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New and Emerging Biological Medications for Asthma, Allergic Rhinitis and Chronic Rhinosinusitis: a Concise Review
AbstractPurpose of ReviewThe purpose of the study is to survey the current literature describing the use of biologic agents in the treatment of asthma, allergic rhinitis, and chronic rhinosinusitis.Recent FindingsThe Food and Drug Administration (FDA) has approved three biologic agents for asthma and four sublingual immunotherapy (SLIT) products for allergic rhinitis (AR). While no agents are specifically approved for chronic rhinosinusitis (CRS), the overlap between asthma, AR, and CRS potentially affords FDA-approved treatment options for CRS patients. In addition to currently approved products for these conditions, othe...
Source: Current Otorhinolaryngology Reports - October 16, 2017 Category: ENT & OMF Source Type: research

Genome-Editing Technologies in Adoptive T Cell Immunotherapy for Cancer
AbstractPurpose of ReviewIn this review, we discuss the most recent developments in gene-editing technology and discuss their application to adoptive T cell immunotherapy.Recent FindingsEngineered T cell therapies targeting cancer antigens have demonstrated significant efficacy in specific patient populations. Most impressively, CD19-directed chimeric antigen receptor T cells (CART19) have led to impressive responses in patients with B-cell leukemia and lymphoma. CTL019, or KYMRIAH ™ (tisagenlecleucel), a CD19 CAR T cell product developed by Novartis and the University of Pennsylvania, was recently approved for clini...
Source: Current Hematologic Malignancy Reports - October 16, 2017 Category: Hematology Source Type: research

Defamation lawsuits: academic sword or shield?
Scientists and academics are used to defending their theories, methods, and results in the classroom, at conferences, and in peer‐reviewed publications. But Pieter Cohen, an assistant professor at Harvard Medical School, learned that he had to defend his research in a defamation suit while reading a supplement industry trade publication (Robins, ). Cohen is known as a “dogged detective” for scrutinizing dietary supplements and for advocating for their stricter oversight by the US Food and Drug Administration (FDA). Libel lawsuits have been abused in the USA and UK to cow scientists and publishers into s...
Source: EMBO Molecular Medicine - October 16, 2017 Category: Molecular Biology Authors: Elizabeth Hall ‐Lipsy, Sarah Malanga Tags: Commentary Source Type: research

Depression and Pharmacogenetics
Depression is the most common and leading devastating psychiatric illness that affects a majority of the world population. The treatment of depression has been a challenge for a majority of patients and healthcare practitioners. The advent of pharmacogenomics (PGx) empowered the Food and Drug Administration to approve some antidepressant biomarkers for PGx model of treatment. The PGx testing identifies whether an individual is a poor metabolizer, ultra/rapid metabolizer, intermediate metabolizer, or essential metabolizer of an antidepressants before prescription. (Source: Archives of Psychiatric Nursing)
Source: Archives of Psychiatric Nursing - October 16, 2017 Category: Nursing Authors: David Nana Ampong Source Type: research

Rapid deployment aortic valve systems: The surgeons' alternative to Transcatheter Aortic Valve Implantation?
The authors appreciate the comments and the opportunity to respond. Like other rapid-deployment aortic valve replacement  premarket studies, TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement)1 was a single-armed, observational study approved by the Food and Drug Administration. As we noted in our manuscript, the randomized trial by Borger and colleagues2 demonstrated a 24% reduction in clamp time with the use of the INTUITY valve compared with a conventionally implanted bioprosthetic group. (Source: The Journal of Thoracic and Cardiovascular Surgery)
Source: The Journal of Thoracic and Cardiovascular Surgery - October 15, 2017 Category: Cardiovascular & Thoracic Surgery Authors: Glenn R. Barnhart, W. Randolph Chitwood, Eugene A. Grossi Tags: Acquired: Aortic valve: Letters to the editor Source Type: research

