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Strategies to Incorporate Left Atrial Appendage Occlusion Into Clinical Practice
The left atrial appendage (LAA) has been identified as a predominant source of thrombus formation leading to significant thromboembolic events in patients with nonvalvular atrial fibrillation. Medical therapy to eliminate thrombus formation in the LAA has been the standard of care for several decades, but mechanical approaches designed to exclude the LAA from the circulation have recently been developed. The largest body of randomized and nonrandomized data to date has been for the Watchman device (Boston Scientific, Natick, Massachusetts), which was recently approved by the Food and Drug Administration for selected patien...
Source: Journal of the American College of Cardiology: Cardiovascular Imaging - May 25, 2015 Category: Radiology Source Type: research

Voucher program advances development of drugs for rare pediatric diseases [FDA UPDATE]
(Source: AAP News)
Source: AAP News - May 25, 2015 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Rare Diseases Program/Office of New Drugs, Division of Pediatric and Maternal Health Tags: FDA Update, Pharmacology Source Type: research

Use of Robotics in Oncology Surgery.
Abstract Robotic surgery is a surgical procedure that adds a computer 
technology-enhanced device to the interaction between a surgeon and a patient during a surgical operation. This technology assumes a degree of control previously only reserved for the surgeon (Herron & Marohn, 2008). The surgeon sits at a console, typically in the operating room, directing and controlling the movements of one or more robotic arms. This technology has taken off in the United States during the past few years. Da Vinci® Surgical System, the leading robotic technology manufactured by Intuitive Surgical, Inc. (2014), has becom...
Source: Clinical Journal of Oncology Nursing - May 24, 2015 Category: Nursing Authors: Doyle-Lindrud S Tags: Clin J Oncol Nurs Source Type: research

Nursing Considerations for Patients With Sarcoma on Pazopanib Therapy.
Abstract BACKGROUND: Pazopanib was approved by the U.S. Food and Drug Administration for use in patients with soft tissue sarcoma (STS) in 2012. Because of the scarcity of effective treatments for advanced STS, pazopanib has become commonly prescribed. OBJECTIVES: The purpose of this study was to assess the knowledge level of nurses regarding the safe administration of pazopanib, as well as management of its side effects. The study was also intended to examine the consistency of patient education about pazopanib. METHODS: A 12-question online survey was completed by six nurses working in the outpatient sarc...
Source: Clinical Journal of Oncology Nursing - May 24, 2015 Category: Nursing Authors: Holland J, Flaherty C Tags: Clin J Oncol Nurs Source Type: research

A review on the analysis of ingredients with health care effects in health food in Taiwan
Publication date: Available online 22 May 2015 Source:Journal of Food and Drug Analysis Author(s): Pai-Wen Wu This review article discusses the analysis of ingredients with health care effects in health food in Taiwan. The top 10 items on the list of registered health food products up to 2014 in Taiwan are described, including monocolin K, ω-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid), β-glucans, inulin, catechism, oligosaccharides, resistant maltodextrin, amino acids, medium chain fatty acids, and polysaccharides. Some analytical methods for the analysis of ingredients with health care effects are a...
Source: Journal of Food and Drug Analysis - May 24, 2015 Category: Food Science Source Type: research

Considerations About Pollen Used for the Production of Allergen Extracts
This article provides an overview of the subject of pollen for use in allergen extracts. (Source: The Journal of Allergy and Clinical Immunology: In Practice)
Source: The Journal of Allergy and Clinical Immunology: In Practice - May 23, 2015 Category: Allergy & Immunology Source Type: research

Author reply
Thank you for the opportunity to respond to the letter by Drs Hashmonay and Parikh. The VIVID and VISTA studies were pivotal, US Food and Drug Administration registration-supporting studies of patients with diabetic macular edema comparing an anti-vascular endothelial growth factor (VEGF) agent (intravitreal aflibercept injection) head-to-head against laser therapy. The focus of the discussion in our recent paper1 was to compare our studies with the comparably designed, registration-supporting, pivotal studies of ranibizumab, namely, the RISE and RIDE studies2; there was no intention to overlook other studies. (Source: Ophthalmology)
Source: Ophthalmology - May 22, 2015 Category: Opthalmology Authors: David M. Brown, Jean-Francois Korobelnik, VISTA and VIVID study investigators Tags: Correspondence Source Type: research

