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https://www.readbyqxmd.com/read/29437768/fda-approval-ribociclib-for-the-treatment-of-postmenopausal-women-with-hormone-receptor-positive-her2-negative-advanced-or-metastatic-breast-cancer
#1
Anand Shah, Erik Bloomquist, Shenghui Tang, Wentao Fu, Youwei Bi, Qi Liu, Jingyu Yu, Ping Zhao, Todd R Palmby, Kirsten B Goldberg, C J George Chang, Paresma Patel, Elleni Alebachew, Amy Tilley, William F Pierce, Amna Ibrahim, Gideon M Blumenthal, Rajeshwari Sridhara, Julia A Beaver, Richard Pazdur
On March 13, 2017, the U.S. Food and Drug Administration approved ribociclib (KISQALI, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The approval was based on a randomized, double-blind, placebo-controlled, international clinical trial (MONALEESA-2)...
February 7, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29429043/treatment-patterns-healthcare-resource-utilization-and-spending-among-medicaid-enrolled-children-with-chronic-idiopathic-spontaneous-urticaria-in-the-united-states
#2
Paul V Williams, Abhishek Kavati, Dominic Pilon, Yongling Xiao, Maryia Zhdanava, Maria-Magdalena Balp, Patrick Lefebvre, Benjamin Ortiz, Vivian Hernandez-Trujillo
INTRODUCTION: Few studies have described chronic idiopathic/spontaneous urticaria (CIU/CSU) healthcare burden in adults, while this information remains largely unknown in children. We aimed to describe treatment patterns, healthcare resource utilization (HRU), and costs in CIU/CSU pediatric patients, as well as to compare HRU and costs in CIU/CSU and CIU/CSU-free pediatric patients. METHODS: Medicaid claims from four states (09/01/2013-03/31/2016) were used to identify patients less than 12 years old...
February 10, 2018: Dermatology and Therapy
https://www.readbyqxmd.com/read/29411099/vitrectomy-for-optic-disc-pit-maculopathy-a-long-term-follow-up-study
#3
Ferdinando Bottoni, Matteo Cereda, Roberta Secondi, Sara Bochicchio, Giovanni Staurenghi
PURPOSE: To evaluate the clinical outcomes of vitrectomy with induction of posterior vitreous detachment for the treatment of optic disc pit maculopathy. METHODS: We retrospectively evaluated medical records and imaging studies of 11 consecutive patients with optic disc pit maculopathy who underwent vitrectomy at Sacco University Hospital, Milan, Italy, between October 2008 and December 2015. Induction of a posterior vitreous detachment (PVD) was the aim of our surgery...
February 6, 2018: Graefe's Archive for Clinical and Experimental Ophthalmology
https://www.readbyqxmd.com/read/29406838/real-world-characteristics-and-treatment-patterns-in-patients-with-urticaria-initiating-omalizumab-in-the-united-states
#4
Xuehua Ke, Abhishek Kavati, Debra Wertz, Qing Huang, Liya Wang, Vincent J Willey, Judith J Stephenson, Benjamin Ortiz, Brandee Paknis, Jonathan A Bernstein, Lisa A Beck
BACKGROUND: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. OBJECTIVE: To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world...
December 19, 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29398176/profound-vasoplegia-during-sacubitril-valsartan-treatment-after-heart-transplantation
#5
Aws Almufleh, Lisa M Mielniczuk, Radoslav Zinoviev, Andrew Moeller, Ross A Davies, Ellamae Stadnick, Vincent Chan, Sharon Chih
Vasoplegia occurs in up to 16% of patients who undergo heart transplantation (HT) and is associated with significant morbidity and mortality. We present a case of a 61-year-old man with ischemic cardiomyopathy receiving sacubitril/valsartan (Entresto; Novartis, Cambridge, MA) who developed profound hypotension after HT. He was treated with intravenous methylene blue and high-dose vasopressors, but developed acute kidney injury requiring dialysis and a prolonged stay in the intensive care unit. This case supports a potent vasodilatory effect of sacubitril/valsartan, and if confirmed by other studies, might warrant consideration for withholding treatment while awaiting HT, particularly in patients with risk factors for vasoplegia...
