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Overactive bladder (OAB) is a condition affecting millions of individuals in the United States. Anticholinergics are the mainstay of treatment. Bladder botulinum toxin injections have shown an improvement in symptoms of OAB equivalent to anticholinergic therapy. Percutaneous tibial nerve stimulation can decrease symptoms of urinary frequency and urge incontinence. Sacral neuromodulation for refractory patients has been approved by the Food and Drug Administration for treatment of OAB, urge incontinence, and urinary retention. Few randomized, head-to-head comparisons of the different available alternatives exist; however, p...
Source: Obstetrics and Gynecology Clinics - February 13, 2016 Category: OBGYN Authors: Nicola White, Cheryl B. Iglesia Source Type: research
Registries as Tools for Clinical Excellence and the Development of the Pelvic Floor Disorders Registry
Surgical device innovation has been less regulated than drug development, allowing integration of unproven techniques and materials into standard practice. Successful device registries gather information on patient outcomes and can provide postmarket surveillance of new technologies and allow comparison with currently established treatments or devices. The Pelvic Floor Disorders Registry was developed in collaboration with the Food and Drug Administration, device manufacturers, and other stakeholders to serve as a platform for industry-sponsored postmarket device surveillance, investigator-initiated research, and quality a...
Source: Obstetrics and Gynecology Clinics - February 13, 2016 Category: OBGYN Authors: Emily E. Weber LeBrun Source Type: research
Evaluation of diagnostic medical exposure in Republic of Korea
National statistical data for diagnostic radiation exposure in Republic of Korea were collected from four public institutes and government agencies during the period 2006–2013. The data were pooled, reclassified and analysed. A total of 1574 million exposures occurred during the study period. To evaluate the effective diagnostic radiation exposure dose, the dose conversion factors developed by the Korea Food and Drug Administration were applied. The number of diagnostic radiation exposures was 197 million per year. The collective effective dose averaged 64 043 man Sv y–1, and the annual per caput effective dose...
Source: Radiation Protection Dosimetry - February 13, 2016 Category: Radiology Authors: Lee, S. Y., Lim, H. S., Lee, J., Kim, H. S. Tags: Papers Source Type: research
Development of the sporadic inclusion body myositis physical functioning assessment (sIFA)
This article is protected by copyright. All rights reserved. (Source: Muscle and Nerve)
Source: Muscle and Nerve - February 13, 2016 Category: Internal Medicine Authors: Carla DeMuro, Sandy Lewis, Linda Lowes, Lindsay Alfano, Brian Tseng, Ari Gnanasakthy Tags: Research Article Source Type: research
Analytical Similarity Assessment in Biosimilar Studies
Abstract For assessment of biosimilarity, the US Food and Drug Administration (FDA) recommends a stepwise approach for obtaining the totality-of-the-evidence for demonstrating biosimilarity between a proposed biosimilar product and an innovative (reference) biological product. The stepwise approach starts with analytical studies for functional and structural characterization at various stages of manufacturing process of the proposed biosimilar product. Analytical similarity assessment involves identification of critical quality attributes (CQAs) that are relevant to clinical outcomes. FDA proposes first classifyin...
Source: The AAPS Journal - February 12, 2016 Category: Drugs & Pharmacology Source Type: research
Adjunctive Pramipexole May Benefit Patients With Refractory Depression
An article published in the February issue of the American Journal of Psychiatry shows that pramipexole—a selective D3 receptor agonist approved for the treatment of Parkinson’s disease and restless legs syndrome—may be an effective adjunctive therapy for treatment-resistant depression.Studies have long suggested that agents that enhance dopamine neurotransmission may be particularly useful in reducing treatment-resistant depression. A previous study comparing pramipexole with placebo in an 8-week randomized, double-blind trial with 60 outpatients with major depression for whom at least one adequate antidepressant me...
Source: Psychiatr News - February 11, 2016 Category: Psychiatry Tags: bipolar depression pramipexole treatment resistant depression Source Type: research
Prostatic specific antigen. From its early days until becoming a prostate cancer biomarker.
Authors: Dellavedova T Abstract Prostate-specific antigen (PSA) has been since the mid 80's the most commonly used biomarker for measuring current and future risk of prostate cancer, for its early detection and to measure response to treatments and detecting recurrence in all stages of the disease. PSA's early development came along with progress in the field of immunology, which allowed detection and study of antigens from different tissues and fluids when injecting them into rabbits to promote immune response. Rubin Flocks in 1960 was the first to investigate and discover prostate-specific antigens in benign and ...