Efficacy and Safety of Pembrolizumab in Patients Enrolled in KEYNOTE-030 in the United States: An Expanded Access Program
KEYNOTE-030 (ClinicalTrials.gov ID, NCT02083484) was a global expanded access program that allowed access to pembrolizumab, an antiprogrammed death 1 antibody, for patients with advanced melanoma before its regulatory approval. Patients with unresectable stage III/IV melanoma that progressed after standard-of-care therapy, including ipilimumab and, if BRAFV600 mutant, a BRAF inhibitor, were eligible to receive pembrolizumab 2 mg/kg every 3 weeks. Response was assessed by immune-related response criteria by investigator review. Adverse events (AEs) were graded according to the National Cancer Institute Common Termino...
Source: Journal of Immunotherapy - October 14, 2017 Category: Allergy & Immunology Tags: Basic Studies Source Type: research

Establishing Standards on Colors from Natural Sources
Abstract Color additives are applied to many food, drug, and cosmetic products. With up to 85% of consumer buying decisions potentially influenced by color, appropriate application of color additives and their safety is critical. Color additives are defined by the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) as any dye, pigment, or substance that can impart color to a food, drug, or cosmetic or to the human body. Under current U.S. Food and Drug Administration (FDA) regulations, colors fall into 2 categories as those subject to an FDA certification process and those that are exempt from certification often refe...
Source: Journal of Food Science - October 14, 2017 Category: Food Science Authors: James E. Simon, Eric A. Decker, Mario G. Ferruzzi, M. Monica Giusti, Carla D. Mejia, Mark Goldschmidt, Stephen T. Talcott Tags: Concise Reviews & Hypotheses in Food Science Source Type: research

Vaxchora: The First FDA-Approved Cholera Vaccination in the United States.
Authors: Mosley JF, Smith LL, Brantley P, Locke D, Como M Abstract Vaxchora is the first vaccine approved by the Food and Drug Administration for the prophylaxis of cholera infection. Cholera, a potentially life-threatening bacterial infection that occurs in the intestines and causes severe diarrhea and dehydration, has a low incidence in the U.S., but a high incidence in Africa, Southeast Asia, and other locations around the world. These areas draw travelers from the U.S., so cholera can present in patients who return from visits to these regions. Previous means of prophylaxis included the use of doxycycline for t...
Source: P and T - October 13, 2017 Category: Drugs & Pharmacology Tags: P T Source Type: research

Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association –cardiac safety research consortium cosponsored think tank
Publication date: December 2017 Source:American Heart Journal, Volume 194 Author(s): Harry A. Seifert, Raleigh E. Malik, Mondira Bhattacharya, Kevin R. Campbell, Sally Okun, Carrie Pierce, Jeffrey Terkowitz, J. Rick Turner, Mitchell W. Krucoff, Gregory E. Powell This white paper provides a summary of the presentations and discussions from a think tank on “Enabling Social Listening for Cardiac Safety Monitoring” trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016....
Source: American Heart Journal - October 13, 2017 Category: Cardiology Source Type: research

Inhibitory effect of the anthelmintic drug pyrvinium pamoate on T315I BCR ‑ABL‑positive CML cells.
Inhibitory effect of the anthelmintic drug pyrvinium pamoate on T315I BCR‑ABL‑positive CML cells. Mol Med Rep. 2017 Oct 02;: Authors: Zhang J, Jin Y, Pan J Abstract Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder characterized by a chromosome translocation that generates the BCR‑ABL oncogene, which encodes a constitutively activated tyrosine kinase. Despite progress in controlling CML at the chronic phase by first and second generations of BCR‑ABL tyrosine kinase inhibitors (TKIs), effective drugs with good safety are not available for CML patients harboring T315I BCR‑A...
Source: Molecular Medicine Reports - October 11, 2017 Category: Molecular Biology Tags: Mol Med Rep Source Type: research

Dihydroxyacetone and sunless tanning: Knowledge, myths, and current understanding
Sunless tanning products, which contain dihydroxyacetone (DHA), produce a relatively long-lasting simulated tan without the risks of photodamage. DHA is a sugar that interacts with proteins in the skin to form brown-colored products called melanoidins.1 This reaction is limited to the stratum corneum, and in  vitro skin absorption studies have found no significant systemic absorption of DHA when applied topically to the skin.2 In this Commentary, we review current misconceptions among the lay media and general public about the established risks of DHA-containing sunless tanning products, as well as US Food and Drug Ad...
Source: Journal of the American Academy of Dermatology - October 11, 2017 Category: Dermatology Authors: Amy Huang, Neil Brody, Tracey N. Liebman Tags: Commentary Source Type: research