Eruptive squamous cell carcinomas with keratoacanthoma‐like features in a patient treated with Ruxolitinib
This article is protected by copyright. All rights reserved. (Source: British Journal of Dermatology)
Source: British Journal of Dermatology - May 22, 2015 Category: Dermatology Authors: A. Fabiano, P. Calzavara Pinton, P. Monari, E. Moggio, G. Pellacani, A.M. Manganoni, G. Gualdi Tags: Correspondence Source Type: research

Reply
We appreciate your interest in our manuscript detailing the 2014 US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee Meeting regarding Cangrelor, which mirrored the meeting presentations, facts, and discussions. 1 (Source: The American Journal of Cardiology)
Source: The American Journal of Cardiology - May 22, 2015 Category: Cardiology Authors: Ron Waksman, Nevin C. Baker, Thibault Lhermusier Source Type: research

Should Pregnant Women be Included in Phase IV Clinical Drug Trials?
Relatively few drugs, especially those recently approved by the United States Food and Drug Administration (FDA), have published human pregnancy experience. Although all drugs contain animal reproduction data these are usually not predictive of human risk. Clinical trials in pregnant women are rarely conducted because of ethical and legal concerns and it may be many years before sufficient observational data are collected to guide clinical treatment decisions. Because many of these drugs will be used in pregnancy, human data are needed shortly after the drugs come to the market. (Source: American Journal of Obstetrics and Gynecology)
Source: American Journal of Obstetrics and Gynecology - May 22, 2015 Category: OBGYN Authors: Gerald G. Briggs, Janine E. Polifka, Katherine L. Wisner, Eric Gervais, Richard K. Miller, Anick Berard, Gideon Koren, Alicia Forinash, Craig V. Towers Source Type: research

Eruptive squamous cell carcinomas with keratoacanthoma-like features in a patient treated with Ruxolitinib.
This article is protected by copyright. All rights reserved. PMID: 25997466 [PubMed - as supplied by publisher] (Source: The British Journal of Dermatology)
Source: The British Journal of Dermatology - May 22, 2015 Category: Dermatology Authors: Fabiano A, Calzavara Pinton P, Monari P, Moggio E, Pellacani G, Manganoni AM, Gualdi G Tags: Br J Dermatol Source Type: research

Clinical implications of patient-provider agreements in opioid prescribing.
Abstract In June, 2012 the United States Food and Drug Administration (FDA) developed a "blueprint" for prescriber education as a means of directing Certified Medical Education (CME) activities that included content which would meet the regulatory requirements of the class-wide, longacting/ extended-release (LA-ER) opioid Risk Evaluation Mitigation Strategies (REMS). Within the blueprint is the suggested adoption of Patient-Provider Agreements (PPAs) to be used in association with opioid prescribing, but, to our knowledge, there have been no reported evaluations of the role played by opioid-agent PPAs in clinical p...
Source: Current Drug Safety - May 21, 2015 Category: Drugs & Pharmacology Authors: Kraus CN, Baldwin AT, Curro FA, McAllister RG Tags: Curr Drug Saf Source Type: research

PCSK9 Inhibitors and Neurocognitive Adverse Events: Exploring the FDA Directive and a Proposal for N -of-1 Trials
Abstract Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors are a novel class of medications that greatly lower low-density lipoprotein cholesterol (LDL-C) by upregulating LDL receptor availability. In early 2014, the US Food and Drug Administration (FDA) directed developers of PCSK9 inhibitors to monitor neurocognitive adverse effects and consider neurocognitive testing in at least a subset of participants in ongoing late-stage trials. Available trial evidence indicates that neurocognitive adverse events may occur more commonly in individuals receiving an antibody to PCSK9, but these events are unco...
Source: Drug Safety - May 20, 2015 Category: Drugs & Pharmacology Source Type: research

The efficacy of crizotinib in patients with ALK-positive nonsmall cell lung cancer
Molecular profiling of nonsmall cell lung cancer (NSCLC) contributes to better understanding the different molecular subtypes of this heterogeneous group of diseases. The discovery of oncogenic ALK rearrangements in NSCLC and the subsequent success in their therapeutic targeting with crizotinib reinforces the benefits of a precision approach to systemic anticancer therapy. In addition, the rapid development of crizotinib from first discovery thorough accelerated US Food and Drug Administration approval, and late stage confirmatory clinical trials, exemplifies the success of the drug development strategy of close collaborat...
Source: Therapeutic Advances in Respiratory Disease - May 19, 2015 Category: Respiratory Medicine Authors: Pender, A., Popat, S. Tags: Reviews Source Type: research