Source: Archivos Espanoles de Urologia - February 11, 2016 Category: Urology & Nephrology Tags: Arch Esp Urol Source Type: research
Field studies versus database studies on the risks and benefits of medication use during pregnancy: Distinct pieces of the same puzzle
Publication date: Available online 10 February 2016 Source:Reproductive Toxicology Author(s): Anick Bérard, Katherine L. Wisner, Stefanie Hultzsch, Christina Chambers Over the past two decades, findings on medication use during pregnancy have been accumulating from observational data. Generally, field studies with prospective recruitment of subjects have better outcome ascertainment, and more control on the longitudinal collection of data, but have lower sample sizes and thus they often lack statistical power to detect increased risks for rare events such as major congenital malformations. In addition, given the rar...
Source: Reproductive Toxicology - February 11, 2016 Category: Toxicology Source Type: research
Thrombus Around the Redesigned Heartware Hvad Inflow Cannula: A Pathologic Case Series
The HeartWare HVAD1 (HeartWare, Inc., Framingham, MA) is a centrifugal, continuous flow left ventricular assist device (LVAD) that was approved by the United States Food and Drug Administration (FDA) in 2012 for use as a bridge to cardiac transplantation in patients at risk of death from refractory end-stage left ventricular heart failure. Unlike other currently FDA-approved LVADs, the pump itself resides within the thorax on the epicardial surface rather than in an abdominal or extracorporeal location. (Source: The Journal of Heart and Lung Transplantation)
Source: The Journal of Heart and Lung Transplantation - February 11, 2016 Category: Transplant Surgery Authors: Kyle C. Strickland, Jaclyn C. Watkins, Gregory S. Couper, Michael M. Givertz, Robert F. Padera Source Type: research
Botulinum Toxin to Treat Neurogenic Bladder
Semin Neurol 2016; 36: 005-009DOI: 10.1055/s-0035-1571216Alteration in neural control from suprapontine areas to the nerves innervating the bladder can lead to bladder dysfunction and the development of a neurogenic bladder (NGB). Patients with NGB often suffer from urinary incontinence, which can lead to adverse events such as urinary tract infections and decubiti, in addition to creating a large care burden for family members or healthcare providers and significantly impairing patient quality of life. The common failure of anticholinergic medications has spurned the development of second-line treatments, including the us...
Source: Seminars in Neurology - February 11, 2016 Category: Neurology Authors: Smith, Christopher P.Chancellor, Michael B. Source Type: research
Botulinum Toxin Treatment of Cervical Dystonia
Semin Neurol 2016; 36: 047-053DOI: 10.1055/s-0035-1571210The use of botulinum toxin for the treatment of cervical dystonia (CD) was first reported in 1985. Since then, four commercially available formulations have been approved by the U.S. Food and Drug Administration for use in CD, including three botulinum toxin A formulations and one botulinum toxin B formulation. Recent clinical trials have generally demonstrated good efficacy and tolerability. Commonly reported side effects include dysphagia, muscle weakness, and dry mouth. Secondary nonresponse may develop, but the relationship of detected antibodies to clinical resp...
Source: Seminars in Neurology - February 11, 2016 Category: Neurology Authors: Bledsoe, Ian O.Comella, Cynthia L. Source Type: research
Botulinum Toxin for the Treatment of Tremor and Tics
Semin Neurol 2016; 36: 054-063DOI: 10.1055/s-0035-1571217The therapeutic applications of botulinum toxin (BoNT) have grown manifold since its initial approval in 1989 by the U.S. Food and Drug Administration for the treatment of strabismus, blepharospasm, and other facial spasms. Although it is the most potent biologic toxin known to man, long-term studies have established its safety in the treatment of a variety of neurologic and nonneurologic disorders. Despite a paucity of randomized controlled trials, BoNT has been found to be beneficial in treating a variety of tremors and tics when used by clinicians skilled in the a...
Source: Seminars in Neurology - February 11, 2016 Category: Neurology Authors: Lotia, MiteshJankovic, Joseph Source Type: research
Neuroprotective Effects of Poly(ADP-ribose)polymerase Inhibitor Olaparib in Transient Cerebral Ischemia.
