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Advances in treatment of metastatic renal cell carcinoma
Purpose of review: Multiple agents, including vascular endothelial growth factor (VEGF) inhibitors and mammalian target of rapamycin inhibitors have been approved over the past decade for the treatment of metastatic renal cell carcinoma (mRCC). Here, we focus on nivolumab, cabozantinib, and lenvatinib plus everolimus, agents that have recently emerged with positive clinical data leading to ‘Food and Drug Administration approval or pending approval in mRCC. We also review the development of novel agents of interest showing promise in mRCC as part of combination therapy’. Recent findings: Nivolumab and cabozantinib both...
Source: Current Opinion in Urology - July 29, 2016 Category: Urology & Nephrology Tags: NEW INSIGHTS IN DIAGNOSIS AND MANAGEMENT OF RENAL CELL CARCINOMA: Edited by Jose Karam and Tobias Klatte Source Type: research

Novel Oral Anticoagulants in Atrial Fibrillation: Update on Apixaban.
Authors: Mezue K, Obiagwu C, John J, Sharma A, Yang F, Shani J Abstract Almost 800,000 new or recurrent strokes happen every year. Atrial fibrillation, the most common cardiac arrhythmia, is a major risk factor for stroke, accounting for 15-20% of ischemic strokes. Apixaban is a direct inhibitor of Factor Xa that was approved in December 2012 by the US Food and Drug Administration (FDA) for the prevention of stroke in patients with non-valvular atrial fibrillation. It is part of a family of novel oral anticoagulants (NOACs) which have the advantage over warfarin of less dosing variability, rapid onset of action and...
Source: Current Cardiology Reviews - July 29, 2016 Category: Cardiology Tags: Curr Cardiol Rev Source Type: research

New molecular targets for the treatment of sarcoidosis
Purpose of review: Sarcoidosis is a chronic granulomatous disease typically affecting the lung, lymph nodes, and other organ systems. Evidence suggests that the morbidity and mortality rates for sarcoidosis in the USA are rising, despite widespread use of anti-inflammatory therapies. In this review, we survey new therapies that target specific inflammatory pathways in other diseases (such as rheumatoid arthritis, Crohn's disease, and psoriasis) that are similar to pathways relevant to sarcoidosis immunopathogenesis, and therefore, represent potentially new sarcoidosis therapies. Recent findings: Immunopathogenesis of sarc...
Source: Current Opinion in Pulmonary Medicine - July 29, 2016 Category: Respiratory Medicine Tags: SARCOIDOSIS: Edited by Daniel A. Culver and Dominique Valeyre Source Type: research

The Right Therapy for Neurological Disorders: From Randomized Trials to Clinical Practice - Patients versus Investigator Expectations and Needs.
We describe various organizations and programs available that provide increased education and patient involvement. KEY MESSAGE: Stronger partnerships between those living with ALS, clinicians, government, nonprofit organizations, and regulatory agencies will significantly impact treatment development. PMID: 27462978 [PubMed - in process] (Source: Frontiers of Neurology and Neuroscience)
Source: Frontiers of Neurology and Neuroscience - July 29, 2016 Category: Neuroscience Tags: Front Neurol Neurosci Source Type: research

Decision Support Environment for Medical Product Safety Surveillance
Publication date: Available online 28 July 2016 Source:Journal of Biomedical Informatics Author(s): Taxiarchis Botsis, Christopher Jankosky, Deepa Arya, Kory Kreimeyer, Matthew Foster, Abhishek Pandey, Wei Wang, Guangfan Zhang, Richard Forshee, Ravi Goud, David Menschik, Mark Walderhaug, Emily Jane Woo, John Scott We have developed a Decision Support Environment (DSE) for medical experts at the US Food and Drug Administration (FDA). The DSE contains two integrated systems: The Event-based Text-mining of Health Electronic Records (ETHER) and the Pattern-based and Advanced Network Analyzer for Clinical Evalua...
Source: Journal of Biomedical Informatics - July 29, 2016 Category: Information Technology Source Type: research

Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration
Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s. This has commonly been explained through the increase in prohibitive federal regulations during the 1960s that aimed to curb the growing recreational use of the drug. However, closely examining the Food and Drug Administration’s regulation of LSD research in the 1960s will reveal that not only was LSD research never prohibited, but...
Source: History of Psychiatry - July 29, 2016 Category: Psychiatry Authors: Oram, M. Tags: Articles Source Type: research

Molecularly targeted agents and immunotherapy for the treatment of head and neck squamous cell cancer (HNSCC).
Authors: Azoury SC, Gilmore RC, Shukla V Abstract Squamous cell carcinoma is one of the most frequent tumors of the head and neck and often presents at an advanced-stage. Traditionally, treatment for head and neck squamous cell carcinoma (HNSCC) has included surgery, radiation, and chemotherapy depending on both the site and stage of disease. Although the treatment approach for local disease is often standardized, the management of recurrent and advanced disease is evolving. A better understanding of the molecular mechanisms of HNSCC has led to numerous promising investigations and the push for the development of n...
Source: Discovery Medicine - July 28, 2016 Category: Research Tags: Discov Med Source Type: research

FDA strengthens fluoroquinolone warnings
Revised warnings about the risks of being left permanently disabled after taking fluoroquinolone antibiotics have been added to products in the United States following a safety review by the Food and Drug Administration. (Source: The Pharmaceutical Journal)
Source: The Pharmaceutical Journal - July 28, 2016 Category: Drugs & Pharmacology Source Type: research

Dorsal root ganglion stimulation approval by the Food and Drug Administration: advice on evolving the process.
Authors: Deer TR, Pope JE PMID: 27454559 [PubMed - as supplied by publisher] (Source: Expert Review of Neurotherapeutics)
Source: Expert Review of Neurotherapeutics - July 28, 2016 Category: Neurology Tags: Expert Rev Neurother Source Type: research

Pharmacotherapeutic strategies in the treatment of severe Alzheimer's disease.
This article will review the efficacy, safety, and tolerability data of these agents in the treatment of severe AD. Issues related to combination therapy, neuropsychiatric symptoms, and treatment discontinuation are also discussed. EXPERT OPINION: AD therapeutics provide benefits on measures of cognition, functioning, behavior, and global status even in the severe stages of AD. Combination therapy with memantine and ChEIs may provide additive benefits compared with ChEI monotherapy. Decisions regarding discontinuation of these medications should be made on a case-by-case basis, with some evidence suggesting that discon...
Source: Expert Opinion on Pharmacotherapy - July 28, 2016 Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother Source Type: research

Synergistically acting agonists and antagonists of G protein-coupled receptors prevent photoreceptor cell degeneration.
Abstract Photoreceptor cell degeneration leads to visual impairment and blindness in several types of retinal disease. However, the discovery of safe and effective therapeutic strategies conferring photoreceptor cell protection remains challenging. Targeting distinct cellular pathways with low doses of different drugs that produce a functionally synergistic effect could provide a strategy for preventing or treating retinal dystrophies. We took a systems pharmacology approach to identify potential combination therapies using a mouse model of light-induced retinal degeneration. We showed that a combination of U.S. Fo...
Source: Science Signaling - July 28, 2016 Category: Biomedical Science Authors: Chen Y, Palczewska G, Masuho I, Gao S, Jin H, Dong Z, Gieser L, Brooks MJ, Kiser PD, Kern TS, Martemyanov KA, Swaroop A, Palczewski K Tags: Sci Signal Source Type: research

Indoor tanning among New Jersey high school students before and after the enactment of youth access restrictions
We examined indoor tanning rates among New Jersey youth before and after a ban on indoor tanning for those younger than 17 years was enacted on October 1, 2013. (Source: Journal of the American Academy of Dermatology)
Source: Journal of the American Academy of Dermatology - July 27, 2016 Category: Dermatology Authors: Elliot J. Coups, Jerod L. Stapleton, Cristine D. Delnevo Tags: Letter Source Type: research