December 11, 2017: Canadian Journal of Cardiology
https://www.readbyqxmd.com/read/29396246/mycophenolate-plus-methylprednisolone-versus-methylprednisolone-alone-in-active-moderate-to-severe-graves-orbitopathy-mingo-a-randomised-observer-masked-multicentre-trial
#6
George J Kahaly, Michaela Riedl, Jochem König, Susanne Pitz, Katharina Ponto, Tanja Diana, Elena Kampmann, Elisa Kolbe, Anja Eckstein, Lars C Moeller, Dagmar Führer, Mario Salvi, Nicola Curro, Irene Campi, Danila Covelli, Marenza Leo, Michele Marinò, Francesca Menconi, Claudio Marcocci, Luigi Bartalena, Petros Perros, Wilmar M Wiersinga
BACKGROUND: European guidelines recommend intravenous methylprednisolone as first-line treatment for active and severe Graves' orbitopathy; however, it is common for patients to have no response or have relapse after discontinuation of treatment. We aimed to compare the efficacy and safety of add-on mycophenolate to methylprednisolone in comparison with methylprednisolone alone in patients with moderate-to-severe Graves' orbitopathy. METHODS: MINGO was an observer-masked, multicentre, block-randomised, centre-stratified trial done in two centres in Germany and two in Italy...
January 30, 2018: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29393024/axitinib-cabozantinib-everolimus-nivolumab-sunitinib-and-best-supportive-care-in-previously-treated-renal-cell-carcinoma-a-systematic-review-and-economic-evaluation
#7
Steve J Edwards, Victoria Wakefield, Peter Cain, Charlotta Karner, Kayleigh Kew, Mariana Bacelar, Natalie Masento, Fatima Salih
BACKGROUND: Several therapies have recently been approved for use in the NHS for pretreated advanced or metastatic renal cell carcinoma (amRCC), but there is a lack of comparative evidence to guide decisions between them. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of axitinib (Inlyta®, Pfizer Inc., NY, USA), cabozantinib (Cabometyx®, Ipsen, Slough, UK), everolimus (Afinitor®, Novartis, Basel, Switzerland), nivolumab (Opdivo®, Bristol-Myers Squibb, NY, USA), sunitinib (Sutent®, Pfizer, Inc...
January 2018: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29392570/secukinumab-demonstrates-significantly-lower-immunogenicity-potential-compared-to-ixekizumab
#8
Sebastian Spindeldreher, Bernard Maillère, Evelyne Correia, Maxime Tenon, Anette Karle, Philip Jarvis, Frank Kolbinger
INTRODUCTION: Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has been shown to have significant efficacy in the treatment of moderate to severe plaque psoriasis (PsO) and psoriatic arthritis (PsA), demonstrating a rapid onset of action and sustained responses with a favorable safety profile. All biotherapeutics, including monoclonal antibodies (mAbs), can be immunogenic, leading to formation of anti-drug antibodies (ADAs) that can result in loss of response and adverse events such as hypersensitivity reactions...
February 1, 2018: Dermatology and Therapy
https://www.readbyqxmd.com/read/29385370/tisagenlecleucel-in-children-and-young-adults-with-b-cell-lymphoblastic-leukemia
#9
Shannon L Maude, Theodore W Laetsch, Jochen Buechner, Susana Rives, Michael Boyer, Henrique Bittencourt, Peter Bader, Michael R Verneris, Heather E Stefanski, Gary D Myers, Muna Qayed, Barbara De Moerloose, Hidefumi Hiramatsu, Krysta Schlis, Kara L Davis, Paul L Martin, Eneida R Nemecek, Gregory A Yanik, Christina Peters, Andre Baruchel, Nicolas Boissel, Francoise Mechinaud, Adriana Balduzzi, Joerg Krueger, Carl H June, Bruce L Levine, Patricia Wood, Tetiana Taran, Mimi Leung, Karen T Mueller, Yiyun Zhang, Kapildeb Sen, David Lebwohl, Michael A Pulsipher, Stephan A Grupp
BACKGROUND: In a single-center phase 1-2a study, the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel produced high rates of complete remission and was associated with serious but mainly reversible toxic effects in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). METHODS: We conducted a phase 2, single-cohort, 25-center, global study of tisagenlecleucel in pediatric and young adult patients with CD19+ relapsed or refractory B-cell ALL...
February 1, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29383980/optimizing-anti-vegf-treatment-outcomes-for-patients-with-neovascular-age-related-macular-degeneration
#10
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/29370716/helios-history-and-anatomy-of-a-successful-in-house-enterprise-high-throughput-screening-and-profiling-data-analysis-system
#11
Hanspeter Gubler, Nicholas Clare, Laurent Galafassi, Uwe Geissler, Michel Girod, Guy Herr
We describe the main characteristics of the Novartis Helios data analysis software system (Novartis, Basel, Switzerland) for plate-based screening and profiling assays, which was designed and built about 11 years ago. It has been in productive use for more than 10 years and is one of the important standard software applications running for a large user community at all Novartis Institutes for BioMedical Research sites globally. A high degree of automation is reached by embedding the data analysis capabilities into a software ecosystem that deals with the management of samples, plates, and result data files, including automated data loading...
