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Three Newly Approved Drugs for Chronic Lymphocytic Leukemia: Incorporating Ibrutinib, Idelalisib, and Obinutuzumab into Clinical Practice
Publication date: Available online 19 February 2015 Source:Clinical Lymphoma Myeloma and Leukemia Author(s): David S. Sanford , William G. Wierda , Jan A. Burger , Michael J. Keating , Susan M. O'Brien Three agents have received Food and Drug Administration (FDA) approval for treatment of chronic lymphocytic leukemia (CLL) within the past year. Ibrutinib and idelalisib block B-cell receptor signaling through inhibition of Bruton tyrosine kinase and phosphatidylinositol 3-kinase δ molecules respectively, interfering with several pathways required for leukemia cell survival. Idelalisib has shown efficacy in the relapsed s...
Source: Clinical Lymphoma Myeloma and Leukemia - March 28, 2015 Category: Cancer & Oncology Source Type: research

Endoscopic bariatric therapies
The ASGE Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the identified studies. (Source: Gastrointestinal Endoscopy)
Source: Gastrointestinal Endoscopy - March 28, 2015 Category: Gastroenterology Authors: ASGE Bariatric Endoscopy Task Force And ASGE Technology Committee, Barham K. Abu Dayyeh, Steven A. Edmundowicz, Sreenivasa Jonnalagadda, Nitin Kumar, Michael Larsen, Shelby Sullivan, Christopher C. Thompson, Subhas Banerjee Tags: Status evaluation report Source Type: research

(419) Analysis of adverse events of interest reported to the FDA before and after the introduction of abuse deterrent formulation of extended-release oxycodone (OxyContin)
Abuse deterrent formulations (ADFs) of opioids are intended to reduce prescription misuse and abuse that can lead to overdose and death. OxyContin, the first US Food and Drug Administration (FDA)-approved ADF, was introduced in 2010. This analysis examined spontaneous adverse events (AEs) reported involving only the brand name product (OxyContin) from the FDA Adverse Event Reporting System dataset from 8/1/07 through 7/31/13, the 3 years pre- and post-introduction of the new formulation. Preferred terms comprised 3 areas of interest: 1) death and possible fatality; 2) abuse, misuse, and diversion; and 3) efficacy and toler...
Source: The Journal of Pain - March 27, 2015 Category: Materials Science Authors: J. Hoegi, A. Maiers, E. Smith, B. Galer, A. Gammaitoni Source Type: research

Use of 9-Valent Human Papillomavirus (HPV) Vaccine: Updated HPV Vaccination Recommendations of the Advisory Committee on Immunization Practices.
This report summarizes evidence considered by ACIP in recommending 9vHPV as one of three HPV vaccines that can be used for vaccination and provides recommendations for vaccine use. PMID: 25811679 [PubMed - as supplied by publisher] (Source: MMWR Morb Mortal Wkl...)
Source: MMWR Morb Mortal Wkl... - March 27, 2015 Category: Epidemiology Authors: Petrosky E, Bocchini JA, Hariri S, Chesson H, Curtis CR, Saraiya M, Unger ER, Markowitz LE Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Bronchiectasis: which antibiotics to use and when?
Purpose of review: In 2010, the British Thoracic Society published a guideline for the care of patients with noncystic fibrosis (non-CF) bronchiectasis; other recent clinical review articles and original scientific manuscripts have also studied the use of antibiotics in bronchiectasis. This review will summarize the current literature on the indications and options for antibiotic treatment in bronchiectasis. Recent findings: Since 2012, a number of manuscripts have been published that provide evidence to support the use of antibiotics in non-CF bronchiectasis, including macrolide antibiotics, inhaled aminoglycosides and in...
Source: Current Opinion in Pulmonary Medicine - March 26, 2015 Category: Respiratory Medicine Tags: INFECTIOUS DISEASES: Edited by Alimuddin Zumla and Michael S. Niederman Source Type: research

Acetylation of rice starch in an aqueous medium for use in food
The objective of this work was to evaluate the effects of the acetic anhydride concentration, in an aqueous solution, on the degree of acetylation, in physical, thermal, pasting and morphological properties, and enzymatic susceptibility on rice starch acetylated with the acetyl groups' percentage up to 2.5 g/100g. The rice starch was acetylated using different concentrations of acetic anhydride (5 g/100g, 10 g/100g and 20 g/100g, starch db). Acetylation increased the peak viscosity, breakdown, final viscosity, retrogradation and pasting temperature and reduced the hardness of the gels, as well as their adhesiveness and...
Source: LWT Food Science and Technology - March 26, 2015 Category: Food Science Source Type: research

