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https://www.readbyqxmd.com/read/28814660/sustained-immune-tolerance-induction-in-enzyme-replacement-therapy-treated-crim-negative-patients-with-infantile-pompe-disease
#1
Zoheb B Kazi, Ankit K Desai, Kathryn L Berrier, R Bradley Troxler, Raymond Y Wang, Omar A Abdul-Rahman, Pranoot Tanpaiboon, Nancy J Mendelsohn, Eli Herskovitz, David Kronn, Michal Inbar-Feigenberg, Catherine Ward-Melver, Michelle Polan, Punita Gupta, Amy S Rosenberg, Priya S Kishnani
BACKGROUND: Cross-reactive immunological material-negative (CRIM-negative) infantile Pompe disease (IPD) patients develop an immune response against enzyme replacement therapy (ERT) with alglucosidase alfa that nullifies ERT efficacy. Prophylactic immune tolerance induction (ITI) with rituximab, methotrexate, and IVIG successfully prevents development of deleterious rhGAA IgG antibodies; however, safety, likelihood of success, and long-term efficacy of ITI in a larger cohort remain unknown...
August 17, 2017: JCI Insight
https://www.readbyqxmd.com/read/28749924/update-temporary-total-depletion-of-u-s-licensed-yellow-fever-vaccine-for-civilian-travelers-addressed-by-investigational-new-drug-use-of-imported-stamaril-vaccine
#2
Mark D Gershman, Mark J Sotir
Sanofi Pasteur, the manufacturer of the only yellow fever vaccine (YF-VAX) licensed in the United States, has announced that their stock of YF-VAX is totally depleted as of July 24, 2017. YF-VAX for civilian use will be unavailable for ordering from Sanofi Pasteur until mid-2018, when their new manufacturing facility is expected to be completed. However, YF-VAX might be available at some clinics for several months, until remaining supplies at those sites are exhausted. In anticipation of this temporary total depletion, in 2016, Sanofi Pasteur submitted an expanded access investigational new drug application to the Food and Drug Administration to allow for importation and use of Stamaril...
July 28, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28736045/comparative-effectiveness-of-high-dose-versus-standard-dose-influenza-vaccination-on-numbers-of-us-nursing-home-residents-admitted-to-hospital-a-cluster-randomised-trial
#3
Stefan Gravenstein, H Edward Davidson, Monica Taljaard, Jessica Ogarek, Pedro Gozalo, Lisa Han, Vincent Mor
BACKGROUND: Immune responses to influenza vaccines decline with age, reducing clinical effectiveness. We compared the effect of the more immunogenic high-dose trivalent influenza vaccine with a standard-dose vaccine to identify the effect on reducing hospital admissions of nursing home residents in the USA. METHODS: We did a single-blind, pragmatic, comparative effectiveness, cluster-randomised trial with a 2 × 2 factorial design. Medicare-certified nursing homes in the USA located within 50 miles of a Centers for Disease Control and Prevention influenza reporting city were recruited, so long as the facilities were not located in a hospital, had more than 50 long-stay residents, had less than 20% of the population aged under 65 years, and were not already planning to administer the high-dose influenza vaccine to residents...
July 20, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28716893/which-dengue-vaccine-approach-is-the-most-promising-and-should-we-be-concerned-about-enhanced-disease-after-vaccination-there-is-only-one-true-winner
#4
Scott B Halstead
The scientific community now possesses information obtained directly from human beings that makes it possible to understand why breakthrough-enhanced dengue virus (DENV) infections occurred in children receiving Sanofi Pasteur's Dengvaxia tetravalent live attenuated vaccine and to predict the possibility of breakthrough-enhanced DENV infections following immunization with two other tetravalent live attenuated vaccines now in phase III testing. Based upon recent research, Dengvaxia, lacking DENV nonstructural protein antigens, did not protect seronegatives because it failed to raise a competent T-cell response and/or antibodies to NS1...
July 17, 2017: Cold Spring Harbor Perspectives in Biology
https://www.readbyqxmd.com/read/28716892/which-dengue-vaccine-approach-is-the-most-promising-and-should-we-be-concerned-about-enhanced-disease-after-vaccination-questions-raised-by-the-development-and-implementation-of-dengue-vaccines-example-of-the-sanofi-pasteur-tetravalent-dengue-vaccine
#5
Bruno Guy
Dengue is a still-growing public health concern in many tropical and subtropical regions of the world. The development and implementation of an effective dengue vaccine in these regions is a high priority. This insight focuses on the expected characteristics of a safe and efficacious vaccine, referring to the clinical experience obtained during the development of the first tetravalent dengue vaccine from Sanofi Pasteur, now licensed in several endemic countries. Safety and efficacy data from both short- and long-term follow-up of large-scale efficacy studies will be discussed, as well as the next steps following vaccine introduction...