Current status and future trends of high-pressure processing in food industry
Publication date: February 2017 Source:Food Control, Volume 72, Part A Author(s): Hsiao-Wen Huang, Sz-Jie Wu, Jen-Kai Lu, Yuan-Tay Shyu, Chung-Yi Wang The increased consumers' interest in high quality foods with fresh-like sensory and additive free attributes led to the development of non-thermal food processing technologies as alterative to conventionally heat treatments. This review describes the current application status and market trends of high-pressure processing (HPP) technology in food industry. As the most successfully commercialized non-thermal processing technology, HPP eliminates food pathogens at room ...
Source: Food Control - July 27, 2016 Category: Food Science Source Type: research

Translational research of a dynamic hip screw system —from the Society of Chemical Industry to the Food and Drug Administration
This article aims to describe an experience in successfully translating research results into a medical device for clinical practices. When the researchers or developers wish to apply their findings to clinical usages, it must be approved by public authorities, such as the US Food and Drug Administration (FDA). In addition to the development records and risk control documents, all of the materials and testing must be completed by laboratories or manufacturers with good quality controls in accordance with the related regulations or standards. The Orthopaedic Device Research Center dynamic hip screw system (ODRC-DHS system),...
Source: Journal of Orthopaedic Translation - July 27, 2016 Category: Orthopaedics Source Type: research

Re-Born in the USA: CVD 103-HgR Cholera Vaccine for Travellers ’ Indications
Vaxchora (oral live attenuated cholera vaccine [CVD 103-HgR]; PaxVax), expected to be available in the U.S. in September 2016 at an anticipated wholesale price of approximately $300 per dose, was recently approved by the U.S. Food and Drug Administration for persons aged 18 through 64 years [1]. The vaccine is effective if administered as a single dose 8 days prior to potential V. cholerae O1 cholera exposure. The vaccine should not be used for protection against 0139 strains. (Source: Travel Medicine and Infectious Disease)
Source: Travel Medicine and Infectious Disease - July 27, 2016 Category: Infectious Diseases Authors: David O. Freedman Tags: Editorial Source Type: research

New antiepileptic drugs: focus on ezogabine, clobazam, and perampanel
Ezogabine, clobazam, and perampanel are among the newest antiseizure drugs approved by the Food and Drug Administration between 2011 and 2012. Ezogabine and perampanel are approved for adjunctive treatment of partial epilepsy. Perampanel is also approved for adjunctive treatment of primary generalized tonic–clonic seizures. Ezogabine and perampanel have novel mechanisms of action. Ezogabine binds to voltage-gated potassium channels and increases the M-current thereby causing membrane hyperpolarization. Perampanel is a selective, non-competitive 2-amino-3-(3-hydroxy-5-methyl-isoxazol-4-yl)propanoic acid receptor antag...
Source: Journal of Investigative Medicine - July 27, 2016 Category: Research Authors: Rudzinski, L. A., Velez-Ruiz, N. J., Gedzelman, E. R., Mauricio, E. A., Shih, J. J., Karakis, I. Tags: Review Source Type: research

FDA updates warning label for systemic fluoroquinolones
The Food and Drug Administration has amended the boxed warning on labels for fluoroquinolone antibiotics, taken either orally or by injection, to reflect recent findings of the drugs’ alarming... (Source: Hospitalist News)
Source: Hospitalist News - July 26, 2016 Category: Hospital Management Source Type: research

FDA updates warning label for systemic fluoroquinolones
The Food and Drug Administration has amended the boxed warning on labels for fluoroquinolone antibiotics, taken either orally or by injection, to reflect recent findings of the drugs’ alarming... (Source: Clinical Psychiatry News)
Source: Clinical Psychiatry News - July 26, 2016 Category: Psychiatry Source Type: research

FDA updates warning label for systemic fluoroquinolones
The Food and Drug Administration has amended the boxed warning on labels for fluoroquinolone antibiotics, taken either orally or by injection, to reflect recent findings of the drugs’ alarming... (Source: Ob.Gyn. News)
Source: Ob.Gyn. News - July 26, 2016 Category: OBGYN Source Type: research

