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https://www.readbyqxmd.com/read/29313285/treatment-dosing-patterns-and-clinical-outcomes-for-patients-with-type-2-diabetes-starting-or-switching-to-treatment-with-insulin-glargine-300-units-per-milliliter-in-a-real-world-setting-a-retrospective-observational-study
#1
Shaloo Gupta, Hongwei Wang, Neil Skolnik, Liyue Tong, Ryan M Liebert, Lulu K Lee, Peter Stella, Anna Cali, Ronald Preblick
INTRODUCTION: Usage patterns and effectiveness of a longer-acting formulation of insulin glargine at a strength of 300 units per milliliter (Gla-300) have not been studied in real-world clinical practice. This study evaluated differences in dosing and clinical outcomes before and after Gla-300 treatment initiation in patients with type 2 diabetes starting or switching to treatment with Gla-300 to assess whether the benefits observed in clinical trials translate into real-world settings...
January 8, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29290170/cost-effectiveness-of-drugs-to-treat-relapsed-refractory-multiple-myeloma-in-the-united-states
#2
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/29249524/frequency-and-cost-of-vaccinations-administered-outside-minimum-and-maximum-recommended-ages-2014-data-from-6-sentinel-sites-of-immunization-information-systems
#3
Loren Rodgers, Lauren Shaw, Raymond Strikas, Beth Hibbs, JoEllen Wolicki, Cristina V Cardemil, Cindy Weinbaum
OBJECTIVE: To quantify vaccinations administered outside minimum and maximum recommended ages and to determine attendant costs of revaccination by analyzing immunization information system (IIS) records. STUDY DESIGN: We analyzed deidentified records of doses administered during 2014 to persons aged <18 years within 6 IIS sentinel sites (10% of the US population). We quantified doses administered outside of recommended ages according to the Advisory Committee on Immunization Practices childhood immunization schedule and prescribing information in package inserts, and calculated revaccination costs...
December 14, 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/29231157/plant-produced-subunit-vaccine-candidates-against-yellow-fever-induce-virus-neutralizing-antibodies-and-confer-protection-against-viral-challenge-in-animal-models
#4
Stephen Tottey, Yoko Shoji, R Mark Jones, Jessica A Chichester, Brian J Green, Konstantin Musiychuk, Huaxin Si, Slobodanka Manceva, Amy Rhee, Moneim Shamloul, Joey Norikane, Rosane C Guimarães, Elena Caride, Andrea N M R Silva, Marisol Simões, Patricia C C Neves, Renato Marchevsky, Marcos S Freire, Stephen J Streatfield, Vidadi Yusibov
Yellow fever (YF) is a viral disease transmitted by mosquitoes and endemic mostly in South America and Africa with 20-50% fatality. All current licensed YF vaccines, including YF-Vax® (Sanofi-Pasteur, France) and 17DD-YFV (Bio-Manguinhos, Brazil), are based on live attenuated virus produced in hens' eggs and have been widely used. The YF vaccines are considered safe and highly effective. However, a recent increase in demand for YF vaccines and reports of rare cases of YF vaccine-associated fatal adverse events have provoked interest in developing a safer YF vaccine that can be easily scaled up to meet this increased global demand...
December 11, 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/29223138/plant-expressed-fc-fusion-protein-tetravalent-dengue-vaccine-with-inherent-adjuvant-properties
#5
Mi Young Kim, Alastair Copland, Kaustuv Nayak, Anmol Chandele, Muhammad Shamsher Ahmed, Qibo Zhang, Gil Reynolds Diogo, Matthew John Paul, Sven Hofmann, Moon-Sik Yang, Yong-Suk Jang, Julian K-C Ma, Rajko Reljic
Dengue is a major global disease requiring improved treatment and prevention strategies. The recently licensed Sanofi-Pasteur Denvaxia vaccine does not protect children under the age of nine and additional vaccine strategies are thus needed to halt this expanding global epidemic. Here, we employed a molecular engineering approach and plant-expression to produce a humanised and highly immunogenic Poly-Immunoglobulin G Scaffold (PIGS) fused to the consensus dengue envelope protein III domain (cEDIII). The immunogenicity of this IgG Fc receptor targeted vaccine candidate was demonstrated in transgenic mice expressing human FcγRI/CD64, by induction of neutralising antibodies and evidence of cell-mediated immunity...