July 17, 2017: Cold Spring Harbor Perspectives in Biology
https://www.readbyqxmd.com/read/28716402/the-role-of-low-dose-anti-thymocyte-globulin-as-standard-prophylaxis-in-mismatched-and-matched-unrelated-hematopoietic-peripheral-stem-cell-transplantation-for-hematologic-malignancies
#6
Ioanna Sakellari, Ioannis Batsis, Zoi Bousiou, Despina Mallouri, Varnavas Constantinou, Eleni Gavriilaki, Christos Smias, Evangelia Yannaki, Panayotis Kaloyannidis, Giorgos Papaioannou, Niki Stavroyianni, Antonia Syrigou, Damianos Sotiropoulos, Asimina Fylaktou, Aliki Tsompanakou, Riad Saloum, Achilles Anagnostopoulos
INTRODUCTION: Anti-thymocyte globulin (ATG)-based immunosuppressive therapy is often used in allogeneic hematopoietic cell transplantation to reduce incidence and severity of graft-versus-host disease (GVHD). PATIENTS AND METHODS: In our observational study, ATG (rabbit, Thymoglobulin; Sanofi, 5 mg/kg) was administered as a standardized part of the conditioning in 97 patients with a median age of 34 years (range, 14-58 years), allotransplanted for hematologic malignancies from matched (8/8; n = 52) and allele or antigen mismatched (7/8; n = 43 and 6/8; n = 2) unrelated donors...
June 29, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28707285/burden-of-atopic-dermatitis-in-the-united-states-analysis-of-healthcare-claims-data-in-the-commercial-medicare-and-medi-cal-databases
#7
Sulena Shrestha, Raymond Miao, Li Wang, Jingdong Chao, Huseyin Yuce, Wenhui Wei
INTRODUCTION: Comparative data on the burden of atopic dermatitis (AD) in adults relative to the general population are limited. We performed a large-scale evaluation of the burden of disease among US adults with AD relative to matched non-AD controls, encompassing comorbidities, healthcare resource utilization (HCRU), and costs, using healthcare claims data. The impact of AD disease severity on these outcomes was also evaluated. METHODS: Adult AD patients in the Commercial (n = 83,106), Medicare (n = 31,060), and Medi-Cal (n = 5550) databases were matched (1:1) to non-AD controls by demographic characteristics...
July 13, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28674959/treatment-persistence-and-clinical-outcomes-of-tumor-necrosis-factor-inhibitor-cycling-or-switching-to-a-new-mechanism-of-action-therapy-real-world-observational-study-of-rheumatoid-arthritis-patients-in-the-united-states-with-prior-tumor-necrosis-factor-inhibitor
#8
Wenhui Wei, Keith Knapp, Li Wang, Chieh-I Chen, Gary L Craig, Karen Ferguson, Sergio Schwartzman
INTRODUCTION: To examine treatment persistence and clinical outcomes associated with switching from a tumor necrosis factor inhibitor (TNFi) to a medication with a new mechanism of action (MOA) (abatacept, anakinra, rituximab, tocilizumab, or tofacitinib) versus cycling to another TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) among patients with rheumatoid arthritis. METHODS: This retrospective, longitudinal study included patients with rheumatoid arthritis in the JointMan(®) US clinical database who received a TNFi in April 2010 or later and either cycled to a TNFi or switched to a new MOA therapy by March 2015...
July 3, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28644824/mechanism-underlying-acupuncture-ameliorated-depressive-behaviors-by-enhancing-glial-glutamate-transporter-in-chronic-unpredictable-mild-stress-cums-rats
#9
Ding Luo, Rui Ma, Yanan Wu, Xuechun Zhang, Yue Liu, Lin Wang, Wenbin Fu
BACKGROUND Major depressive disorder (MDD) is a recurrent mental illness worldwide. The glutamatergic neurotransmission system is now a target for antidepressant therapy because it takes part in synaptic plasticity and cognition in physical condition and has a potential excitatory neurotoxicity in pathological conditions. Glial glutamate transporter EAAT2 performs 90% of Glu neurotransmission. Therefore, the aim of the study was to evaluate the effect of acupuncture on depressive behaviors and EAAT2 in CUMS...