Updates on cardiovascular outcome trials in diabetes
In 2008 the Food and Drug Administration introduced a guidance for industry that requires the investigation of cardiovascular outcomes of glucose-lowering medications. Since then, an increasing number of cardi... (Source: Cardiovascular Diabetology)
Source: Cardiovascular Diabetology - October 11, 2017 Category: Cardiology Authors: Oliver Schnell, Lars Ryd én, Eberhard Standl and Antonio Ceriello Tags: Review Source Type: research

Quality and Safety in Health Care, Part XXIX: The Transcatheter Valve Therapy Registry
Abstract: The American College of Cardiology, the Society of Thoracic Surgeons, and other organizations cooperated to form the Transcatheter Valve Therapy Registry. This registry studies information on the outcome of valve therapy device placement with a transcatheter approach. The companies that manufacture these devices can use the registry to meet the post–product sale surveillance requirements of the US Food and Drug Administration. There will also be linkage to the registry information from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, which has information on open cardiac valve surgery. (Sour...
Source: Clinical Nuclear Medicine - October 10, 2017 Category: Nuclear Medicine Tags: From the American College of Nuclear Medicine Source Type: research

FDA announces $22m for research into products for patients with rare diseases
The US Food and Drug Administration (FDA) has  announced research grants of more than $22m to develop products for patients with rare diseases over the next four years. (Source: The Pharmaceutical Journal)
Source: The Pharmaceutical Journal - October 10, 2017 Category: Drugs & Pharmacology Source Type: research

Characteristics and Changes of Pediatric Therapeutic Trials under the Best Pharmaceuticals for Children Act
Before 1997, children were usually excluded from therapeutic trials for numerous reasons. Therefore, most drug and biological products lacked adequate pediatric information in labeling.1,2 The Best Pharmaceuticals for Children Act (BPCA)3 and the Pediatric Research Equity Act (PREA)4 use incentives and requirements, respectively, to address this gap, spurring pediatric drug research and development to inform new pediatric drug labeling by allowing the US Food and Drug Administration (FDA) to request and require studies. (Source: The Journal of Pediatrics)
Source: The Journal of Pediatrics - October 10, 2017 Category: Pediatrics Authors: Debbie Avant, Gerold T. Wharton, Dianne Murphy Tags: Medical progress Source Type: research

Clinical Guidance for Managing Statin and Antimicrobial Drug-Drug Interactions
AbstractPurpose of ReviewThis review discusses potential drug-drug interactions between statins and antimicrobials and provides clinician ’s guidance on how to manage these interactions.Recent FindingsIn addition to statin utilization increasing in recent years, there is greater emphasis on using moderate to high-intensity statin doses. Statin-related adverse effects are often dose-dependent; therefore, patients may be at increased risk. Antimicrobial use has also increased in recent years, and various efforts have been implemented to ensure appropriate use of antimicrobials. Commonly used antimicrobials, such as mac...
Source: Current Atherosclerosis Reports - October 9, 2017 Category: Cardiology Source Type: research

Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network
AbstractPurpose of ReviewAn important component of the Food and Drug Administration ’s Sentinel Initiative is the active post-market risk identification and analysis (ARIA) system, which utilizes semi-automated, parameterized computer programs to implement propensity-score adjusted and self-controlled risk interval designs to conduct targeted surveillance of medical products in t he Sentinel Distributed Database. In this manuscript, we review literature relevant to the development of these programs and describe their application within the Sentinel Initiative.Recent FindingsThese quality-checked and publicly availabl...
Source: Current Epidemiology Reports - October 6, 2017 Category: Epidemiology Source Type: research

Adverse Effects of Nutraceuticals and Dietary Supplements.
Abstract Over 70% of Americans take some form of dietary supplement every day, and the supplement industry is currently big business, with a gross of over $28 billion. However, unlike either foods or drugs, supplements do not need to be registered or approved by the US Food and Drug Administration (FDA) prior to production or sales. Under the Dietary Supplement Health and Education Act of 1994, the FDA is restricted to adverse report monitoring postmarketing. Despite widespread consumption, there is limited evidence of health benefits related to nutraceutical or supplement use in well-nourished adults. In contrast...
Source: Annual Review of Pharmacology and Toxicology - October 6, 2017 Category: Drugs & Pharmacology Authors: Ronis MJJ, Pedersen KB, Watt J Tags: Annu Rev Pharmacol Toxicol Source Type: research

