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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
#1
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...
June 16, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28623027/ade-and-dengue-vaccination
#2
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.
June 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
#3
Subhash Tummala, Tarun Singhal, Vinit V Oommen, Gloria Kim, Fariha Khalid, Brian C Healy, Rohit Bakshi
ACTIVITY AVAILABLE ONLINE: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. TARGET AUDIENCE: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). LEARNING OBJECTIVES: 1) Describe the concept of "no evidence of disease activity" in MS.2) Recognize the role of spinal cord imaging in routine monitoring of MS disease activity...
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
#4
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...
June 8, 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
#5
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
#6
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-years-after-vaccination
#7
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 three-dose schedule of CYD-TDV administered 6 months apart across ten phase II and six phase III trials undertaken in 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
#8
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(®))...
May 29, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28547386/dupilumab-first-global-approval
#9
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...
May 25, 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
#10
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
#11
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
https://www.readbyqxmd.com/read/28526489/intravitreous-injection-of-aav2-sflt01-in-patients-with-advanced-neovascular-age-related-macular-degeneration-a-phase-1-open-label-trial
#12
Jeffrey S Heier, Saleema Kherani, Shilpa Desai, Pravin Dugel, Shalesh Kaushal, Seng H Cheng, Cheryl Delacono, Annie Purvis, Susan Richards, Annaig Le-Halpere, John Connelly, Samuel C Wadsworth, Rafael Varona, Ronald Buggage, Abraham Scaria, Peter A Campochiaro
BACKGROUND: Long-term intraocular injections of vascular endothelial growth factor (VEGF)-neutralising proteins can preserve central vision in many patients with neovascular age-related macular degeneration. We tested the safety and tolerability of a single intravitreous injection of an AAV2 vector expressing the VEGF-neutralising protein sFLT01 in patients with advanced neovascular age-related macular degeneration. METHODS: This was a phase 1, open-label, dose-escalating study done at four outpatient retina clinics in the USA...
May 17, 2017: Lancet
https://www.readbyqxmd.com/read/28503712/dupilumab-improves-general-health-related-quality-of-life-in-patients-with-moderate-to-severe-atopic-dermatitis-pooled-results-from-two-randomized-controlled-phase-3-clinical-trials
#13
Eric L Simpson
INTRODUCTION: Patients with moderate-to-severe atopic dermatitis (AD) report a multidimensional disease burden that includes impaired health-related quality-of-life (HRQoL). Changes in overall health status and specific dimensions that contribute to HRQoL were evaluated in adults with moderate-to-severe AD who participated in phase 3 clinical trials of dupilumab, which is a fully human monoclonal antibody that inhibits signaling of cytokines IL-4 and IL-13. METHODS: Two dupilumab phase 3 clinical trials of identical design included the 5-dimension 3-level EuroQol (EQ-5D) as a measure of HRQoL...
June 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/28499051/safety-and-efficacy-of-ziv-aflibercept-in-the-treatment-of-refractory-diabetic-macular-edema
#14
Mohammed Ashraf, Hassan El Kayal, Ahmed A R Souka
BACKGROUND AND OBJECTIVE: To evaluate the safety and efficacy of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Bridgewater, NJ/Regeneron Pharmaceuticals, Tarrytown, NY) in the treatment of refractory diabetic macular edema (DME). PATIENTS AND METHODS: Retrospective case series looking at the safety of ziv-aflibercept in patients with DME refractory to previous anti-vascular endothelial growth factor (VEGF) therapy. Detailed ophthalmologic examination, best-corrected visual acuity, and optical coherence tomography measurements were performed pre-switch, as well as at each monthly follow-up visit...