Surgical Energy-Based Device Injuries and Fatalities Reported to the Food and Drug Administration
Energy-based device adverse events fit 4 major patterns of injury: thermal burns, failure to seal, mechanical failure, and fire. (Source: Journal of the American College of Surgeons)
Source: Journal of the American College of Surgeons - March 26, 2015 Category: Surgery Authors: Douglas M. Overbey, Nicole T. Townsend, Brandon C. Chapman, Daine T. Bennett, Lisa S. Foley, Aline S. Rau, Jeniann A. Yi, Edward L. Jones, Greg V. Stiegmann, Thomas N. Robinson Source Type: research

Antiarrhythmic Properties of Ranolazine: A Review of the Current Evidence
Ranolazine was developed as an antianginal agent and was approved by the Food and Drug Administration in 2006 for use in chronic stable angina pectoris. Experimental and clinical studies have shown that it also has antiarrhythmic properties based on the frequency-dependent blockade of peak sodium channel current (peak INa) and rapidly activating delayed rectifier potassium current (IKr) in the atria and blockade of late phase of the inward sodium current (late INa) in the ventricles. Recent clinical studies have revealed the efficacy of ranolazine in prevention of atrial fibrillation in patients with acute coronary syndrom...
Source: International Journal of Cardiology - March 25, 2015 Category: Cardiology Authors: Tanush Gupta, Sahil Khera, Dhaval Kolte, Wilbert S. Aronow, Sei Iwai Tags: Review Source Type: research

Is there a Role for Bevacizumab in Non-Glial Tumors?
Abstract Angiogenesis is one of the hallmarks of cancer, including brain tumors. The vascular endothelial growth factor (VEGF) family and their receptors are of utmost importance in the complex interaction between pro- and anti-angiogenic factors, and have a crucial role in tumor angiogenesis. Up to date, targeting the VEGF pathway with specific drugs has yielded interesting results in oncology. In particular bevacizumab (Bev), a humanized monoclonal antibody against VEGF-A, has been approved by the Food and Drug Administration (FDA) for use in recurrent glioblastomas failing standard radio-chemotherapy. Bevacizuma...
Source: Current Drug Targets - March 25, 2015 Category: Drugs & Pharmacology Authors: Trevisan E Tags: Curr Drug Targets Source Type: research

Inhaled Technosphere Insulin: A Novel Delivery System and Formulation for the Treatment of Types 1 and 2 Diabetes Mellitus
Complications from uncontrolled diabetes mellitus were reduced significantly with the introduction of insulin more than 90 years ago. Despite the proven benefits of normal glycemic levels, patients are deterred by the inconvenience and perceived pain related to multiple daily subcutaneous insulin injections. Inhaled insulin was first approved by the U.S. Food and Drug Administration (FDA) in 2006, but because profit margins did not achieve expectations, the drug manufacturer discontinued sales 2 years later. The second‐generation inhaled insulin, developed with Technosphere technology, received FDA approval in 2014. The...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - March 24, 2015 Category: Drugs & Pharmacology Authors: Anne J. Kugler, Kristin L. Fabbio, David Q. Pham, Daniel A. Nadeau Tags: Reviews of Therapeutics Source Type: research

Breakthrough Seizures after Starting Vilazodone for Depression
We describe a 22‐year‐old woman with a history of seizure disorder who had been seizure free for the previous 8 years and experienced two breakthrough seizures shortly after starting vilazodone. Her dose of vilazodone had recently been titrated to 40 mg/day when she experienced the first seizure. She was instructed to taper vilazodone over the next several days, then discontinue the drug, and then follow up with her neurologist. Based on the patient's history, physical examination, and recent dose increase, it was plausible that vilazodone was the cause of the seizures. Use of the Naranjo adverse drug reaction probab...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - March 24, 2015 Category: Drugs & Pharmacology Authors: James McKean, Hannah Watts, Robert Mokszycki Tags: Case Report Source Type: research

New Drug Approved to Treat Metastatic Breast Cancer
The US Food and Drug Administration (FDA) has granted accelerated approval for the cyclin-dependent kinase (4/6) inhibitor palbociclib, or Ibrance, to be used in combination with letrozole for the treatment of postmenopausal women who have estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer and who have not yet received an endocrine-based therapy. Continued approval for this indication may be contingent on positive results from a confirmatory phase 3 trial, PALOMA-2, which is now fully enrolled. (Source: JAMA)
Source: JAMA - March 24, 2015 Category: Journals (General) Source Type: research

