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Practice Bulletin No. 168: Cervical Cancer Screening and Prevention.
Authors: Abstract The incidence of cervical cancer in the United States has decreased more than 50% in the past 30 years because of widespread screening. In 1975, the rate was 14.8 per 100,000 women. By 2011, it decreased to 6.7 per 100,000 women. Mortality from the disease has undergone a similar decrease from 5.55 per 100,000 women in 1975 to 2.3 per 100,000 women in 2011 (1). The American Cancer Society (ACS) estimated that there would be 12,900 new cases of cervical cancer in the United States in 2015, with 4,100 deaths from the disease (2). Cervical cancer is much more common worldwide, particularly in count...
Source: Obstetrics and Gynecology - September 25, 2016 Category: OBGYN Tags: Obstet Gynecol Source Type: research

Practice Bulletin No. 168 Summary: Cervical Cancer Screening and Prevention.
Authors: Abstract The incidence of cervical cancer in the United States has decreased more than 50% in the past 30 years because of widespread screening. In 1975, the rate was 14.8 per 100,000 women. By 2011, it decreased to 6.7 per 100,000 women. Mortality from the disease has undergone a similar decrease from 5.55 per 100,000 women in 1975 to 2.3 per 100,000 women in 2011 (1). The American Cancer Society (ACS) estimated that there would be 12,900 new cases of cervical cancer in the United States in 2015, with 4,100 deaths from the disease (2). Cervical cancer is much more common worldwide, particularly in count...
Source: Obstetrics and Gynecology - September 25, 2016 Category: OBGYN Tags: Obstet Gynecol Source Type: research

Targeting Immune Checkpoints in Hematologic Malignancies.
Abstract The use of antibodies that target immune checkpoint molecules on the surface of T-lymphocytes and/or tumor cells has revolutionized our approach to cancer therapy. Cytotoxic-T-lymphocyte antigen (CTLA-4) and programmed cell death protein 1 (PD-1) are the two most commonly targeted immune checkpoint molecules. Although the role of antibodies that target CTLA-4 and PD-1 has been established in solid tumor malignancies and Food and Drug Administration approved for melanoma and non-small cell lung cancer, there remains a desperate need to incorporate immune checkpoint inhibition in hematologic malignancies. U...
Source: Pharmacological Reviews - September 25, 2016 Category: Drugs & Pharmacology Authors: Alatrash G, Daver N, Mittendorf EA Tags: Pharmacol Rev Source Type: research

Association between exogenous testosterone and cardiovascular events: an overview of systematic reviews
Publication date: Available online 23 September 2016 Source:The Lancet Diabetes & Endocrinology Author(s): Oluwadamilola Onasanya, Geetha Iyer, Eleanor Lucas, Dora Lin, Sonal Singh, G Caleb Alexander Given the conflicting evidence regarding the association between exogenous testosterone and cardiovascular events, we systematically assessed published systematic reviews for evidence of the association between exogenous testosterone and cardiovascular events. We searched PubMed, MEDLINE, Embase, Cochrane Collaboration Clinical Trials, ClinicalTrials.gov, and the US Food and Drug Administration website for systematic ...
Source: The Lancet Diabetes and Endocrinology - September 24, 2016 Category: Endocrinology Source Type: research

United states department of health and human services biodosimetry and radiological/nuclear medical countermeasure programs
The United States Department of Health and Human Services (HHS) is fully committed to the development of medical countermeasures to address national security threats from chemical, biological, radiological, and nuclear agents. Through the Public Health Emergency Medical Countermeasures Enterprise, HHS has launched and managed a multi-agency, comprehensive effort to develop and operationalize medical countermeasures. Within HHS, development of medical countermeasures includes the National Institutes of Health (NIH), (led by the National Institute of Allergy and Infectious Diseases), the Office of the Assistant Secretary of ...
Source: Radiation Protection Dosimetry - September 24, 2016 Category: Radiology Authors: Homer, M. J., Raulli, R., DiCarlo-Cohen, A. L., Esker, J., Hrdina, C., Maidment, B. W., Moyer, B., Rios, C., Macchiarini, F., Prasanna, P. G., Wathen, L. Tags: Paper Source Type: research

Access to Emergency Contraception in the Over-the-Counter Era
This study assesses whether LNG EC is sold in accordance with current Food and Drug Administration regulations. (Source: Womens Health Issues)
Source: Womens Health Issues - September 24, 2016 Category: Primary Care Authors: Kelly Cleland, Jamie Bass, Florida Doci, Angel M. Foster Tags: Original article Source Type: research

The promises of quantitative systems pharmacology modelling for drug development
Publication date: Available online 23 September 2016 Source:Computational and Structural Biotechnology Journal Author(s): V.R. Knight-Schrijver, V. Chelliah, L. Cucurull-Sanchez, N. Le Novère Recent growth in annual new therapeutic entity (NTE) approvals by the U.S Food and Drug Administration (FDA) suggests a positive trend in current research and development (R&D) output. Prior to this, the cost of each NTE was considered to be rising exponentially, with compound failure occurring mainly in clinical phases. Quantitative Systems Pharmacology (QSP) modelling, as an additional tool in the drug discovery arsenal, a...
Source: Computational and Structural Biotechnology Journal - September 24, 2016 Category: Biotechnology Source Type: research

