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https://www.readbyqxmd.com/read/28719222/how-drug-life-cycle-management-patent-strategies-may-impact-formulary-management
#1
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/28719221/biosimilars-biologics-that-meet-patients-needs-and-healthcare-economics
#2
Mark McCamish, William Yoon, James McKay
Biologics have revolutionized medical care, yet uniform access to these effective medicines remains difficult due to the increasing costs of healthcare. As patent exclusivity on the early biologics wanes, regulatory and legal systems are adapting to bring competition to the field in the form of biosimilars. Biosimilars are biologics that offer the same clinical benefit in one or more of the same indications as the reference biologic drug and bring competition to the biologics space. Legislation creating a pathway resulting in the first US approvals of biosimilars has been in place since 2010, but the regulatory methodology and science of evaluating the sameness of two biologics has been in use for decades...
September 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/28719091/multimodal-analgesia-as-an-alternative-to-the-risks-of-opioid-monotherapy-in-surgical-pain-management
#3
John J Savarese, Norman G Tabler
Clinicians have long been aware of the danger of overreliance on opioids to manage acute pain, such as the pain accompanying surgery. The risk of adverse drug events is higher with opioids than with any other common class of drugs. Overreliance on opioids increases length of stay and hospital costs, while decreasing patient satisfaction. Opioids can lead to problems that continue well after discharge, including chronic pain, abuse and addiction, and even death. Increasingly, prescribed opioids have proved to lead to heroin addiction...
July 2017: Journal of Healthcare Risk Management: the Journal of the American Society for Healthcare Risk Management
https://www.readbyqxmd.com/read/28718326/cns-anticancer-drug-discovery-and-development-2016-conference-insights
#4
Victor A Levin, Lauren E Abrey, Timothy P Heffron, Peter J Tonge, Arvin C Dar, William A Weiss, James M Gallo
CNS Anticancer Drug Discovery and Development November 2016, AZ, USA The 2016 second CNS Anticancer Drug Discovery and Development Conference addressed diverse viewpoints about why new drug discovery/development focused on CNS cancers has been sorely lacking. Despite more than 70,000 individuals in the USA being diagnosed with a primary brain malignancy and 151,669-286,486 suffering from metastatic CNS cancer, in 1999, temozolomide was the last drug approved by the US FDA as an anticancer agent for high-grade gliomas...
July 18, 2017: CNS Oncology
https://www.readbyqxmd.com/read/28718275/-assessment-of-adherence-to-antibiotic-treatment-in-primary-care-by-determining-levels-of-the-drug-using-a-liquid-chromatography-technique
#5
P Navarro-Gómez, A Sorlózano-Puerto, M M Olmo-Navas, P Nieto-Guindo, R Dueñas-Alcalá, J Gutiérrez-Fernández, R Romero-González, M A Rodriguez-Maresca
OBJECTIVE: The lack of adherence to antibiotic treatments is a matter of special interest, which has important clinical implications, as it is associated with therapeutic failure and increased bacterial resistance causing a high sani-tary cost. The objective of our study was to assess the degree of adherence to prescribed antibiotic treatment in outpatients through the detection of these in blood, urine or sputum. METHODS: Concentrations of antibiotics prescribed in 39 patients (34 with clinical suspicion of urinary tract infection and 5 with clinical suspicion of low respiratory tract infection) treated in Primary Care consultations of the Sanitary District of Almería (Spain) were determined by ultra-high performance liquid chromatography coupled to tandem mass spectrometry...
July 18, 2017: Revista Española de Quimioterapia: Publicación Oficial de la Sociedad Española de Quimioterapia
https://www.readbyqxmd.com/read/28717748/bevacizumab-in-advanced-cervical-cancer-issues-and-challenges-for-low-and-middle-income-countries
#6
Bishal Gyawali, Mahesh Iddawela
Bevacizumab became the first molecular antibody to show survival benefit in advanced cervical cancer. In the GOG-0240 (Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer) trial, it improved overall survival by a significant 3.7 months over platinum doublet chemotherapy alone. However, this discovery is not likely to improve the status of global cervical cancer because more than 85% of patients with cervical cancer live in low- and middle-income countries and cannot afford bevacizumab...
April 2017: Journal of Global Oncology
https://www.readbyqxmd.com/read/28717715/compulsory-licenses-for-cancer-drugs-does-circumventing-patent-rights-improve-access-to-oncology-medications
#7
REVIEW
Cinthia Leite Frizzera Borges Bognar, Brittany L Bychkovsky, Gilberto de Lima Lopes
Worldwide, there are enormous inequities in cancer control that cause poor outcomes among patients with cancer who live in low- and middle-income countries (LMICs). One of the biggest challenges that oncology faces today is how to increase patient access to expensive, but life-saving, therapies in LMICs. Access to cancer medications in LMICs is a major problem, especially in recent years, as the costs of these therapies continue to rise exponentially. One mechanism available to LMICs to improve access to cancer medications allows a country to pursue a compulsory license for a given drug...