Predicting Vaccination Intention and Benefit and Risk Perceptions: The Incorporation of Affect, Trust, and Television Influence in a Dual‐Mode Model
Major health behavior change models tend to consider health decisions as primarily resulting from a systematic appraisal of relevant beliefs, such as the perceived benefits and risks of a pharmacological intervention. Drawing on research from the disciplines of risk management, communication, and psychology, this study proposed the inclusion of a heuristic route in established theory and tested the direction of influence between heuristic and systematic process variables. Affect and social trust were included as key heuristics in the proposed dual‐mode framework of health decision making. Furthermore, exposure to health...
Source: Risk Analysis - March 24, 2015 Category: Global & Universal Authors: Nien‐Tsu Nancy Chen Tags: Original Research Article Source Type: research

Insulin Pump Risks and Benefits: A Clinical Appraisal of Pump Safety Standards, Adverse Event Reporting, and Research Needs: A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group
Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error, or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe...
Source: Diabetes Care - March 24, 2015 Category: Endocrinology Authors: Heinemann, L.; Fleming, G. A.; Petrie, J. R.; Holl, R. W.; Bergenstal, R. M.; Peters, A. L. Tags: Scientific Statement Source Type: research

Amounts of Artificial Food Dyes and Added Sugars in Foods and Sweets Commonly Consumed by Children
Artificial food colors (AFCs) are used to color many beverages, foods, and sweets in the United States and throughout the world. In the United States, the Food and Drug Administration (FDA) limits the AFCs allowed in the diet to 9 different colors. The FDA certifies each batch of manufactured AFCs to guarantee purity and safety. The amount certified has risen from 12 mg/capita/d in 1950 to 62 mg/capita/d in 2010. Previously, we reported the amounts of AFCs in commonly consumed beverages. In this article, the amounts of AFCs in commonly consumed foods and sweets are reported. In addition, the amount of sugars in each produc...
Source: Clinical Pediatrics - March 23, 2015 Category: Pediatrics Authors: Stevens, L. J., Burgess, J. R., Stochelski, M. A., Kuczek, T. Tags: Commentaries Source Type: research

Direct-to-consumer genomics on the scales of autonomy
Direct-to-consumer (DTC) genetic services have generated enormous controversy from their first emergence. A dramatic recent manifestation of this is the Food and Drug Administration's (FDA) cease and desist order against 23andMe, the leading provider in the market. Critics have argued for the restrictive regulation of such services, and even their prohibition, on the grounds of the harm they pose to consumers. Their advocates, by contrast, defend them as a means of enhancing the autonomy of those same consumers. Autonomy emerges as a key battle-field in this debate, because many of the ‘harm’ arguments can be i...
Source: Journal of Medical Ethics - March 23, 2015 Category: Medical Ethics Authors: Vayena, E. Tags: Open access Genetics Source Type: research

Stroke Mimics and Acute Stroke Evaluation: Clinical Differentiation and Complications after Intravenous Tissue Plasminogen Activator
Intravenous tissue-plasminogen activator remains the only U.S. Food and Drug Administration-approved treatment for acute ischemic stroke. Timely administration of fibrinolysis is balanced with the need for accurate diagnosis. Stroke mimics represent a heterogeneous group of patients presenting with acute-onset focal neurological deficits. If these patients arrive within the extended time window for acute stroke treatment, these stroke mimics may erroneously receive fibrinolytics. (Source: The Journal of Emergency Medicine)
Source: The Journal of Emergency Medicine - March 22, 2015 Category: Emergency Medicine Authors: Peggy L. Nguyen, Jason J. Chang Tags: Clinical Review Source Type: research

K + larity for Spironolactone At Last!
Spironolactone was approved by the US Food and Drug Administration (FDA) 30 years ago for several noncutaneous conditions, such as congestive heart failure. It acts as an aldosterone antagonist and thereby promotes diuresis, reduces blood pressure, and retains potassium. Aside from these mechanisms of action, spironolactone also exerts several antiandrogenic effects in the skin. Spironolactone decreases sebum production by competing with both dihydrotestosterone (DHT) and testosterone for the androgen receptors and also halts the conversion of testosterone to the more potent sebum producer DHT. In addition, spironolactone ...
Source: JAMA Dermatology - March 22, 2015 Category: Dermatology Source Type: research

Advancing Regulatory Science to Bring Novel Medical Devices for Use in Emergency Care to Market: The Role of the Food and Drug Administration
This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. (Source: Annals of Emergency Medicine)
Source: Annals of Emergency Medicine - March 21, 2015 Category: Emergency Medicine Source Type: research