Morcellation of occulted sarcomas during laparoscopic myomectomy and hystrectomy for patients with large fibroid uterus.
Authors: Tinelli A, Farghaly SA Abstract In April 2014, the United States of America Food and Drug Administration (FDA) published a safety communication warning of the risk of an unsuspected uterine sarcoma being morcellated during a laparoscopic procedure, and advised against the use of power morcellation. In November of the same year, this agency stated: 1. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for "en bloc" tissue removal. 2. Laparoscopic power morcellators are contr...
Source: Minerva Ginecologica - October 5, 2017 Category: OBGYN Tags: Minerva Ginecol Source Type: research

Venetoclax for the treatment of chronic lymphocytic leukemia.
Authors: Gentile M, Petrungaro A, Uccello G, Vigna E, Recchia AG, Caruso N, Bossio S, De Stefano L, Palummo A, Storino F, Martino M, Morabito F Abstract INTRODUCTION: Venetoclax, an orally bioavailable inhibitor of BCL-2, was approved in 2016 by the United States Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL) patients with 17p deletion [del(17p)], who have received at least one prior therapy. Areas covered: We focus on the mechanism of action of venetoclax and on the clinical trial data that led to approval of venetoclax for CLL patients. We also review the studies in whi...
Source: Expert Opinion on Investigational Drugs - October 5, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Investig Drugs Source Type: research

How can one optimize induction therapy in AML?
Publication date: Available online 4 October 2017 Source:Best Practice & Research Clinical Haematology Author(s): Selina M. Luger Induction therapy for acute myeloid leukemia has not changed much since 1973, when the 7 + 3 regimen of cytarabine and daunorubicin was born. Since then, various strategies have been evaluated to improve patient response, including dose intensification, the incorporation of additional agents into the regimen, the development of novel agents, and modified approaches for older patients. Recently, two novel agents, CPX-351 and gemtuzumab ozogamicin, have been approved by the US F...
Source: Best Practice and Research Clinical Haematology - October 5, 2017 Category: Hematology Source Type: research

How can one optimize induction therapy in AML?
Induction therapy for acute myeloid leukemia has not changed much since 1973, when the 7  + 3 regimen of cytarabine and daunorubicin was born. Since then, various strategies have been evaluated to improve patient response, including dose intensification, the incorporation of additional agents into the regimen, the development of novel agents, and modified approaches for older patients . Recently, two novel agents, CPX-351 and gemtuzumab ozogamicin, have been approved by the US Food and Drug Administration. (Source: Best Practice and Research. Clinical Haematology)
Source: Best Practice and Research. Clinical Haematology - October 5, 2017 Category: Hematology Authors: Selina M. Luger Source Type: research

Impact of Federal Regulatory Changes on Clinical Pharmacology and Drug Development: the Common Rule and the 21st Century Cures Act.
Abstract The Federal Policy for the Protection of Human Subjects, generally referred to as the "Common Rule," is the basis for the human research protection policies of 16 signatory federal agencies and governs virtually all federally funded research involving humans. The Common Rule was originally published in 1991. It has been recognized that changes to the Common Rule are needed to accommodate changes in the research environment and advances in information technology. The Department of Health & Human Services (HHS) issued an Advance Notice of Proposed Rulemaking in the Federal Register in 2011 and...
Source: The Journal of Clinical Pharmacology - October 5, 2017 Category: Drugs & Pharmacology Authors: Burris JF, Puglisi JT Tags: J Clin Pharmacol Source Type: research

Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-Daily Extended-Release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.
This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands. METHODS: Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispens...
Source: Clinical Therapeutics - October 5, 2017 Category: Drugs & Pharmacology Authors: Park-Wyllie L, van Stralen J, Castillon G, Sherman SE, Almagor D Tags: Clin Ther Source Type: research

