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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/28647879/disposal-of-household-pharmaceuticals-in-insular-communities-social-attitude-behaviour-evaluation-and-prevention-activities
#2
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
#3
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/28558416/fast-ultra-high-performance-liquid-chromatography-with-diode-array-and-mass-spectrometry-method-for-determination-of-tadalafil-drug-substance-and-its-impurities
#4
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/28533252/national-trends-in-prescription-drug-expenditures-and-projections-for-2017
#5
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/28474001/pharmaceutical-use-and-spending-trend-in-medicare-beneficiaries-with-dementia-from-2006-to-2012
#6
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
https://www.readbyqxmd.com/read/28371718/comparability-study-of-rituximab-originator-and-follow-on-biopharmaceutical
#7
Othman Montacir, Houda Montacir, Murat Eravci, Andreas Springer, Stephan Hinderlich, Amirhossein Saadati, Maria Kristina Parr
Immunglobolin G (IgG)-based biopharmaceuticals are emerging on the pharmaceuticals market due to their high target selectivity in different diseases. In parallel, a growing interest by other companies to produce similar or highly similar follow-on biologics exits, once the patent of blockbuster biotherapeutics is about to expire. In correlation to their complex structure, an analytical challenge is facing the approval of these biosimilars. Health authorities (e.g. FDA and EMA) have issued several guidelines to define critical quality attributes during manufacturing process changes...
June 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28348532/ethical-implications-of-the-mild-encephalitis-hypothesis-of-schizophrenia
#8
Rita Riedmüller, Sabine Müller
Schizophrenia is a serious mental disease with a high mortality rate and severe social consequences. Due to insufficient knowledge about its etiopathogenesis, curative treatments are not available. One of the most promising new research concepts is the mild encephalitis hypothesis of schizophrenia, developed mainly by Karl Bechter and Norbert Müller. According to this hypothesis, a significant subgroup of schizophrenia patients suffer from a mild, but chronic, form of encephalitis with markedly different etiologies ranging from viral infections, traumas to autoimmune diseases...
2017: Frontiers in Psychiatry
https://www.readbyqxmd.com/read/28264706/erratum-to-disposal-practices-of-unused-and-expired-pharmaceuticals-among-general-public-in-kabul
#9
Mohammad Bashaar, Vijay Thawani, Mohamed Azmi Hassali, Fahad Saleem
No abstract text is available yet for this article.
March 6, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28231332/the-moderating-role-of-absorptive-capacity-and-the-differential-effects-of-acquisitions-and-alliances-on-big-pharma-firms-innovation-performance
#10
K D S Fernald, H P G Pennings, J F van den Bosch, H R Commandeur, E Claassen
In the context of increased pharmaceutical innovation deficits and Big Pharma blockbusters' patent expirations, this paper examines the moderating role of firms' absorptive capacity in external innovation activities of Big Pharma firms. The study indicates a rising interest of Big Pharma in acquisitions of and alliances with biotechnology companies. Unfortunately, this increased interest is not reflected in the number of new drugs generated by Big Pharma. We find that acquisitions of biotech companies have negatively affected Big Pharma firms' innovation performance on average but these acquisitions might have a positive effect at higher levels of acquiring firms' absorptive capacity...
2017: PloS One
https://www.readbyqxmd.com/read/28213391/the-politics-and-policies-of-regulating-generics-in-latin-america-a-survey-of-seventeen-states
#11
Cassandra M Sweet
When patents expire, are equivalent generic alternatives available to citizens? This article contributes to current discussion on access to medicine in the aftermath of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The focus is on off-patent or "generic" medicines: their product definitions, quality standards and prescription procedures. Drawing from a survey conducted of seventeen countries across the Latin American region, this article examines the differences in definition of off-patent products and the paradox of their relatively lower consumption across multiple developing states...
June 2017: Journal of Health Politics, Policy and Law
https://www.readbyqxmd.com/read/28142147/history-of-erythropoiesis-stimulating-agents-the-development-of-biosimilars-and-the-future-of-anemia-treatment-in-nephrology
#12
Kamyar Kalantar-Zadeh
BACKGROUND: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world...
2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28116676/scientific-and-regulatory-considerations-for-generic-complex-drug-products-containing-nanomaterials
#13
Nan Zheng, Dajun D Sun, Peng Zou, Wenlei Jiang
In the past few decades, the development of medicine at the nanoscale has been applied to oral and parenteral dosage forms in a wide range of therapeutic areas to enhance drug delivery and reduce toxicity. An obvious response to these benefits is reflected in higher market shares of complex drug products containing nanomaterials than that of conventional formulations containing the same active ingredient. The surging market interest has encouraged the pharmaceutical industry to develop cost-effective generic versions of complex drug products based on nanotechnology when the associated patent and exclusivity on the reference products have expired...