December 9, 2017: Plant Biotechnology Journal
https://www.readbyqxmd.com/read/29209946/usability-and-patient-preference-phase-3-study-of-the-sarilumab-pen-in-patients-with-active-moderate-to-severe-rheumatoid-arthritis
#6
Alan Kivitz, Lydie Baret-Cormel, Hubert van Hoogstraten, Sheldon Wang, Janie Parrino, Christine Xu, Marina Stanislav
INTRODUCTION: Sarilumab is a human monoclonal antibody that blocks the interleukin-6 receptor alpha (IL-6Rα). The phase 3 SARIL-RA-EASY study (EASY) assessed the robustness of an autoinjector (pen) for administering sarilumab when used by adults with active moderate-to-severe rheumatoid arthritis (RA) who are candidates for anti-IL-6R therapy in an unsupervised real-world setting. METHODS: EASY was a 12-week, multicenter, randomized, open-label, parallel-group usability study of the sarilumab pen and prefilled syringe...
December 5, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29157068/quadrivalent-inactivated-influenza-vaccine-vaxigriptetra%C3%A2
#7
Viviane Gresset-Bourgeois, Phillip S Leventhal, Stéphanie Pepin, Rosalind Hollingsworth, Marie-Pierre Kazek-Duret, Iris De Bruijn, Sandrine I Samson
VaxigripTetra™ (IIV4; Sanofi Pasteur) is a quadrivalent split-virion influenza vaccine approved in Europe in 2016 for individuals ≥ 3 years of age. IIV4 builds on the well-established record of the trivalent split-virion influenza vaccine (Vaxigrip®). Areas covered: This literature review summarizes the rationale for developing quadrivalent influenza vaccines and discusses the phase III clinical trial results supporting the immunogenicity, safety, and tolerability of IIV4. Expert Commentary: IIV4 is immunogenic and well tolerated...
November 20, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/29149860/anaphylactic-shock-with-methylprednisolone-sodium-succinate-in-a-child-with-short-bowel-syndrome-and-cow-s-milk-allergy
#8
Federica Porcaro, Maria Giovanna Paglietti, Antonella Diamanti, Francesca Petreschi, Alessandra Schiavino, Valentina Negro, Valentina Pecora, Alessandro Fiocchi, Renato Cutrera
BACKGROUND: Medications with methyl-prednisolone sodium succinate containing lactose, which potentially contains traces of cow's milk proteins (CMP), could cause allergic reactions or compromise treatment of acute allergic reactions in sensitized patients. CASE PRESENTATION: We describe the unusual case of a one-year-old child affected by short bowel syndrome and history of severe cow's milk allergy (CMA) and anaphylactic reaction due to intravenous administration of methyl-prednisolone sodium succinate (Solu-Medrol 40 mg, Pfizer)...
November 17, 2017: Italian Journal of Pediatrics
https://www.readbyqxmd.com/read/29143919/iglarlixi-reduces-glycated-hemoglobin-to-a-greater-extent-than-basal-insulin-regardless-of-levels-at-screening-post-hoc-analysis-of-lixilan-l
#9
Elisabeth Niemoeller, Elisabeth Souhami, Yujun Wu, Klaus H Jensen
INTRODUCTION: The treatment of patients with type 2 diabetes uncontrolled on basal insulin and oral glucose-lowering drugs was investigated previously in the LixiLan-L trial. In the LixiLan-L trial, patients experienced a 6-week run-in with insulin glargine U100 (iGlar) as part of the screening phase, followed by treatment with a fixed-ratio combination of iGlar + lixisenatide (iGlarLixi) or iGlar alone over 30 weeks. In the study reported here, we investigated the achievement of glycemic control in those who completed the 30-week LixiLan-L trial, as assessed by change in glycated hemoglobin (HbA1c) levels from screening, both for the overall category and for screening HbA1c subcategories...