Letter to the editor by the authors of Exact Calculation of Power and Sample Size in Bioequivalence Studies Using Two One‐sided Tests, Pharmaceutical Statistics, DOI: 10.1002/pst.1666
This article reflects the views of the authors and should not be construed to be those of the US Food and Drug Administration. Copyright © 2015 John Wiley & Sons, Ltd. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - March 21, 2015 Category: Statistics Authors: Meiyu Shen, Estelle Russek‐Cohen, Eric V Slud Tags: Letter to the Editor Source Type: research

Neurological Complications Associated with Epidural Steroid Injections
Abstract Multiple case reports of neurological complications resulting from intraarterial injection of corticosteroids have led the Food and Drug Administration (FDA) to issue a warning, requiring label changes, warning of serious neurological events, some resulting in death. The FDA has identified 131 cases of neurological adverse events, including 41 cases of arachnoiditis. A review of the literature reveals an overwhelming proportion of the complications are related to transforaminal epidural injections, of which cervical transforaminal epidural injections constituted the majority of neurological complications...
Source: Current Pain and Headache Reports - March 20, 2015 Category: Neurology Source Type: research

Notes from the field: listeriosis associated with stone fruit - United States, 2014.
Abstract On July 19, 2014, a packing company in California (company A) voluntarily recalled certain lots of stone fruits, including whole peaches, nectarines, plums, and pluots, because of concern about contamination with Listeria monocytogenes based on internal company testing. On July 31, the recall was expanded to cover all fruit packed at their facility during June 1-July 17. After the initial recall, clinicians, state and local health departments, CDC, and the Food and Drug Administration (FDA) received many inquiries about listeriosis from concerned consumers, many of whom had received automated telephone cal...
Source: MMWR Morb Mortal Wkl... - March 20, 2015 Category: Epidemiology Authors: Jackson BR, Salter M, Tarr C, Conrad A, Harvey E, Steinbock L, Saupe A, Sorenson A, Katz L, Stroika S, Jackson KA, Carleton H, Kucerova Z, Melka D, Strain E, Parish M, Mody RK Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Development of Novel Pharmaceutical Agents for Alzheimer's Disease: The Impact of Regulatory Initiatives in Japan and the United States.
Abstract PURPOSE: The incidence of Alzheimer's disease (AD) has been steadily increasing worldwide. AD is a serious disease that has both societal and economic impacts. The greatest risk factor for AD is aging. Thus, because of the rapidly aging population in Japan, the development of new, effective drugs for AD is urgently needed. The goal of the present article was to analyze the status, clarify the problems, and discuss the scientific and political challenges of disease-modifying drug development for AD. METHODS: Public data, official documents, literature, and news releases were surveyed and discussed. ...
Source: Clinical Therapeutics - March 20, 2015 Category: Drugs & Pharmacology Authors: Tsukamoto K Tags: Clin Ther Source Type: research

Assessing the likelihood of new-onset inflammatory bowel disease following tumor necrosis factor-alpha inhibitor therapy for rheumatoid arthritis and juvenile rheumatoid arthritis
Abstract The association between inhibition of tumor necrosis factor-alpha (TNF-α) in patients with rheumatoid arthritis (RA) and juvenile rheumatoid arthritis (JRA) and the onset of inflammatory bowel disease (IBD) is unclear. We sought to evaluate this association by analyzing adverse events (AEs) reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) with a standardized scoring tool for drug-induced AEs. A search of the FAERS for RA or JRA (January 2003–December 2011) reported with adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab was performed. This datas...
Source: Rheumatology International - March 19, 2015 Category: Rheumatology Source Type: research

Endoscopic submucosal dissection
The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. (Source: Gastrointestinal Endoscopy)
Source: Gastrointestinal Endoscopy - March 19, 2015 Category: Gastroenterology Authors: ASGE Technology Committee, John T. Maple, Barham K. Abu Dayyeh, Shailendra S. Chauhan, Joo Ha Hwang, Sri Komanduri, Michael Manfredi, Vani Konda, Faris M. Murad, Uzma D. Siddiqui, Subhas Banerjee Tags: Technology status evaluation report Source Type: research

Proteometabolomics of bladder cancer: Current and future prospects.
Abstract Urinary bladder cancer (BC) is fifth most common cancer worldwide; the diagnostic methods are mostly instrumental approaches including cystoscopy and cytology. Since BC recurrence rate is high, consequently requires long-term follow-up. The molecular assays that can precisely identify BC at an early stage are obligatory. Although several noninvasive urine and blood samples based biomarkers have been proposed in the last decade but only few have been approved by Food and drug administration (FDA) for clinical purpose. Hence the search for more suitable biomarker is still on. In this review, we summarize the...
Source: Cancer Biomarkers : Section A of Disease Markers - March 19, 2015 Category: Cancer & Oncology Authors: Bansal N, Gupta A, Sankhwar SN Tags: Cancer Biomark Source Type: research