FDA updates warning label for systemic fluoroquinolones
The Food and Drug Administration has amended the boxed warning on labels for fluoroquinolone antibiotics, taken either orally or by injection, to reflect recent findings of the drugs’ alarming... (Source: Internal Medicine News)
Source: Internal Medicine News - July 26, 2016 Category: Internal Medicine Source Type: research

Reply Bioresorbable Scaffold Thrombosis: Why BRS Size Matters
< span class="paragraphSection" > We thank Dr. Foin and colleagues for their letter and  fully share their comments. As they state, the results of our study are in line with the evidence from the ABSORB III study that the scaffold footprint (or strut/artery ratio [SAR]) is a strong predictor of patient prognosis < a href="#bib1" class="reflinks" > (1) < /a > . This concept has led to a warning against the use of scaffolds in vessels < 2.5  mm, which was reinforced strongly at the recent Food and Drug Administration panel, and with which we fully agree. < /span > (Source: Journal of the American College of Cardiology)
Source: Journal of the American College of Cardiology - July 26, 2016 Category: Cardiology Source Type: research

Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union
< h3 class= " a-plus-plus " > Abstract < /h3 > < p class= " a-plus-plus " > In Japan, the development of generic oral dry powder inhaler (DPI) drug products for marketing approval has recently increased. The Pharmaceuticals and Medical Devices Agency (PMDA) considers the required data for each drug product in the consultation meeting. However, guidelines for DPI drug products have been published by the US Food and Drug Administration and the European Medicines Agency. Recently, the basic principles of bioequivalence evaluations of generic DPI drug products were published in March 2016 by the Ministry of Health, Labour and ...
Source: Clinical Pharmacokinetics - July 26, 2016 Category: Drugs & Pharmacology Source Type: research

Remote breath ‐testing device approved for premarket clearance
Last month, the Food and Drug Administration granted 510(k) premarket clearance for the Soberlink Breathalyzer, a real‐time mobile‐breath sobriety technology. The device is for medical use by health care providers to remotely measure alcohol in human breath, for the purpose of aiding in the detection and monitoring of alcohol consumption in those who suffer from alcohol use disorders. (Source: The Brown University Child and Adolescent Psychopharmacology Update)
Source: The Brown University Child and Adolescent Psychopharmacology Update - July 26, 2016 Category: Psychiatry Tags: From the FDA Source Type: research

Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes. Final order.
Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes. Final order. Fed Regist. 2016 Jul 26;81(143):48703-7 Authors: Abstract The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification. PMID: 27459751 [PubMed - in pr...
Source: Fed Regist - July 26, 2016 Category: American Health Tags: Fed Regist Source Type: research

Trial Design and Efficacy Thresholds for Granting Breakthrough Therapy Designation in Oncology.
Abstract Breakthrough therapy designation (BTD) is a new approach created by the US Congress and the US Food and Drug Administration (FDA) as part of the FDA Innovation and Safety Act of 2012 to expedite the drug development process for serious illness, including cancer. By law, to qualify for BTD, a new molecular entity must demonstrate substantial clinical improvement over existing therapies. Although the administrative requirements for granting BTD have been made available by the FDA, the actual trial designs, end points, and quantitative therapeutic thresholds involved in the granting process have not been made...
Source: JOP - July 26, 2016 Category: Gastroenterology Authors: Kern KA Tags: J Oncol Pract Source Type: research

BRCA somatic mutations and epigenetic BRCA modifications in serous ovarian cancer
The significant activity of poly(ADP-ribose)polymerase (PARP) inhibitors in the treatment of germline BRCA mutation-associated ovarian cancer, which represents ~15% of HGS cases, has recently led to European Medicines Agency and food and drug administration approval of olaparib. Accumulating evidence suggests that PARP inhibitors may have a wider application in the treatment of sporadic ovarian cancers. Up to 50% of HGS ovarian cancer patients may exhibit homologous recombination deficiency (HRD) through mechanisms including germline BRCA mutations, somatic BRCA mutations, and BRCA promoter methylation. In this review, we ...
Source: Annals of Oncology - July 25, 2016 Category: Cancer & Oncology Authors: Moschetta, M., George, A., Kaye, S. B., Banerjee, S. Tags: reviews Source Type: research

