Jasilek, Lindsay Claxton, Matthew Taylor, Ruth Pulikottil-Jacob
INTRODUCTION: The estimation of utility values for the economic evaluation of therapies for wet age-related macular degeneration (AMD) is a particular challenge. Previous economic models in wet AMD have been criticized for failing to capture the bilateral nature of wet AMD by modelling visual acuity (VA) and utility values associated with the better-seeing eye only. METHODS: Here we present a de novo regression analysis using generalized estimating equations (GEE) applied to a previous dataset of time trade-off (TTO)-derived utility values from a sample of the UK population that wore contact lenses to simulate visual deterioration in wet AMD...
October 10, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28976302/certolizumab-pegol-and-secukinumab-for-treating-active-psoriatic-arthritis-following-inadequate-response-to-disease-modifying-antirheumatic-drugs-a-systematic-review-and-economic-evaluation
#10
Mark Corbett, Fadi Chehadah, Mousumi Biswas, Thirimon Moe-Byrne, Stephen Palmer, Marta Soares, Matthew Walton, Melissa Harden, Pauline Ho, Nerys Woolacott, Laura Bojke
BACKGROUND: Several biologic therapies are approved by the National Institute for Health and Care Excellence (NICE) for psoriatic arthritis (PsA) patients who have had an inadequate response to two or more synthetic disease-modifying antirheumatic drugs (DMARDs). NICE does not specifically recommend switching from one biologic to another, and only ustekinumab (UST; STELARA(®), Janssen Pharmaceuticals, Inc., Horsham, PA, USA) is recommended after anti-tumour necrosis factor failure. Secukinumab (SEC; COSENTYX(®), Novartis International AG, Basel, Switzerland) and certolizumab pegol (CZP; CIMZIA(®), UCB Pharma, Brussels, Belgium) have not previously been appraised by NICE...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28971900/pan-phosphatidylinositol-3-kinase-inhibition-with-buparlisib-in-patients-with-relapsed-and-refractory-non-hodgkin-lymphoma
#11
Anas Younes, Gilles Salles, Giovanni Martinelli, Robert Gregory Bociek, Dolores Caballero Barrigon, Eva González Barca, Mehmet Turgut, John Gerecitano, Oliver Kong, Chaitali Babanrao Pisal, Ranjana Tavorath, Won Seog Kim
Phosphatidylinositol 3-kinase mechanistic target of rapamycin pathway activation plays a role in the pathogenesis of non-Hodgkin lymphoma. This multicenter, open-label Phase II study evaluated buparlisib (BKM120), a pan-class I Phosphatidylinositol 3-kinase inhibitor, in patients with relapsed or refractory non-Hodgkin lymphoma. Patients received buparlisib 100 mg once daily in three separate cohorts (diffuse large B-cell lymphoma, mantle cell lymphoma, or follicular lymphoma) until progression, intolerance, or withdrawal of consent...
September 29, 2017: Haematologica
https://www.readbyqxmd.com/read/28944734/outcomes-based-contracting-experience-research-findings-from-u-s-and-european-stakeholders
#12
Tara Nazareth, John J Ko, Rahul Sasane, Christian Frois, Stephen Carpenter, Sebastian Demean, Ashok Vegesna, Eric Wu, Robert P Navarro
BACKGROUND: Outcomes-based contracts (OBCs), a type of risk-sharing arrangement (RSA), have emerged as a promising avenue for payers to engage with pharmaceutical manufacturers to share risk and improve patient access to medicines via evaluation of real-world outcomes. OBJECTIVE: To assess the level of recent OBC activity and stakeholder perceptions of these arrangements, as well as the outlook for future OBC activity from a payer and manufacturer perspective in the United States and EU-5 (France, Germany, Italy, Spain, and the United Kingdom)...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944733/performance-based-risk-sharing-arrangements-for-pharmaceutical-products-in-the-united-states-a-systematic-review
#13
Justin S Yu, Lauren Chin, Jennifer Oh, Jorge Farias
BACKGROUND: Value for money is a growing necessity in today's U.S. health care system in which drug spending is expected to increase by an average rate of 6.7% yearly through 2025. In response to uncertainty about real-world clinical and economic outcomes for many drugs, health insurers and pharmacy benefit managers (PBMs) have implemented various contracts and arrangements with drug manufacturers that can collectively be described as performance-based risk-sharing arrangements (PBRSAs)...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944728/performance-based-risk-sharing-arrangements-u-s-payer-experience
#14
Joseph A Goble, Brian Ung, Sascha van Boemmel-Wegmann, Robert P Navarro, Andrew Parece
BACKGROUND: As a result of global concern about rising drug costs, many U.S. payers and European agencies such as the National Health Service have partnered with pharmaceutical companies in performance-based risk-sharing arrangements (PBRSAs) by which manufacturers share financial risk with health care purchasing entities and authorities. However, PBRSAs present many administrative and legal challenges that have minimized successful contract experiences in the United States. OBJECTIVE: To (a) identify drug and disease characteristics and contract components that contribute to successful PBRSA experiences and the primary barriers to PBRSA execution and (b) explore solutions to facilitate contract negotiation and execution...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944727/changing-the-way-we-pay-for-health-care-is-value-the-new-plastic
#15
Robert P Navarro
Navarro is a clinical professor in the College of Pharmacy at the University of Florida, Gainesville, and is an assistant editor with the Journal of Managed Care and Specialty Pharmacy. Navarro reports consulting fees from Analysis Group, Amgen, Novartis, and Allergan.
