keyword
MENU ▼
Read by QxMD icon Read
search

Sanofi

keyword
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
#1
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
#2
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/m(2), 5-fluorouracil bolus 400 mg/m(2), oxaliplatin 85 mg/m(2) and 5-fluorouracil 2400 mg/m(2) 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
#3
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
#4
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
#5
EDITORIAL
(no author information available yet)
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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/28937844/immunogenicity-and-safety-of-the-southern-hemisphere-2015-formulation-of-vaxigrip%C3%A2
#13
Mathilde Latreille-Barbier, Regine Rouzier, Beatrice Astruc, Nathalie Lavis, Yves Donazzolo
An inactivated split-virion trivalent influenza vaccine (IIV3; Vaxigrip®, Sanofi Pasteur) has been available globally since 1968. Here, we describe the results of an open-label, post-licensure trial (EudraCT no. 2014-005078-12) to confirm the immunogenicity and safety of the Southern Hemisphere 2015 formulation of IIV3. Adults 18-60 years of age and > 60 years of age (60 per age group) received a single 0.5-ml intramuscular injection of IIV3. Between baseline and day 21 after vaccination, hemagglutination inhibition (HAI) titers for each strain in IIV3 increased, on average, by at least 11-fold for younger adults and at least 5-fold for older adults...
September 22, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28934061/current-safety-issues-with-quadrivalent-meningococcal-conjugate-vaccines
#14
Tanya R Myers, Michael M McNeil
Invasive meningococcal disease, although rare, can present as sudden, life-threatening disease with high risk of mortality or severe long-term sequelae. The main prevention strategy for invasive meningococcal disease in the United States is the routine vaccination of adolescents and other persons at increased risk of meningococcal disease with quadrivalent meningococcal conjugate vaccines. Two such vaccines are currently licensed and available in the United States, Menactra® (Sanofi Pasteur) and Menveo® (Glaxo Smith Kline), and usage in the adolescent population have steadily increased since their introduction...
September 21, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28933626/immunogenicity-and-safety-of-the-2015-southern-hemisphere-formulation-of-a-split-virion-inactivated-quadrivalent-vaccine
#15
Cecilia Montalban, May Book Montellano, Jaime Santos, Nathalie Lavis
An inactivated split-virion quadrivalent influenza vaccine (IIV4; Fluzone® Quadrivalent; Sanofi Pasteur) has been available in the US since 2013 and in the Southern Hemisphere since 2015. Here, we describe the results of an open-label, post-licensure trial (WHO Universal Trial Number, U1111-1143-9256) to confirm the immunogenicity and safety of the Southern Hemisphere 2015 formulation of IIV4. Adults 18-60 years of age and > 60 years of age (n = 60 per age group) received a single 0.5-mL intramuscular injection of IIV4...
September 21, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28933625/immunogenicity-and-safety-of-a-split-virion-quadrivalent-influenza-vaccine-in-adults-18-60%C3%A2-years-of-age-in-the-republic-of-korea
#16
Won Suk Choi, Ji Yun Noh, Jacob Lee, Jun Yong Choi, Jin-Soo Lee, Moo Soo Kim, Hee Soo Kim, Joon Bang, Nathalie Lavis, Woo Joo Kim
VaxigripTetra® (Sanofi Pasteur, Lyon, France) is a quadrivalent split-virion inactivated influenza vaccine (IIV4) containing two B-lineage strains approved in the European Union and Taiwan in 2016 for individuals ≥ 3 years of age. Here, we describe an observer-blind, randomized, controlled, multicenter trial study evaluating the immunogenicity and safety of the Northern Hemisphere 2015-2016 formulations of IIV4 and the licensed split-virion trivalent inactivated influenza vaccine (IIV3) in the Republic of Korea (ClinicalTrials...
September 21, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28933010/economic-evaluation-of-dupilumab-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-in-adults
#17
Andreas Kuznik, Gaëlle Bégo-Le-Bagousse, Laurent Eckert, Abhijit Gadkari, Eric Simpson, Christopher N Graham, LaStella Miles, Vera Mastey, Puneet Mahajan, Sean D Sullivan
INTRODUCTION: Dupilumab significantly improves signs and symptoms of atopic dermatitis (AD), including pruritus, symptoms of anxiety and depression, and health-related quality of life versus placebo in adults with moderate-to-severe AD. Since the cost-effectiveness of dupilumab has not been evaluated, the objective of this analysis was to estimate a value-based price range in which dupilumab would be considered cost-effective compared with supportive care (SC) for treatment of moderate-to-severe AD in an adult population...
September 20, 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/28913822/improved-glycemic-control-in-a-patient-group-performing-7-point-profile-self-monitoring-of-blood-glucose-and-intensive-data-documentation-an-open-label-multicenter-observational-study
#18
Jochen Sieber, Frank Flacke, Manuela Link, Cornelia Haug, Guido Freckmann
INTRODUCTION: Regular self-monitoring of blood glucose (SMBG) is recommended as an integral part of therapy for all patients with diabetes treated with insulin. In the current study, the effects on glycemic control of taking 7-point SMBG profiles and using a diabetes management system (DMA) on a smartphone were investigated. METHODS: In a 12-week, open-label, multicenter, observational study, 51 patients [26 with type 1 diabetes mellitus (T1DM) and 25 with type 2 diabetes mellitus (T2DM)] were instructed to perform SMBG at least seven times a day using DMA combined with the iBGStar (®) SMBG system...
October 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28894310/chemical-stability-of-plerixafor-after-opening-of-single-use-vial
#19
Jack T Seki, Andrea Bozovic, Roy Lee, Rita Kwong, Eshetu G Atenafu, Anna Xu, Jin-Hyeun Huh
BACKGROUND: The addition of the immunostimulant plerixafor to the current standard-of-care regimens of granulocyte colony-stimulating growth factor with or without chemotherapy has improved clinical results in terms of successful stem cell mobilization and the outcomes of stem cell transplant in various settings. With this medical innovation has come an added financial cost for institutions where stem cell transplants are routinely performed, and there may be a further financial burden when the contents of partial vials of the drug are wasted, given that plerixafor vials (Mozobil, Sanofi-Aventis Canada Inc) are currently deemed suitable only for single use...
July 2017: Canadian Journal of Hospital Pharmacy
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
keyword
keyword
19507
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"