January 1, 2018: SLAS Discovery
https://www.readbyqxmd.com/read/29361468/neoadjuvant-plus-adjuvant-dabrafenib-and-trametinib-versus-standard-of-care-in-patients-with-high-risk-surgically-resectable-melanoma-a-single-centre-open-label-randomised-phase-2-trial
#12
Rodabe N Amaria, Peter A Prieto, Michael T Tetzlaff, Alexandre Reuben, Miles C Andrews, Merrick I Ross, Isabella C Glitza, Janice Cormier, Wen-Jen Hwu, Hussein A Tawbi, Sapna P Patel, Jeffrey E Lee, Jeffrey E Gershenwald, Christine N Spencer, Vancheswaran Gopalakrishnan, Roland Bassett, Lauren Simpson, Rosalind Mouton, Courtney W Hudgens, Li Zhao, Haifeng Zhu, Zachary A Cooper, Khalida Wani, Alexander Lazar, Patrick Hwu, Adi Diab, Michael K Wong, Jennifer L McQuade, Richard Royal, Anthony Lucci, Elizabeth M Burton, Sangeetha Reddy, Padmanee Sharma, James Allison, Phillip A Futreal, Scott E Woodman, Michael A Davies, Jennifer A Wargo
BACKGROUND: Dual BRAF and MEK inhibition produces a response in a large number of patients with stage IV BRAF-mutant melanoma. The existing standard of care for patients with clinical stage III melanoma is upfront surgery and consideration for adjuvant therapy, which is insufficient to cure most patients. Neoadjuvant targeted therapy with BRAF and MEK inhibitors (such as dabrafenib and trametinib) might provide clinical benefit in this high-risk p opulation. METHODS: We undertook this single-centre, open-label, randomised phase 2 trial at the University of Texas MD Anderson Cancer Center (Houston, TX, USA)...
January 17, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29352367/continuous-manufacturing-of-co-crystals-challenges-and-prospects
#13
REVIEW
Rahul B Chavan, Rajesh Thipparaboina, Balvant Yadav, Nalini R Shastri
The last decade has witnessed extensive growth in the field of co-crystallization for mitigating the solubility and dissolution-related issues of poorly soluble drugs. This is largely because co-crystals can modify the physicochemical properties of drugs without any covalent modification in the drug molecules. The US Food and Drug Administration (FDA) now considers drug products that are designed to contain a new co-crystal, analogous to new polymorph of the active pharmaceutical ingredient (API). This positive change in regulatory perspective coupled with successful commercialization of valsartan-sacubitril co-crystal (Entresto, Novartis) has now brought co-crystals into focus, in both industries as well as academia...
January 19, 2018: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29343975/spotlight-on-midostaurin-in-the-treatment-of-flt3-mutated-acute-myeloid-leukemia-and-systemic-mastocytosis-design-development-and-potential-place-in-therapy
#14
REVIEW
Ellen Weisberg, Martin Sattler, Paul W Manley, James D Griffin
The Fms-like tyrosine kinase-3 (FLT3; fetal liver kinase-2; human stem cell tyrosine kinase-1; CD135) is a class III receptor tyrosine kinase that is normally involved in regulating the proliferation, differentiation, and survival of both hematopoietic cells and dendritic cells. Mutations leading it to be constitutively activated make it an oncogenic driver in ~30% of acute myeloid leukemia (AML) patients where it is associated with poor prognosis. The prevalence of oncogenic FLT3 and the dependency on its constitutively activated kinase activity for leukemia growth make this protein an attractive target for therapeutic intervention...
2018: OncoTargets and Therapy
https://www.readbyqxmd.com/read/29301391/locacorten-vioform-ototoxicity-upon-guinea-pig-middle-ear-application
#15
Owen Woods, Issam Saliba
Background and Objectives: Locacorten Vioform (Novartis UK) is frequently prescribed for otomycosis. Its component, Clioquinol, also has anti-bacterial properties. Up to this point, its ototoxic potential has not been evaluated. Our objective aims to evaluate Locacorten Vioform's potential ototoxicity when applied directly to the middle ear cavity. Materials and Methods: We performed an experimental prospective animal study in our animal research center with 20 Hartley guinea pigs divided into 2 groups...