May 1, 2017: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/28478972/long-term-management-of-moderate-to-severe-atopic-dermatitis-with-dupilumab-and-concomitant-topical-corticosteroids-liberty-ad-chronos-a-1-year-randomised-double-blinded-placebo-controlled-phase-3-trial
#15
Andrew Blauvelt, Marjolein de Bruin-Weller, Melinda Gooderham, Jennifer C Cather, Jamie Weisman, David Pariser, Eric L Simpson, Kim A Papp, H Chih-Ho Hong, Diana Rubel, Peter Foley, Errol Prens, Christopher E M Griffiths, Takafumi Etoh, Pedro Herranz Pinto, Ramon M Pujol, Jacek C Szepietowski, Karel Ettler, Lajos Kemény, Xiaoping Zhu, Bolanle Akinlade, Thomas Hultsch, Vera Mastey, Abhijit Gadkari, Laurent Eckert, Nikhil Amin, Neil M H Graham, Gianluca Pirozzi, Neil Stahl, George D Yancopoulos, Brad Shumel
BACKGROUND: Dupilumab (an anti-interleukin-4-receptor-α monoclonal antibody) blocks signalling of interleukin 4 and interleukin 13, type 2/Th2 cytokines implicated in numerous allergic diseases ranging from asthma to atopic dermatitis. Previous 16-week monotherapy studies showed that dupilumab substantially improved signs and symptoms of moderate-to-severe atopic dermatitis with acceptable safety, validating the crucial role of interleukin 4 and interleukin 13 in atopic dermatitis pathogenesis...
May 4, 2017: Lancet
https://www.readbyqxmd.com/read/28472025/addressing-a-yellow-fever-vaccine-shortage-united-states-2016-2017
#16
Mark D Gershman, Kristina M Angelo, Julian Ritchey, David P Greenberg, Riyadh D Muhammad, Gary Brunette, Martin S Cetron, Mark J Sotir
Recent manufacturing problems resulted in a shortage of the only U.S.-licensed yellow fever vaccine. This shortage is expected to lead to a complete depletion of yellow fever vaccine available for the immunization of U.S. travelers by mid-2017. CDC, the Food and Drug Administration (FDA), and Sanofi Pasteur are collaborating to ensure a continuous yellow fever vaccine supply in the United States. As part of this collaboration, Sanofi Pasteur submitted an expanded access investigational new drug (eIND) application to FDA in September 2016 to allow for the importation and use of an alternative yellow fever vaccine manufactured by Sanofi Pasteur France, with safety and efficacy comparable to the U...
May 5, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28448782/amcp-partnership-forum-driving-value-and-outcomes-in-oncology
#17
(no author information available yet)
Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28408227/efficient-and-practical-synthesis-of-fondaparinux
#18
Yili Ding, Chamakura V N S Vara Prasad, Hua Bai, Bingyun Wang
Combining advantageous sequences of Alchemia and Sanofi methods of synthesis of Fondaparinux, a more efficient and practical synthetic strategy for the synthesis of corresponding protected pentasaccharide was developed. The protected pentasaccharide was smoothly converted into Fondaparinux in overall high yield (1%).
April 5, 2017: Bioorganic & Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/28395555/alirocumab-for-the-treatment-of-hypercholesterolaemia
#19
REVIEW
Giuseppe Della Pepa, Lutgarda Bozzetto, Giovanni Annuzzi, Angela Albarosa Rivellese
Prescription of statins for low-density lipoprotein cholesterol (LDL-C) reduction is the standard of care in primary and secondary prevention of cardiovascular disease; nevertheless, a large number of patients treated with statins are unable to reach the recommended LDL-C targets. Therefore, there is need for safe and effective novel therapies for the pharmacological management of hypercholesterolaemia, in addition or as alternative to lipid-lowering therapies (LLT) currently in use. Areas covered: In 2015, the Food and Drug Administration and the European Medicines Agency approved alirocumab (Praluent®; Sanofi), a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), for the treatment of hypercholesterolaemic patients unable to meet LDL-C targets, as an adjunct to diet in addition/alternative to LLT...
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28390397/modelling-the-therapeutic-dose-range-of-single-low-dose-primaquine-to-reduce-malaria-transmission-through-age-based-dosing
#20
Daniel Joseph Hayes, Clifford George Banda, Alexandra Chipasula-Teleka, Dianne Janette Terlouw
BACKGROUND: Low-dose primaquine is a key candidate for use in malaria transmission reduction and elimination campaigns such as mass drug administration (MDA). Uncertainty about the therapeutic dose range (TDR) required for general and paediatric populations challenge the implementation of the World Health Organisation's recommendation to add 0.25 mg/kg to current standard antimalarial treatment in such settings. Modelling work shows that for low-dose primaquine to have an impact, high efficacy and extensive population coverage are needed...
April 8, 2017: BMC Infectious Diseases
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