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https://www.readbyqxmd.com/read/29338483/reply-to-prehospital-intubation-further-confounders-in-trial-results
#1
Tomas Nuño, Kurt R Denninghoff, Qi Pauls, Sharon D Yeatts, Robert Silbergleit, Yuko Y Palesch, Lisa H Merck, Geoff Manley, David W Wright
No abstract text is available yet for this article.
January 17, 2018: Prehospital Emergency Care
https://www.readbyqxmd.com/read/29330813/characteristics-of-elderly-patients-initiating-sitagliptin-or-non-dpp-4-inhibitor-oral-antihyperglycemic-agents-analysis-of-a-cross-sectional-us-claims-database
#2
Tongtong Wang, Ann Marie McNeill, Yong Chen, Edward A O'Neill, Samuel S Engel
INTRODUCTION: Previous analyses concluded that patients initiating treatment with sitagliptin are older and have more comorbidities than patients initiating treatment with other oral antihyperglycemic agents (OAHAs). However, these studies focused on the general population or subjects ≤ 65 years of age. We sought to compare differences in baseline characteristics of elderly patients (≥ 65 years of age) with T2DM initiating sitagliptin vs. non-DPP-4 inhibitor (non-DPP-4i) OAHA in the MarketScan® Medicare Supplemental Database...
January 12, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29298119/secondary-patents-in-the-pharmaceutical-industry-missing-the-wood-for-the-trees
#3
Saritha Kiran, Mohan Kulkarni
Introduction The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products. Areas covered The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed patents, US patent data...
January 3, 2018: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/29290170/cost-effectiveness-of-drugs-to-treat-relapsed-refractory-multiple-myeloma-in-the-united-states
#4
Josh J Carlson, Gregory F Guzauskas, Richard H Chapman, Patricia G Synnott, Shanshan Liu, Elizabeth T Russo, Steven D Pearson, Elizabeth D Brouwer, Daniel A Ollendorf
BACKGROUND: New 3-drug regimens have been developed and approved to treat multiple myeloma (MM). The absence of direct comparative data and the high cost of treatment support the need to assess the relative clinical and economic outcomes across all approved regimens. OBJECTIVE: To evaluate the cost-effectiveness of treatments for relapsed and/or refractory MM from a U.S. health system perspective. METHODS: We developed a partition survival model with 3 health states (progression-free, progression, and death) to evaluate the following regimens: carfilzomib (CFZ), elotuzumab (ELO), ixazomib (IX), daratumumab (DAR), and panobinostat (PAN) in combination with lenalidomide (LEN) or bortezomib (BOR) plus dexamethasone (DEX) in the second and/or third line of therapy...
January 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29288370/letermovir-first-global-approval
#5
Esther S Kim
Letermovir (Prevymis™) is an orally or intravenously administered cytomegalovirus (CMV) DNA terminase complex inhibitor being developed by Merck & Co., Inc., under a global license from AiCuris Anti-infective Cures GmbH. Letermovir has been approved in Canada and the USA for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant (HSCT). In addition, letermovir has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, and is under review in several countries, including Japan...
January 2018: Drugs
https://www.readbyqxmd.com/read/29287689/present-therapeutic-role-of-cholesteryl-ester-transfer-protein-inhibitors
#6
REVIEW
Nicola Ferri, Alberto Corsini, Cesare R Sirtori, Massimiliano Ruscica
Therapeutic interventions aimed at increasing high-density lipoprotein (HDL) levels, in order to reduce the residual cardiovascular (CV) risk of optimally drug treated patients have not provided convincing results, so far. Transfer of cholesterol from extrahepatic tissues to the liver appears to be the major atheroprotective function of HDL, and an elevation of HDL levels could represent an effective strategy. Inhibition of the cholesteryl ester transfer protein (CETP), raising HDL-cholesterol (HDL-C) and apolipoprotein A-I (apoA-I) levels, reduces low-density lipoprotein-cholesterol (LDL-C) and apoB levels, thus offering a promising approach...