Applications of contrast-enhanced ultrasound in the pediatric abdomen
AbstractContrast-enhanced ultrasound (CEUS) is a radiation-free, safe, and in specific clinical settings, highly sensitive imaging modality. Over the recent decades, there is cumulating experience and a large volume of published safety and efficacy data on pediatric CEUS applications. Many of these applications have been directly translated from adults, while others are unique to the pediatric population. The most frequently reported intravenous abdominal applications of CEUS in children are the characterization of focal liver lesions, monitoring of solid abdominal tumor response to treatment, and the evaluation of intra-a...
Source: Abdominal Imaging - October 4, 2017 Category: Radiology Source Type: research

Simultaneous LC-MS/MS analysis of eicosanoids and related metabolites in human serum, sputum, and BALF.
Abstract The differences among individual eicosanoids in eliciting different physiological and pathological responses are largely unknown because of the lack of valid and simple analytical methods for the quantification of individual eicosanoids and their metabolites in serum, sputum, and BALF. Therefore, a simple and sensitive LC-MS/MS method for the simultaneous quantification of 34 eicosanoids in human serum, sputum, and BALF was developed and validated. This method is valid and sensitive with a limit of quantification ranging from 0.2 to 3 ng/ml for the various analytes, has a large dynamic range (500 ng/ml), ...
Source: Biomedical Chromatography : BMC - October 4, 2017 Category: Biomedical Science Authors: Thakare R, Chhonker YS, Gautam N, Nelson A, Casaburi R, Criner G, Dransfield MT, Make B, Schmid KK, Rennard SI, Alnouti Y Tags: Biomed Chromatogr Source Type: research

Personalized medicine and Hispanic health: improving health outcomes and reducing health disparities – a National Heart, Lung, and Blood Institute workshop report
AbstractPersons of Hispanic/Latino descent may represent different ancestries, ethnic and cultural groups and countries of birth. In the U.S., the Hispanic/Latino population is projected to constitute 29% of the population by 2060. A personalized approach focusing on individual variability in genetics, environment, lifestyle and socioeconomic determinants of health may advance the understanding of some of the major factors contributing to the health disparities experienced by Hispanics/Latinos and other groups in the U.S., thus leading to new strategies that improve health care outcomes. However, there are major gaps in ou...
Source: BMC Proceedings - October 3, 2017 Category: Biomedical Science Source Type: research

Tri-Ponderal Mass Index and Body Fat Percentages in Adolescents —Reply
In Reply We thank Kelly et al for their suggestion to investigate the accuracy of the triponderal mass index (TMI; weight/height3) vs body mass index in estimating visceral adipose tissue (VAT) percentage in adolescents. We agree with the authors that estimating VAT may better identify adolescents at risk for insulin resistance and dyslipidemia, leading to better risk stratification. While the National Health and Nutrition Examination Survey data set includes VAT data as measured by the Hologic dual-energy x-ray absorptiometry (DXA) system in adults, it does not include VAT data for adolescents. To date, the US Food and Dr...
Source: JAMA Pediatrics - October 2, 2017 Category: Pediatrics Source Type: research

Medical Devices; Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation. Final order.
Abstract The Food and Drug Administration (FDA or we) is classifying the high intensity ultrasound system for prostate tissue ablation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the high intensity ultrasound system for prostate tissue ablation’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance pa...
Source: Fed Regist - October 2, 2017 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Right-to-Try Investigational Therapies for Incurable Disorders
ABSTRACT Patients with life-threatening disorders such as amyotrophic lateral sclerosis, for which only minimally effective medical therapies currently exist, often seek treatments not proven to be effective and not approved by regulatory agencies for use outside of experimental treatment trials. The expanded access (compassionate use) provisions of the US Food and Drug Administration (FDA) for access to such therapies are often perceived as being inadequate. In response, states have passed right-to-try laws designed to improve access to experimental therapies for patients willing to assume the risks associated with such t...
Source: CONTINUUM: Lifelong Learning in Neurology - October 1, 2017 Category: Neurology Tags: Ethical and Medicolegal Issues Source Type: research