US health insurance is an obstacle to disease-modifying treatments in MS
In 1993, the first disease-modifying therapy (DMT) specifically for relapsing-remitting multiple sclerosis (RRMS) was introduced, and an untreatable disease became treatable. The US Food and Drug Administration now has approved 14 DMTs in 8 classes with different mechanisms of action, administration routes, and side effects.1 This therapeutic palette allows neurologists to control RRMS in most patients. (Source: Neurology)
Source: Neurology - July 25, 2016 Category: Neurology Authors: Bourdette, D., Patti, F. Tags: All Neurotology, Multiple sclerosis EDITORIALS Source Type: research

Update on New Therapies With Immune Checkpoint Inhibitors.
Abstract BACKGROUND: Immunotherapy has had a long history in cancer treatment and, with recent breakthroughs, new drugs are available that have shown promising results. OBJECTIVES: The current article discusses an overview of immune function, including immunoediting and the theory of immune checkpoints, as well as specific drugs that have been approved as immune checkpoint inhibitors. Additional discussion includes a review of nursing implications and administration, side effects, adverse events, and the future of immuno-oncology. METHODS: This review of literature focused on locating, summarizing, and synt...
Source: Clinical Journal of Oncology Nursing - July 23, 2016 Category: Nursing Authors: Peterson JJ, Steele-Moses SK Tags: Clin J Oncol Nurs Source Type: research

Pharmacologic Cardioversion in Structural Heart Disease: Keep Ibutilide in Your Back Pocket
Introduction: Atrial fibrillation and atrial flutter are common rhythm perturbations in patients with structural heart disease, including both heart failure with reduced and heart failure with preserved ejection fraction. Agents to facilitate pharmacologic cardioversion are limited in this patient population and include amiodarone, ibutilide, and dofetilide. Despite a low rate of successful cardioversion and potential serious toxicities, amiodarone remains the more widely utilized agent. Ibutilide, a class III antiarrhythmic drug that was approved by the Food and Drug Administration for use in 1995 has a conversion rate of...
Source: Journal of Cardiac Failure - July 23, 2016 Category: Cardiology Authors: Lisa M. LeMond, Megan Treacy, Robert L. Page Source Type: research

Cariprazine for the Treatment of Schizophrenia: A Review of this Dopamine D3-Preferring D3/D2 Receptor Partial Agonist.
Authors: Citrome L Abstract Cariprazine is an antipsychotic medication and received approval by the U.S. Food and Drug Administration for the treatment of schizophrenia in September 2015. Cariprazine is a dopamine D3 and D2 receptor partial agonist, with a preference for the D3 receptor. Cariprazine is also a partial agonist at the serotonin 5-HT1A receptor and acts as an antagonist at 5-HT2B and 5-HT2A receptors. The recommended dose range of cariprazine for the treatment of schizophrenia is 1.5-6 mg/d; the starting dose of 1.5 mg/d is potentially therapeutic. Cariprazine is administered once daily and is primaril...
Source: Clinical Schizophrenia and Related Psychoses - July 23, 2016 Category: Psychiatry Tags: Clin Schizophr Relat Psychoses Source Type: research

Sublingual Immunotherapy for the Polyallergic Patient
Publication date: Available online 21 July 2016 Source:The Journal of Allergy and Clinical Immunology: In Practice Author(s): Amber N. Pepper, Moisés A. Calderón, Thomas B. Casale Allergen immunotherapy is the only disease-modifying treatment for allergic diseases. Sublingual immunotherapy (SLIT) in liquid and tablet form has been used by clinicians in Europe for years, but has only recently gained popularity and approval in the United States. In 2014, the US Food and Drug Administration approved 3 SLIT tablets for the treatment of allergic rhinitis, with or without allergic conjunctivitis. Immunotherapy treatment s...
Source: The Journal of Allergy and Clinical Immunology: In Practice - July 23, 2016 Category: Allergy & Immunology Source Type: research

Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with  a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial
Medical studies have shown some potential for infiltrations of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, San Diego, CA), a slow-release bupivacaine solution, to extend postoperative benefits of numbness/pain relief for up to several days. Because the Food and Drug Administration has approved Exparel only for infiltrations, we wanted to evaluate if it would be effective as an infiltration to control postoperative pain. The purpose of this study was to compare an infiltration of bupivacaine with liposomal bupivacaine for postoperative numbness and pain in symptomatic patients diagnosed with pulpal necrosis expe...
Source: Journal of Endodontics - July 23, 2016 Category: Dentistry Authors: Brandon Glenn, Melissa Drum, Al Reader, Sara Fowler, John Nusstein, Mike Beck Tags: Consort Randomized Clinical Trial Source Type: research

Therapeutic monoclonal antibodies and derivatives: Historical perspectives and future directions.
Abstract Biologics, both monoclonal antibodies (mAbs) and fusion proteins, have revolutionized the practice of medicine. This year marks the 30th anniversary of the Food and Drug Administration approval of the first mAb for human use. In this review, we examine the biotechnological breakthroughs that spurred the explosive development of the biopharmaceutical mAb industry, as well as how critical lessons learned about human immunology informed the development of improved biologics. We also discuss the most common mechanisms of action of currently approved biologics and the indications for which they have been approv...
Source: Biotechnology Advances - July 23, 2016 Category: Biotechnology Authors: Rodgers KR, Chou RC Tags: Biotechnol Adv Source Type: research

Abatacept autoinjector approved to treat rheumatoid arthritis
An autoinjector for subcutaneously administering abatacept (Orencia) has been approved by the Food and Drug Administration for the treatment of rheumatoid arthritis, making it the third delivery... (Source: Internal Medicine News)
Source: Internal Medicine News - July 22, 2016 Category: Internal Medicine Source Type: research

Michaelis –Menten elimination kinetics of etanercept, rheumatoid arthritis biologics, after intravenous and subcutaneous administration in rats
< h3 class= " a-plus-plus " > Abstract < /h3 > < p class= " a-plus-plus " > Etanercept was approved by the Food and Drug Administration (FDA) in 2010 as a biologic agent for the treatment of rheumatoid arthritis (RA). The aim of the study was to investigate the pharmacokinetic properties of etanercept after intravenous and subcutaneous injection in rats. The plasma concentration of etanercept was determined using an enzyme-linked immunosorbent assay (ELISA). Intravenous and subcutaneous administration of 2  mg/kg of etanercept to rats showed that etanercept was slowly absorbed (time to reach the peak drug concentration [ ...
Source: European Journal of Drug Metabolism and Pharmacokinetics - July 22, 2016 Category: Drugs & Pharmacology Source Type: research

Viruses, Vol. 8, Pages 203: Ectromelia Virus Disease Characterization in the BALB/c Mouse: A Surrogate Model for Assessment of Smallpox Medical Countermeasures
In 2007, the United States – Food and Drug Administration (FDA) issued guidance concerning animal models for testing the efficacy of medical countermeasures against variola virus (VARV), the etiologic agent for smallpox. Ectromelia virus (ECTV) is naturally-occurring and responsible for severe mortality and morbidity as a r esult of mousepox disease in the murine model, displaying similarities to variola infection in humans. Due to the increased need of acceptable surrogate animal models for poxvirus disease, we have characterized ECTV infection in the BALB/c mouse. Mice were inoculated intranasally with a high lethal do...
Source: Viruses - July 22, 2016 Category: Virology Authors: Jennifer Garver Lauren Weber Eric Vela Mike Anderson Richard Warren Michael Merchlinsky Christopher Houchens James Rogers Tags: Article Source Type: research

Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib
< h3 class= " a-plus-plus " > Abstract < /h3 > < p class= " a-plus-plus " > Alectinib, a lipophilic, basic, anaplastic lymphoma kinase (ALK) inhibitor with very low aqueous solubility, has received Food and Drug Administration-accelerated approval for the treatment of patients with ALK+ non-small-cell lung cancer. This paper describes the application of physiologically based absorption modeling during clinical development to predict and understand the impact of food and gastric pH changes on alectinib absorption. The GastroPlus < sup class= " a-plus-plus " > ™ < /sup > software was used to develop an absorption model int...
Source: The AAPS Journal - July 22, 2016 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects.
This study was conducted to assess the pharmacokinetic (PK) properties, oral bioavailability, and safety of once daily tedizolid phosphate 200 mg in Chinese subjects to support its further clinical development in China. METHODS: This Phase I single-center study, conducted in 16 healthy Chinese male subjects, consisted of a single-dose administration, 1:1 randomized, two-way, intravenous (IV)/oral (PO) crossover of tedizolid phosphate 200 mg (Part 1) and, after a 7-day washout, a nonrandomized, multiple-dose, 7-day tedizolid phosphate 200 mg once daily administration (IV for 3 days, PO for 4 days; Part 2). Blood samples...
Source: Clinical Therapeutics - July 22, 2016 Category: Drugs & Pharmacology Authors: Chen R, Shen K, Chang X, Tanaka T, Li L, Hu P Tags: Clin Ther Source Type: research

Pharmacology of dextromethorphan: Relevance to dextromethorphan/quinidine (Nuedexta ®) clinical use
Publication date: August 2016 Source:Pharmacology &amp; Therapeutics, Volume 164 Author(s): Charles P. Taylor, Stephen F. Traynelis, Joao Siffert, Laura E. Pope, Rae R. Matsumoto Dextromethorphan (DM) has been used for more than 50years as an over-the-counter antitussive. Studies have revealed a complex pharmacology of DM with mechanisms beyond blockade of N-methyl-d-aspartate (NMDA) receptors and inhibition of glutamate excitotoxicity, likely contributing to its pharmacological activity and clinical potential. DM is rapidly metabolized to dextrorphan, which has hampered the exploration of DM therapy separate fr...
Source: Pharmacology and Therapeutics - July 21, 2016 Category: Drugs & Pharmacology Source Type: research

Clinical Use of the Urine Biomarker [TIMP-2]  × [IGFBP7] for Acute Kidney Injury Risk Assessment
Publication date: July 2016 Source:American Journal of Kidney Diseases, Volume 68, Issue 1 Author(s): Anitha Vijayan, Sarah Faubel, David J. Askenazi, Jorge Cerda, William H. Fissell, Michael Heung, Benjamin D. Humphreys, Jay L. Koyner, Kathleen D. Liu, Girish Mour, Thomas D. Nolin, Azra Bihorac Acute kidney injury (AKI) is a serious complication, commonly occurring in the critically ill population, with devastating short- and long-term consequences. Despite standardization of the definition and staging of AKI, early recognition remains challenging given that serum creatinine level is a marker, albeit imperfe...
Source: American Journal of Kidney Diseases - July 21, 2016 Category: Urology & Nephrology Source Type: research

Novel approaches to mitigating parathion toxicity: targeting cytochrome P450 –mediated metabolism with menadione
Accidental or intentional exposures to parathion, an organophosphorus (OP) pesticide, can cause severe poisoning in humans. Parathion toxicity is dependent on its metabolism by the cytochrome P450 (CYP) system to paraoxon (diethyl 4‐nitrophenyl phosphate), a highly poisonous nerve agent and potent inhibitor of acetylcholinesterase. We have been investigating inhibitors of CYP‐mediated bioactivation of OPs as a method of preventing or reversing progressive parathion toxicity. It is well recognized that NADPH–cytochrome P450 reductase, an enzyme required for the transfer of electrons to CYPs, mediates chemical redox cy...
Source: Annals of the New York Academy of Sciences - July 21, 2016 Category: Science Authors: Yi ‐Hua Jan, Jason R. Richardson, Angela A. Baker, Vladimir Mishin, Diane E. Heck, Debra L. Laskin, Jeffrey D. Laskin Tags: Original Article Source Type: research