December 26, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29275135/effect-of-a-multifaceted-social-franchising-model-on-quality-and-coverage-of-maternal-newborn-and-reproductive-health-care-services-in-uttar-pradesh-india-a-quasi-experimental-study
#7
Sarah Tougher, Varun Dutt, Shreya Pereira, Kaveri Haldar, Vasudha Shukla, Kultar Singh, Paresh Kumar, Catherine Goodman, Timothy Powell-Jackson
BACKGROUND: How to harness the private sector to improve population health in low-income and middle-income countries is heavily debated and one prominent strategy is social franchising. We aimed to evaluate whether the Matrika social franchising model-a multifaceted intervention that established a network of private providers and strengthened the skills of both public and private sector clinicians-could improve the quality and coverage of health services along the continuum of care for maternal, newborn, and reproductive health...
December 20, 2017: Lancet Global Health
https://www.readbyqxmd.com/read/29251608/manufacturing-the-truth-from-designing-clinical-trials-to-publishing-trial-data
#8
Margaret Whitstock
This paper expands on some of the points made by Deepak Natarajan on techniques used in designing clinical trials of new drugs to ensure favourable outcomes. It also considers the nexus between the manufacturers of new drugs and the publishers of medical journals in which edited versions of these favourable outcomes are presented to the medical fraternity. The argument will be illustrated by referring to the clinical trials of rofecoxib (Vioxx®) and etoricoxib (Arcoxia®). Both these drugs are COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) manufactured by Merck and Co...
November 14, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/29239195/-immunotherapy-of-colorectal-and-anal-carcinoma
#9
J Tomášek, I Kiss
BACKGROUND: The lower part of the digestive tract includes the large intestine, rectum and anus. Treatment algorithms of cancers in these localities have significant differences in both early and advanced stages. The vast majority of metastatic cases are incurable. A few years ago, it was generally accepted that gastrointestinal tumors are poorly immunogenic and modern immunotherapy would not work in gastrointestinal cancers. The breakthrough has become the recognition of the mismatch repair system (MMR) that affects the microsatellite instability (MSI) and its role in the development of colorectal carcinoma (CRC)...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/29217288/avelumab-in-metastatic-urothelial-carcinoma-after-platinum-failure-javelin-solid-tumor-pooled-results-from-two-expansion-cohorts-of-an-open-label-phase-1-trial
#10
Manish R Patel, John Ellerton, Jeffrey R Infante, Manish Agrawal, Michael Gordon, Raid Aljumaily, Carolyn D Britten, Luc Dirix, Keun-Wook Lee, Mathew Taylor, Patrick Schöffski, Ding Wang, Alain Ravaud, Arnold B Gelb, Junyuan Xiong, Galit Rosen, James L Gulley, Andrea B Apolo
BACKGROUND: The approval of anti-programmed death ligand 1 (PD-L1) and anti-programmed death 1 agents has expanded treatment options for patients with locally advanced or metastatic urothelial carcinoma. Avelumab, a human monoclonal anti-PD-L1 antibody, has shown promising antitumour activity and safety in this disease. We aimed to assess the safety profile in patients (both post-platinum therapy and cisplatin-naive) treated with avelumab and to assess antitumour activity of this drug in post-platinum patients...
December 4, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29211658/letermovir-prophylaxis-for-cytomegalovirus-in-hematopoietic-cell-transplantation
#11
Francisco M Marty, Per Ljungman, Roy F Chemaly, Johan Maertens, Sanjeet S Dadwal, Rafael F Duarte, Shariq Haider, Andrew J Ullmann, Yuta Katayama, Janice Brown, Kathleen M Mullane, Michael Boeckh, Emily A Blumberg, Hermann Einsele, David R Snydman, Yoshinobu Kanda, Mark J DiNubile, Valerie L Teal, Hong Wan, Yoshihiko Murata, Nicholas A Kartsonis, Randi Y Leavitt, Cyrus Badshah
Background Cytomegalovirus (CMV) infection remains a common complication after allogeneic hematopoietic-cell transplantation. Letermovir is an antiviral drug that inhibits the CMV-terminase complex. Methods In this phase 3, double-blind trial, we randomly assigned CMV-seropositive transplant recipients, 18 years of age or older, in a 2:1 ratio to receive letermovir or placebo, administered orally or intravenously, through week 14 after transplantation; randomization was stratified according to trial site and CMV disease risk...