Emtricitabine/rilpivirine/tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults
This paper reviews the current literature and information on the combination drug Complera™ (rilpivirine/emtricitabine/tenofovir disoproxil fumarate) that was approved by the Food and Drug Administration (FDA) in August 2011.PubMed, Cochrane and Embase (2001–2014) were searched for primary and review articles on rilpivirine, emtricitabine, and tenofovir disoproxil fumarate, individually or in combination. Data from drug manufacturer and product label was also used. Clinical trial reports were selected, extracted and analyzed to include relevant and recent ones. (Source: Journal of Infection and Public Health)
Source: Journal of Infection and Public Health - May 19, 2015 Category: Global & Universal Authors: Wissam K. Kabbara, Wijdan H. Ramadan Tags: Review Source Type: research

Reversing resistance: The next generation antibacterials
Neel Jayesh ShahIndian Journal of Pharmacology 2015 47(3):248-255Irrational antibiotic usage has led to vast spread resistance to available antibiotics, but we refuse to slide back to "preantibiotic era." The threat is serious with the "Enterococcus, Staphylococcous, Klebsiella, Acinetobacter, Pseudomonas and Enterobacter" organisms causing nosocomial infections that are difficult to treat because of the production of extended spectrum β-lactamases, carbapenamases and metallo-β-lactamases. Facing us is a situation where soon multidrug resistance would have spread across the globe...
Source: Indian Journal of Pharmacology - May 18, 2015 Category: Drugs & Pharmacology Authors: Neel Jayesh Shah Source Type: research

Prevalence and Perioperative Outcomes of Off-Label Total Hip and Knee Arthroplasty in the United States, 2000–2010
“Off-label use” refers to medical device utilization for purposes or subpopulations other than those approved by the United States Food and Drug Administration. The primary goal of this study was to determine the current epidemiology of off-label total hip and knee arthroplasty (THA and TKA, respectively) in the United States and to project further off-label use through 2040. Over the past decade, the prevalence of off-label THA and TKA was 30.4% and 37.0%, respectively, growing ~70% from 2000 – 2010. (Source: The Journal of Arthroplasty)
Source: The Journal of Arthroplasty - May 18, 2015 Category: Orthopaedics Authors: Tennison Malcolm, Caleb R. Szubski, Nicholas K. Schiltz, Alison K. Klika, Siran M. Koroukian, Wael K. Barsoum Source Type: research

Endoscopic Treatment of Gastroesophageal Reflux Disease.
Abstract Multiple new endoluminal devices and therapies have been devised to create a more effective antireflux barrier in patients with gastroesophageal reflux disease (GERD). Most of these therapies have been abandoned, because they were ineffective and/or had significant adverse effects. However, there are currently two therapies (Stretta, EsophyX) that have US Food and Drug Administration approval and continue to be used in select patients with GERD. The clinical management of GERD, disease complications, endoluminal techniques, evidence for efficacy, and controversies concerning endoluminal therapy for GERD ar...
Source: The Surgical Clinics of North America - May 15, 2015 Category: Surgery Authors: Hummel K, Richards W Tags: Surg Clin North Am Source Type: research

Anything to Stay Alive: The Challenges of a Campaign for an Experimental Drug
Abstract Drug‐resistant tuberculosis (TB) has a high mortality rate. Most medicines used to treat it are poorly tested and have terrible side effects. Activists have campaigned for patients with drug‐resistant TB to have access to experimental drugs, particularly one called bedaquiline, before these have been approved by regulatory authorities such as the Food and Drug Administration (FDA) in the United States (US) and the Medicines Control Council (MCC) in South Africa. Some activists have also campaigned for bedaquiline to be approved by regulatory authorities before testing of the drug is completed. These campaigns ...
Source: Developing World Bioethics - May 15, 2015 Category: Medical Ethics Authors: Nathan Geffen Tags: Original Article Source Type: research