Harnessing basic and clinic tools to evaluate SGLT2 inhibitor nephrotoxicity
Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a new class of medications that target the transporter that reabsorbs ~90% of glucose in the S1 segment of the proximal convoluted tubule. As a result, SGLT2 inhibition increases urinary glucose excretion, effectively lowering plasma glucose levels. In addition to reducing hemoglobin A1c levels, these drugs also lower body weight, blood pressure, and uric acid levels in Type 2 diabetes mellitus (T2DM) patients. Importantly, empagliflozin has been observed to slow progression of kidney disease and reduce dialysis requirements in T2DM patients. However, the Food and Drug ...
Source: AJP: Renal Physiology - October 1, 2017 Category: Urology & Nephrology Authors: Saly, D. L., Perazella, M. A. Tags: PERSPECTIVE Source Type: research

Usefulness of radium-223 in patients with bone metastases.
Abstract Castration-resistant prostate osseous metastases can be challenging to treat. There is a new era of clinical advancement with the Food and Drug Administration approval of radium-223 for use in these patients. Radium-223 is the only clinically used therapeutic radiopharmaceutical that emits alpha particles, making it extremely safe for therapeutic purposes for the patient as well as close contacts. This review discusses radium-223's mechanism of action, pharmacokinetics, indications, and safety profile, as well as findings of concluded clinical trials. PMID: 28966451 [PubMed] (Source: Baylor Universit...
Source: Baylor University Medical Center Proceedings - October 1, 2017 Category: Universities & Medical Training Authors: Gupta N, Devgan A, Bansal I, Olsavsky TD, Li S, Abdelbaki A, Kumar Y Tags: Proc (Bayl Univ Med Cent) Source Type: research

Skeletal and Uterotrophic Effects of Endoxifen in Female Rats.
Abstract Endoxifen, the primary active metabolite of tamoxifen, is currently being investigated as a novel endocrine therapy for the treatment of breast cancer. Tamoxifen is a selective estrogen receptor modulator that elicits potent anti-breast cancer effects. However, long-term use of tamoxifen also induces bone loss in premenopausal women and is associated with an increased risk of endometrial cancer in postmenopausal women. For these reasons, we have used a rat model system to comprehensively characterize the impact of endoxifen on the skeleton and uterus. Our results demonstrate that endoxifen elicits benefic...
Source: Endocrinology - October 1, 2017 Category: Endocrinology Authors: Gingery A, Iwaniec UT, Subramaniam M, Turner RT, Pitel KS, McGovern RM, Reid JM, Marler RJ, Ingle JN, Goetz MP, Hawse JR Tags: Endocrinology Source Type: research

The Rise and Fall of Bone Morphogenetic Protein
BACKGROUND CONTEXT: The United States Food and Drug Administration (FDA) issued a warning in 2008 against the use of recombinant bone morphogenetic protein (BMP). Patient demographics and economic data associated with the insertion of BMP are critical to understanding and improving health care utilization. Given the increasing focus on health care utilization and value-based care, it is essential to understand the demographic and economic data surrounding utilization of BMP. (Source: The Spine Journal)
Source: The Spine Journal - October 1, 2017 Category: Orthopaedics Authors: Joseph L. Laratta, Jamal Shillingford, Comron Saifi, Joseph M. Lombardi, John R. Dimar, Steven D. Glassman, Ronald A. Lehman, Lawrence G. Lenke Source Type: research

Five-Year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease
BACKGROUND CONTEXT: The activL artificial disc received Food and Drug Administration approval in 2015 based on 2-year follow-up data. Long-term outcomes with this lumbar total disc replacement have not been reported to date. (Source: The Spine Journal)
Source: The Spine Journal - October 1, 2017 Category: Orthopaedics Authors: James J. Yue, Rolando Garcia Source Type: research

Household triclosan and triclocarban effects on the infant and maternal microbiome
This study reveals an effect on mothers through oral rather than skin exposure. (Source: EMBO Molecular Medicine)
Source: EMBO Molecular Medicine - October 1, 2017 Category: Molecular Biology Authors: Jessica V Ribado, Catherine Ley, Thomas D Haggerty, Ekaterina Tkachenko, Ami S Bhatt, Julie Parsonnet Tags: Research Article Source Type: research

