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https://www.readbyqxmd.com/read/28448782/amcp-partnership-forum-driving-value-and-outcomes-in-oncology
#1
(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/28448778/economic-impact-of-above-label-dosing-with-etanercept-adalimumab-or-ustekinumab-in-patients-with-psoriasis
#2
Steven R Feldman, Yang Zhao, Huanxue Zhou, Vivian Herrera, Haijun Tian, Yunfeng Li
BACKGROUND: Patients with moderate-to-severe psoriasis may be treated with above-label doses of biologics in an attempt to optimize outcomes. Dose escalation will have an effect on the cost of treatment. OBJECTIVE: To examine costs related to above-label use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: A retrospective study was performed using a large U.S. claims database. Patients were included in the study if they were aged ≥ 18 years with a diagnosis of psoriasis (excluding psoriatic arthritis) and had at least 1 medication fill for etanercept, adalimumab, or ustekinumab between January 1, 2011, and June 30, 2012...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28440680/efficacy-and-safety-of-baricitinib-in-japanese-patients-with-active-rheumatoid-arthritis-a-52-week-randomized-single-blind-extension-study
#3
Yoshiya Tanaka, Taeko Ishii, Zhihong Cai, Douglas Schlichting, Terence Rooney, William Macias
OBJECTIVES: The objective of this study is to evaluate the efficacy and safety of long-term (64 weeks; 52-week extension of a 12-week study) baricitinib treatment in Japanese patients with active rheumatoid arthritis (RA) despite methotrexate therapy. METHODS: Patients (N = 145) with active RA were randomized to placebo, 1mg, 2mg, 4mg, or 8mg baricitinib for the first 12 weeks. During the 52-week extension period, patients on 4mg or 8mg baricitinib remained on the same dose and all other patients were re-randomized to 4mg or 8mg baricitinib...
April 25, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28416195/pitavastatin-versus-pravastatin-in-adults-with-hiv-1-infection-and-dyslipidaemia-intrepid-12-week-and-52-week-results-of-a-phase-4-multicentre-randomised-double-blind-superiority-trial
#4
Judith A Aberg, Craig A Sponseller, Douglas J Ward, Vladimir A Kryzhanovski, Stuart E Campbell, Melanie A Thompson
BACKGROUND: People living with HIV-1 infection are at greater risk for cardiovascular disease than seronegative adults. Treatment of dyslipidaemia with statins has been challenging in people with HIV because of an increased potential for drug interactions due to competing cytochrome P450 metabolism between statins and commonly used antiretroviral agents. Neither pitavastatin nor pravastatin depend on cytochrome P450 for primary metabolism. We aimed to assess the safety and efficacy of pitavastatin versus pravastatin in adults with HIV and dyslipidaemia...
April 13, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28388667/the-effect-of-federal-and-state-off-label-marketing-investigations-on-drug-prescribing-the-case-of-olanzapine
#5
Bo Wang, David M Studdert, Ameet Sarpatwari, Jessica M Franklin, Joan Landon, Aaron S Kesselheim
In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa). In a series of settlements between 2008 and 2010, Eli Lilly paid $1...
2017: PloS One
https://www.readbyqxmd.com/read/28376984/insulin-almost-a-century-of-lifesaving
#6
(no author information available yet)
The identification and purification of insulin in 1922 changed life for individuals with type 1 diabetes mellitus (T1DM). Its discovery was, to a certain extent, serendipitous. Although medical researchers suspected that some type of hormone was responsible for carbohydrate metabolism, by the end of the 19th century they had made little progress. When World War I broke out, efforts stalled. A somewhat cantankerous group of Canadian researchers led by Frederick Grant Banting, a surgeon, are credited with insulin's discovery...
April 1, 2017: Consultant Pharmacist: the Journal of the American Society of Consultant Pharmacists
https://www.readbyqxmd.com/read/28371303/a-comparative-pharmacokinetic-study-of-2-pemetrexed-formulations-in-indian-adult-chemonaive-patients-with-adenocarcinoma-stage-iii-iv-non-small-cell-lung-cancer
#7
Krunal Kavathiya, Murari Gurjar, Anand Patil, Madhura Naik, Vanita Noronha, Amit Joshi, Vikram Gota, Kumar Prabhash
The study aimed to compare the pharmacokinetics of 2 pemetrexed formulations (Pemgem, Dr. Reddy's Laboratories w.r.t; Alimta, Eli Lilly) in adult chemonaive subjects with adenocarcinoma stage III/IV non-small cell lung cancer. All patients received 500 mg/m(2) pemetrexed (Alimta or Pemgem) as a 10-minute infusion on day 1 of a 21-day cycle. Plasma pemetrexed concentrations were determined on day 1 of cycle 1. Area under the concentration-time curve (AUC0-inf ) and the maximum plasma concentration (Cmax ) were estimated using noncompartment analysis and compared between the 2 arms...