This study aimed to evaluate the effects of olaparib in transient cerebral ischemia. A mouse model of transient middle cerebral artery occlusion was used. Reperfusion was performed at 2 h after ischemia. Different doses of olaparib (1, 3, 5, 10 and 25 mg/kg) were administered intraperitoneally immediately after reperfusion. Twenty-four hours after ischemia, the neurological score was assessed, and grip and string tests were performed to evaluate the behavioral deficits in the mice. Cresyl violet staining was used to assess cerebral edema and the lesion volume. Immunohistochemistry was performed to evaluate the expression...
Source: Neurochemical Research - February 11, 2016 Category: Neuroscience Authors: Teng F, Zhu L, Su J, Zhang X, Li N, Nie Z, Jin L Tags: Neurochem Res Source Type: research
Endoscopic Treatments of Obesity: A Comprehensive Review
This study provides a comprehensive overview of the endoscopic treatments of obesity and summarizes their outcomes. (Source: Surgery for Obesity and Related Diseases)
Source: Surgery for Obesity and Related Diseases - February 11, 2016 Category: Surgery Authors: Christopher J. Neylan, Daniel T. Dempsey, Colleen M. Tewksbury, Noel N. Williams, Kristoffel R. Dumon Source Type: research
Harnessing T cells to fight cancer with BiTE® antibody constructs – past developments and future directions
Summary Bispecific T‐cell engager (BiTE®) antibody constructs represent a novel immunotherapy that bridges cytotoxic T cells to tumor cells, thereby inducing target cell‐dependent polyclonal T‐cell activation and proliferation, and leading to apoptosis of bound tumor cells. Anti‐CD19 BiTE® blinatumomab has demonstrated clinical activity in Philadelphia chromosome (Ph)‐negative relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL) eventually resulting in conditional approval by the U.S. Food and Drug Administration in 2014. This drug is currently further developed in pediatric and Ph+ r/r, as well as i...
Source: Immunological Reviews - February 10, 2016 Category: Allergy & Immunology Authors: Matthias Klinger, Jonathan Benjamin, Roman Kischel, Sabine Stienen, Gerhard Zugmaier Tags: Invited Review Source Type: research
BCR signaling inhibitors: an overview of toxicities associated with ibrutinib and idelalisib in patients with chronic lymphocytic leukemia
The B-cell receptor signaling inhibitors ibrutinib and idelalisib are revolutionizing the treatment landscape of chronic lymphocytic leukemia (CLL) and other B-cell malignancies. These oral agents, both alone and in combination with other drugs, have shown remarkable clinical activity in relapsed or refractory CLL across all risk groups, and have been approved by the Food and Drug Administration for this indication. Preliminary data suggest that an even greater benefit can be expected in treatment-naïve CLL patients. Both ibrutinib and idelalisib are well tolerated by most patients, including older, frailer individuals. T...
Source: Mediterranean Journal of Hematology and Infectious Diseases - February 9, 2016 Category: Hematology Source Type: research
Detection rate of actionable mutations in diverse cancers using a biopsy-free (blood) circulating tumor cell DNA assay.
Authors: Schwaederle M, Husain H, Fanta PT, Piccioni DE, Kesari S, Schwab RB, Banks KC, Lanman RB, Talasaz A, Parker BA, Kurzrock R Abstract Analysis of cell-free DNA using next-generation sequencing (NGS) is a powerful tool for the detection/monitoring of alterations present in circulating tumor DNA (ctDNA). Plasma extracted from 171 patients with a variety of cancers was analyzed for ctDNA (54 genes and copy number variants (CNVs) in three genes (EGFR, ERBB2 and MET)). The most represented cancers were lung (23%), breast (23%), and glioblastoma (19%). Ninety-nine patients (58%) had at least one detectable alterat...
Source: Oncotarget - February 9, 2016 Category: Cancer & Oncology Tags: Oncotarget Source Type: research
Dietary supplements quality analysis tools from the United States Pharmacopeia
The United States Food and Drug Administration (FDA) issued the dietary supplement (DS) current good manufacturing practice (GMP) regulations in compliance with the mandate from the Dietary Supplements Health and Education Act (DSHEA), with the intention of protecting public health by ensuring the quality of DS. The GMP regulations require manufacturers to establish their own quality specifications for identity, purity, strength, composition, and absence of contaminants. Numerous FDA‐conducted GMP inspections found that the private specifications set by these manufacturers are often insufficient to ensure adequate qualit...