June 23, 2017: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
https://www.readbyqxmd.com/read/28623551/which-patients-will-benefit-from-a-switch-in-therapy-from-premixed-insulin-to-insulin-glargine-plus-oral-antidiabetic-drugs-further-analysis-of-the-lantus-registry-study
#10
Shi Bu, Xuelian Zhang, Haiqing Zhu, Ying Shuai, Xiaoyan Xing, Wenying Yang
INTRODUCTION: This subgroup analysis of data from the 16-week Lantus Registry Study in China investigated the characteristics of patients with type 2 diabetes mellitus (T2DM) associated with clinical benefits of transitioning therapy from premixed insulin to insulin glargine (100 U/ml) plus oral antidiabetic drugs (OADs). METHODS: The modified intention-to-treat population of the Lantus Registry Study, comprising 1847 patients with T2DM, were included in the current subgroup analyses...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28623027/ade-and-dengue-vaccination
#11
Ruth Aralí Martínez-Vega, Gabriel Carrasquila, Expedito Luna, José Ramos-Castañeda
The vaccine against Dengue virus (DENV), Dengvaxia® (CYD), produced by Sanofi-Pasteur, has been registered by several national regulatory agencies; nevertheless, the performance and security of this vaccine have been challenged in a series of recent papers. In this work, we intend to contribute to the debate by analyzing the concept of an enhancing vaccine, presenting objections to the epidemiological model base of the concept and, likewise, presenting data that contradict that concept.
July 13, 2017: Vaccine
https://www.readbyqxmd.com/read/28603465/spinal-cord-as-an-adjunct-to-brain-magnetic-resonance-imaging-in-defining-no-evidence-of-disease-activity-in-multiple-sclerosis
#12
Subhash Tummala, Tarun Singhal, Vinit V Oommen, Gloria Kim, Fariha Khalid, Brian C Healy, Rohit Bakshi
Background: Monitoring patients with multiple sclerosis (MS) for “no evidence of disease activity” (NEDA) may help guide disease-modifying therapy (DMT) management decisions. Whereas surveillance brain magnetic resonance imaging (MRI) is common, the role of spinal cord monitoring for NEDA is unknown. Objective: To evaluate the role of brain and spinal cord 3T MRI in the 1-year evaluation of NEDA. Methods: Of 61 study patients (3 clinically isolated syndrome, 56 relapsing-remitting, 2 secondary progressive), 56 (91...
May 2017: International Journal of MS Care
https://www.readbyqxmd.com/read/28602585/janus-kinase-2-inhibitor-fedratinib-in-patients-with-myelofibrosis-previously-treated-with-ruxolitinib-jakarta-2-a-single-arm-open-label-non-randomised-phase-2-multicentre-study
#13
Claire N Harrison, Nicolaas Schaap, Alessandro M Vannucchi, Jean-Jacques Kiladjian, Ramon V Tiu, Pierre Zachee, Eric Jourdan, Elliott Winton, Richard T Silver, Harry C Schouten, Francesco Passamonti, Sonja Zweegman, Moshe Talpaz, Joanne Lager, Zhenming Shun, Ruben A Mesa
BACKGROUND: Myelofibrosis is a chronic myeloproliferative neoplasm characterised by splenomegaly, cytopenias, bone marrow fibrosis, and debilitating symptoms including fatigue, weight loss, and bone pain. Mutations in Janus kinase-2 (JAK2) occur in approximately 50% of patients. The only approved JAK2 inhibitor for myelofibrosis is the dual JAK1 and JAK2 inhibitor, ruxolitinib. 58-71% of patients treated with ruxolitinib in clinical trials so far have not achieved the primary endpoint of 35% or more reduction in spleen volume from baseline assessed by MRI or CT...
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28601342/organ-preservation-for-rectal-cancer-greccar-2-a-prospective-randomised-open-label-multicentre-phase-3-trial
#14
Eric Rullier, Philippe Rouanet, Jean-Jacques Tuech, Alain Valverde, Bernard Lelong, Michel Rivoire, Jean-Luc Faucheron, Mehrdad Jafari, Guillaume Portier, Bernard Meunier, Igor Sileznieff, Michel Prudhomme, Frédéric Marchal, Marc Pocard, Denis Pezet, Anne Rullier, Véronique Vendrely, Quentin Denost, Julien Asselineau, Adélaïde Doussau
BACKGROUND: Organ preservation is a concept proposed for patients with rectal cancer after a good clinical response to neoadjuvant chemotherapy, to potentially avoid morbidity and side-effects of rectal excision. The objective of this study was to compare local excision and total mesorectal excision in patients with a good response after chemoradiotherapy for lower rectal cancer. METHODS: We did a prospective, randomised, open-label, multicentre, phase 3 trial at 15 tertiary centres in France that were experts in the treatment of rectal cancer...