January 23, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28112087/tackling-the-climate-targets-set-by-the-paris-agreement-cop-21-green-leadership-empowers-public-hospitals-to-overcome-obstacles-and-challenges-in-a-resource-constrained-environment
#14
E Weimann, B Patel
The healthcare sector itself contributes to climate change, the creation of hazardous waste, use of toxic metals such as mercury, and water and air pollution. To mitigate the effect of healthcare provision on the deteriorating environment and avoid creating further challenges for already burdened health systems, Global Green Hospitals was formed as a global network. Groote Schuur Hospital (GSH), as the leading academic hospital in Africa, joined the network in 2014. Since then, several projects have been initiated to reduce the amount of general waste, energy consumption and food waste, and create an environmentally friendlier and more sustainable hospital in a resource-constrained public healthcare setting...
December 21, 2016: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
https://www.readbyqxmd.com/read/28068518/impact-of-space-environment-on-stability-of-medicines-challenges-and-prospects
#15
REVIEW
Priti Mehta, Dhara Bhayani
To upkeep health of astronauts in a unique, isolated, and extreme environment of space is the primary goal for a successful space mission, hence, safe and efficacious medications are essential for the wellness of astronauts. Space medication has been challenged with problems related to efficacy. Along with altered physiology, one of the possible reasons could be instability of space medications in the presence of harsh spaceflight environmental conditions. Altered physical and chemical stability can result in reduced potency which can result in reduced efficacy...
March 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28066115/comparison-of-the-knowledge-attitude-and-practices-of-doctors-nurses-and-pharmacists-regarding-the-use-of-expired-and-disposal-of-unused-medicines-in-delhi
#16
COMPARATIVE STUDY
Kriti Bhayana, Harmeet Singh Rehan, Tarun Arora
OBJECTIVES: The use of out-of-date medicines and improper disposal of pharmaceutical products harm consumers and environment. To limit pharmaceutical load on the environment, it is important that healthcare professionals (HCPs) are aware of and have good practices toward their disposal. MATERIALS AND METHODS: A pretested instructor administered questionnaire containing 21 questions was used to assess knowledge, attitude, and practices (KAP) of 300 HCPs toward use and disposal of unwanted/expired medicines...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28061902/disposal-practices-of-unused-and-expired-pharmaceuticals-among-general-public-in-kabul
#17
Mohammadk Bashaar, Vijay Thawani, Mohamed Azmi Hassali, Fahad Saleem
BACKGROUND: Most of the medicine users remain unaware about the disposal of unused or expired medicines. The aim of this study was to know the disposal practices of unused and expired medicines among the general public in Kabul. METHODS: This was a descriptive, cross-sectional survey, conducted through face-to-face interviews using prevalidated structured questionnaire. Returned questionnaires were double-checked for accuracy. Statistical Package for Social Science (SPSS) version 23 was used for statistical analysis...
January 7, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28012020/product-safety-spillovers-and-market-viability-for-biologic-drugs
#18
John Romley, Tiffany Shih
When a pharmaceutical manufacturer experiences a safety problem, negative impacts on profitability can spread to its competitors. Reduced consumer confidence, product recalls, and litigation are limited to the responsible manufacturer only if that manufacturer can be clearly linked to the safety problem. We analyze the impact of "accountability" for safety problems on manufacturer entry decisions and investments to mitigate risk. Consistent with prior research, we find investment levels increase with accountability in a duopoly market, and that accountability can thus enhance market viability and improve consumer welfare...
December 23, 2016: International Journal of Health Economics and Management
https://www.readbyqxmd.com/read/27881996/quality-of-drug-stores-storage-practices-regulatory-compliance-in-karachi-pakistan
#19
Syed Shaukat Ali Muttaqi Shah, Baqar Shyum Naqvi, Mashhad Fatima, Asif Khaliq, Abdul Latif Sheikh, Muhammad Baqar
OBJECTIVE: To assess and evaluate the drug storage quality and regulatory compliance among privately operated drug stores of Karachi Pakistan. METHODS: A cross-sectional survey of drug stores located in Karachi was conducted from May to December 2013. A total of 1003 drug stores that were involved in the sales, purchase and dispensing of pharmaceutical products were approached by non-probability purposive sampling technique, and the information was collected using a close ended, structured questionnaire...
September 2016: Pakistan Journal of Medical Sciences Quarterly
https://www.readbyqxmd.com/read/27804787/pharmaceutical-patent-applications-in-freeze-drying
#20
REVIEW
Edmond Ekenlebie, Tomaž Einfalt, Arianna Irò Karytinos, Andrew Ingham
Injectable products are often the formulation of choice for new therapeutics; however, formulation in liquids often enhances degradation through hydrolysis. Thus, freeze-drying (lyophilization) is regularly used in pharmaceutical manufacture to reduce water activity. Here we examine its contribution to 'state of the art' and look at its future potential uses. A comprehensive search of patent databases was conducted to characterize the international patent landscape and trends in the use of freeze-drying. A total of 914 disclosures related to freeze-drying, lyophilization or drying of solid systems in pressures and temperatures equivalent to those of freeze-drying were considered over the period of 1992-2014...
September 2016: Pharmaceutical Patent Analyst
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