Source: Drug Testing and Analysis - February 9, 2016 Category: Drugs & Pharmacology Authors: Nandakumara Sarma, Gabriel Giancaspro, Jaap Venema Tags: Perspective Source Type: research
Congress Seeks FDA Documents About Generic Drugs
Expressing concern over higher generic drug prices, the chair of the House Committee on Oversight and Government Reform and a dozen other Republican committee members recently wrote to the acting Food and Drug Administration (FDA) commissioner requesting information about the agency’s process for reviewing generic drug applications. (Source: JAMA)
Source: JAMA - February 9, 2016 Category: Journals (General) Source Type: research
Metabolite targeting: development of a comprehensive targeted metabolomics platform for the assessment of diabetes and its complications
Abstract Biomarker studies for metabolic disorders like diabetes mellitus (DM) are an important approach towards a better understanding of the underlying pathophysiological mechanisms of diseases (Roberts and Gerszten in Cell Metab 18:43–50, 2013; Wilson et al. in Proteome Res 4:591–598, 2005). Furthermore, screening of potential metabolic biomarkers opens the opportunity of early diagnosis as well as therapy and drug monitoring of metabolic disorders (Rhee et al. in J Clin Invest 10:1–10, 2011; Wang et al. in Nat Med 17:448–458, 2011; Wenk in Nat Rev Drug Discov 4:594–610, 2005). The aim of the present...
Source: Metabolomics - February 9, 2016 Category: Biology Source Type: research
Shedding More Light on Valve Thrombosis After Transcatheter Aortic Valve Replacement ∗
Based on strong evidence from randomized clinical trials and large registries, transcatheter aortic valve replacement (TAVR) has been enthusiastically embraced as a lifesaving and life-changing therapy for older, frail patients with severe aortic stenosis who are either inoperable or at high risk for conventional surgical aortic valve replacement (SAVR). Currently more than 200,000 patients worldwide have received such a valve, including >50,000 patients in U.S. pivotal trials with 1 of the 3 valves commercially approved by the Food and Drug Administration (FDA). These valves, Sapien XT and Sapien 3 (Edwards Lifesciences...
Source: Journal of the American College of Cardiology: Cardiovascular Imaging - February 8, 2016 Category: Radiology Source Type: research
No Shot: US Vaccine Prices And Shortages [Economics Of Vaccines]
In 2004 an Institute of Medicine report warned of vaccine shortages, raising concerns about disease outbreaks. More than a decade later, we looked for progress in reducing vaccine shortages. We analyzed data on vaccine sales and shortages reported by practitioners and patients to the Food and Drug Administration and the American Society of Health-System Pharmacists in the period 2004–13. We found that the number of annual vaccine shortages peaked in 2007, when there were shortages of seven vaccines; there were only two shortages in 2013. There were no shortages of vaccines with a mean price per dose greater than $75 ...
Source: Health Affairs - February 8, 2016 Category: Global & Universal Authors: Ridley, D. B., Bei, X., Liebman, E. B. Tags: Access To Care, Public Health, Vaccines Economics Of Vaccines Source Type: research
Clinical Application of Spine Trabecular Bone Score (TBS)
Abstract Trabecular bone score (TBS) is a software program recently approved by the US Food and Drug Administration for post-acquisition processing of lumbar spine dual-energy X-ray absorptiometry images that allows assessment of bone texture as a surrogate for bone microarchitecture. Low TBS values are associated with increased risk of major osteoporotic fracture risk in postmenopausal women and men aged 40 years and older independent of BMD. TBS data can be used to adjust FRAX probability of fracture. As such, TBS data can be useful in osteoporosis treatment initiation decisions. Following treatment initiation,...
Source: Clinical Reviews in Bone and Mineral Metabolism - February 8, 2016 Category: Internal Medicine Source Type: research
Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.
This article is protected by copyright. All rights reserved. PMID: 26853718 [PubMed - as supplied by publisher] (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - February 8, 2016 Category: Drugs & Pharmacology Authors: Sekine S, Pinnow EE, Wu E, Kurtzig R, Hall M, Dal Pan GJ Tags: Clin Pharmacol Ther Source Type: research
How Cancers Escape Immune Destruction and Mechanisms of Action for the New Significantly Active Immune Therapies: Helping Nonimmunologists Decipher Recent Advances
With the Food and Drug Administration and other worldwide regulatory authorities’ approval of ipilimumab (Yervoy), sipuleucel-T (Provenge), nivolumab (Opdivo), and pembrolizumab (Keytruda), oncologic therapy has now moved into noncancer cell targets within the immune system. For many nonimmunologists, understanding how these vastly different therapies work to improve survival, like no other therapies have in the past, is a challenge. The present report reviews the normal function of the immune system, how cancers escape the normal immune system, and how these new therapies improve immune system reactions against canc...
