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https://www.readbyqxmd.com/read/28528802/symptomatic-dengue-infection-during-pregnancy-and-livebirth-outcomes-in-brazil-2007-13-a-retrospective-observational-cohort-study
#1
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
#2
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 16, 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
#3
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 16, 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
#4
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...
May 13, 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/28499051/safety-and-efficacy-of-ziv-aflibercept-in-the-treatment-of-refractory-diabetic-macular-edema
#5
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
#6
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
#7
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
#8
(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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/28357772/switch-to-combined-glp1-receptor-agonist-lixisenatide-with-basal-insulin-glargine-in-poorly-controlled-t2dm-patients-with-premixed-insulin-therapy-a-clinical-observation-and-pilot-study-in-nine-patients
#12
Jürgen Harreiter, Lana Kosi-Trebotic, Albert Lukas, Peter Wolf, Yvonne Winhofer, Anton Luger, Alexandra Kautzky-Willer, Michael R Krebs
INTRODUCTION: To prove the feasibility and safety of a conversion to once-daily injected GLP1 agonist (lixisenatide) and long-acting basal insulin analogue (glargine) in patients with T2DM and poorly controlled glycemia previously treated with multiple injections of premixed insulins (iPremix) in an outpatient setting. METHODS: Nine patients with T2DM currently receiving iPremix formulations and poor glycemic control were switched to once-daily injected lixisenatide (Lixi) and basal insulin analogue glargine (iGlar) for a 12-week period...
March 29, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28345444/budgetary-impact-of-cabazitaxel-use-after-docetaxel-treatment-for-metastatic-castration-resistant-prostate-cancer
#13
Kyle Flannery, Ed Drea, Louis Hudspeth, Shelby Corman, Xin Gao, Mei Xue, Raymond Miao
BACKGROUND: With the approval of several new treatments for metastatic castration-resistant prostate cancer (mCRPC), budgetary impact is a concern for health plan decision makers. Budget impact models (BIMs) are becoming a requirement in many countries as part of formulary approval or reimbursement decisions. Cabazitaxel is a second-generation taxane developed to overcome resistance to docetaxel and is approved for the treatment of patients with mCRPC previously treated with a docetaxel-containing regimen...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28345442/predicting-1-year-statin-adherence-among-prevalent-users-a-retrospective-cohort-study
#14
Alexis A Krumme, Jessica M Franklin, Danielle L Isaman, Olga S Matlin, Angela Y Tong, Claire M Spettell, Troyen A Brennan, William H Shrank, Niteesh K Choudhry
BACKGROUND: Attempts to predict who is at risk of future nonadherence have largely focused on predictions at the time of therapy initiation; however, these users are only a small proportion of all patients on therapy at any point in time. Methods to predict nonadherence for established medication users, which have not been previously described in the literature, would be helpful to guide efforts to enhance the use of evidence-based therapies. OBJECTIVE: To test approaches for adherence prediction among prevalent statin users, namely the use of short-term filling behavior, investigator-specified predictors from medical and pharmacy administrative claims, and the empirical selection of potential predictors using the high-dimensional propensity score variable selection algorithm...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28345435/predicting-adherence-and-persistence-with-oral-bisphosphonate-therapy-in-an-integrated-health-care-delivery-system
#15
Rita L Hui, Annette L Adams, Fang Niu, Bruce Ettinger, David K Yi, Malini Chandra, Joan C Lo
BACKGROUND: Examining drug exposure is essential to pharmacovigilance, especially for bisphosphonate (BP) therapy. OBJECTIVE: To examine differences in 4 measures of oral BP exposure: treatment discontinuation, adherence, persistence, and nonpersistence. METHODS: Among women aged ≥ 50 years who initiated oral BP therapy during 2002-2007 with at least 3 years of health plan membership follow-up, discontinuation was defined by evidence of no further treatment during the study observation period...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28345434/effect-of-diabetes-treatment-related-attributes-on-costs-to-type-2-diabetes-patients-in-a-real-world-population
#16
Jie Meng, Roman Casciano, Yi-Chien Lee, Lee Stern, Dmitry Gultyaev, Liyue Tong, Brice Kitio-Dschassi
BACKGROUND: Type 2 diabetes mellitus (T2DM) results in a substantial economic burden on patients, health care systems, and society. Most literature assessing the cost of T2DM focuses on the long-term complications of the disease, the association between glucose control and cost, and patient characteristics resulting in poor and costly outcomes. However, it is likely that attributes specific to diabetes therapy can affect the use of costly resources. OBJECTIVE: To estimate the effect of diabetes treatment-related attributes, such as improved efficacy, adherence, and reduced risk for hypoglycemia, on costs to T2DM patients...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28287348/survival-in-idiopathic-pulmonary-fibrosis-perspectives-from-pulmonary-arterial-hypertension
#17
Toby M Maher, Fred Dejonckheere, Steven D Nathan
Maher has received grants, consulting fees, and speaker fees from GlaxoSmithKline and UCB and grants from Novartis. He has also received consulting fees and speaker fees from AstraZeneca, Bayer, Biogen Idec, Boehringer Ingelheim, Cipla, Lanthio, InterMune International AG (a wholly owned Roche subsidiary since 2014), F. Hoffmann-La Roche, Sanofi-Aventis, and Takeda. Maher is supported by a National Institute for Health Research Clinician Scientist Fellowship (NIHR Ref: CS:-2013-13-017). Dejonckheere is an employee of F...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28287347/predicting-life-expectancy-for-pirfenidone-in-idiopathic-pulmonary-fibrosis
#18
Mark Fisher, Steven D Nathan, Christian Hill, Jade Marshall, Fred Dejonckheere, Per-Olof Thuresson, Toby M Maher
BACKGROUND: Conducting an adequately powered survival study in idiopathic pulmonary fibrosis (IPF) is challenging due to the rare nature of the disease and the need for extended follow-up. Consequently, registration trials of IPF treatments have not been designed to estimate long-term survival. OBJECTIVE: To predict life expectancy for patients with IPF receiving pirfenidone versus best supportive care (BSC) in a population that met the inclusion criteria of patients enrolled in the ASCEND and CAPACITY trials...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28272834/urate-oxidase-for-the-prevention-and-treatment-of-tumour-lysis-syndrome-in-children-with-cancer
#19
REVIEW
Daniel Kl Cheuk, Alan Ks Chiang, Godfrey Cf Chan, Shau Yin Ha
BACKGROUND: Tumour lysis syndrome (TLS) is a serious complication of malignancies and can result in renal failure or death. Previous reviews did not find clear evidence of benefit of urate oxidase in children with cancer. This review is the second update of a previously published Cochrane review. OBJECTIVES: To assess the effects and safety of urate oxidase for the prevention and treatment of TLS in children with malignancies. SEARCH METHODS: In March 2016 we searched CENTRAL, MEDLINE, Embase, and CINAHL...
March 8, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28243461/days-out-of-role-due-to-common-physical-and-mental-conditions-in-portugal-results-from-the-who-world-mental-health-survey
#20
Graça Cardoso, Miguel Xavier, Gemma Vilagut, Maria Petukhova, Jordi Alonso, Ronald C Kessler, José Miguel Caldas-de-Almeida
BACKGROUND: One important aspect of the societal burden of mental disorders is the extent to which these problems cause disability. AIMS: To assess days out of role associated with commonly occurring mental disorders in comparison with physical disorders in Portugal. METHOD: National cross-sectional survey, with home interviews carried out with 3849 adult (aged 18+) respondents (57.3% response rate). RESULTS: Twelve-month prevalence for any mental disorder was 21...
January 2017: BJPsych Open
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