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https://www.readbyqxmd.com/read/28727871/biosimilars-in-oncology-in-the-united-states-a-review
#1
Chadi Nabhan, Sandeep Parsad, Anthony R Mato, Bruce A Feinberg
Importance: Biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product. The availability of biosimilars might provide an opportunity to lower health care expenditures as a result of the inherent price competition with their reference product. Understanding how biosimilar cancer drugs are regulated, approved, and paid for, as well as their impact in a value-based care environment, is essential for physicians and other stakeholders in oncology...
July 20, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28719222/how-drug-life-cycle-management-patent-strategies-may-impact-formulary-management
#2
Jan Berger, Jeffrey D Dunn, Margaret M Johnson, Kurt R Karst, W Chad Shear
Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers...
October 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/28683089/the-composite-autonomic-symptom-scale-31-is-a-useful-screening-tool-for-patients-with-parkinsonism
#3
Younsoo Kim, Jin Myoung Seok, Jongkyu Park, Kun-Hyun Kim, Ju-Hong Min, Jin Whan Cho, Suyeon Park, Hyun-Jin Kim, Byoung Joon Kim, Jinyoung Youn
Differentiation of multiple system atrophy with predominant parkinsonism (MSA-P) and Parkinson's disease (PD) is important, but an effective tool for differentiation has not been identified. We investigated the efficacy of the composite autonomic symptom scale 31 (COMPASS 31) questionnaire as a tool for evaluating autonomic function in parkinsonism patients. In this study, we enrolled drug-naïve patients with MSA-P and PD, and administered the COMPASS-31 and an objective autonomic dysfunction test (AFT). Demographic and clinical data, including parkinsonism and autonomic dysfunction, were compared between the two groups...
2017: PloS One
https://www.readbyqxmd.com/read/28655675/emergence-and-spread-of-antibiotic-resistance-in-west-africa%C3%A2-contributing-factors-and-threat-assessment
#4
A S Ouedraogo, H Jean Pierre, A L Bañuls, R Ouédraogo, S Godreuil
The emergence and spread of antibiotic resistance present a major public health issue in both developed (DC) and less developed countries (LDC). Worldwide, its main cause is the uncontrolled and unjustified use of antibiotics. In countries with limited resources, such as West African nations, other features, more specifically socioeconomic and behavioral factors, contribute to exacerbate this problem. The objective of this review is to give an update of the common and specific factors involved in the amplification of antibiotic resistance phenomena in LCD, particularly in West African countries...
June 1, 2017: Médecine et Santé Tropicales
https://www.readbyqxmd.com/read/28652703/ct-p13-design-development-and-place-in-therapy
#5
REVIEW
Tommaso Gabbani, Simona Deiana, Vito Annese
The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28647879/disposal-of-household-pharmaceuticals-in-insular-communities-social-attitude-behaviour-evaluation-and-prevention-activities
#6
Antonis A Zorpas, Maria Dimitriou, Irene Voukkali
The increase in medicine and drug consumption have resulted in identifying these emerging pollutants in all aquatic compartments, ranging from surface water and groundwater resources to the marine environment. Pharmaceuticals are an indispensable part of life today. A large number of pharmaceuticals are used in a daily basis in the treatment, prevention, cure or diagnosis of diseases or to otherwise enhance people's physical or mental well-being. This paper focuses on the evaluation of the attitude of citizens in Cyprus regarding the disposal of pharmaceuticals as well as to identify the main reasons why pharmaceutical wastes are produced...
June 25, 2017: Environmental Science and Pollution Research International
https://www.readbyqxmd.com/read/28642701/the-market-of-biopharmaceutical-medicines-a-snapshot-of-a-diverse-industrial-landscape
#7
Evelien Moorkens, Nicolas Meuwissen, Isabelle Huys, Paul Declerck, Arnold G Vulto, Steven Simoens
Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market. Methods: A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28631599/efficacy-and-safety-of-omalizumab-in-children-and-adolescents-with-moderate-to-severe-asthma-a-systematic-literature-review
#8
Jonathan Corren, Abhishek Kavati, Benjamin Ortiz, Jennifer A Colby, Kimberly Ruiz, Brett A Maiese, Sarah M Cadarette, Reynold A Panettieri
BACKGROUND: There are limited pediatric data about the use of omalizumab, especially the effectiveness and safety of omalizumab in the real-world management of allergic asthma. OBJECTIVE: The objective of this study was to summarize the safety and efficacy of omalizumab in both randomized clinical trials (RCT) used for U.S. Food and Drug Administration registration and real-world studies (RWS) based on clinical care of children with moderate-to-severe asthma. METHODS: Studies that evaluated omalizumab use in patients <18 years old and with asthma, published between January 2003 and October 2016, were retrieved from medical literature data bases...