Source: The Oncologist - February 8, 2016 Category: Cancer & Oncology Authors: Messerschmidt, J. L., Prendergast, G. C., Messerschmidt, G. L. Tags: Review, New Drug Development and Clinical Pharmacology Source Type: research
Multidrug co-crystals: towards the development of effective therapeutic hybrids.
Abstract Co-crystals have garnered the interest of the pharmaceutical industry with the introduction of regulatory guidelines by the US Food and Drug Administration (FDA) as a result of expanded patent portfolios. The Phase II clinical success of tramadol and celecoxib co-crystal for the treatment of acute pain followed by a recent reflection paper published by the European Medicines Agency (EMA) have further boosted the development of drug-drug co-crystals. Here, we shed light on the developments of drug-drug co-crystals and highlight future perspectives for exploring new therapeutic hybrids deploying drug-drug, d...
Source: Drug Discovery Today - February 8, 2016 Category: Drugs & Pharmacology Authors: Thipparaboina R, Kumar D, Chavan RB, Shastri NR Tags: Drug Discov Today Source Type: research
Advisory Committee on Immunization Practices Recommended Immunization Schedules for Persons Aged 0 Through 18 Years - United States, 2016.
Abstract Each year, the Advisory Committee on Immunization Practices (ACIP)* reviews the recommended immunization schedules for persons aged 0 through 18 years to ensure that the schedules reflect current recommendations for Food and Drug Administration-licensed vaccines. In October 2015, ACIP approved the recommended immunization schedules for persons aged 0 through 18 years for 2016; the 2016 schedules include several changes from the 2015 immunization schedules. For 2016, the figures, footnotes, and tables will be published on the CDC immunization schedule website (http://www.cdc.gov/vaccines/schedules/index.htm...
Source: MMWR Morb Mortal Wkl... - February 5, 2016 Category: Epidemiology Authors: Robinson CL, Advisory Committee on Immunization Practices (ACIP), ACIP Child/Adolescent Immunization Work Group Tags: MMWR Morb Mortal Wkly Rep Source Type: research
FDA announces new plan to combat opioid abuse
Food and Drug Administration officials are calling for a sweeping overhaul of the agency’s approach to opioid medications, including renewed efforts to improve how opioids are approved, labeled, and... (Source: Rheumatology News)
Source: Rheumatology News - February 5, 2016 Category: Rheumatology Source Type: research
Probiotics and Alcoholic Liver Disease: Treatment and Potential Mechanisms.
Authors: Li F, Duan K, Wang C, McClain C, Feng W Abstract Despite extensive research, alcohol remains one of the most common causes of liver disease in the United States. Alcoholic liver disease (ALD) encompasses a broad spectrum of disorders, including steatosis, steatohepatitis, and cirrhosis. Although many agents and approaches have been tested in patients with ALD and in animals with experimental ALD in the past, there is still no FDA (Food and Drug Administration) approved therapy for any stage of ALD. With the increasing recognition of the importance of gut microbiota in the onset and development of a variety...
Source: Gastroenterology Research and Practice - February 5, 2016 Category: Gastroenterology Tags: Gastroenterol Res Pract Source Type: research
Nutritional consequences of long-term acid suppression; are they clinically important?
Purpose of review: As acid suppression therapies with proton pump inhibitors are an extremely common practice for common acid-related diseases, there has been increased scrutiny on the safety of this class of therapy. Recent findings: There have been increasing reports of allegation of harm with the sustained use of proton pump inhibitors, in particular with potential adverse effects on vitamin and mineral absorption. This has prompted a number of product label changes directed by the US Food and Drug Administration, raising concerns for ongoing continued use among clinicians and patients. Summary: This review highlights...
Source: Current Opinion in Gastroenterology - February 5, 2016 Category: Gastroenterology Tags: NUTRITION: Edited by Eamonn M.M. Quigley Source Type: research
Forxiga (dapagliflozin): Plausible role in the treatment of diabetes‐associated neurological disorders
This study explores the molecular interactions between AChE and SGLT2 with a new US Food and Drug Administration approved antidiabetic drug Forxiga (dapagliflozin) to explore a possible link between the treatments of AD and diabetes. Docking study was performed using “Autodock4.2.” Hydrophobic and cation–π interactions play an important role in the correct positioning of dapagliflozin within the catalytic site (CAS) of SGLT2 and AChE enzymes to permit docking. Free energy of binding (ΔG) of “dapagliflozin–SGLT2” and “dapagliflozin–CAS domain of AChE” interactions was found to be –6.25 and –6.28 kcal...
