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https://www.readbyqxmd.com/read/28088112/a-current-perspective-on-the-oncopreventive-and-oncolytic-properties-of-selective-serotonin-reuptake-inhibitors
#1
REVIEW
Daniel P Radin, Parth Patel
Current cancer research strongly focuses on identifying novel pathways that can be selectively exploited in the clinic and identifying drugs capable of exploiting cancer vulnerabilities. Occasionally, drugs identified to exploit a cancer-specific vulnerability are on the market for clinical indications in another disease area. Rebranding them as anti-cancer drugs is a process commonly referred to as drug repurposing and is typically a faster method than bringing a novel drug to market. Selective serotonin reuptake inhibitors (SSRIs) are primarily used for treating several types of depression, but over the past two decades mounting evidence suggests that drugs in this class have oncolytic properties and reduce the risk of certain cancers...
January 11, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28086792/irish-general-practitioner-attitudes-toward-decriminalisation-and-medical-use-of-cannabis-results-from-a-national-survey
#2
Des Crowley, Claire Collins, Ide Delargy, Eamon Laird, Marie Claire Van Hout
BACKGROUND: Governmental debate in Ireland on the de facto decriminalisation of cannabis and legalisation for medical use is ongoing. A cannabis-based medicinal product (Sativex®) has recently been granted market authorisation in Ireland. This unique study aimed to investigate Irish general practitioner (GP) attitudes toward decriminalisation of cannabis and assess levels of support for use of cannabis for therapeutic purposes (CTP). METHODS: General practitioners in the Irish College of General Practitioner (ICGP) database were invited to complete an online survey...
January 13, 2017: Harm Reduction Journal
https://www.readbyqxmd.com/read/28080154/biocompatibility-assessments-for-medical-devices-evolving-regulatory-considerations
#3
Lesley Reeve, Paul Baldrick
Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, differences in proposed biocompatibility assessments or test methods lead to confusion and inefficiencies in generating the package of supporting nonclinical data. Areas covered: Modifications to available guidance for biological safety testing of medical devices, as described by the International Organisation for Standardisation (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and sometimes decreased the level of harmonisation in testing requirements...
January 12, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28079786/fatal-postoperative-systemic-pulmonary-hypertension-in-benfluorex-induced-valvular-heart-disease-surgery-a-case-report
#4
Christophe Baufreton, Patrick Bruneval, Marie-Christine Rousselet, Pierre-Vladimir Ennezat, Olivier Fouquet, Raphael Giraud, Carlo Banfi
RATIONALE: Drug-induced valvular heart disease (DI-VHD) remains an under-recognized entity. PATIENT CONCERNS: This report describes a heart valve replacement which was complicated by intractable systemic pulmonary arterial hypertension in a 61-year-old female with severe restrictive mitral and aortic disease. The diagnosis of valvular disease was preceded by a history of unexplained respiratory distress. The patient had been exposed to benfluorex for 6.5 years. DIAGNOSES: The diagnostic procedure documented specific drug-induced valvular fibrosis...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28077911/a-decade-of-data-protection-for-innovative-drugs-in-canada-issues-limitations-and-time-for-a-reassessment
#5
Megan Kendall, Declan Hamill
Drug regulators in Canada and in other nations require innovative pharmaceutical companies to submit undisclosed clinical or other data as a condition of approving the marketing of new pharmaceutical products-the origination of which involves considerable effort and investment. Data protection regulations were enacted in Canada in 2006, which-to some extent-closed a loophole in intellectual property law that had previously left innovative companies with no effective data protection for their clinical data. Although the regulations were intended to clarify and effectively implement Canada's international treaty obligations in the spirit of innovation, a review of Canada's first decade of effective data protection shows that Health Canada and Canadian courts have interpreted the scope of data protection for innovative drugs in a narrow manner that undermines and is inconsistent with the intent of the regulations...
December 1, 2016: Biotechnology Law Report
https://www.readbyqxmd.com/read/28075542/considering-marijuana-legalization-carefully-insights-for-other-jurisdictions-from-analysis-for-vermont
#6
Jonathan P Caulkins, Beau Kilmer
BACKGROUND AND AIMS: In 2014 the legislature of Vermont, USA passed a law requiring the Secretary of Administration to report on the consequences of legalizing marijuana. The RAND Corporation was commissioned to write that report. This paper summarizes insights from that analysis that are germane to other jurisdictions. METHOD: Translation of key findings from the RAND Corporation report to the broader policy debate. RESULTS: Marijuana legalization encompasses a wide range of possible regimes, distinguished along at least four dimensions: which organizations are allowed to produce and supply the drug, the regulations under which they operate, the nature of the products that can be distributed and taxes and prices...
