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https://www.readbyqxmd.com/read/27932620/dissecting-antibodies-induced-by-a-chimeric-yellow-fever-dengue-live-attenuated-tetravalent-dengue-vaccine-cyd-tdv-in-na%C3%A3-ve-and-dengue-exposed-individuals
#1
Sandra Henein, Jesica Swanstrom, Anthony M Byers, Janice M Moser, S Farzana Shaik, Matthew Bonaparte, Nicholas Jackson, Bruno Guy, Ralph Baric, Aravinda M de Silva
Sanofi Pasteur has developed a chimeric yellow fever-dengue, live-attenuated, tetravalent dengue vaccine (CYD-TDV) that is currently approved for use in several countries. In clinical trials, CYD-TDV was efficacious at reducing laboratory-confirmed cases of dengue disease. Efficacy varied by dengue virus (DENV) serotype and pre-vaccination dengue immune status. We compared the properties of antibodies in naïve and DENV exposed individuals who received CYD-TDV. We depleted specific populations of DENV-reactive antibodies from immune sera to estimate the contribution of serotype-cross reactive and type-specific antibodies to neutralization...
December 8, 2016: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/27902313/streptomyces-caelicus-an-antibiotic-producing-species-of-the-genus-streptomyces-and-streptomyces-canchipurensis-li-et-al-2014-are-later-heterotypic-synonym-of-streptomyces-muensis-ningthoujam-et-al-2013
#2
Joachim Wink, Peter Schumann, Hans-Peter Klenk, Nestor Zaburannyi, Martin Westermann, Karin Martin, Stefanie P Glaeser, Peter Kämpfer, Ewelina Atasayar
"Streptomyces caelicus" DSM 40835T was first reported as the producer of the antibiotic griselimycin by some coworkers of Rhone Poulenc in 1971. The project on isolation of the antibiotic compound was stopped because of the bad solubility and selectivity of the compound towards Mycobacteria. At Sanofi-Aventis, Germany, the project was re-evaluated in 2007 and the gene cluster of griselimycin could be identified, characterized and was patented in 2013. At this time, "S. caelicus" was an invalid name. During the strain characterization work it was found, that S...
October 26, 2016: International Journal of Systematic and Evolutionary Microbiology
https://www.readbyqxmd.com/read/27888023/integrated-process-for-the-purification-and-immobilization-of-the-envelope-protein-domain-iii-of-dengue-virus-type-2-expressed-in-rachiplusia-nu-larvae-and-its-potential-application-in-a-diagnostic-assay
#3
María Emilia Smith, Alexandra Marisa Targovnik, Julieta Cerezo, María Alejandra Morales, María Victoria Miranda, Julián Rodríguez Talou
Dengue incidence has grown dramatically in the last years, with about 40% of the world population at risk of infection. Recently, a vaccine developed by Sanofi Pasteur has been registered, but only in a few countries. Moreover, specific antiviral drugs are not available. Thus, an efficient and accurate diagnosis is important for disease management. To develop a low-cost immunoassay for dengue diagnosis, in the present study we expressed the envelope protein domain III of dengue virus type 2 in Rachiplusia nu larvae by infection with a recombinant baculovirus...
November 22, 2016: Protein Expression and Purification
https://www.readbyqxmd.com/read/27871759/rabbit-atg-or-basiliximab-induction-for-rapid-steroid-withdrawal-after-renal-transplantation-harmony-an-open-label-multicentre-randomised-controlled-trial
#4
Oliver Thomusch, Michael Wiesener, Mirian Opgenoorth, Andreas Pascher, Rainer Peter Woitas, Oliver Witzke, Bernd Jaenigen, Markus Rentsch, Heiner Wolters, Thomas Rath, Tülay Cingöz, Urs Benck, Bernhard Banas, Christian Hugo
BACKGROUND: Standard practice for immunosuppressive therapy after renal transplantation is quadruple therapy using antibody induction, low-dose tacrolimus, mycophenolate mofetil, and corticosteroids. Long-term steroid intake significantly increases cardiovascular risk factors with negative effects on the outcome, especially post-transplantation diabetes associated with morbidity and mortality. In this trial, we examined the efficacy and safety parameters of rapid steroid withdrawal after induction therapy with either rabbit antithymocyte globulin (rabbit ATG) or basiliximab in immunologically low-risk patients during the first year after kidney transplantation...