November 16, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29140155/persistent-prevention-of-oxaliplatin-induced-peripheral-neuropathy-using-calmangafodipir-pledox%C3%A2-a-placebo-controlled-randomised-phase-ii-study-pliant
#10
Bengt Glimelius, Nebojsa Manojlovic, Per Pfeiffer, Baadur Mosidze, Galina Kurteva, Mia Karlberg, Devalingam Mahalingam, Peter Buhl Jensen, Jan Kowalski, Marie Bengtson, Malin Nittve, Jacques Näsström
PURPOSE: Oxaliplatin causes disabling acute and chronic peripheral neuropathy. We explored the preventive effects of calmangafodipir, mimicking the mitochondrial enzyme manganese superoxide dismutase, thereby protecting cells from oxidative stress, in a placebo-controlled, double-blinded randomised phase II study (ClinicalTrials.gov.NCT01619423) in patients with metastatic colorectal cancer (mCRC). PATIENT AND METHODS: mCRC patients treated with modified FOLFOX-6 (folinic acid 200 mg/m2, 5-fluorouracil bolus 400 mg/m2, oxaliplatin 85 mg/m2 and 5-fluorouracil 2400 mg/m2 continuous infusion for 46 h) every fortnight for 8 cycles in first or second line were eligible...
November 15, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/29126116/c-621-15-w-and-others-v-sanofi-pasteur-an-example-of-judicial-distortion-and-indifference-to-science
#11
Laura R Smillie, Mark R Eccleston-Turner, Sarah L Cooper
This case commentary examines the CJEU's recent decision in C-621/15 W and Others v Sanofi Pasteur MSD SNC [2017] ECR I. This commentary critically examines the decision through the lens of the cultural conflict between law and science. We argue that the CJEU's decision reflects both a distortion of scientific knowledge and an improper indifference to the legitimate methods by which scientific knowledge is generated in the context of vaccines. These judicial approaches may, the authors argue, inadvertently fuel the vaccine scepticism that is growing across the developed world, and in particular in Europe...
November 8, 2017: Medical Law Review
https://www.readbyqxmd.com/read/29120697/enhancing-antibody-patent-protection-using-epitope-mapping-information
#12
Xiaoxiang Deng, Ulrich Storz, Benjamin J Doranz
As the $100B therapeutic monoclonal antibody (mAb) market continues to grow, developers of therapeutic mAbs increasingly face the need to strengthen patent protection of their products and enforce their patents in courts. In view of changes in the patent law landscape, patent applications are strategically using information on the precise binding sites of their mAbs, i.e., the epitopes, to support patent novelty, non-obviousness, subject matter, and a tightened written description requirement for broad genus antibody claims...
November 9, 2017: MAbs
https://www.readbyqxmd.com/read/29097739/sanofi-cell-research-outstanding-paper-award-of-2016
#13
EDITORIAL
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No abstract text is available yet for this article.
November 2017: Cell Research
https://www.readbyqxmd.com/read/29083969/personalized-care-and-the-role-of-insulin-as-a-vehicle-to-optimizing-treatments-in-diabetes-care
#14
Nella Bieszk, Michael Grabner, Wenhui Wei, John Barron, Ralph Quimbo, Tingjian Yan, Beth Biel, James W Chu
BACKGROUND: In patients with type 2 diabetes (T2D) with poor glycemic control, there is an unmet need for treatment optimization involving the initiation and/or intensification of insulin therapy, which is often delayed because of clinical inertia. Educational initiatives that target patients and physicians might be one way to address this need. OBJECTIVE: To evaluate the effectiveness of educational materials mailed to physicians and their patients in affecting initiation of insulin therapy and other health care outcomes...
November 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29054729/hib-antibody-responses-in-infants-following-diphtheria-tetanus-acellular-pertussis-and-conjugated-haemophilus-influenzae-type-b-hib-combination-vaccines-with-decreasing-amounts-of-tetanus-toxoid
#15
Henry H Bernstein, Elisabeth R Seyferth
BACKGROUND: While combination vaccines have contributed to improved vaccine uptake rates in children, studies have documented varied immunogenicity to specific vaccine components. We studied whether varying the amount of tetanus toxoid (TT) in a DTaP and Hib combination vaccine would result in immunogenicity comparable with separate, concurrent administration. METHODS: We evaluated the immunogenicity of Massachusetts Biologic Laboratories (MBL) diphtheria, tetanus, and acellular pertussis (mDTaP) vaccine combined with tetanus-conjugated MBL Haemophilus influenzae type b vaccine (mHib) in a single injection (DTaPH)...