December 2016: Addiction
https://www.readbyqxmd.com/read/28075182/dispersing-the-mists-an-experimental-history-of-medicine-study-into-the-quality-of-volatile-inhalations
#7
Barry Murnane, Cathal T Gallagher, Noel Snell, Mark Sanders, Ramin Moshksar, Darragh Murnane
BACKGROUND: Dr. Nelson's Improved Inhaler was first marketed with an advertisement in The Lancet in 1865. Revolutionary at the time for its ease of use and patient-friendliness, the inhaler is still in use for self-treatment by many all over the world. On the occasion of its 150th anniversary, this study reports an experimental historical medicine approach to identify evidence for the quality of vapor inhalers. METHODS: Through accessing reviews of the device's use by the contemporary medical establishment, it was established that Dr...
January 11, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28073934/the-influence-of-customer-medicine-seller-transactional-dynamics-on-childhood-diarrhoea-management-a-qualitative-study-in-ghana
#8
Lauren Rosapep, Emily Sanders, Kathryn Banke
In 2004, the World Health Organization (WHO) and United Nations Children's Fund (UNICEF) jointly revised the recommended treatment for acute paediatric diarrhoea to specify supplementing reduced osmolarity oral rehydration salts (ORS) with zinc. In many countries, however, a significant knowledge-practice gap persists in appropriate diarrhoea management among private healthcare providers. For example, the United States Agency for International Development (USAID)-funded Strengthening Health Outcomes through the Private Sector (SHOPS) project recently demonstrated that over-the-counter medicine sellers (MS) in Ghana recommended inappropriate diarrhoea treatments, despite their demonstrated knowledge of appropriate treatment protocols...
January 10, 2017: Health Policy and Planning
https://www.readbyqxmd.com/read/28073687/adverse-event-detection-using-the-fda-post-marketing-drug-safety-surveillance-system-cardiotoxicity-associated-with-loperamide-abuse-and-misuse
#9
Kimberley A Swank, Eileen Wu, Cindy Kortepeter, Jana McAninch, Robert L Levin
OBJECTIVE: The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. METHODS: We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016...
January 7, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28071818/safety-profile-of-the-direct-oral-anticoagulants-an-analysis-of-the-who-database-of-adverse-drug-reactions
#10
Luca Monaco, Chiara Biagi, Valentino Conti, Mauro Melis, Monia Donati, Mauro Venegoni, Alberto Vaccheri, Domenico Motola
AIM: Direct oral anticoagulants (DOACs) have shown non-inferiority to warfarin for stroke prevention in non-valvular atrial fibrillation (AF) and a more promising safety profile. Unanswered safety aspects remain to addressed and available evidence on the risk associated with these drugs are conflicting. In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase...
January 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28070733/glp-1-ra-treatment-patterns-among-type-2-diabetes-patients-in-five-european-countries
#11
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)...
January 9, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28069987/transgenic-zebrafish-reporter-lines-as-alternative-in-vivo-organ-toxicity-models
#12
Kar Lai Poon, Xingang Wang, Serene Gp Lee, Ashley S Ng, Wei Huang Goh, Zhonghua Zhao, Muthafar Al-Haddawi, Haishan Wang, Sinnakaruppan Mathavan, Phillip W Ingham, Claudia Mcginnis, Tom J Carney
Organ toxicity, particularly liver toxicity, remains one of the major reasons for termination of drug candidates in the development pipeline as well as withdrawal or restrictions of marketed drugs. A screening-amenable alternative in vivo model such as zebrafish would therefore find immediate application in the early prediction of unacceptable organ toxicity. To identify highly upregulated genes as biomarkers of toxic responses in the zebrafish model, a set of well-characterized reference drugs that cause drug induced liver injury (DILI) in the clinic were applied to zebrafish larvae and adults...
January 9, 2017: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/28069260/drugs-and-medical-devices-adverse-events-and-the-impact-on-women-s-health
#13
REVIEW
Jennifer L Carey, Nathalie Nader, Peter R Chai, Stephanie Carreiro, Matthew K Griswold, Katherine L Boyle
A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed...
January 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28068848/the-safety-of-emerging-biosimilar-drugs-for-the-treatment-of-rheumatoid-arthritis
#14
J Braun, J Kay
Biological disease-modifying anti-rheumatic drugs (bDMARDs), often administered in combination with methotrexate, target specific inflammatory mediators and have transformed the treatment of rheumatic diseases, especially rheumatoid arthritis (RA) but also the spondyloarthritides. However, the high cost of these drugs in many countries restricts patient access. As many bDMARDs have reached or are near to patent expiration, numerous biosimilar drugs are in development and some have already been approved. Biosimilars are generally priced lower than their reference products (RPs), or bio-originators, and as prices come down it is hoped that patient access to these drugs will increase, making the safety of these drugs an area of major interest...