Paraphenylenediamine in black henna temporary tattoos: 12-year Food and Drug Administration data on incidence, symptoms, and outcomes
Paraphenylenediamine (PPD) became 1 of the 5 chemicals labeled as “strong sensitizers” by the Consumer Product Safety Commission (formerly designated by the Food and Drug Administration [FDA]) in 1961,1 but reports of reactions date back to the late 19th century, when it first appeared in hair dye.2 Currently, PPD in cosmetics meant for the skin is prohibited, and is limited in hair dye to 6%; however, it continues to be found in unregulated temporary tattoos and black henna products at alarming levels—ranging up to almost 30%. (Source: Journal of the American Academy of Dermatology)
Source: Journal of the American Academy of Dermatology - March 18, 2015 Category: Dermatology Authors: Alina Goldenberg, Sharon E. Jacob Tags: Commentary Source Type: research

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men
In 2012, the US Food and Drug Administration approved Truvada as a pre-exposure prophylaxis (PrEP) for adults at risk of HIV. PrEP is highly effective at preventing HIV when taken daily, but no gold standard exists for consistently administering PrEP to populations at highest risk. The "I Am Men’s Health" program used an innovative methodology to generate adherence to PrEP in 23 mostly young men who have sex with men of color (yMSMc), during a 28-week period from February to September 2013. Adherence was measured using weekly medication pickup rates. The average age of the participants was 21 years, and the majority ...
Source: Journal of the International Association of Physicians in AIDS Care (JIAPAC) - March 18, 2015 Category: Infectious Diseases Authors: Daughtridge, G. W., Conyngham, S. C., Ramirez, N., Koenig, H. C. Tags: Short Communications Source Type: research

Benzodiazepine exposure increases risk of Alzheimer's disease
Commentary on: Billioti de Gage S, Moride Y, Ducruet T, et al. Benzodiazepine use and risk of Alzheimer's disease: case-control study. BMJ 2014;349:g5205. Context Benzodiazepines (BZ) are widely prescribed for older patients. They have Food and Drug Administration (FDA) indications for a number of conditions including generalised anxiety disorder, panic disorder and insomnia. However, there are many worries about safety in the elderly including withdrawal, tolerance, ataxia, drug–drug interactions and adverse effects on cognition. For these reasons most guidelines recommend against long-term use of BZ. The study pres...
Source: Evidence-Based Medicine - March 17, 2015 Category: Internal Medicine Authors: Rosenberg, P. B. Tags: Epidemiologic studies, Dementia, Drugs: CNS (not psychiatric), Sleep disorders (neurology), Unwanted effects / adverse reactions, Anxiety disorders (including OCD and PTSD), Drugs: psychiatry, Memory disorders (psychiatry), Psychiatry of old age, Psychoti Source Type: research

Fixed drug eruptions with modafinil
Loknath Ghoshal, Mausumi SinhaIndian Journal of Pharmacology 2015 47(2):224-226Modafinil is a psychostimulant drug, which has been approved by the US Food and Drug Administration for the treatment of narcolepsy associated excessive daytime sleepiness, sleep disorder related to shift work, and obstructive sleep apnea syndrome. However, presently it is being used as a lifestyle medicine; in India, it has been misused as an "over the counter" drug. Modafinil is known to have several cutaneous side effects. Fixed drug eruption (FDE) is a distinctive drug induced reaction pattern characterized by recurrence of eruptio...
Source: Indian Journal of Pharmacology - March 17, 2015 Category: Drugs & Pharmacology Authors: Loknath GhoshalMausumi Sinha Source Type: research

TG-interacting factor transcriptionally induced by AKT/FOXO3A is a negative regulator that antagonizes arsenic trioxide-induced cancer cell apoptosis.
Abstract Arsenic trioxide (ATO) is a multi-target drug approved by the Food and Drug Administration as the first-line chemotherapeutic agent for the treatment of acute promyelocytic leukemia. In addition, several clinical trials are being conducted with arsenic-based drugs for the treatment of other hematological malignancies and solid tumors. However, ATO's modest clinical efficacy on some cancers, and potential toxic effects on humans have been reported. Determining how best to reduce these adverse effects while increasing its therapeutic efficacy is obviously a critical issue. Previously, we demonstrated that th...
Source: Toxicology and Applied Pharmacology - March 16, 2015 Category: Toxicology Authors: Liu ZM, Tseng HY, Cheng YL, Yeh BW, Wu WJ, Huang HS Tags: Toxicol Appl Pharmacol Source Type: research