March 29, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28370344/conformational-dynamics-of-cathepsin-d-and-binding-to-a-small-molecule-bace1-inhibitor
#8
Christopher R Ellis, Cheng-Chieh Tsai, Fang-Yu Lin, Jana Shen
BACE1 is a major therapeutic target for prevention and treatment of Alzheimer's disease. Developing inhibitors that can selectively target BACE1 in favor of other proteases, especially cathepsin D (CatD), has presented significant challenges. Here, we investigate the conformational dynamics and protonation states of BACE1 and CatD using continuous constant pH molecular dynamics with pH replica-exchange sampling protocol. Despite similar structure, BACE1 and CatD exhibit markedly different active site dynamics...
June 5, 2017: Journal of Computational Chemistry
https://www.readbyqxmd.com/read/28361463/clinical-outcomes-of-patients-with-diabetes-who-exhibit-upper-quartile-insulin-antibody-responses-after-treatment-with-ly2963016-or-lantus-%C3%A2-insulin-glargine
#9
Liza L Ilag, Timothy M Costigan, Mark A Deeg, Robyn K Pollom, Curtis L Chang, Robert J Konrad, Melvin J Prince
INTRODUCTION: We compared insulin antibody response (IAR) profiles in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who received LY2963016 insulin glargine (LY IGlar) or Lantus(®) insulin glargine (IGlar) and evaluated the potential relationship between higher IARs and clinical and safety outcomes with a focus on patients who exhibited antibody responses in the upper quartile. METHODS: Data from ELEMENT-1 (52-week open-label in T1D) and ELEMENT-2 (24-week, double-blind study in T2D) were analyzed...
March 30, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28345441/prevalence-and-cost-of-subsequent-fractures-among-u-s-patients-with-an-incident-fracture
#10
Jessica Weaver, Shiva Sajjan, E Michael Lewiecki, Steven T Harris, Panagiotis Marvos
BACKGROUND: The prevalence and cost of subsequent fractures among patients with an incident fracture are not well defined. OBJECTIVE: To assess the prevalence of, and costs associated with, subsequent fractures in the year after an incident fracture. METHODS: This was a retrospective claims database analysis using data from Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (commercial group)...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28290136/baricitinib-first-global-approval
#11
Anthony Markham
Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs)...
March 13, 2017: Drugs
https://www.readbyqxmd.com/read/28230450/characteristics-and-medication-use-of-psoriasis-patients-who-may-or-may-not-qualify-for-randomized-controlled-trials
#12
William Malatestinic, Beth Nordstrom, Jashin J Wu, Orin Goldblum, Kathleen Solotkin, Chen-Yen Lin, Kristin Kistler, Kathy Fraeman, Joseph Johnston, Lcdr Lesley Hawley, Nicholas Sicignano, Andre Araujo
BACKGROUND: Clinical trials impose exclusion criteria that may limit the generalizability of results. OBJECTIVES: To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. METHODS: Moderate-to-severe psoriasis patients were identified from the U...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28230446/economic-impact-of-treatment-duration-and-persistence-with-basal-insulin-in-previously-insulin-naive-users
#13
Samaneh Kalirai, Ran Duan, Dongju Liu, Beverly L Reed
BACKGROUND: Although insulin is a well-established therapy that is associated with improved clinical outcomes, adherence and persistence with insulin regimens are poor in patients with type 2 diabetes mellitus (T2DM). Diabetes-related health care costs and the impact of insulin persistence patterns on these health care costs have been previously studied; however, these aspects of insulin therapy have limited data beyond the first year of use and have not been characterized among patients previously naive to basal insulin...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28210100/the-cost-effectiveness-of-a-nsclc-patient-assistance-program-for-pemetrexed-maintenance-therapy-in-people-s-republic-of-china
#14
Qiang Shi, Shanlian Hu, Wesley E Furnback, Gregory F Guzauskas, Jiejing Shen, Bruce Cm Wang
BACKGROUND: Eli Lilly and the China Primary Health Care Foundation are currently implementing a patient assistance program (PAP) in China, which allows first-line nonsquamous non-small-cell lung cancer (NSCLC) patients who complete four cycles of pemetrexed induction therapy to receive free, continuous pemetrexed maintenance therapy. OBJECTIVE: To estimate the cost-effectiveness of pemetrexed maintenance therapy vs basic standard care (BSC) and the economic impacts of providing a PAP for pemetrexed maintenance therapy to NSCLC patients who have completed pemetrexed induction therapy in a Chinese health care setting...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28199814/baricitinib-versus-placebo-or-adalimumab-in-rheumatoid-arthritis
#15
RANDOMIZED CONTROLLED TRIAL
Peter C Taylor, Edward C Keystone, Désirée van der Heijde, Michael E Weinblatt, Liliana Del Carmen Morales, Jaime Reyes Gonzaga, Sergey Yakushin, Taeko Ishii, Kahaku Emoto, Scott Beattie, Vipin Arora, Carol Gaich, Terence Rooney, Douglas Schlichting, William L Macias, Stephanie de Bono, Yoshiya Tanaka
BACKGROUND: Baricitinib is an oral, reversible inhibitor of the Janus kinases JAK1 and JAK2 that may have therapeutic value in patients with rheumatoid arthritis. METHODS: We conducted a 52-week, phase 3, double-blind, placebo- and active-controlled trial in which 1307 patients with active rheumatoid arthritis who were receiving background therapy with methotrexate were randomly assigned to one of three regimens in a 3:3:2 ratio: placebo (switched to baricitinib after 24 weeks), 4 mg of baricitinib once daily, or 40 mg of adalimumab (an anti-tumor necrosis factor α monoclonal antibody) every other week...