January 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28068113/perceptions-of-harm-and-addiction-of-snus-an-exploratory-study
#15
Annette R Kaufman, Emily Grenen, Meredith Grady, Bryan Leyva, Rebecca A Ferrer
Tobacco companies in the United States are prohibited from making reduced harm claims without filing a modified risk tobacco product application with the Food and Drug Administration and obtaining an order to market as such. However, it is possible that product marketing may suggest reduced risk to individuals. This study examines perceptions, in particular those related to harm and addiction, of snus print advertisements using a combination of eye-tracking, survey, and semistructured interviews. Participants were 22 male smokers ages 19-29 (M = 26...
December 2016: Psychology of Addictive Behaviors: Journal of the Society of Psychologists in Addictive Behaviors
https://www.readbyqxmd.com/read/28065194/osteoporosis-drugs-marketed-in-the-united-states-generic-competition-pricing-structure-and-dispersion-among-payers
#16
Bander Balkhi, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio
BACKGROUND: Despite the cost of pharmaceuticals, studies assessing prices of osteoporosis drugs are lacking. This study examined trends in prices of osteoporosis drugs in the United States in the period 1988-2014, assessed pricing structure of osteoporosis drugs, and evaluated price trends before and after generic drugs market entry. METHODS: Data were derived from the U.S. Food and Drug Administration, the RedBook, the Centers for Medicare & Medicaid Services, and the Federal Supply Schedule (FSS)...
January 9, 2017: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/28064506/simultaneous-analysis-of-3-mcpd-and-1-3-dcp-in-asian-style-sauces-using-quechers-extraction-and-gas-chromatography-triple-quadrupole-mass-spectrometry
#17
Susan Genualdi, Patricia Jean Nyman, Lowri S deJager
Acid hydrolyzed vegetable protein (aHVP) is used for flavoring a wide variety of foods and also in the production of non-fermented soy sauce. During the production of aHVP, chloropropanols including 3-monochloropropane-1,2-diol (3-MCPD) and 1,3 dichloropropane-2-ol (1,3-DCP) can be formed through the reaction of the hydrochloric acid catalyst and residual fat and the reaction of 3-MCPD with acetic acid, respectively. 3-MCPD is a carcinogen and 1,3-DCP has been classified as a genotoxic carcinogen. The European Union (EU) has set a maximum concentration of 0...
January 8, 2017: Journal of Agricultural and Food Chemistry
https://www.readbyqxmd.com/read/28064095/indomethacin-electrospun-nanofibers-for-colonic-drug-delivery-in-vitro-dissolution-studies
#18
Abbas Akhgari, Zohreh Heshmati, Hadi Afrasiabi Garekani, Fatemeh Sadeghi, Atena Sabbagh, Behzad Sharif Makhmalzadeh, Ali Nokhodchi
Generally, although the conventional drug delivery systems, such as using only pH-dependent polymers or time-dependent release systems are popular, the individuals' variations of physiological conditions usually lead to premature or imperfect drug release from each of these systems. Therefore, a combination of pH- and time-dependent polymers could be more reliable for delivering drugs to the lower GI tract such as colon. To this end, electrospinning method was used as a fabrication approach for preparing electrospun nanofibers of indomethacin aimed for colon delivery...
December 23, 2016: Colloids and Surfaces. B, Biointerfaces
https://www.readbyqxmd.com/read/28064090/molecular-insight-into-atypical-instability-behavior-of-fixed-dose-combination-containing-amlodipine-besylate-and-losartan-potassium
#19
Tarun Handa, Shalu Jhajra, Shweta Bhagat, P V Bharatam, Asit K Chakraborti, Saranjit Singh
Combination therapy with the use of fixed-dose combinations (FDCs) is evincing increasing interest of prescribers, manufacturers and even regulators, evidently due to the primary benefit of improved patient compliance. However, owing to potential of drug-drug interaction, FDCs require closer scrutiny with respect to their physical and chemical stability. Accordingly, the purpose of the present study was to explore stability behavior of a popular antihypertensive combination of amlodipine besylate (AML) and losartan potassium (LST)...
December 29, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28063756/-synthetic-cannabinoids-a-new-addiction-matrix
#20
Amandine Scocard, Amine Benyamina, Sarah Coscas, Laurent Karila
Synthetic cannabinoids (SC) belong to the emergent market of new psychoactive substances, sold on the Internet or specialized shops. Since the 1970s, more than 160 new SC have invaded the drug market. These substances imitate the psychoactive effects of cannabis. Underestimated for too long, SC's market growth and consequences are no longer to be ignored, first of all in terms of public health. SC were first synthesized during researches on the endocannabinoid system. Though they are agonists of the cannabinoid receptors 1 and 2, as Δ9-tetrahydrocannabinol in cannabis, they can also have a really high affinity with these receptors, rising up their potency...
January 4, 2017: La Presse Médicale
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