January 5, 2018: Journal of Audiology & Otology
https://www.readbyqxmd.com/read/29290170/cost-effectiveness-of-drugs-to-treat-relapsed-refractory-multiple-myeloma-in-the-united-states
#16
Josh J Carlson, Gregory F Guzauskas, Richard H Chapman, Patricia G Synnott, Shanshan Liu, Elizabeth T Russo, Steven D Pearson, Elizabeth D Brouwer, Daniel A Ollendorf
BACKGROUND: New 3-drug regimens have been developed and approved to treat multiple myeloma (MM). The absence of direct comparative data and the high cost of treatment support the need to assess the relative clinical and economic outcomes across all approved regimens. OBJECTIVE: To evaluate the cost-effectiveness of treatments for relapsed and/or refractory MM from a U.S. health system perspective. METHODS: We developed a partition survival model with 3 health states (progression-free, progression, and death) to evaluate the following regimens: carfilzomib (CFZ), elotuzumab (ELO), ixazomib (IX), daratumumab (DAR), and panobinostat (PAN) in combination with lenalidomide (LEN) or bortezomib (BOR) plus dexamethasone (DEX) in the second and/or third line of therapy...
January 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29243028/perspectives-from-the-patient-and-the-healthcare-professional-in-multiple-sclerosis-social-media-and-patient-education
#17
Daniel Kantor, Jeremy R Bright, Jeri Burtchell
A diagnosis of multiple sclerosis (MS) is life-altering. Because the course of MS is heterogeneous, patients may face uncertainty in terms of long-term physical and cognitive challenges, potential loss of employment, and the risk of social isolation. Patients often turn to the Internet and social media for information about MS and its management, and to seek out fellow patients and support groups. Here, we examine the use of social media and the Internet among patients with MS, considering its impact on patient education...
December 14, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/29241762/eltrombopag-for-advanced-myelodysplastic-syndromes-or-acute-myeloid-leukaemia-and-severe-thrombocytopenia-aspire-a-randomised-placebo-controlled-phase-2-trial
#18
Moshe Mittelman, Uwe Platzbecker, Boris Afanasyev, Sebastian Grosicki, Raymond S M Wong, Achilles Anagnostopoulos, Benjamin Brenner, Claudio Denzlinger, Giuseppe Rossi, Arnon Nagler, Regina Garcia-Delgado, Maria Socorro O Portella, Zewen Zhu, Dominik Selleslag
BACKGROUND: Thrombocytopenia is a life-threatening complication in patients with advanced myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). In this study (ASPIRE), we aimed to assess eltrombopag, an oral thrombopoietin receptor agonist, for thrombocytopenia (grade 4) treatment in adult patients with advanced MDS or AML. METHODS: ASPIRE consisted of an open-label, double-blind phase for 8 weeks and a randomised, double-blind phase (parts 1 and 2, reported here) for 12 weeks, and an open-label extension (part 3)...
December 11, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/29226764/chimeric-antigen-receptor-t-cells-in-refractory-b-cell-lymphomas
#19
Stephen J Schuster, Jakub Svoboda, Elise A Chong, Sunita D Nasta, Anthony R Mato, Özlem Anak, Jennifer L Brogdon, Iulian Pruteanu-Malinici, Vijay Bhoj, Daniel Landsburg, Mariusz Wasik, Bruce L Levine, Simon F Lacey, Jan J Melenhorst, David L Porter, Carl H June
Background Patients with diffuse large B-cell lymphoma or follicular lymphoma that is refractory to or that relapses after immunochemotherapy and transplantation have a poor prognosis. High response rates have been reported with the use of T cells modified by chimeric antigen receptor (CAR) that target CD19 in B-cell cancers, although data regarding B-cell lymphomas are limited. Methods We used autologous T cells that express a CD19-directed CAR (CTL019) to treat patients with diffuse large B-cell lymphoma or follicular lymphoma that had relapsed or was refractory to previous treatments...
December 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29223745/buparlisib-plus-fulvestrant-in-postmenopausal-women-with-hormone-receptor-positive-her2-negative-advanced-breast-cancer-progressing-on-or-after-mtor-inhibition-belle-3-a-randomised-double-blind-placebo-controlled-phase-3-trial
#20
Angelo Di Leo, Stephen Johnston, Keun Seok Lee, Eva Ciruelos, Per E Lønning, Wolfgang Janni, Ruth O'Regan, Marie-Ange Mouret-Reynier, Dimitar Kalev, Daniel Egle, Tibor Csőszi, Roberto Bordonaro, Thomas Decker, Vivianne C G Tjan-Heijnen, Sibel Blau, Alessio Schirone, Denis Weber, Mona El-Hashimy, Bharani Dharan, Dalila Sellami, Thomas Bachelot
BACKGROUND: Activation of the PI3K/AKT/mTOR pathway occurs frequently in breast cancer that is resistant to endocrine therapy. Approved mTOR inhibitors effectively inhibit cell growth and proliferation but elicit AKT phosphorylation via a feedback activation pathway, potentially leading to resistance to mTOR inhibitors. We evaluated the efficacy and safety of buparlisib plus fulvestrant in patients with advanced breast cancer who were pretreated with endocrine therapy and mTOR inhibitors...
December 6, 2017: Lancet Oncology
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