October 2016: Journal of Global Oncology
https://www.readbyqxmd.com/read/28717397/how-do-we-avoid-disaster-when-exiting-the-european-medicines-agency-making-the-most-of-brexit-in-pharmaceutical-regulation
#8
EDITORIAL
Anthony James Hatswell
As the UK prepares to leave the EU, it must decide what path it is to take with a large number of regulatory and technical agencies who provide collaboration at the European level. In the case of pharmaceuticals, the European Medicines Agency (EMA) provides pan-European licencing for novel pharmaceuticals. Should the UK depart from the EMA system, this article highlights the loss to patients immediately (slower access to novel treatments), and in the long term by having no access to some novel products as companies choose not to launch in the UK...
2017: Ecancermedicalscience
https://www.readbyqxmd.com/read/28716821/abnormalities-in-alternative-splicing-in-diabetes-therapeutic-targets
#9
REVIEW
Zodwa Dlamini, Fortunate Mokoena, Rodney Hull
Diabetes mellitus (DM) is a non-communicable, metabolic disorder that affects 416 million individuals worldwide. Type 2 diabetes contributes to a vast 85-90% of the diabetes incidences while 10-15% of patients suffer from type 1 diabetes. These two predominant forms of DM cause a significant loss of functional pancreatic β-cell mass causing different degrees of insulin deficiency, most likely, due to increased β-cell apoptosis. Treatment options involve the use of insulin sensitisers, α-glucosidase inhibitors, and β-cell secretagogues which are often expensive, limited in efficacy and carry detrimental adverse effects...
August 2017: Journal of Molecular Endocrinology
https://www.readbyqxmd.com/read/28716625/a-comparative-study-of-phenotypic-and-genotypic-first-and-second-line-drug-resistance-testing-of-mycobacterium-tuberculosis
#10
Fatemeh Sakhaee, Morteza Ghazanfari, Nayereh Ebrahimzadeh, Farzam Vaziri, Fatemeh Rahimi Jamnani, Mehdi Davari, Safoora Gharibzadeh, Fatemeh Hemati Mandjin, Abolfazl Fateh, Seyed Davar Siadat
This study aimed to evaluate the frequency of resistance to first- and second-line drugs using phenotypic and genotypic methods and its correlation with resistance-linked mutations in Mycobacterium tuberculosis (M. tb) isolated in Iran. Three different methods, including the indirect proportion method(PM), direct and indirect nitrate reductase assay(NRA), and direct sequencing were used to assess drug resistance. In this study, sensitivity, specificity, agreement, costs, and turnaround time of these methods were compared in 395 smear positive isolates...
July 15, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28716338/changing-innovation-into-a-registered-product-from-concept-to-regulatory-approval
#11
Linda Rhodes
Innovation in animal health pharmaceuticals is important to address unmet and underserved medical needs, and often comes from products initially developed for human medicine. The purpose of the review is to help readers understand how breakthroughs from human biotechnology may be developed for use in veterinary medicine, while understanding the key drivers to success, the difficulties of regulatory approval, and the realistic risks and rewards of developing applications for animals. The types of human drugs which may be useful for veterinary applications are reviewed, including examples...
July 6, 2017: Theriogenology
https://www.readbyqxmd.com/read/28716293/costs-of-providing-infusion-therapy-for-rheumatoid-arthritis-in-a-hospital-based-infusion-center-setting
#12
Jordana Schmier, Kristine Ogden, Nancy Nickman, Michael T Halpern, Mary Cifaldi, Arijit Ganguli, Yanjun Bao, Vishvas Garg
PURPOSE: Many hospital-based infusion centers treat patients with rheumatoid arthritis (RA) with intravenous biologic agents, yet may have a limited understanding of the overall costs of infusion in this setting. The purposes of this study were to conduct a microcosting analysis from a hospital perspective and to develop a model using an activity-based costing approach for estimating costs associated with the provision of hospital-based infusion services (preparation, administration, and follow-up) in the United States for maintenance treatment of moderate to severe RA...
July 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28716171/the-personal-financial-burden-of-chronic-rhinosinusitis-a-canadian-perspective
#13
Jonathan Yip, Allan D Vescan, Ian J Witterick, Eric Monteiro
BACKGROUND: Previous studies describe the financial burden of chronic rhinosinusitis (CRS) from the perspective of third-party payers, but, to our knowledge, none analyze the costs borne by patients (i.e., out-of-pocket expenses [OOPE]). Furthermore, this burden has not been previously investigated in the context of a publicly funded health care system. OBJECTIVE: The purpose of this study was to characterize the financial impact of CRS on patients, specifically by evaluating its associated OOPEs and the perceived financial burden...