Watching, but not waiting: vascular neurology perspective on the disparate regulatory pathways for stroke
Vascular neurologists have keenly watched the Watchman device (Atritech, Plymouth, Minnesota, USA) regulatory approval process. We are, as always, searching for additional options in the prevention and treatment of stroke to better care for our patients, and new approaches to the management of atrial fibrillation play a large part in this effort. Recently, a Food and Drug Administration (FDA) panel voted 13:1 in favor of the Watchman device for the prevention of ischemic stroke in non-valvular atrial fibrillation.1 The panelists came to this decision after reviewing data from large randomized trials that compared anticoagu...
Source: Journal of NeuroInterventional Surgery - May 14, 2015 Category: Neurosurgery Authors: Sheth, S. A., Nogueira, R. G., Noorian, A. R., Liebeskind, D. S. Tags: Editorials Source Type: research

Antifibrotic Therapies in the Liver
Semin Liver Dis 2015; 35: 184-198DOI: 10.1055/s-0035-1550055Significant progress has been made in understanding the principles underlying the development of liver fibrosis. This includes appreciating its dynamic nature, the importance of active fibrolysis in fibrosis regression, and the plasticity of cell populations endowing them with fibrogenic or fibrolytic properties. This is complemented by an increasing array of therapeutic targets with known roles in the progression or regression of fibrosis. With a key role for fibrosis in determining clinical outcomes and encouraging data from recently Food and Drug Administration...
Source: Seminars in Liver Disease - May 14, 2015 Category: Gastroenterology Authors: Mehal, W. Z.Schuppan, D. Source Type: research

Breast‐implant‐associated anaplastic large cell lymphoma in a patient with Li‐Fraumeni syndrome
This article is protected by copyright. All rights reserved. (Source: Histopathology)
Source: Histopathology - May 14, 2015 Category: Pathology Authors: Yi‐Shan Lee, Armando Filie, Diane Arthur, Antonio T. Fojo, Elaine S. Jaffe Tags: Correspondence Source Type: research

A survey of neonatal pharmacokinetic and pharmacodynamic studies in pediatric drug development.
This article is protected by copyright. All rights reserved. PMID: 25975723 [PubMed - as supplied by publisher] (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - May 14, 2015 Category: Drugs & Pharmacology Authors: Wang J, Avant D, Green D, Seo S, Fisher J, Mulberg AE, McCune SK, Burckart GJ Tags: Clin Pharmacol Ther Source Type: research

Current methods for the synthesis of homogeneous antibody-drug conjugates.
Abstract Development of efficient and safe cancer therapy is one of the major challenges of the modern medicine. Over the last few years antibody-drug conjugates (ADCs) have become a powerful tool in cancer treatment with two of them, Adcetris® (brentuximab vedotin) and Kadcyla® (ado-trastuzumab emtansine), having recently been approved by the Food and Drug Administration (FDA). Essentially, an ADC is a bioconjugate that comprises a monoclonal antibody that specifically binds tumor surface antigen and a highly potent drug, which is attached to the antibody via either cleavable or stable linker. This approach ensu...
Source: Biotechnology Advances - May 14, 2015 Category: Biotechnology Authors: Sochaj AM, Świderska KW, Otlewski J Tags: Biotechnol Adv Source Type: research

Homozygous autosomal dominant hypercholesterolaemia: prevalence, diagnosis, and current and future treatment perspectives
Purpose of review: Homozygous autosomal dominant hypercholesterolemia (hoADH) is a rare genetic disorder caused by mutations in LDL receptor, apolipoprotein B, and/or proprotein convertase subtilisin-kexin type 9. Both the genetic mutations and the clinical phenotype vary largely among individual patients, but patients with hoADH are typically characterized by extremely elevated LDL-cholesterol (LDL-C) levels, and a very high-risk for premature cardiovascular disease. Current lipid-lowering therapies include bile acid sequestrants, statins, and ezetimibe. To further decrease LDL-C levels in hoADH, lipoprotein apheresis is ...
Source: Current Opinion in Lipidology - May 12, 2015 Category: Lipidology Tags: LIPID METABOLISM: Edited by Kausik K. Ray and G. Kees Hovingh Source Type: research