November 18, 2016: Lancet
https://www.readbyqxmd.com/read/27864015/prediction-of-overall-survival-for-patients-with-metastatic-castration-resistant-prostate-cancer-development-of-a-prognostic-model-through-a-crowdsourced-challenge-with-open-clinical-trial-data
#5
Justin Guinney, Tao Wang, Teemu D Laajala, Kimberly Kanigel Winner, J Christopher Bare, Elias Chaibub Neto, Suleiman A Khan, Gopal Peddinti, Antti Airola, Tapio Pahikkala, Tuomas Mirtti, Thomas Yu, Brian M Bot, Liji Shen, Kald Abdallah, Thea Norman, Stephen Friend, Gustavo Stolovitzky, Howard Soule, Christopher J Sweeney, Charles J Ryan, Howard I Scher, Oliver Sartor, Yang Xie, Tero Aittokallio, Fang Liz Zhou, James C Costello
BACKGROUND: Improvements to prognostic models in metastatic castration-resistant prostate cancer have the potential to augment clinical trial design and guide treatment strategies. In partnership with Project Data Sphere, a not-for-profit initiative allowing data from cancer clinical trials to be shared broadly with researchers, we designed an open-data, crowdsourced, DREAM (Dialogue for Reverse Engineering Assessments and Methods) challenge to not only identify a better prognostic model for prediction of survival in patients with metastatic castration-resistant prostate cancer but also engage a community of international data scientists to study this disease...
November 15, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27824837/sanofi-and-google-in-type-2-diabetes-smartphone-tie-up
#6
Eric Smalley
No abstract text is available yet for this article.
November 8, 2016: Nature Biotechnology
https://www.readbyqxmd.com/read/27811942/sanofi-cell-research-outstanding-paper-award-of-2015
#7
EDITORIAL
(no author information available yet)
No abstract text is available yet for this article.
November 2016: Cell Research
https://www.readbyqxmd.com/read/27811836/recommendations-for-use-of-meningococcal-conjugate-vaccines-in-hiv-infected-persons-advisory-committee-on-immunization-practices-2016
#8
Jessica R MacNeil, Lorry G Rubin, Monica Patton, Ismael R Ortega-Sanchez, Stacey W Martin
At its June 2016 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of meningococcal conjugate vaccine (serogroups A, C, W, and Y; including MenACWY-D [Menactra, Sanofi Pasteur] or MenACWY-CRM [Menveo, GlaxoSmithKline]) for persons aged ≥2 months with human immunodeficiency virus (HIV) infection. ACIP has previously recommended routine vaccination of persons aged ≥2 months who have certain medical conditions that increase risk for meningococcal disease (1), including persons who have persistent (e...
November 4, 2016: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/27809689/two-decades-of-pharmacovigilance-and-clinical-experience-with-highly-purified-rabies-immunoglobulin-f-ab-2-fragments
#9
Elisa Reveneau, Pascale Cottin, Anvar Rasuli
Rabies is a worldwide zoonotic viral disease with no specific treatment once symptoms occur; manifest disease is almost always fatal. WHO recommendations for exposed individuals include immediate attention to the wound and use of rabies immunoglobulin and/or vaccine for post-exposure prophylaxis (PEP). Here, we provide an overview of the clinical experience with a highly purified preparation of F(ab')2 fragments from equine rabies immunoglobulin (F(ab')2 pERIG; Favirab(TM)) in rabies PEP. Areas covered: Our review comprises a retrospective analysis of adverse event reports in the Sanofi Pasteur global pharmacovigilance database for F(ab')2 pERIG, including adverse event reports from eight Sanofi Pasteur-sponsored clinical trials and post-market surveillance data collected between 1995 and 2014...