July 1, 2017: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/28625146/cephalosporins-associated-pseudomembranous-colitis-in-an-elderly-male-patient-a-case-report
#9
Prashant Maheshbhai Parmar, Vipul V Solanki, Manish J Barvaliya, Bhavesh Chavada, C B Tripathi
A 78 year old male patient developed pseudomembranous colitis after administration of Ceftriaxone and Cefazolin for the treatment of pleural effusion. The reaction was confirmed by Ultrasonography and CT scan. Causative agents were stopped and patient was managed by systemic therapy. Patient was expired due to respiratory complications as there was complexity in management of disease due to development of pseudomembranous colitis. Increase awareness of prescribers for high-risk drugs, close monitoring, with immediate withdrawal of the culprit drug can reduce the complexity of management which occurred due to development of such adverse drug reaction...
June 15, 2017: Current Drug Safety
https://www.readbyqxmd.com/read/28585582/factors-associated-with-mortality-to-drug-resistant-tuberculosis-and-their-programmatic-management-in-treatment-centres-of-punjab-pakistan
#10
Shamsa Kanwal, Abdul Majeed Akhtar, Anzar Ahmed
OBJECTIVE: To describe the characteristics and assess the factors of mortality in drug-resistant tuberculosis patients. METHODS: This retrospective study was conducted at 11 programmatic management of drug-resistant tuberculosis centres located in different cities of the Punjab province of Pakistan, and comprised record of patients with drug-resistant tuberculosis from January 2010 to September 2015. Data was retrieved from patient medical records using electronic nominal review system of the provincial tuberculosis control programme...
June 2017: JPMA. the Journal of the Pakistan Medical Association
https://www.readbyqxmd.com/read/28559151/generic-imatinib-in-chronic-myeloid-leukemia-survival-of-the-cheapest
#11
Madhav Danthala, Sadashivudu Gundeti, Siva Prasad Kuruva, Krishna Chaitanya Puligundla, Praveen Adusumilli, Ashok Pillai Karnam, Stalin Bala, Meher Lakshmi Konatam, Lakshmi Srinivas Maddali, Raghunadha Rao Digumarti
INTRODUCTION: The patent expiration of imatinib mesylate (Gleevec; Novartis) on February 1, 2016, has brought the focus back on generic versions of the drug, and an opportunity to provide a safe and cost-effective alternative. The objective of our study was to determine the molecular and cytogenetic responses, survival endpoints (event-free survival, failure-free survival, transformation-free survival, overall survival), and safety of innovator and generic brands of imatinib. MATERIALS AND METHODS: In this retrospective analysis, data from 1812 patients with chronic myeloid leukemia treated with frontline imatinib mesylate (innovator/generic) at a single institution between 2008 and 2014 is included...
May 10, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28558416/fast-ultra-high-performance-liquid-chromatography-with-diode-array-and-mass-spectrometry-method-for-determination-of-tadalafil-drug-substance-and-its-impurities
#12
Ludovit Schreiber, Radoslav Halko, Milan Hutta
Tadalafil is used for the treatment of erectile dysfunction and its related patents expired in 2016, therefore related generic drugs production is supposed to be increased. This work is focused on developing a fast ultra high performance liquid chromatography (UHPLC) with diode array detector (DAD) and/or mass spectrometry (MS) detection for the separation and determination of tadalafil and its impurities in pharmaceutical samples. Modern reversed-phase stationary phase with sub-2 micron particle size, Zorbax StableBond Rapid Resolution High Definition with octylsilane chemically bonded phase to totally porous silica particles was used for the solving this problem...
May 30, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/28553081/ten-years-of-biosimilar-recombinant-human-growth-hormone-in-europe
#13
REVIEW
Paul Saenger
Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years. With the expiration of patent exclusivity for the first wave of rhGH products and other biopharmaceuticals, the opportunity emerged for the development of biosimilar medicines. A biosimilar is defined by the European Medicines Agency (EMA) as a biological medicine that is similar to another biological medicine that has already been authorized for use. The EMA led the way (well ahead of the Food and Drug Administration in the US) in developing the biosimilar concept, and the type of science-based regulatory framework required to ensure high-quality, safe, and effective biosimilar medicines; the provisions for approval of biosimilars have been in place in Europe since 2005...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28533252/national-trends-in-prescription-drug-expenditures-and-projections-for-2017
#14
Glen T Schumock, Edward C Li, Michelle D Wiest, Katie J Suda, JoAnn Stubbings, Linda M Matusiak, Robert J Hunkler, Lee C Vermeulen
PURPOSE: Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2017 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2016 were obtained from the QuintilesIMS National Sales Perspectives database and analyzed. Other factors that may influence drug spending in hospitals and clinics in 2017, including new drug approvals and patent expirations, were also reviewed...