Novel Biologic Agents for Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia.
Abstract The incidence of non-Hodgkin lymphomas is on the rise worldwide. The aggressive non-Hodgkin lymphomas can potentially be cured with front-line therapy, but indolent ones, such as chronic lymphocytic leukemia/small lymphocytic lymphoma, cannot. Relapsed/refractory non-Hodgkin lymphomas have a poor overall outcome, typically with shorter responses after each relapse. Novel therapies are sought to improve outcomes in this patient population. This review discusses the promising new biologic therapies that have emerged over the last 5 years. Some have already achieved US Food and Drug Administration approval, w...
Source: Oncology (Williston Park, N.Y.) - March 15, 2015 Category: Cancer & Oncology Authors: Siddiqi T, Rosen ST Tags: Oncology (Williston Park) Source Type: research

Structure-based development and optimization of therapy antibody drugs against TNFα.
In this study, we launched a screen of a phage display library to isolate novel anti-TNFα antibodies based on the adalimumab epitope. Structural analysis, the phage display antibody isolation technology, step-by-step antibody optimization, complementarity-determining region residues random mutagenesis, phage ELISA, binding affinity characterization, and cell signaling assays were used for the development and optimization of the novel anti-TNFα antibodies. Moreover, one of the novel antibodies, hAta09, has a superior inhibitory effect on TNFα function and signaling. Taken together, our report established that the novel a...
Source: Amino Acids - March 14, 2015 Category: Biochemistry Authors: Fu W, Wang X, Yang W, Takeda H, Hu S, Lou Z, Zhao J, Bethune AN, Guo Y Tags: Amino Acids Source Type: research

Review of Tenofovir Use in HIV-infected Children
Tenofovir disoproxil fumarate (TDF) is approved by the Food and Drug Administration for use in children ages 2 years and older and is recommended by the World Health Organization for use as a preferred first-line nucleotide reverse transcriptase inhibitor in adults and adolescents ages 10 years and older. The simplicity of once daily dosing, few metabolic side effects and efficacy against hepatitis B virus make TDF suitable for use in a large scale program. Unlike thymidine analoge nucleoside reverse transcriptase inhibitors (NRTIs); tenofovir does not induce multi-NRTI resistance mutations, so more NRTI options are availa...
Source: The Pediatric Infectious Disease Journal - March 13, 2015 Category: Infectious Diseases Tags: HIV Reports Source Type: research

Digital Health Tools for Diabetes
Digital health tools are providing patients with easier ways to keep track of their blood glucose levels and other key self-reported data, such as carbohydrates ingested, medication administered, and physical activity. Data are often uploaded into the cloud where physicians and other members of the care team can access them. Clinical studies are beginning to demonstrate efficacy of some of these tools, and Food and Drug Administration approval, when present, provides some much-needed validation. It is anticipated that these tools will continue to evolve and patient acceptance will continue to grow. Physician and care teams...
Source: The Journal of Ambulatory Care Management - March 13, 2015 Category: Emergency Medicine Tags: Original Articles Source Type: research

Changing paradigms in organ preservation and resuscitation
This article aims to review the recent advances in machine perfusion and organ preservation solutions. Recent findings: Flow and pressure-based machine perfusion has shown improved kidney graft function and survival, especially among expanded criteria donors. Pressure-based machine perfusion is demonstrating promising results in preservation and resuscitation of liver, pancreas, heart, and also lung grafts. August 2014 marked Food and Drug Administration approval of XPSTM- XVIVO Perfusion System (XVIVO Perfusion Inc., Englewood, Colorado, USA), a device for preserving and resuscitating lung allografts initially considered ...
Source: Current Opinion in Organ Transplantation - March 13, 2015 Category: Surgery Tags: ORGAN PRESERVATION AND PROCUREMENT: Edited by Johnny C. Hong Source Type: research

Drug interactions involving antiepileptic drugs: Assessment of the consistency among three drug compendia and FDA-approved labels
Publication date: March 2015 Source:Epilepsy & Behavior, Volume 44 Author(s): Dana Ekstein , Matanya Tirosh , Yonatan Eyal , Sara Eyal Interactions of antiepileptic drugs (AEDs) with other substances may lead to adverse effects and treatment failure. To avoid such interactions, clinicians often rely on drug interaction compendia. Our objective was to compare the concordance for twenty-two AEDs among three drug interaction compendia (Micromedex, Lexi-Interact, and Clinical Pharmacology) and the US Food and Drug Administration-approved product labels. For each AED, the overall concordance among data sources regardi...
Source: Epilepsy and Behavior - March 13, 2015 Category: Neurology Source Type: research