October 17, 2017: Vaccine
https://www.readbyqxmd.com/read/29045063/evaluating-manufacturing-process-profile-comparability-with-multivariate-equivalence-testing-case-study-of-cell-culture-small-scale-model-transfer
#16
Yang Cao, Daniel Obeng, Guodong Hui, Luting Xue, Yukun Ren, Xianjie Yu, Fei Wang, Chad Atwell
This paper studies the Generalized Mahalanobis Distance (GMD) approach proposed by Hoffelder(1) which measures the dissimilarity of two multivariate Gaussian distributions with arbitrary covariance matrices and unequal sample sizes. This investigation demonstrated that, with appropriate adjustment, the GMD approach can achieve the targeted nominal Type I error and provide sufficient power for testing equivalence between two profile populations. The adjusted GMD approach was applied to examine the equivalence of harvest profiles between a 12L small scale model and 2000L manufacturing scale in a transfer study performed at Sanofi Speciality Care Framingham Biologics...
October 16, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/29039054/treatment-persistence-and-healthcare-costs-among-patients-with-rheumatoid-arthritis-changing-biologics-in-the-usa
#17
Benjamin Chastek, Chieh-I Chen, Clare Proudfoot, Shraddha Shinde, Andreas Kuznik, Wenhui Wei
INTRODUCTION: After a patient with rheumatoid arthritis (RA) fails tumor necrosis factor inhibitor (TNFi) treatment, clinical guidelines support either cycling to another TNFi or switching to a different mechanism of action (MOA), but payers often require TNFi cycling before they reimburse switching MOA. This study examined treatment persistence, cost, and cost per persistent patient among MOA switchers versus TNFi cyclers. METHODS: This study of Commercial and Medicare Advantage claims data from the Optum Research Database included patients with RA and at least one claim for a TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between January 2012 and September 2015 who changed to another TNFi or a different MOA therapy (abatacept, tocilizumab, or tofacitinib) within 1 year...
October 16, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29035430/the-use-pattern-and-clinical-impact-of-new-antiplatelet-agents-including-prasugrel-and-ticagrelor-on-30-day-outcomes-after-acute-myocardial-infarction-in-korea-korean-health-insurance-review-and-assessment-data
#18
Choongki Kim, Dong Ho Shin, Chul Min Ahn, Jung Sun Kim, Byeong Keuk Kim, Young Guk Ko, Donghoon Choi, Myeong Ki Hong, Juhee Park, Hyeyeong Lee, Yoon Jung Choi, Youn Song Choi, Sang Kwon Oh, Yangsoo Jang
BACKGROUND AND OBJECTIVES: Despite the favorable efficacy of new antiplatelet agents demonstrated in randomized controlled trials, their clinical implications in Korea are unclear. The purpose of this study was to investigate trends in antiplatelet agent use for acute myocardial infarction (AMI) and their impact on 30-day clinical outcomes. METHODS: AMI patients undergoing percutaneous coronary intervention between 2010 and 2015 were assessed using claim data from the Health Insurance Review and Assessment Service...
September 12, 2017: Korean Circulation Journal
https://www.readbyqxmd.com/read/28968138/safety-immunogenicity-and-lot-to-lot-consistency-of-a-split-virion-quadrivalent-influenza-vaccine-in-younger-and-older-adults-a-phase-iii-randomized-double-blind-clinical-trial
#19
Sanie Sesay, Jerzy Brzostek, Ingo Meyer, Yves Donazzolo, Geert Leroux-Roels, Régine Rouzier, Béatrice Astruc, Henryk Szymanski, Nicole Toursarkissian, Corinne Vandermeulen, Edyta Kowalska, Pierre Van Damme, Camille Salamand, Stephanie Pepin
Here, we report a randomized multicenter phase III trial assessing the lot-to-lot consistency of the 2014-2015 Northern Hemisphere quadrivalent split-virion inactivated influenza vaccine (IIV4; Sanofi Pasteur) and comparing its immunogenicity and safety with that of trivalent inactivated influenza vaccine (IIV3) in younger and older adults (EudraCT no. 2014-000785-21). Younger (18-60 y, n = 1114) and older (>60 y, n = 1111) adults were randomized 2:2:2:1:1 to receive a single dose of one of three lots of IIV4, the licensed IIV3 containing the B Yamagata lineage strain, or an investigational IIV3 containing the B Victoria lineage strain...
October 2, 2017: Human Vaccines & Immunotherapeutics
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
#20
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
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