May 22, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28521791/exploring-the-role-of-socioeconomic-factors-in-the-development-and-spread-of-anti-malarial-drug-resistance-a-qualitative-study
#15
Philip Emeka Anyanwu, John Fulton, Etta Evans, Timothy Paget
BACKGROUND: Malaria remains a global health issue with the burden unevenly distributed to the disadvantage of the developing countries of the world. Poverty contributes to the malaria burden as it has the ability to affect integral aspects of malaria control. There have been renewed efforts in the global malaria control, resulting in reductions in the global malaria burden over the last decade. However, the development of resistance to artemisinin-based combination therapy threatens the sustainability of the present success in malaria control...
May 18, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28485435/perturbation-of-the-pulmonary-surfactant-monolayer-by-single-walled-carbon-nanotubes-a-molecular-dynamics-study
#16
Yan Xu, Zhen Luo, Shixin Li, Weiguo Li, Xianren Zhang, Yi Y Zuo, Fang Huang, Tongtao Yue
Single-walled carbon nanotubes (SWCNTs) are at present synthesized on a large scale with a variety of applications. The increasing likelihood of exposure to SWCNTs, however, puts human health at a high risk. As the front line of the innate host defense system, the pulmonary surfactant monolayer (PSM) at the air-water interface of the lungs interacts with the inhaled SWCNTs, which in turn inevitably perturb the ultrastructure of the PSM and affect its biophysical functions. Here, using molecular dynamics simulations, we demonstrate how the diameter and length of SWCNTs critically regulate their interactions with the PSM...
May 9, 2017: Nanoscale
https://www.readbyqxmd.com/read/28482701/looking-to-the-future-and-learning-lessons-from-the-recent-past-changing-stakeholder-perceptions-of-biosimilars-in-cancer
#17
Won Seog Kim, Michinori Ogura, Hyuk-Chan Kwon, Dasom Choi
As the patents for many biologic anticancer drugs expire, significant growth in the use of biosimilars is predicted, offering an opportunity to help combat the rising costs of treatment and increase patient access to biologic therapy. Attainment of regulatory approval, involving numerous nonclinical and clinical comparative studies versus each reference product, is only one of several barriers to realize the potential gains offered by biosimilars. It is important to understand the current perceptions and informational needs of different stakeholders if biosimilars are to be accepted and widely used in the clinic...
May 2017: Future Oncology
https://www.readbyqxmd.com/read/28480175/demographic-and-socioeconomic-characteristics-of-outpatients-could-modify-their-attitude-towards-misusing-medications-in-northern-jordan
#18
Mansour Haddad, Mohamed Elsaed Ebada
BACKGROUND: Potentially inappropriate drug use, including prescribed and over-the-counter medications, is associated with increased morbidity and mortality. It also contributes to unnecessary expenditure on health services. This survey was undertaken to investigate the incidence of drug misuse and associated socioeconomic/demographic characteristics in Irbid, Jordan. DESIGN AND METHODS: The present cross section study was conducted using a validated 5-point Likert scale questionnaire to be self-reported by 480 outpatients visiting clinics in three major medical centres in Irbid, Jordan between 20th October 2015 and 27th November 2015...
April 13, 2017: Journal of Public Health Research
https://www.readbyqxmd.com/read/28480154/congenital-tracheobronchomegaly-mounier-kuhn-syndrome-in-a-woman-with-human-immunodeficiency-virus-a-case-report
#19
Amanda Fletcher, Justin Stowell, Socrates Jamoulis
Congenital tracheobronchomegaly (Mounier-Kuhn Syndrome, MKS) is a rare idiopathic disorder characterized by dilation of the central airways, including the trachea and first through fourth order bronchi. MKS disproportionately affects men and results in chronic respiratory tract infections. The diagnosis is made through the synthesis of clinical and radiological data. Here we report a unique case of MKS in a patient with human immunodeficiency virus (HIV) infection. A 45-year-old African American woman with a past medical history of HIV, tobacco and recreational drug abuse, chronic obstructive pulmonary disease, sleep apnea, and a 15-year history of recurrent respiratory infections presented with dyspnea, wheezing, a productive cough, increased yellow-green sputum production, and subjective fevers...
April 4, 2017: Curēus
https://www.readbyqxmd.com/read/28474001/pharmaceutical-use-and-spending-trend-in-medicare-beneficiaries-with-dementia-from-2006-to-2012
#20
Inmaculada Hernandez, Yuting Zhang
Objectives: The aim of the study was to examine the trend in incidence and prevalence of dementia, use and spending of antidementia and antipsychotic drugs among dementia patients. Methods: Using 2006-2012 Medicare claims data, we identified individuals with diagnosis of dementia and collected their pharmacy claims in 2006-2012. We built regression models to test the trend in number of prescriptions and spending on antidementia, antipsychotic, and other drugs. Results: The prevalence of dementia did not change during our study period...
January 2017: Gerontology & Geriatric Medicine
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