Targeted Therapy in Advanced Bladder Cancer
This article outlines representative trials of targeted therapies in UC and discusses the significance of genetic preselection in trial design as a method to optimize responses to these agents, thus, hopefully expanding the armamentarium of treatment options against this lethal disease. (Source: Urologic Clinics of North America)
Source: Urologic Clinics of North America - March 13, 2015 Category: Urology & Nephrology Authors: Emmet J. Jordan, Gopa Iyer Source Type: research

Injectable Fillers: Review of Material and Properties
This article will review the materials and properties of the currently available soft tissue fillers: hyaluronic acid, calcium hydroxylapatite, poly-l-lactic acid, polymethylmethacrylate, and autologous fat (and aspirated tissue including stem cells).[...]Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.Article in Thieme eJournals:Table of contents  |  Abstract  |  Full text (Source: Facial Plastic Surgery)
Source: Facial Plastic Surgery - March 12, 2015 Category: Cosmetic Surgery Authors: Attenello, Natalie HuangMaas, Corey S. Source Type: research

Supercritical Anti-Solvent Precipitation of Ethyl Cellulose
Publication date: Available online 6 March 2015 Source:The Journal of Supercritical Fluids Author(s): R. Djerafi , Y. Masmoudi , C. Crampon , A. Meniai , E. Badens Supercritical Anti-Solvent (SAS) process is considered to be a clean technology suitable for particle design. It is generally used in order to micronize compounds of interest under mild operating conditions of temperature and with very low residual solvent traces in the end-product. By varying the process parameters, the properties of the produced powders can be adjusted with defined size (generally micron or nanometer sized particles), morphology and a narrow...
Source: The Journal of Supercritical Fluids - March 11, 2015 Category: Chemistry Source Type: research

Metabolite Profiling of Tissues of Acorus calamus and Acorus tatarinowii Rhizomes by Using LMD, UHPLC-QTOF MS, and GC-MS
In this report, the metabolite profiles and essential oil content of A. calamus and Acorus tatarinowii rhizomes were analysed and compared using UHPLC-QTOF-MS and GC-MS techniques. The metabolite profiles were similar; however, β-asarone content was higher in A. calamus rhizomes. The developed methods can be applied for microscopic and macroscopic identification, and quality control of food products containing β-asarone.[...]Georg Thieme Verlag KG Stuttgart · New YorkArticle in Thieme eJournals:Table of contents  |  Abstract  |  Full text (Source: Planta Medica)
Source: Planta Medica - March 11, 2015 Category: Drugs & Pharmacology Authors: Jaiswal, YoginiLiang, ZhitaoHo, AlanChen, HubiaoZhao, Zhongzhen Tags: Analytical Studies Source Type: research

Drug interactions involving antiepileptic drugs: Assessment of the consistency among three drug compendia and FDA-approved labels.
Abstract Interactions of antiepileptic drugs (AEDs) with other substances may lead to adverse effects and treatment failure. To avoid such interactions, clinicians often rely on drug interaction compendia. Our objective was to compare the concordance for twenty-two AEDs among three drug interaction compendia (Micromedex, Lexi-Interact, and Clinical Pharmacology) and the US Food and Drug Administration-approved product labels. For each AED, the overall concordance among data sources regarding existence of interactions and their classification was poor, with less than twenty percent of interactions listed in all four...
Source: Epilepsy and Behaviour - March 11, 2015 Category: Neurology Authors: Ekstein D, Tirosh M, Eyal Y, Eyal S Tags: Epilepsy Behav Source Type: research

International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences
The objective of this article is to discuss the similarities and differences among these approaches used by international regulatory authorities when applications of generic and/or subsequent entry locally acting OIDPs are evaluated. We focused on four jurisdictions that currently have published related guidances for generic and/or subsequent entry OIDPs. They are Therapeutic Goods Administration (TGA) in Australia, Health Canada (HC) in Canada, European Medicines Association (EMA) of European Union (EU), and the Food and Drug Administration (FDA) in the United States of America (USA). The comparisons of these bioequivalen...
Source: The AAPS Journal - March 10, 2015 Category: Drugs & Pharmacology Source Type: research