Spectacle‐related eye injuries, spectacle‐impact performance and eye protection
The aim was to review the prevalence of spectacle‐related ocular trauma and the performance of currently available spectacle materials and to identify the risk factors associated with spectacle‐related ocular trauma. A literature review was conducted using Medline, Embase and Google with the keywords ‘eyeglasses’ OR ‘spectacles’ AND ‘ocular injury’ / ‘eye injury’/ ‘eye trauma’ / ‘ocular trauma’. Articles published prior to 1975 were excluded from this review because of advances in spectacle lens technology and Food and Drug Administration legislative changes requiring impact resistance of all pr...
Source: Clinical and Experimental Optometry - May 12, 2015 Category: Opthalmology Authors: Annette K Hoskin, Swetha Philip, Stephen J Dain, David A Mackey Tags: Review Source Type: research

CT staging and monitoring of fibrotic interstitial lung diseases in clinical practice and treatment trials: a Position Paper from the Fleischner society
Publication date: Available online 11 May 2015 Source:The Lancet Respiratory Medicine Author(s): David M Hansell , Jonathan G Goldin , Talmadge E King Jr , David A Lynch , Luca Richeldi , Athol U Wells CT is increasingly being used to stage and quantify the extent of diffuse lung diseases both in clinical practice and in treatment trials. The role of CT in the assessment of patients entering treatment trials has greatly expanded as clinical researchers and pharmaceutical companies have focused their efforts on developing safe and effective drugs for interstitial lung diseases, particularly for idiopathic pulmonary fibros...
Source: The Lancet Respiratory Medicine - May 12, 2015 Category: Respiratory Medicine Source Type: research

Daily left prefrontal repetitive transcranial magnetic stimulation for medication-resistant burning mouth syndrome
Burning mouth syndrome (BMS) is a persistent and chronic burning sensation in the mouth in the absence of any abnormal organic findings. The pathophysiology of BMS is unclear and its treatment is not fully established. Although antidepressant medication is commonly used for treatment, there are some medication-resistant patients, and a new treatment for medication-resistant BMS is needed. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technology approved by the US Food and Drug Administration (FDA) for the treatment of depression. (Source: International Journal of Oral and Maxillofacial Surgery)
Source: International Journal of Oral and Maxillofacial Surgery - May 12, 2015 Category: ENT & OMF Authors: Y. Umezaki, B.W. Badran, T.S. Gonzales, M.S. George Tags: Case Report Source Type: research

Persistent dilemmas in zoster eye disease.
Abstract Herpes zoster ophthalmicus (HZO) is a common, vision and potentially life-threatening disease caused by the reactivation of the varicella-zoster virus (VZV) in the distribution of the first division of cranial nerve V. Although the rate of herpes zoster increases with age, over half of the people with zoster in general, including HZO, are under age 60. In addition, over 90% of people with zoster are immunocompetent, even though the disease is more common and severe in immunocompromised patients. The incidence of zoster is increasing worldwide for unknown reasons. The epidemiology has not yet been impacted ...
Source: The British Journal of Ophthalmology - May 12, 2015 Category: Opthalmology Authors: Cohen EJ, Kessler J Tags: Br J Ophthalmol Source Type: research

On Chlorofluorocarbon Bans and Inhaled Albuterol Prices
The competing concerns and interests of both individuals and society must be considered when establishing regulatory policy. In 2008, the US Food and Drug Administration (FDA) banned albuterol inhalers containing chlorofluorocarbons. This decision was questioned at the time because the chlorofluorocarbons emitted from inhalers have an insignificant effect on ozone and because of the anticipated costs of transitioning to hydrofluoroalkane inhalers for patients with respiratory disease. With the ban, generically manufactured chlorofluorocarbon inhalers were discontinued, leaving only branded hydrofluoroalkane inhalers availa...
Source: JAMA Internal Medicine - May 11, 2015 Category: Internal Medicine Source Type: research

How Did Multiple FDA Actions Affect the Utilization and Reimbursed Costs of Thiazolidinediones in US Medicaid?
This study examined the effects of these multiple FDA actions on utilization and reimbursed costs of thiazolidinediones in state Medicaid programs. METHODS: State Drug Utilization Data from the Centers for Medicare & Medicaid Services were assessed. An interrupted time series design and segmented linear regression models were used to examine changes in market shares according to both prescription volume and reimbursed costs for rosiglitazone and pioglitazone in the Northeast and Midwest regions of the United States after multiple FDA actions. FINDINGS: Compared with expected rates, there were relative reduction...
Source: Clinical Therapeutics - May 11, 2015 Category: Drugs & Pharmacology Authors: Hsu JC, Ross-Degnan D, Wagner AK, Zhang F, Lu CY Tags: Clin Ther Source Type: research