November 4, 2016: Expert Review of Vaccines
https://www.readbyqxmd.com/read/27809345/bioequivalence-study-between-a-fixed-dose-single-pill-formulation-of-nebivolol-plus-hydrochlorothiazide-and-separate-formulations-in-healthy-subjects-using-high-performance-liquid-chromatography-coupled-to-tandem-mass-spectrometry
#10
Celso Francisco Pimentel Vespasiano, Tiago Luders Laurito, Renan Donomae Iwamoto, Ronilson Agnaldo Moreno, Gustavo D Mendes, Gilberto De Nucci
Systemic arterial hypertension is a major risk factor for cerebrovascular disease. Therefore, an adequate control of blood pressure is of enormous importance. One of the many fixed-dose single-pill antihypertensive formulations available on the market is the combination of nebivolol and hydrochlorothiazide. The objective of this study was to develop two distinct high performance liquid chromatography coupled to tandem mass spectrometry methods to simultaneously quantify nebivolol and hydrochlorothiazide in human plasma...
November 3, 2016: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/27796905/lixisenatide-improves-glycemic-control-in-asian-type-2-diabetic-patients-inadequately-controlled-with-oral-antidiabetic-drugs-an-individual-patient-data-meta-analysis
#11
Hua Shu, Li-Na Gu, Li-Chuang Men, Ju-Ming Lu
INTRODUCTION: Lixisenatide is a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus (T2DM). Its efficacy and safety have been assessed in a series of phase 3 studies included in the GetGoal program. In these studies, lixisenatide was found to be superior to placebo in glycemic control. The aim of this meta-analysis was to assess the safety and efficacy of lixisenatide as an adjunct therapy in Asian patients with T2DM in adequately controlled with oral antidiabetic drugs (OADs)...
December 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/27796143/the-mechanistic-role-of-antibodies-to-dengue-virus-in-protection-and-disease-pathogenesis
#12
Esther Shuyi Gan, Donald Heng Rong Ting, Kuan Rong Chan
Dengue is a prevalent disease in tropical and subtropical countries with an estimated 400 million people infected annually. While significant advancement has been made in the chase for an effective dengue vaccine, the recently licensed Sanofi vaccine was, in contrast to in vitro data, only partially protective. Areas covered: This suggests that our understanding of the serological correlates for dengue is currently inadequate. With growing evidence supporting the role of fragment crystalizable gamma receptors (FcγRs) in antibody-mediated neutralization or antibody-dependent enhancement (ADE) of dengue virus (DENV) infection, FcγR-expressing cells have been increasingly used for measuring neutralizing antibody responses elicited by dengue vaccines...
October 31, 2016: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/27770303/cabazitaxel-for-hormone-relapsed-metastatic-prostate-cancer-previously-treated-with-a-docetaxel-containing-regimen-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#13
Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
October 22, 2016: PharmacoEconomics
https://www.readbyqxmd.com/read/27743352/evaluating-the-relationship-between-metabolic-syndrome-and-liver-biopsy-proven-non-alcoholic-steatohepatitis-in-china-a-multicenter-cross-sectional-study-design
#14
Zheng-Jie Xu, Jun-Ping Shi, De-Rong Yu, Li-Juan Zhu, Ji-Dong Jia, Jian-Gao Fan
INTRODUCTION: Non-alcoholic steatohepatitis (NASH) is a serious form of non-alcoholic fatty liver disease (NAFLD) that can progress to advanced fibrosis, cirrhosis, and hepatocellular carcinoma. Differentiating between non-alcoholic fatty liver (NAFL) and NASH/advanced fibrosis is an important step in the management of NAFLD. Metabolic syndrome (MS) and its components are important risk factors for NAFLD, and NASH is thought to be the hepatic injury of MS. The prevalence of NASH among NAFLD patients with MS is thought to be high...
October 14, 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27701113/benefits-and-risks-of-the-sanofi-pasteur-dengue-vaccine-modeling-optimal-deployment
#15
Neil M Ferguson, Isabel Rodríguez-Barraquer, Ilaria Dorigatti, Luis Mier-Y-Teran-Romero, Daniel J Laydon, Derek A T Cummings
The first approved dengue vaccine has now been licensed in six countries. We propose that this live attenuated vaccine acts like a silent natural infection in priming or boosting host immunity. A transmission dynamic model incorporating this hypothesis fits recent clinical trial data well and predicts that vaccine effectiveness depends strongly on the age group vaccinated and local transmission intensity. Vaccination in low-transmission settings may increase the incidence of more severe "secondary-like" infection and, thus, the numbers hospitalized for dengue...