Source: Biotechnology and Applied Biochemistry - February 5, 2016 Category: Biochemistry Authors: Sibhghatulla Shaikh, Syed Mohd. Danish Rizvi, Shazi Shakil, Sania Riyaz, Deboshree Biswas, Roshan Jahan Tags: Original Article Source Type: research
Lucas Richert, Conservatism, Consumer Choice and the Food and Drug Administration during the Reagan Era
(Source: Social History of Medicine)
Source: Social History of Medicine - February 5, 2016 Category: History of Medicine Authors: Hall, W. Tags: Book Reviews Source Type: research
New Management Strategies in Heart Failure.
Abstract Despite >100 clinical trials, only 2 new drugs had been approved by the US Food and Drug Administration for the treatment of chronic heart failure in more than a decade: the aldosterone antagonist eplerenone in 2003 and a fixed dose combination of hydralazine-isosorbide dinitrate in 2005. In contrast, 2015 has witnessed the Food and Drug Administration approval of 2 new drugs, both for the treatment of chronic heart failure with reduced ejection fraction: ivabradine and another combination drug, sacubitril/valsartan or LCZ696. Seemingly overnight, a range of therapeutic possibilities, evoking new physio...
Source: Circulation Research - February 5, 2016 Category: Cardiology Authors: Owens AT, Brozena SC, Jessup M Tags: Circ Res Source Type: research
APA Urges Members to Support Reclassification of ECT Devices
Five years after it last broached the matter, the Food and Drug Administration (FDA) is again proposing to reclassify electroconvulsive therapy (ECT) from a Class III (high risk) medical device to Class II (low risk). APA supports this change.Opposition from anti-psychiatry groups was blamed for the FDA's maintaining the Class III status in 2011. Opponents to reclassification argued then that ECT causes memory problems, cognitive impairment, and other adverse effects. Supporters noted that current ECT practices, using anesthesia and muscle relaxants, significantly reduce those effects.The FDA in a recent Federal Register n...
Source: Psychiatr News - February 4, 2016 Category: Psychiatry Tags: antipsychiatry APA ECT electroconvulsive therapy FDA Food and Drug Administration Renee Binder Saul Levin Source Type: research
Search for Inhibitors of the Ubiquitin-Proteasome System from Natural Sources for Cancer Therapy.
Abstract Since the approval of the proteasome inhibitor, Velcade(®), by the Food and Drug Administration (FDA) for the treatment of relapsed multiple myeloma, inhibitors of the ubiquitin-proteasome system have been attracting increasing attention as promising drug leads for cancer therapy. While the development of drugs for diseases related to this proteolytic system has mainly been achieved by searching libraries of synthetic small molecules or chemical modifications to drug leads, limited searches have been conducted on natural sources. We have been searching natural sources for inhibitors that target this prote...
Source: Chemical and Pharmaceutical Bulletin - February 3, 2016 Category: Drugs & Pharmacology Authors: Tsukamoto S Tags: Chem Pharm Bull (Tokyo) Source Type: research
Cognitive Function as a Trans-Diagnostic Treatment Target in Stimulant Use Disorders.
Authors: Sofuoglu M, DeVito EE, Waters AJ, Carroll KM Abstract Stimulant use disorder is an important public health problem, with an estimated 2.1 million current users in the United States alone. No pharmacological treatments are approved by the U.S. Food and Drug Administration (FDA) for stimulant use disorder and behavioral treatments have variable efficacy and limited availability. Most individuals with stimulant use disorder have other comorbidities, most with overlapping symptoms and cognitive impairments. The goal of this article is to present a rationale for cognition as a treatment target in stimulant use...
Source: Journal of Dual Diagnosis - February 3, 2016 Category: Addiction Tags: J Dual Diagn Source Type: research
The Role of Neoadjuvant Trials in Drug Development for Solid Tumors.
Abstract The relatively low success rate of phase II oncology trials in predicting success of novel drugs in phase III trials and in gaining regulatory approval may be due to reliance on the endpoint of response rate defined by the Response Evaluation Criteria in Solid Tumors (RECIST). The neoadjuvant treatment paradigm allows the anti-tumor activity of a novel therapy to be determined on a pathological basis at the time of surgery instead of by RECIST, which was not developed to guide clinical decision making or correlate with long-term outcomes. Indeed, the US Food and Drug Administration (FDA) endorsed pathologi...