Analysis of the Interaction between Clopidogrel, Aspirin, and Proton Pump Inhibitors Using the FDA Adverse Event Reporting System Database.
The objective of this study was to analyze the effect of the simultaneous use of clopidogrel, aspirin, and PPIs on hemorrhagic and embolic/thrombotic events using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Reports of hemorrhagic and embolic/thrombotic events between 2004 and 2013 were analyzed with a reporting odds ratio (ROR) algorithm and logistic regression methods. The Medical Dictionary for Regulatory Activities Preferred Terms was used to identify such events. Regarding hemorrhagic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those o...
Source: Biological and Pharmaceutical Bulletin - May 9, 2015 Category: Drugs & Pharmacology Authors: Suzuki Y, Suzuki H, Umetsu R, Uranishi H, Abe J, Nishibata Y, Sekiya Y, Miyamura N, Hara H, Tsuchiya T, Kinosada Y, Nakamura M Tags: Biol Pharm Bull Source Type: research

Endoscopic Treatment of Gastroesophageal Reflux Disease
Multiple new endoluminal devices and therapies have been devised to create a more effective antireflux barrier in patients with gastroesophageal reflux disease (GERD). Most of these therapies have been abandoned, because they were ineffective and/or had significant adverse effects. However, there are currently two therapies (Stretta, EsophyX) that have US Food and Drug Administration approval and continue to be used in select patients with GERD. The clinical management of GERD, disease complications, endoluminal techniques, evidence for efficacy, and controversies concerning endoluminal therapy for GERD are reviewed and di...
Source: Surgical Clinics of North America - May 9, 2015 Category: Surgery Authors: Kristin Hummel, William Richards Source Type: research

Clinical Pharmacokinetic and Pharmacodynamic Profile of Lacosamide
Abstract Lacosamide—a third-generation antiepileptic drug available in multiple formulations—was first approved in 2008 as adjunctive therapy for partial-onset seizures (POS) in adults. In 2014, lacosamide was approved as monotherapy for POS by the US Food and Drug Administration (FDA). A loading dose administration was approved in 2013 by the European Medicines Agency and in 2014 by the FDA. Unlike traditional sodium channel blockers affecting fast inactivation, lacosamide selectively enhances sodium channel slow inactivation. This mechanism of action results in stabilization of hyperexcitable neuronal membra...
Source: Clinical Pharmacokinetics - May 8, 2015 Category: Drugs & Pharmacology Source Type: research

Failure of interleukin 13 blockade in ulcerative colitis
Contrary to a decade ago, clinical development in ulcerative colitis (UC) has become highly active with multiple promising innovative assets currently in early and late phase clinical studies. The anti-integrin α4β7 monoclonal antibody vedolizumab has been leading this wave, and has received marketing authorisation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) based on an excellent efficacy and safety record. One of the targets that had raised high hopes several years ago was interleukin 13 (IL-13), together with IL-4 and IL-5 the signature cytokine of a T helper 2 (Th2) im...
Source: Gut - May 8, 2015 Category: Gastroenterology Authors: Tilg, H., Kaser, A. Tags: Commentary Source Type: research

Use of Pharmacogenomics and Biomarkers in the Development of New Drugs for Alzheimer Disease in Japan.
Abstract PURPOSE: Pharmacogenomics (PGx) and biomarkers have been utilized for improving the benefit/risk ratios of drugs and the efficiency of drug development. In the development of drugs for Alzheimer disease (AD), a number of clinical trials have failed to demonstrate clinical efficacy. To overcome this circumstance, the importance of using PGx/biomarkers for enhancing recruitment into clinical trials and for evaluating the efficacy of treatments has been increasingly recognized. In this article, the current status and examples of the use of PGx/biomarkers in Japan for drug development are explained. METHOD...
Source: Clinical Therapeutics - May 8, 2015 Category: Drugs & Pharmacology Authors: Otsubo Y Tags: Clin Ther Source Type: research

Final Guidance Issued on Abuse-Deterrent Opioids
The Food and Drug Administration (FDA) has issued a final guidance document to provide manufacturers with a framework for evaluating and labeling abuse-deterrent opioids. Congress had threatened to cut the FDA commissioner’s budget by $20 million if the agency did not finalize its January 2013 draft document by June 30 (http://1.usa.gov/1NKgeFl). (Source: JAMA)
Source: JAMA - May 5, 2015 Category: Journals (General) Source Type: research