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28943267/the-effect-of-physical-activity-on-mortality-and-cardiovascular-disease-in-130%C3%A2-000-people-from-17-high-income-middle-income-and-low-income-countries-the-pure-study
#16
Scott A Lear, Weihong Hu, Sumathy Rangarajan, Danijela Gasevic, Darryl Leong, Romaina Iqbal, Amparo Casanova, Sumathi Swaminathan, R M Anjana, Rajesh Kumar, Annika Rosengren, Li Wei, Wang Yang, Wang Chuangshi, Liu Huaxing, Sanjeev Nair, Rafael Diaz, Hany Swidon, Rajeev Gupta, Noushin Mohammadifard, Patricio Lopez-Jaramillo, Aytekin Oguz, Katarzyna Zatonska, Pamela Seron, Alvaro Avezum, Paul Poirier, Koon Teo, Salim Yusuf
BACKGROUND: Physical activity has a protective effect against cardiovascular disease (CVD) in high-income countries, where physical activity is mainly recreational, but it is not known if this is also observed in lower-income countries, where physical activity is mainly non-recreational. We examined whether different amounts and types of physical activity are associated with lower mortality and CVD in countries at different economic levels. METHODS: In this prospective cohort study, we recruited participants from 17 countries (Canada, Sweden, United Arab Emirates, Argentina, Brazil, Chile, Poland, Turkey, Malaysia, South Africa, China, Colombia, Iran, Bangladesh, India, Pakistan, and Zimbabwe)...
September 21, 2017: Lancet
https://www.readbyqxmd.com/read/28920784/treatment-success-in-three-andean-bears-tremarctos-ornatus-with-alopecia-syndrome-using-oclacitinib-maleate-apoquel%C3%A2
#17
Gabby J Drake, Tim Nuttall, Javier López, William Magnone, Antoine Leclerc, Romain Potier, Alexis Lécu, Maëlle Guézénec, Lydia Kolter, Amélie Nicolau, Karin Lemberger, Didier Pin, Sallie B Cosgrove
Andean bear (Tremarctos ornatus) alopecia syndrome (ABAS) commonly affects captive bears, particularly sexually mature females. ABAS is characterized by bilaterally symmetrical predominantly flank alopecia with or without profound pruritus and secondary bacterial and Malassezia infections. There is no effective treatment and severely affected bears have been euthanized. This paper describes the successful management of ABAS in three female Andean bears. Skin biopsies and cytology revealed a mixed dermal inflammatory infiltrate, alopecia, hyperkeratosis, and Malassezia dermatitis...
September 2017: Journal of Zoo and Wildlife Medicine: Official Publication of the American Association of Zoo Veterinarians
https://www.readbyqxmd.com/read/28919011/dabrafenib-plus-trametinib-in-patients-with-previously-untreated-braf-v600e-mutant-metastatic-non-small-cell-lung-cancer-an-open-label-phase-2-trial
#18
MULTICENTER STUDY
David Planchard, Egbert F Smit, Harry J M Groen, Julien Mazieres, Benjamin Besse, Åslaug Helland, Vanessa Giannone, Anthony M D'Amelio, Pingkuan Zhang, Bijoyesh Mookerjee, Bruce E Johnson
BACKGROUND: BRAF(V600E) mutation occurs in 1-2% of lung adenocarcinomas and acts as an oncogenic driver. Dabrafenib, alone or combined with trametinib, has shown substantial antitumour activity in patients with previously treated BRAF(V600E)-mutant metastatic non-small-cell lung cancer (NSCLC). We aimed to assess the activity and safety of dabrafenib plus trametinib treatment in previously untreated patients with BRAF(V600E)-mutant metastatic NSCLC. METHODS: In this phase 2, sequentially enrolled, multicohort, multicentre, non-randomised, open-label study, adults (≥18 years of age) with previously untreated metastatic BRAF(V600E)-mutant NSCLC were enrolled into cohort C from 19 centres in eight countries within North America, Europe, and Asia...
October 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28891408/adjuvant-dabrafenib-plus-trametinib-in-stage-iii-braf-mutated-melanoma
#19
Georgina V Long, Axel Hauschild, Mario Santinami, Victoria Atkinson, Mario Mandalà, Vanna Chiarion-Sileni, James Larkin, Marta Nyakas, Caroline Dutriaux, Andrew Haydon, Caroline Robert, Laurent Mortier, Jacob Schachter, Dirk Schadendorf, Thierry Lesimple, Ruth Plummer, Ran Ji, Pingkuan Zhang, Bijoyesh Mookerjee, Jeff Legos, Richard Kefford, Reinhard Dummer, John M Kirkwood
Background Combination therapy with the BRAF inhibitor dabrafenib plus the MEK inhibitor trametinib improved survival in patients with advanced melanoma with BRAF V600 mutations. We sought to determine whether adjuvant dabrafenib plus trametinib would improve outcomes in patients with resected, stage III melanoma with BRAF V600 mutations. Methods In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 870 patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations to receive oral dabrafenib at a dose of 150 mg twice daily plus trametinib at a dose of 2 mg once daily (combination therapy, 438 patients) or two matched placebo tablets (432 patients) for 12 months...
September 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28886178/ethics-approval-in-applications-for-open-access-clinical-trial-data-an-analysis-of-researcher-statements-to-clinicalstudydatarequest-com
#20
Derek So, Bartha M Knoppers
Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR), which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval...
2017: PloS One
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