Source: Clinical Cancer Research - February 3, 2016 Category: Cancer & Oncology Authors: Funt SA, Chapman PB Tags: Clin Cancer Res Source Type: research
Severe jaundice due to intrahepatic cholestasis after initiating anticoagulation with rivaroxaban
Rivaroxaban, a highly selective direct factor Xa inhibitor, is a new oral anticoagulant approved by the US Food and Drug Administration in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation. Because of its efficacy and once-a-day dosing, it is commonly preferred in patients with nonvalvular atrial fibrillation and intolerance to warfarin in clinical practice. However, it can result in some adverse effects such as bleeding, rashes and liver injury. Here, we described a very rare adverse reaction of rivaroxaban, jaundice due to intrahepatic cholestasis, appeared in a 71-year-old male patien...
Source: Blood Coagulation and Fibrinolysis - February 2, 2016 Category: Hematology Tags: Case Reports Source Type: research
Testosterone and Cardiovascular Disease
Testosterone (T) is the principal male sex hormone. As men age, T levels typically fall. Symptoms of low T include decreased libido, vasomotor instability, and decreased bone mineral density. Other symptoms may include depression, fatigue, erectile dysfunction, and reduced muscle strength/mass. Epidemiology studies show that low levels of T are associated with more atherosclerosis, coronary artery disease, and cardiovascular events. However, treating hypogonadism in the aging male has resulted in discrepant results in regard to its effect on cardiovascular events. Emerging studies suggest that T may have a future role in t...
Source: Journal of the American College of Cardiology - February 2, 2016 Category: Cardiology Source Type: research
Investigator-Reported Bleeding Versus Post Hoc Adjudication of Bleeding Lessons From the CHAMPION PHOENIX Trial
Cangrelor, a potent intravenous, reversible, platelet P2Y12 inhibitor, was recently approved by both the U.S. Food and Drug Administration and the European Medicines Agency as an adjunct for percutaneous coronary intervention. The approval was based on CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention) (1), a multicenter, double-dummy, double-blind trial, which randomized 11,145 patients with stable angina, non–ST-segment elevation acute coronary syndrome or ST-segment elevation myocardial infarction to receive cangrelor or cl...
Source: Journal of the American College of Cardiology - February 2, 2016 Category: Cardiology Source Type: research
Novel Therapeutic Strategies for Dementia.
Abstract Dementia represents a major problem of health and disability, with a relevant economic impact on our society. Despite important advances in pathogenesis, diagnosis and treatment, its primary causes still remain elusive, accurate biomarkers are not well characterized, and the available pharmacological treatments are not cost-effective. Alzheimer disease (AD), the most prevalent form of dementia, is a polygenic/multifactorial/complex disorder in which hundreds of defective genes distributed across the human genome may contribute to its pathogenesis. Diverse environmental factors, cerebrovascular dysfunction,...
Source: CNS and Neurological Disorders Drug Targets - February 2, 2016 Category: Drugs & Pharmacology Authors: Cacabelos R, Torrellas C, Carrera I, Cacabelos P, Corzo L, Fernández-Novoa L, Tellado I, Carril JC, Aliev G Tags: CNS Neurol Disord Drug Targets Source Type: research
Role of the FDA in Affordability of Off-Patent Pharmaceuticals
This Viewpoint maintains that the US Food and Drug Administration (FDA) should have a more active role in the approval and marketing of off-patent pharmaceutical products. (Source: JAMA)
Source: JAMA - February 2, 2016 Category: Journals (General) Source Type: research
ReCAP: Association Between the Number of Suppliers for Critical Antineoplastics and Drug Shortages: Implications for Future Drug Shortages and Treatment.
Abstract QUESTION ASKED: Cancer drug shortages remain common in the United States and may force oncologists to prioritize patients for treatment, improvise standard treatment regimens, and potentially choose unproven treatment options for patients with curable disease. Because increased competition may reduce drug shortages, the objective of our study was to investigate the association between the number of suppliers for first-line breast, colon, and lung antineoplastics and resulting drug shortages. SUMMARY ANSWER: Among 35 antineoplastic drugs approved for first-line treatment of breast, colon, and lung cance...