New Anthrax Treatment Approved
The Food and Drug Administration (FDA) has approved a new treatment for inhalational anthrax. (Source: JAMA)
Source: JAMA - May 5, 2015 Category: Journals (General) Source Type: research

Warning for Hepatitis C Treatments Given With Amiodarone
Life-threatening symptomatic bradycardia can occur when the antiarrhythmia drug amiodarone is taken with either of 2 hepatitis C treatments containing sofosbuvir in combination with another direct-acting antiviral drug, the Food and Drug Administration (FDA) has warned (http://1.usa.gov/1xBtd8o). (Source: JAMA)
Source: JAMA - May 5, 2015 Category: Journals (General) Source Type: research

Medical devices; physical medicine devices; classification of the powered lower extremity exoskeleton; republication. Final order; republication.
Abstract The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled ``Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton'' that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered lower extremity exoskeleton's classi...
Source: Fed Regist - May 4, 2015 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

RP-HPLC method development for the simultaneous determination of timolol maleate and human serum albumin in albumin nanoparticles
Publication date: 10 July 2015 Source:Journal of Pharmaceutical and Biomedical Analysis, Volume 111 Author(s): Carolina Boiero , Daniel Allemandi , Marcela Longhi , Juan M. Llabot An isocratic high-performance liquid chromatographic method was developed and validated for the simultaneous determination of human serum albumin (HSA) and timolol in albumin nanoparticles. This method involved a reversed-phase-C18 column thermostated at 25°C, UV detection at 276nm, flow rate of 1.0ml/min and a mobile phase compounded by 0.05% (v/v) trifluoroacetic acid in water/0.05% (v/v) trifluoroacetic acid in an acetonitrile (40:60, v/v) ...
Source: Journal of Pharmaceutical and Biomedical Analysis - May 3, 2015 Category: Drugs & Pharmacology Source Type: research

[Correspondence] Informed use of bedaquiline for tuberculosis
In their Viewpoint (Jan 31, p 477),1 Laia Ruiz Mingote and colleagues highlight the urgent need for additional safety data on bedaquiline, the first new tuberculosis drug to receive US Food and Drug Administration (FDA) approval in more than 40 years. Because the drug received accelerated approval based solely on phase 2 studies, critical safety data for bedaquiline are incomplete. In view of the scarcity of data, increased mortality in the bedaquiline group of one phase 2 trial, and public health importance of the drug, the FDA's accelerated approval required that a patient registry be set up to assess serious adverse eve...
Source: LANCET - May 1, 2015 Category: Journals (General) Authors: Erica M Lessem, John Bernardo, Caitlin Reed, Donna H Wegener Tags: Correspondence Source Type: research

What are the comparative benefits and harms of augmentation treatments in major depression?
Authors: Shelton RC Abstract The majority of depressed patients do not experience sufficient response to their initial antidepressant medication. Augmentation strategies, particularly the use of atypical antipsychotics to augment selective serotonin reuptake inhibitors (SSRIs), have proliferated over the last 15 years, and 2 atypical antipsychotics, aripiprazole and quetiapine, have received US Food and Drug Administration approval for adjunctive therapy in treatment-resistant depression. Alternatively, data in treatment-resistant depression exist for most of the atypicals and for other treatments, including lithiu...
Source: Journal of Clinical Psychiatry - May 1, 2015 Category: Psychiatry Tags: J Clin Psychiatry Source Type: research

Transdermal Buprenorphine, Opioid Rotation to Sublingual Buprenorphine, and the Avoidance of Precipitated Withdrawal: A Review of the Literature and Demonstration in Three Chronic Pain Patients Treated With Butrans
We present a case series of a novel method of sublingual buprenorphine introduction without an induction period, using the recently Food and Drug Administration-approved low-dose transdermal buprenorphine (Butrans; Purdue Pharma L.P.) as a bridge medication. In these cases, buprenorphine was started in opioid-dependent chronic noncancer pain patients who had taken short-acting opioid medications within hours of the initiation of the rotation. This method avoids the painful abstinence period and did not result in precipitated withdrawal or other significant adverse effects. (Source: American Journal of Therapeutics)
Source: American Journal of Therapeutics - May 1, 2015 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