December 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29209274/optimizing-patient-management-and-adherence-for-children-receiving-growth-hormone
#12
Carlo L Acerini, Katarzyna Wac, Peter Bang, Dagmar Lehwalder
Poor adherence with growth hormone (GH) therapy has been associated with worse clinical outcomes, which in children relates specifically to their linear growth and loss of quality of life. The "360° GH in Europe" meeting, held in Lisbon, Portugal, in June 2016 and funded by Merck KGaA (Germany), examined many aspects of GH diseases. The three sessions, entitled "Short Stature Diagnosis and Referral," "Optimizing Patient Management," and "Managing Transition," each benefited from three guest speaker presentations, followed by an open discussion and are reported as a manuscript, authored by the speakers...
2017: Frontiers in Endocrinology
https://www.readbyqxmd.com/read/29203974/deterministic-role-of-cea-and-msi-status-in-predicting-outcome-of-crc-patients-a-perspective-study-amongst-hospital-attending-eastern-indian-populations
#13
Banerjee Koyel, Das Priyabrata, Bhattacharya Rittwika, Dasgupta Swati, Mukhopadhyay Soma, Basak Jayasri, Mukhopadhyay Ashis
Carcinoembryonic antigen (CEA) is an important deterministic factor in predicting colorectal carcinoma (CRC) progression. It is also evident that microsatellite instability (MSI) which results in a hypermutable phenotype of genomic DNA is common in CRC. Owing to the scarcity of reports from India, our aim of this study was to understand the clinicopathological correlations of CEA status with surgery and chemotherapy, correlate the same with socio-demographic status of the patients, determine the MSI status amongst them and understand the prognostic implications of CEA and MSI as CRC progression marker amongst patients...
December 2017: Indian Journal of Surgical Oncology
https://www.readbyqxmd.com/read/29186497/for-as-long-as-necessary-examining-30-years-of-merck-co-inc-s-focus-on-achieving-elimination-of-onchocerciasis-and-lymphatic-filariasis
#14
Kenneth M Gustavsen, Brenda D Colatrella, Theresa McCoy
Established by Merck & Co., Inc. (known as MSD outside of the United States and Canada) in 1987, the Mectizan Donation Program (MDP) is the longest running disease-specific program of its kind. Initially aimed at control of onchocerciasis (river blindness), the company expanded its commitment through the MDP in 1998 to include lymphatic filariasis (LF). Both diseases are now candidates for elimination and the company is engaged in several global partnerships to help advance towards that goal. To support the steadily growing demand from country-led disease elimination programs, the company has put in place several administrative and operational improvements...
November 23, 2017: International Health
https://www.readbyqxmd.com/read/29174682/herpes-zoster-vaccine-live-a-10%C3%A2-year-review-of-post-marketing-safety-experience
#15
English D Willis, Meredith Woodward, Elizabeth Brown, Zoran Popmihajlov, Patricia Saddier, Paula W Annunziato, Neal A Halsey, Anne A Gershon
BACKGROUND: Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. METHODS: All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed...
December 19, 2017: Vaccine
https://www.readbyqxmd.com/read/29159895/proliferation-and-differentiation-of-mesenchymal-stem-cells-on-scaffolds-containing-chitosan-calcium-polyphosphate-and-pigeonite-for-bone-tissue-engineering
#16
S Dhivya, A Keshav Narayan, R Logith Kumar, S Viji Chandran, M Vairamani, N Selvamurugan
OBJECTIVES: Treatment of critical-sized bone defects with cells and biomaterials offers an efficient alternative to traditional bone grafts. Chitosan (CS) is a natural biopolymer that acts as a scaffold in bone tissue engineering (BTE). Polyphosphate (PolyP), recently identified as an inorganic polymer, acts as a potential bone morphogenetic material, whereas pigeonite (Pg) is a novel iron-containing ceramic. In this study, we prepared and characterized scaffolds containing CS, calcium polyphosphate (CaPP) and Pg particles for bone formation in vitro and in vivo...