Response to the Food and Drug Administration warning on the use of anaesthetics in young children.
PMID: 29026047 [PubMed - in process] (Source: Hong Kong Med J)
Source: Hong Kong Med J - October 1, 2017 Category: General Medicine Authors: Wong S, Hui TW Tags: Hong Kong Med J Source Type: research

Levetiracetam ‐induced rhabdomyolysis: Analysis of reports from the Food and Drug Administration's Adverse Event Reporting System database
(Source: Muscle and Nerve)
Source: Muscle and Nerve - September 30, 2017 Category: Internal Medicine Authors: Carla Carnovale, Marta Gentili, Stefania Antoniazzi, Emilio Clementi, Sonia Radice Tags: Letter to the Editor Source Type: research

Emerging treatments in acute myeloid leukemia: current standards and unmet challenges.
Authors: Percival ME, Estey E Abstract Acute myeloid leukemia (AML) is rare and difficult to treat. Although remission is achieved in most patients with newly diagnosed disease, relapse occurs in most cases. For more than 40 years, the standard up-front induction treatment has been a combination of continuous-infusion cytarabine and an anthracycline. Risk stratification by molecular and cytogenetic characteristics and measurable residual disease (MRD) status informs decisions regarding referral to consolidative allogeneic hematopoietic cell transplant. In 2017, for the first time in years, 4 drugs are under conside...
Source: Clinical Advances in Hematology and Oncology - September 29, 2017 Category: Cancer & Oncology Tags: Clin Adv Hematol Oncol Source Type: research

Behind the Black Box: The Evidence for the U.S. Food and Drug Administration Warning about the Risk of General Anesthesia in Children Younger than 3 Years
Summary: On December 14, 2016, the U.S. Food and Drug Administration issued a Drug Safety Communication warning “that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.” Health care professionals were urged to “balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last more than 3 hours or if multiple procedures are required in child...
Source: Plastic and Reconstructive Surgery - September 29, 2017 Category: Cosmetic Surgery Tags: Pediatric/Craniofacial: Special Topics Source Type: research

U.S. Food and Drug Administration Authors Publish Articles on Dermal Filler Materials, Injections, Methods, and Skin Preparation
No abstract available (Source: Plastic and Reconstructive Surgery)
Source: Plastic and Reconstructive Surgery - September 29, 2017 Category: Cosmetic Surgery Tags: Letters Source Type: research

Drug Hypersensitivity and Desensitizations
Hypersensitivity to drugs has increased in the twenty-first century due to an explosion in new and targeted medications to address diseases through personalized and precision medicine. From 45 monoclonal antibodies in 2017, there will be 75 in 2020, with four US Food and Drug Administration approvals targeting allergic diseases in the last 6  months. Small molecules are the newest generation of drugs, and reactions to apparently poorly allergenic compounds are becoming more frequent. As I was working with the authors on their submissions for this issue, I was asked to consult for a pharmaceutical company whose star me...
Source: Immunology and Allergy Clinics of North America - September 29, 2017 Category: Allergy & Immunology Authors: Mariana C. Castells Tags: Preface Source Type: research

Expert Perspectives on Management of Moderate-to-Severe Atopic Dermatitis: A Multidisciplinary Consensus Addressing Current and Emerging Therapies
Publication date: Available online 29 September 2017 Source:The Journal of Allergy and Clinical Immunology: In Practice Author(s): Mark Boguniewicz, Andrew F. Alexis, Lisa A. Beck, Julie Block, Lawrence F. Eichenfield, Luz Fonacier, Emma Guttman-Yassky, Amy S. Paller, David Pariser, Jonathan I. Silverberg, Mark Lebwohl Atopic dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease that affects children and adults. Until recently, the only Food and Drug Administration–approved systemic treatment option for patients with moderate-to-severe AD was systemic steroids, which are not recommended by curre...
Source: The Journal of Allergy and Clinical Immunology: In Practice - September 29, 2017 Category: Allergy & Immunology Source Type: research