A Case Report of Orbital Inflammatory Syndrome Secondary to Ipilimumab
Ipilimumab is a monoclonal antibody to cytotoxic T-lymphocyte antigen-4, a negative regulator of T-cell–mediated immune response. Ipilimumab is approved by the US Food and Drug Administration for the treatment of advanced melanoma. However, its use frequently has been associated with immune-related side effects, which can be explained by its mechanism of action. More common adverse effects include dermatitis, colitis, hepatitis, and endocrinopathies, but many less common immune-related adverse effects that involve various tissues and organ systems have been reported with more widespread use of ipilimumab since its approv...
Source: Ophthalmic Plastic and Reconstructive Surgery - May 1, 2015 Category: Opthalmology Tags: Case Reports Source Type: research

Novel Oral Anticoagulants: Efficacy, Laboratory Measurement, and Approaches to Emergent Reversal.
Abstract Warfarin, the most commonly used of the vitamin K antagonists, has been a mainstay of oral anticoagulation for decades. However, its usage is limited by morbidity and mortality secondary to bleeding as well as a cumbersome therapeutic monitoring process. In the past several years, a number of competing novel oral anticoagulants (NOACs) have been developed, each of which aspires to match or exceed warfarin's effectiveness while mitigating bleeding risk and eliminating therapeutic monitoring requirements. At present, 1 oral direct thrombin inhibitor and 2 direct factor Xa inhibitors are approved by the US Fo...
Source: Archives of Pathology and Laboratory Medicine - May 1, 2015 Category: Laboratory Medicine Authors: Gehrie E, Tormey C Tags: Arch Pathol Lab Med Source Type: research

Emerging treatments in Neurogastroenterology: Perspectives of guanylyl cyclase C agonists use in functional gastrointestinal disorders and inflammatory bowel diseases
Abstract BackgroundFunctional gastrointestinal disorders (FGID) and inflammatory bowel diseases (IBD) are the most frequent pathologic conditions affecting the gastrointestinal (GI) tract and both significantly reduce patients’ quality of life. Recent studies suggest that guanylyl cyclase C (GC‐C) expressed in the GI tract constitutes a novel pharmacological target in the treatment of FGID and IBD. Endogenous GC‐C agonists – guanylin peptides: guanylin and uroguanylin, by the regulation of water and electrolyte transport, are involved in the maintenance of homeostasis in the intestines and integrity of the intestin...
Source: Neurogastroenterology and Motility - May 1, 2015 Category: Gastroenterology Authors: A. Jarmuż, M. Zielińska, M. Storr, J. Fichna Tags: Review Article Source Type: research

The Development or Exacerbation of Eating Disorder Symptoms After Topiramate Initiation
The Food and Drug Administration recently approved topiramate for migraine prevention in adolescents. Given the well-established appetite-suppressant side effects of topiramate, as well as data suggesting a potential comorbidity between migraine and eating disorders, susceptible young migraine patients may be at a greater risk for the development or worsening of eating disorder symptoms with topiramate therapy. This case series comprises 7 adolescent patients in whom serious eating disorders developed or were exacerbated after the initiation of topiramate therapy. Clinical characteristics of these patients are highlighted....
Source: PEDIATRICS - May 1, 2015 Category: Pediatrics Authors: Lebow, J., Chuy, J. A., Cedermark, K., Cook, K., Sim, L. A. Tags: Case Report Source Type: research

OARSI Clinical Trials Recommendations: An abbreviated regulatory guide to the clinical requirements for development of therapeutics in osteoarthritis
In this brief abbreviated review of regulatory issues regarding the development of drugs and or devices for the treatment of osteoarthritis (OA), the steps that are expected by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are discussed. (Source: Osteoarthritis and Cartilage)
Source: Osteoarthritis and Cartilage - May 1, 2015 Category: Rheumatology Authors: L.S. Simon Tags: Review Source Type: research

Sufficiency of Information in 510(k) Summaries
To the Editor In their report on the lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices, Zuckerman and colleagues create a misleading impression of the evaluation of class II implants by the US Food and Drug Administration (FDA). Although the data are accurate, an understanding of the intricacies of device regulation is required to judge the agency’s performance. (Source: JAMA Internal Medicine)
Source: JAMA Internal Medicine - May 1, 2015 Category: Internal Medicine Source Type: research