February 16, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28076825/polar-aromatic-periphery-increases-agonist-potency-of-spirocyclic-free-fatty-acid-receptor-gpr40-agonists-inspired-by-ly2881835
#16
Mikhail Krasavin, Alexey Lukin, Daria Bagnyukova, Nikolay Zhurilo, Aleksei Golovanov, Sergey Zozulya, Ihor Zahanich, Daniel Moore, Irina G Tikhonova
A series of spirocyclic compounds inspired by Eli Lilly's phase 1 antidiabetic FFA1 receptor agonist LY2881835 was designed to include polar aromatic periphery groups and explore a possibility of building additional contacts with the target near the agonist binding site. The frontrunner compound in the series (9i) was shown to be a potent (EC50 = 260 nM) FFA1 agonist with excellent aqueous (PBS) solubility and good Caco-2 permeability. The observed structure-activity relationships were rationalized by a docking study...
February 15, 2017: European Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28070733/glp-1-ra-treatment-patterns-among-type-2-diabetes-patients-in-five-european-countries
#17
Victoria Divino, Mitch DeKoven, Farhad Ali Khan, Kristina S Boye, Hélène Sapin, Kirsi Norrbacka
INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a relatively new class of injectable drugs used in the treatment of type 2 diabetes (T2D). This retrospective database study evaluated real-world treatment patterns of T2D patients initiating GLP-1 RAs in Belgium (BE), France (FR), Germany (DE), The Netherlands (NL) and Sweden (SE). METHODS: Adult T2D patients initiating exenatide twice daily (exBID), exenatide once weekly (exQW), liraglutide (LIRA) or lixisenatide (LIXI) during 2013 were identified using the QuintilesIMS (QuintilesIMS, Durham, NC, and Danbury, CT, USA) longitudinal retail pharmacy databases (LRx; BE/FR/DE/NL) and national health register data (SE)...
February 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28045649/cost-effectiveness-of-pemetrexed-in-combination-with-cisplatin-as-first-line-treatment-for-patients-with-advanced-non-squamous-non-small-cell-lung-cancer-in-spain
#18
Jonathan González García, Fernando Gutiérrez Nicolás, Gloria Julia Nazco Casariego, Cristina Valcárcel Nazco, Jose Norberto Batista López, Juana Oramas Rodríguez
INTRODUCTION: Lung cancer is the third most frequent neoplastic tumour in Spain, with around 27 000 new cases diagnosed per year; 80-95% of these are non-small-cell cancer (NSCLC), and the majority of cases are diagnosed in advanced stages of the disease, and for this reason it is one of the oncologic conditions with higher mortality rates (21.4% mean survival at 5 years). The main treatment regimens used for first-line treatment of NSCLC are: cisplatin/pemetrexed (cis/pem), cisplatin/gemcitabine/ bevacizumab (cis/gem/bev), and carboplatin/paclitaxel/ bevacizumab (carb/pac/bev)...
January 1, 2017: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#19
(no author information available yet)
Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27995580/olaratumab-first-global-approval
#20
Matt Shirley
Olaratumab (Lartruvo™) is a fully human IgG1 monoclonal antibody targeted against the human platelet-derived growth factor (PDGF) receptor α (PDGFRα). It was developed by Eli Lilly and Co. (previously ImClone Systems) after PDGFRα was identified as a potential therapeutic target in a variety of cancers. Olaratumab acts by selectively binding PDGFRα, thereby blocking PDGF ligand binding and inhibiting PDGFRα activation and downstream signalling. In October 2016, olaratumab received its first global approval, in the USA, for use in combination with doxorubicin for the treatment of adult patients with soft tissue sarcoma...
December 19, 2016: Drugs
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