September 2, 2016: Science
https://www.readbyqxmd.com/read/27699623/clinical-pharmacokinetics-and-pharmacodynamics-of-insulin-glargine-300%C3%A2-u-ml
#16
Jennifer N Clements, Tiffaney Threatt, Eileen Ward, Kayce M Shealy
Concentrated insulin analogs have recently been approved and are available for clinical use in the management of diabetes mellitus. One new product is insulin glargine U-300 (Sanofi), a basal concentrated insulin of 300 U/mL. Several studies have been conducted and completed evaluating blood samples for the pharmacokinetics of insulin glargine U-300 and euglycemic clamp procedures for the pharmacodynamics. This concentrated insulin has a low within-day variability and high day-to-day reproducibility, allowing for a more constant and prolonged duration of action, compared with insulin glargine U-100 (100 U/mL)...
October 4, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27690741/two-phase-3-trials-of-dupilumab-versus-placebo-in-atopic-dermatitis
#17
Eric L Simpson, Thomas Bieber, Emma Guttman-Yassky, Lisa A Beck, Andrew Blauvelt, Michael J Cork, Jonathan I Silverberg, Mette Deleuran, Yoko Kataoka, Jean-Philippe Lacour, Külli Kingo, Margitta Worm, Yves Poulin, Andreas Wollenberg, Yuhwen Soo, Neil M H Graham, Gianluca Pirozzi, Bolanle Akinlade, Heribert Staudinger, Vera Mastey, Laurent Eckert, Abhijit Gadkari, Neil Stahl, George D Yancopoulos, Marius Ardeleanu
Background Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important drivers of atopic or allergic diseases such as atopic dermatitis. Methods In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1 and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment. Patients were randomly assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg) or placebo weekly or the same dose of dupilumab every other week alternating with placebo...
September 30, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27668566/variation-in-private-payer-coverage-of-rheumatoid-arthritis-drugs
#18
James D Chambers, Colby L Wilkinson, Jordan E Anderson, Matthew D Chenoweth
BACKGROUND: Payers in the United States issue coverage determinations to guide how their enrolled beneficiaries use prescription drugs. Because payers create their own coverage policies, how they cover drugs can vary, which in turn can affect access to care by beneficiaries. OBJECTIVE: To examine how the largest private payers based on membership cover drugs indicated for rheumatoid arthritis and to determine what evidence the payers reported reviewing when formulating their coverage policies...
October 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27667332/a-phase-1-open-label-randomized-study-to-compare-the-immunogenicity-and-safety-of-different-administration-routes-and-doses-of-virosomal-influenza-vaccine-in-elderly
#19
Yotam Levin, Efrat Kochba, Georgi Shukarev, Sarah Rusch, Guillermo Herrera-Taracena, Pierre van Damme
BACKGROUND: Influenza remains a significant problem in elderly despite widespread vaccination coverage. This randomized, phase-I study in elderly compared different strategies of improving vaccine immunogenicity. METHODS: A total of 370 healthy participants (⩾65years) were randomized equally 1:1:1:1:1:1 to six influenza vaccine treatments (approximately 60-63 participants per treatment arm) at day 1 that consisted of three investigational virosomal vaccine formulations at doses of 7...
October 17, 2016: Vaccine
https://www.readbyqxmd.com/read/27641781/continuous-glucose-monitoring-for-patients-with-type-1-diabetes-and-impaired-awareness-of-hypoglycaemia-in-control-a-randomised-open-label-crossover-trial
#20
Cornelis A J van Beers, J Hans DeVries, Susanne J Kleijer, Mark M Smits, Petronella H Geelhoed-Duijvestijn, Mark H H Kramer, Michaela Diamant, Frank J Snoek, Erik H Serné
BACKGROUND: Patients with type 1 diabetes who have impaired awareness of hypoglycaemia have a three to six times increased risk of severe hypoglycaemia. We aimed to assess whether continuous glucose monitoring (CGM) improves glycaemia and prevents severe hypoglycaemia compared with self-monitoring of blood glucose (SMBG) in this high-risk population. METHODS: We did a randomised, open-label, crossover trial (IN CONTROL) at two medical centres in the Netherlands...
November 2016: Lancet Diabetes & Endocrinology
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