June 7, 2017: Lancet
https://www.readbyqxmd.com/read/28599764/different-insulin-concentrations-in-resuspended-vs-unsuspended-nph-insulin-practical-aspects-of-subcutaneous-injection-in-patients-with-diabetes
#15
P Lucidi, F Porcellati, A Marinelli Andreoli, P Candeloro, P Cioli, G B Bolli, C G Fanelli
AIMS: This study measured the insulin concentration (Ins[C]) of NPH insulin in vials and cartridges from different companies after either resuspension (R+) or not (R-; in the clear/cloudy phases of unsuspended NPH). METHODS: Measurements included Ins[C] in NPH(R+) and in the clear/cloudy phases of NPH(R-), and the time needed to resuspend NPH and time for NPH(R+) to separate again into clear/cloudy parts. RESULTS: In vials of NPH(R+) (assumed to be 100%), Ins[C] in the clear phase of NPH(R-) was<1%, but 230±41% and 234±54% in the cloudy phases of Novo Nordisk and Eli Lilly NPH, respectively...
June 6, 2017: Diabetes & Metabolism
https://www.readbyqxmd.com/read/28598256/integrated-immunogenicity-analysis-of-a-tetravalent-dengue-vaccine-up-to-4%C3%A2-y-after-vaccination
#16
Claire Vigne, Martin Dupuy, Aline Richetin, Bruno Guy, Nicholas Jackson, Matthew Bonaparte, Branda Hu, Melanie Saville, Danaya Chansinghakul, Fernando Noriega, Eric Plennevaux
Two large pivotal phase III studies demonstrated the efficacy of the tetravalent dengue vaccine (CYD-TDV; Dengvaxia®, Sanofi Pasteur) against all dengue serotypes. Here we present an unprecedented integrated summary of the immunogenicity of CYD-TDV to identify the parameters driving the neutralizing humoral immune response and evolution over time. We summarized the immunogenicity profiles of a 3-dose schedule of CYD-TDV administered 6 months apart across 10 phase II and 6 phase III trials undertaken in dengue endemic and non-endemic countries...
June 9, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28555339/role-of-mobile-technology-to-improve-diabetes-care-in-adults-with-type-1-diabetes-the-remote-t1d-study-ibgstar-%C3%A2-in-type-1-diabetes-management
#17
Satish K Garg, Viral N Shah, Halis K Akturk, Christie Beatson, Janet K Snell-Bergeon
INTRODUCTION: The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation. METHODS: The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano(®) and an intervention group using SMBG with iPhone plus glucose meter (iBGStar(®))...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28547386/dupilumab-first-global-approval
#18
REVIEW
Matt Shirley
Dupilumab (Dupixent(®)) is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α (IL-4Rα) subunit. Dupilumab inhibits the signalling of the type 2 cytokines IL-4 and IL-13 and was co-developed by Regeneron Pharmaceuticals and Sanofi as a potential therapeutic agent for the treatment of atopic or allergic diseases. In March 2017 dupilumab received its first global approval, in the USA, for use in the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable...
July 2017: Drugs
https://www.readbyqxmd.com/read/28528802/symptomatic-dengue-infection-during-pregnancy-and-livebirth-outcomes-in-brazil-2007-13-a-retrospective-observational-cohort-study
#19
Laura B Nascimento, Cláudio M Siqueira, Giovanini E Coelho, João B Siqueira
BACKGROUND: Dengue is a major public health challenge in Brazil. We assessed the relationship between symptomatic dengue infection during pregnancy and adverse birth outcomes in the country between 2007 and 2013. METHODS: We did a retrospective observational cohort study using information reported in the Brazilian national reportable disease information system (SINAN) and the livebirth information system (SINASC) databases. We probabilistically linked confirmed dengue-positive and dengue-negative pregnancies with live childbirths using Fine-Grained Record Integration and Linkage (FRIL) software...
May 18, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28526658/nonclinical-pharmacology-and-toxicology-of-the-first-biosimilar-insulin-glargine-drug-product-basaglar-%C3%A2-abasaglar-%C3%A2-approved-in-the-european-union
#20
Richard A Byrd, Rebecca A Owens, Jamie L Blackbourne, David E Coutant, Mark W Farmen, M Dodson Michael, Julie S Moyers, A Eric Schultze, Michael K Sievert, Niraj K Tripathi, John L Vahle
Basaglar(®)/Abasaglar(®) (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus(®) (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity...
May 17, 2017: Regulatory Toxicology and Pharmacology: RTP
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