Source: JOP - February 2, 2016 Category: Gastroenterology Authors: Parsons HM, Schmidt S, Karnad AB, Liang Y, Pugh MJ, Fox ER, Parsons HM, Schmidt S, Karnad AB, Liang Y, Pugh MJ, Fox ER Tags: J Oncol Pract Source Type: research
Revisiting Essure—Toward Safe and Effective Sterilization
Obstet Gynecol Surv 2016;71(2):86–87 In 2002, a novel nonsurgical birth control implant, the Essure system, was fast tracked for Food and Drug Administration (FDA) approval. At that time, Essure was and has remained the only permanent birth control option for women other than tubal litigation, a major surgical procedure. (Source: Obstetrical and Gynecological Survey)
Source: Obstetrical and Gynecological Survey - February 1, 2016 Category: OBGYN Tags: Gynecology: Contraception Source Type: research
What is the Future of Open Intraperitoneal Power-Morcellation of Fibroids?
In November 2014, the Food and Drug Administration (FDA) calculated that for every 498 women having surgery for presumed fibroids, one woman would be found to have an occult leiomyosarcoma (LMS). The FDA issued a safety communication warning against the use of laparoscopic morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids. This communication was prompted by concern that if a patient had an occult LMS, the morcellator might spread tumor cells within the peritoneal cavity. We submit that the FDA directive was based on a flawed and misleading analysis. More rigorous evidence...
Source: Clinical Obstetrics and Gynecology - February 1, 2016 Category: OBGYN Tags: Modern Management of Fibroids Source Type: research
A droplet-based microfluidic immunosensor for high efficiency melamine analysis
We report a droplet-based microfluidic immunosensor for the rapid and accurate detection of melamine, an organic base that has been implicated in widescale adulteration of food products such as milk. Our melamine assay is based on the competitive reaction between native melamine and a melamine-fluorescein isothiocyanate (FITC) conjugate against an anti-hapten antibody. The adoption of fluorescence polarization, allows the quantification of melamine in a more direct and rapid manner than established heterogeneous methods based on liquid chromatography, mass spectrometry, and enzyme-linked immunosorbent assay (ELISA). The de...
Source: Biosensors and Bioelectronics - February 1, 2016 Category: Biotechnology Source Type: research
Oritavancin: A New Lipoglycopeptide Antibiotic in the Treatment of Gram-Positive Infections
Abstract Resistance among Gram-positive organisms has been steadily increasing over the last several years; however, the development of new antibiotics to treat infections caused from these organisms has fallen short of the emergent need. Specifically, resistance among Staphylococcus aureus and Enterococcus spp. to essential antibiotics is considered a major problem. Oritavancin is a semisynthetic lipoglycopeptide antibiotic that was recently approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI). While structurally related to vancomycin, oritavancin also possesses unique mechani...
Source: Infectious Diseases and Therapy - February 1, 2016 Category: Infectious Diseases Source Type: research
Medical Countermeasures for Children in Public Health Emergencies, Disasters, or Terrorism
Significant strides have been made over the past 10 to 15 years to develop medical countermeasures (MCMs) to address potential disaster hazards, including chemical, biological, radiologic, and nuclear threats. Significant and effective collaboration between the pediatric health community, including the American Academy of Pediatrics, and federal partners, such as the Office of the Assistant Secretary for Preparedness and Response, Centers for Disease Control and Prevention, Federal Emergency Management Agency, National Institutes of Health, Food and Drug Administration, and other federal agencies, over the past 5 years has...
Source: PEDIATRICS - February 1, 2016 Category: Pediatrics Authors: DISASTER PREPAREDNESS ADVISORY COUNCIL Tags: Disaster Preparedness From the American Academy of Pediatrics Source Type: research
Pelvic Organ Prolapse Surgery in Academic Female Pelvic Medicine and Reconstructive Surgery Urology Practice in the Setting of the Food and Drug Administration Public Health Notifications
To understand the effect of the FDA PHN's regarding TVM for POP on surgeon practice patterns in tertiary care academic medical centers. (Source: Urology)
Source: Urology - February 1, 2016 Category: Urology & Nephrology Authors: Austin Younger, Goran Rac, J. Quentin Clemens, Kathleen Kobashi, Aqsa Khan, Victor Nitti, Ilana Jacobs, Gary E. Lemack, Elizabeth T. Brown, Roger Dmochowski, Lara Maclachlan, Arthur Mourtzinos, David Ginsberg, Michelle Koski, Ross Rames, Eric Rovner Tags: Ambulatory, Office-based, and Geriatric Urology Source Type: research