Sentinel Modular Program for Propensity Score–Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia
Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. We conducted a cohort assessment to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce in an expedited fashion the known association between glyburide (vs. glipizide) and serious hypoglycemia. Thirteen data partners who contribute to the Sentinel Distributed Database participated in this analysis. A pretested and customizable analytic program was run at each individual site. De-identified summary results from each data partner were returned and aggregated at the Sentinel Operations...
Source: Epidemiology - September 28, 2017 Category: Epidemiology Tags: Methods Source Type: research

Pharmacotherapy of eating disorders
Purpose of review: Medications are commonly prescribed in the treatment of eating disorders. In this review, we discuss relevant medications used for the treatment of bulimia nervosa, binge eating disorder (BED), and anorexia nervosa. We focus on recent research developments, where applicable, in addition to discussing important findings from older studies to provide a complete synopsis of the current evidence base for eating disorder treatment using pharmacologic agents. Recent findings: Medications are generally useful for patients with bulimia nervosa and BED. For bulimia nervosa, antidepressant medications are the pri...
Source: Current Opinion in Psychiatry - September 28, 2017 Category: Psychiatry Tags: EATING DISORDERS: Edited by Hans W. Hoek Source Type: research

Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies
Cariprazine, a potent dopamine D3 and D2 receptor partial agonist antipsychotic with preferential binding to D3 receptors, is Food and Drug Administration approved for treating schizophrenia and manic or mixed episodes of bipolar I disorder. A post-hoc safety/tolerability analysis of data from the four acute trials in the cariprazine schizophrenia clinical development program (NCT00404573; NCT00694707; NCT01104766; NCT01104779) was carried out using the overall safety population (all patients who received ≥1 dose of study drug) and modal daily dose subgroups (1.5–3, 4.5–6, and 9–12 mg/day). Thes...
Source: International Clinical Psychopharmacology - September 28, 2017 Category: Psychiatry Tags: Original Articles Source Type: research

Placebo response in trichotillomania
Trichotillomania is a functionally impairing, often overlooked disorder with no Food and Drug Administration-approved medications indicated for its treatment. The ability of clinical trials to detect the beneficial effects of pharmacologic treatment in trichotillomania has been hampered by the high placebo response rate. Very little is known about baseline demographic and clinical characteristics that may be predictive of placebo response in such patients. Overall, 104 participants assigned to placebo were pooled from five double-blind trials conducted at three sites in the USA and Canada. Participants were classified as p...
Source: International Clinical Psychopharmacology - September 28, 2017 Category: Psychiatry Tags: Original Articles Source Type: research

FDA approves first under-skin continuous glucose monitoring system
The first system that monitors blood glucose levels without the need to take blood has been  approved by the US Food and Drug Administration. (Source: The Pharmaceutical Journal)
Source: The Pharmaceutical Journal - September 28, 2017 Category: Drugs & Pharmacology Source Type: research

Laboratory-Developed Tests: A Legislative and Regulatory Review [Review]
BACKGROUND: Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests—now commonly referred to as laboratory-developed tests (LDTs)—are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT: This review provides an overvie...
Source: Clinical Chemistry - September 28, 2017 Category: Chemistry Authors: Genzen, J. R., Mohlman, J. S., Lynch, J. L., Squires, M. W., Weiss, R. L. Tags: Laboratory Management Review Source Type: research

Interlaboratory validation of an improved method for detection of Cyclospora cayetanensis in produce using a real-time PCR assay.
Abstract A collaborative validation study was performed to evaluate the performance of a new U.S. Food and Drug Administration method developed for detection of the protozoan parasite, Cyclospora cayetanensis, on cilantro and raspberries. The method includes a sample preparation step in which oocysts are recovered from produce using an enhanced produce washing solution containing 0.1% Alconox and a commercially available method to disrupt the C. cayetanensis oocysts and extract DNA. A real-time PCR assay targeting the C. cayetanensis 18S rDNA gene with an internal amplification control to monitor PCR inh...
Source: Food Microbiology - September 26, 2017 Category: Food Science Authors: Murphy HR, Cinar HN, Gopinath G, Noe KE, Chatman LD, Miranda NE, Wetherington JH, Neal-McKinney J, Pires GS, Sachs E, Stanya KJ, Johnson CL, Nascimento FS, Santin M, Molokin A, Samadpour M, Janagama H, Kahler A, Miller C, da Silva AJ Tags: Food Microbiol Source Type: research