November 21, 2017: Cell Proliferation
https://www.readbyqxmd.com/read/29159457/ertugliflozin-in-patients-with-stage-3-chronic-kidney-disease-and-type-2-diabetes-mellitus-the-vertis-renal-randomized-study
#17
George Grunberger, Sarah Camp, Jeremy Johnson, Susan Huyck, Steven G Terra, James P Mancuso, Zhi Wei Jiang, Gregory Golm, Samuel S Engel, Brett Lauring
INTRODUCTION: Ertugliflozin is a sodium-glucose cotransporter 2 inhibitor in development for type 2 diabetes mellitus (T2DM). The safety and efficacy of ertugliflozin were evaluated over 52 weeks in patients with chronic kidney disease (CKD). METHODS: In this double-blind randomized study (NCT01986855), patients with glycated hemoglobin (A1C) 7.0-10.5% and stage 3 CKD [estimated glomerular filtration rate (eGFR) ≥ 30 to < 60 mL/min/1.73 m(2)] who were undergoing treatment with standard diabetes therapy (or therapies) including insulin and/or sulfonylureas were randomized to once-daily ertugliflozin 5 mg, 15 mg, or placebo...
November 20, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29150925/one-pot-synthesis-of-a-multi-template-molecularly-imprinted-polymer-for-the-extraction-of-six-sulfonamide-residues-from-milk-before-hplc-with-diode-array-detection
#18
Maria Kechagia, Victoria Samanidou, Abuzar Kabir, Kenneth G Furton
A highly selective molecularly imprinted polymer sorbent was synthesized and employed for the simultaneous determination of six sulfonamide antibiotic residues (sulfanilamide, sulfacetamide, sulfadiazine, sulfathiazole, sulfamerazine and sulfamethizole) in milk samples. Multi-analyte imprinted particles were used as sorbent in solid phase extraction. Sulfonamides were separated on a high-performance liquid chromatography column (Merck-Lichrospher RP18e, 5 μm 250 × 4 mm) and further identified and quantified by diode array detection...
November 18, 2017: Journal of Separation Science
https://www.readbyqxmd.com/read/29136283/population-pk-analyses-of-ubrogepant-mk-1602-a-cgrp-receptor-antagonist-enriching-in-clinic-plasma-pk-sampling-with-outpatient-dried-blood-spot-sampling
#19
Chi-Chung Li, Marissa Dockendorf, Ken Kowalski, Bei Yang, Yang Xu, Iris Xie, Huub Jan Kleijn, Rolien Bosch, Christopher Jones, Bob Thornton, Eugene E Marcantonio, Tiffini Voss, Kevin P Bateman, Prajakti A Kothare
Merck & Co., Inc. (Kenilworth, New Jersey) has recently published an integrated strategy for implementation of dried blood spots (DBS) in late-stage trials for population pharmacokinetic (PK) modeling. We applied this strategy for another late-stage clinical program: ubrogepant (MK-1602), a novel oral calcitonin gene-related peptide receptor antagonist for acute treatment of migraine. At the time of implementation, ubrogepant was entering phase 2 development. DBS was implemented to acquire PK information proximal to an acute migraine event to enable exposure-response modeling...
November 14, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29129441/health-related-quality-of-life-results-for-pembrolizumab-versus-chemotherapy-in-advanced-pd-l1-positive-nsclc-keynote-024-a-multicentre-international-randomised-open-label-phase-3-trial
#20
Julie R Brahmer, Delvys Rodríguez-Abreu, Andrew G Robinson, Rina Hui, Tibor Csőszi, Andrea Fülöp, Maya Gottfried, Nir Peled, Ali Tafreshi, Sinead Cuffe, Mary O'Brien, Suman Rao, Katsuyuki Hotta, Jin Zhang, Gregory M Lubiniecki, Anne C Deitz, Reshma Rangwala, Martin Reck
BACKGROUND: In the phase 3 KEYNOTE-024 trial, treatment with pembrolizumab conferred longer progression-free survival than did platinum-based therapy in patients with treatment-naive, advanced non-small-cell lung cancer (NSCLC) with a programmed cell death-ligand 1 (PD-L1) tumour proportion score of 50% or greater (PD-L1-positive). Here we report the prespecified exploratory endpoint of pembrolizumab versus chemotherapy on patient-reported outcomes (PROs). METHODS: In this multicentre, international, randomised, open-label, phase 3 trial, we recruited patients with treatment-naive, stage IV NSCLC in 102 sites in 16 countries...
November 9, 2017: Lancet Oncology
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