Groundbreaking smoking cessation study highlights safety of varenicline, bupropion
The largest‐ever trial of pharmacotherapy for smoking cessation, requested of two drug manufacturers by the Food and Drug Administration (FDA), has found no significant increase in neuropsychiatric adverse events from varenicline or bupropion compared with nicotine replacement therapy or placebo. The findings likely will intensify the discussion of whether regulators in the United States and other countries should revisit boxed warnings on the two smoking cessation treatments. Study results were published online April 22 in The Lancet. (Source: The Brown University Psychopharmacology Update)
Source: The Brown University Psychopharmacology Update - July 20, 2016 Category: Psychiatry Tags: Adverse Events Source Type: research

Viruses, Vol. 8, Pages 197: Reporter-Expressing, Replicating-Competent Recombinant Arenaviruses
Several arenaviruses cause hemorrhagic fever (HF) disease in humans and pose an important public health problem in their endemic regions. To date, no Food and Drug Administration (FDA)-licensed vaccines are available to combat human arenavirus infections, and current anti-arenaviral drug therapy is limited to an off-label use of ribavirin that is only partially effective. The development of arenavirus reverse genetic approaches has provided investigators with a novel and powerful approach for the study of arenavirus biology including virus–host interactions underlying arenavirus induced disease. The use of cell-based min...
Source: Viruses - July 20, 2016 Category: Virology Authors: Luis Martínez-SobridoJuan de la Torre Tags: Review Source Type: research

Neurotherapeutic Strategies for Multiple Sclerosis
This article discusses approved FDA therapies as well as commonly used practice-based therapies for MS, as well as those therapies that can be used in patients attempting to become pregnant, or in patients with an established pregnancy, who require concomitant treatment secondary to recalcitrant disease activity. (Source: Neurologic Clinics)
Source: Neurologic Clinics - July 19, 2016 Category: Neurology Authors: Teresa C. Frohman, Shin C. Beh, Eric J. Kildebeck, Ram Narayan, Katherine Treadaway, Benjamin Greenberg, Elliot M. Frohman Source Type: research

Indoor tanning among New Jersey high school students before and after the enactment of youth access restrictions
We examined indoor tanning rates among New Jersey youth before and after a ban on indoor tanning for those younger than 17 years was enacted on October 1, 2013. (Source: Journal of the American Academy of Dermatology)
Source: Journal of the American Academy of Dermatology - July 19, 2016 Category: Dermatology Authors: Elliot J. Coups, Jerod L. Stapleton, Cristine D. Delnevo Tags: Letter Source Type: research

Lessons learned from cardiovascular outcome clinical trials with dipeptidyl peptidase 4 (DPP-4) inhibitors
Abstract Previous trials of glucose-lowering strategies in subjects with type 2 diabetes have demonstrated a beneficial effect of intensive glycemic control on microvascular complications but failed to show a clear benefit on cardiovascular complications. The findings of meta-analyses of rosiglitazone trials suggesting that rosiglitazone might increase the risk of myocardial infarction have cast doubt on the cardiovascular safety of glucose-lowering drugs. In 2008, the US Food and Drug Administration has implemented rigorous criteria to approve new glucose-lowering drugs, requiring proof of cardiovascular safety....
Source: Endocrine - July 19, 2016 Category: Endocrinology Source Type: research

Overview of the 2016 US Food and Drug Administration Circulatory System Devices Panel Meeting on the AngelMed Guardian System.
PMID: 27436882 [PubMed - in process] (Source: Circulation)
Source: Circulation - July 19, 2016 Category: Cardiology Authors: Rogers T, Steinvil A, Torguson R, Waksman R Tags: Circulation Source Type: research

E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability. Notice.
E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability. Notice. Fed Regist. 2016 Jul 19;81(138):46938-40 Authors: Food and Drug Administration, HHS Abstract The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances ...
Source: Fed Regist - July 19, 2016 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Generic Drug Approvals Since the 1984 Hatch-Waxman Act
This study uses US Food and Drug Administration data to identify approved generic drugs manufactured between September 30, 1984, and January 11, 2016 and compares the effects of number of generic drugs associated with brand-name drugs. (Source: JAMA Internal Medicine)
Source: JAMA Internal Medicine - July 18, 2016 Category: Internal Medicine Source Type: research