July 1, 2017: American Journal of Rhinology & Allergy
https://www.readbyqxmd.com/read/28716156/generic-atorvastatin-is-as-effective-as-the-brand-name-drug-lipitor-%C3%A2-in-lowering-cholesterol-levels-a-cross-sectional-retrospective-cohort-study
#14
Alexander Loch, Jan Philipp Bewersdorf, Daniel Kofink, Dzafir Ismail, Imran Zainal Abidin, Ramesh Singh Veriah
BACKGROUND: In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin...
July 17, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28716121/identification-of-trunk-mutations-in-gastric-carcinoma-a-case-study
#15
Zhan Zhou, Shanshan Wu, Jun Lai, Yuan Shi, Chixiao Qiu, Zhe Chen, Yufeng Wang, Xun Gu, Jie Zhou, Shuqing Chen
BACKGROUND: Intratumor heterogeneity (ITH) poses an urgent challenge for cancer precision medicine because it can cause drug resistance against cancer target therapy and immunotherapy. The search for trunk mutations that are present in all cancer cells is therefore critical for each patient. CASE PRESENTATION: In this study, we aimed to evaluate the efficiency of multiregional sequencing for the identification of trunk mutations present in all regions of a tumor as a case study...
July 17, 2017: BMC Medical Genomics
https://www.readbyqxmd.com/read/28715206/high-throughput-screening-and-quantitation-of-target-compounds-in-biofluids-by-coated-blade-spray-mass-spectrometry
#16
Marcos Tascon, German Augusto Gómez-Ríos, Nathaly Reyes-Garcés, Justen J Poole, Ezel Boyaci, Janusz Pawliszyn
Most contemporary methods of screening and quantitating controlled substances and therapeutic drugs in biofluids typically require laborious, time-consuming, and expensive analytical workflows. In recent years, our group has worked towards developing microextraction (µe)-mass spectrometry (MS) technologies that merge all of the tedious steps of the classical methods into a simple, efficient, and low-cost methodology. Unquestionably, the automation of these technologies allows for faster sample throughput, greater reproducibility, and radically reduced analysis times...
July 17, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28714357/pharmaceutical-assistance-programs-for-cancer-patients-in-the-era-of-orally-administered-chemotherapeutics
#17
Aaron Mitchell, Benyam Muluneh, Rachana Patel, Ethan Basch
Introduction The rising cost of cancer drugs may make treatment unaffordable for some patients. Patients often rely on drug manufacturer-administered Pharmaceutical Assistance Programs (PAPs) to obtain drugs and reduced or no cost. The overall usage of PAPs within cancer care delivery is unknown. Methods We included all cancer patients across an academically affiliated, integrated health system in North Carolina during 2014 ( N = 8591). We identified the subset of patients receiving PAP assistance to afford one or more cancer drugs, in order to calculate the proportion of patients receiving PAP assistance, and the retail value of the assistance...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28714329/synthetic-sutures-clinical-evaluation-and-future-developments
#18
Roxanna E Abhari, Joana A Martins, Hayley L Morris, Pierre-Alexis Mouthuy, Andrew Carr
Today's sutures are the result of a 4000-year innovation process with regard to their materials and manufacturing techniques, yet little has been done to enhance the therapeutic value of the suture itself. In this review, we explore the historical development, regulatory database and clinical literature of sutures to gain a fuller picture of suture advances to date. First, we examine historical shifts in suture manufacturing companies and review suture regulatory databases to understand the forces driving suture development...
January 1, 2017: Journal of Biomaterials Applications
https://www.readbyqxmd.com/read/28713793/phenotypic-antimicrobial-resistance-profile-of-isolates-causing-clinical-mastitis-in-dairy-animals
#19
Carlotta Ceniti, Domenico Britti, Adriano Michele Luigi Santoro, Rosanna Musarella, Lucia Ciambrone, Francesco Casalinuovo, Nicola Costanzo
Mastitis is the most frequent and costly disease of lactating animals and is associated with a significant reduction in milk yield, increased cost and culling. Early and specific antibiotic based treatment reduces the severity of the disease. Over the years the extensive use of antimicrobials has led to increase antimicrobial resistance. The present study was designed to investigate the prevalence of microorganisms responsible for mastitis and their antimicrobial resistance pattern. A total of 282 milk samples were collected from different animal species (sheep, cows and goats) with clinical mastitis...
April 13, 2017: Italian Journal of Food Safety
https://www.readbyqxmd.com/read/28713441/analysis-of-raw-biofluids-by-mass-spectrometry-using-microfluidic-diffusion-based-separation
#20
Joshua Heinemann, Brigit Noon, Daniel Willems, Katherine Budeski, Brian Bothner
Elucidation and monitoring of biomarkers continues to expand because of their medical value and potential to reduce healthcare costs. For example, biomarkers are used extensively to track physiology associated with drug addiction, disease progression, aging, and industrial processes. While longitudinal analyses are of great value from a biological or healthcare perspective, the cost associated with replicate analyses is preventing the expansion of frequent routine testing. Frequent testing could deepen our understanding of disease emergence and aid adoption of personalized healthcare...
January 21, 2017: Analytical Methods: Advancing Methods and Applications
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