Rescue of Methyl-CpG Binding Protein 2 Dysfunction-induced Defects in Newborn Neurons by Pentobarbital
Abstract Rett syndrome is a neurodevelopmental disorder that usually arises from mutations or deletions in methyl-CpG binding protein 2 (MeCP2), a transcriptional regulator that affects neuronal development and maturation without causing cell loss. Here, we show that silencing of MeCP2 decreased neurite arborization and synaptogenesis in cultured hippocampal neurons from rat fetal brains. These structural defects were associated with alterations in synaptic transmission and neural network activity. Similar retardation of dendritic growth was also observed in MeCP2-deficient newborn granule cells in the dentate gyr...
Source: Neurotherapeutics - March 10, 2015 Category: Neurology Source Type: research

Bill Would Require Law-Breaking Drug Companies to Help Fund Research
On January 22, Sen Elizabeth Warren (D, Mass) introduced the Medical Innovation Act, which targets blockbuster drug companies that break the law and opt to enter into a settlement agreement with the government to avoid a trial. The companies would have to pay a small portion of their profits over 5 years to the National Institutes of Health (NIH) and Food and Drug Administration (FDA). The NIH and FDA would use the money to fund research focusing on new treatments, especially for diseases that represent a disproportionate amount of government spending through such programs as Medicare and Medicaid. (Source: JAMA)
Source: JAMA - March 10, 2015 Category: Journals (General) Source Type: research

Oral Triptans in Children and Adolescents: An Update
Abstract This review evaluates the recent progress in clinical trials on oral triptans for acute migraine in children and adolescents. Randomized controlled trials (RCT) on the treatment of migraine in pediatric patients were rare and difficult to design. In particular, high placebo response in many of the trials made it difficult to prove efficacy of triptans. Using a “novel study design” for RCT, a study successfully proved the efficacy of an oral rizatriptan. This trial enrolled patients with unsatisfactory response to nonsteroidal anti-inflammatory or acetaminophen and with migraine lasting longer than 3...
Source: Current Pain and Headache Reports - March 10, 2015 Category: Neurology Source Type: research

17β-Estradiol and Natural Progesterone for Menopausal Hormone Therapy: REPLENISH Phase 3 Study Design of a Combination Capsule and Evidence Review
Several formulations of hormone therapy (HT) containing estrogens and progestins have been approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of menopausal symptoms. The primary indication for HT is the relief of moderate to severe vasomotor symptoms (VMS) [1]. The most effective treatment for hot flushes is HT consisting of estrogens with or without progestogens [2]. However, publication of data showing possible harm in women of a mean age of 63 that were treated for more than 5 years with conjugated equine estrogens (CEE) and medroxyprogesterone acetate ...
Source: Maturitas - March 10, 2015 Category: Primary Care Authors: Sebastian Mirkin, Julia M. Amadio, Brian A. Bernick, James H. Pickar, David F. Archer Tags: Review Source Type: research

Considerations for Drug Development for Heart Failure
I read with great interest the thoughtful editorial by Greene and Gheorghiade (1) proposing rigorous testing in a small homogenous cohort of patients hospitalized with heart failure in early phase trials in order to elucidate the mechanisms of action and benefit for maximal pairing of the new therapy with subsequent phase III trial population. Considering that the last heart failure drug approved by the Food and Drug Administration was the combination of hydralazine and isosorbide dinitrate in 2005, this concept could be equally applied to outpatient heart failure population. (Source: Journal of the American College of Cardiology)
Source: Journal of the American College of Cardiology - March 9, 2015 Category: Cardiology Source Type: research

Regulatory Forum Opinion Piece*: Blinding and Binning in Histopathology Methods in the Biomarker Qualification Process.
This article offers a personal opinion on blinded evaluations and data binning in the context of biomarker qualification studies. PMID: 25755101 [PubMed - as supplied by publisher] (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - March 9, 2015 Category: Pathology Authors: Rouse R Tags: Toxicol Pathol Source Type: research

Quantification of plant sterols/stanols in foods and dietary supplements containing added phytosterols
The objective of the present study was to validate a method for the determination of the content and composition of plant sterols/stanols in foods and dietary supplements containing added phytosterols. Chromatographic conditions with this method permitted the near-baseline resolution of the five major phytosterols (campesterol, campestanol, stigmasterol, β-sitosterol, sitostanol) that are the subject of the United States Food and Drug Administration's (FDA) health claim on the relationship between phytosterols and reduced risk of CHD. Analyzed samples (n =25) showed total phytosterol contents that varied from 0.2 to 55.2g...
Source: Journal of Food Composition and Analysis - March 8, 2015 Category: Food Science Source Type: research