FTY720 Reduces Synuclein Pathology [Neurobiology]
Patients with Parkinson's disease (PD) often have aggregated α-synuclein (aSyn) in enteric nervous system (ENS) neurons, which may be associated with the development of constipation. This occurs well before the onset of classic PD motor symptoms. We previously found that aging A53T transgenic (Tg) mice closely model PD-like ENS aSyn pathology, making them appropriate for testing potential PD therapies. Here we show that Tg mice overexpressing mutant human aSyn develop ENS pathology by 4 months. We then evaluated the responses of Tg mice and their WT littermates to the Food and Drug Administration-approved drug FTY720 (fin...
Source: Journal of Biological Chemistry - September 23, 2016 Category: Chemistry Authors: Vidal–Martinez, G., Vargas–Medrano, J., Gil–Tommee, C., Medina, D., Garza, N. T., Yang, B., Segura–Ulate, I., Dominguez, S. J., Perez, R. G. Tags: Molecular Bases of Disease Source Type: research

Comparing episodes of antidepressants use with intermittent episodes of no use: A higher relative risk of suicide attempts but not of suicide at young age
The Food and Drug Administration has issued a number of advisories regarding a possible causal link between antidepressants and suicide behaviour among young persons. We investigated the age dependency of (fatal) suicide attempts associated with antidepressants (N=232,561). By linking insurance claims with the death register of Statistics Netherlands (2002–2011), rates of (fatal) suicide attempts were estimated during antidepressant use and intermittent episodes without use. The age dependency of the relative risk of attempts and of suicide during episodes with compared with episodes without antidepressants was inves...
Source: Journal of Psychopharmacology - September 23, 2016 Category: Psychiatry Authors: Termorshuizen, F., Smeets, H. M., Boks, M. P., Heerdink, E. R. Tags: Original Papers Source Type: research

Effect of wire fretting on the corrosion resistance of common medical alloys
Abstract Metallic medical devices such as intravascular stents can undergo fretting damage in vivo that might increase their susceptibility to pitting corrosion. As a result, the US Food and Drug Administration has recommended that such devices be evaluated for corrosion resistance after the devices have been fatigue tested in situations where significant micromotion can lead to fretting damage. Three common alloys that cardiovascular implants are made from [MP35N cobalt chromium (MP35N), electropolished nitinol (EP NiTi), and 316LVM stainless steel (316LVM)] were selected for this study. In order to evaluate the effect of...
Source: Journal of Biomedical Materials Research Part B: Applied Biomaterials - September 23, 2016 Category: Materials Science Authors: Danyal A. Siddiqui, Shiril Sivan, Jason D. Weaver, Matthew Di Prima Tags: Original Research Report Source Type: research

Isotretinoin treatment in a patient with known peanut allergy and positive IgE test results for soybean
Isotretinoin is a retinoid that is approved by the US Food and Drug Administration for the treatment of acne vulgaris and used off label for other dermatologic conditions, including hidradenitis suppurativa (HS). Isotretinoin decreases comedones and sebum production, influences cell-cycle progression, and reduces inflammation.1 Prescribing information leaflets state that oral isotretinoin is contraindicated in patients with known allergy to isotretinoin, peanut, or soya.2 Soybean oil is found within the capsules; thus, patients with peanut allergy might be considered at risk because of the known cross-reactivity between so...
Source: Annals of Allergy, Asthma and Immunology - September 23, 2016 Category: Allergy & Immunology Authors: Santiago Alvarez-Arango, Angela Hou, Michelle A. Lowes, Elina Jerschow Tags: Letter Source Type: research

A Standardized Ten-Step Approach to the Sizing and Planning of a Fenestrated Endovascular Aortic Aneurysm Repair
Fenestrated endovascular aneurysm repair (EVAR) is now a Food and Drug Administration-approved treatment in the United States for short-neck infrarenal aortic aneurysms and for juxtarenal aortic aneurysms. Fenestrated EVAR repairs necessitate more involved sizing and planning than does standard EVAR. Sizing and planning of fenestrated cases can often appear overly complicated and intimidating and act as a barrier to physicians interested in learning these techniques. This video describes a standardized 10-step approach to the sizing and planning of a fenestrated endovascular aortic aneurysm repair. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - September 22, 2016 Category: Surgery Authors: Andres Schanzer, Jessica Simons, Francesco Aiello, Danielle Doucet, Robert Steppacher, Elias Arous, Louis Messina Tags: Abstract from the 2016 New England Society for Vascular Surgery Annual Meeting Source Type: research

Review Reveals Complex Association Between Hypnotic Medications and Suicidality
Modern hypnotic medications are associated with suicidality, but the association may often be confounded by the presence of mental illness. Moreover, many hypnotic-associated suicides have also involved use of other sedatives or alcohol. Finally, hypnotic-associated suicide may also occur specifically at times of peak drug effect —an occurrence that might be mitigated by judicious prescription and use of hypnotic medications.Those are among the complex findings around the association of hypnotic medications and risk of suicide from areview of literature and Food and Drug Administration (FDA) adverse-event reports publish...
Source: Psychiatr News - September 22, 2016 Category: Psychiatry Tags: ajp in advance FDA hypnotic medications literature review suicide Source Type: research

Robot-assisted laparoscopic liver resection: A review
Publication date: Available online 21 September 2016 Source:Journal of Visceral Surgery Author(s): C. Salloum, C. Lim, A. Malek, P. Compagnon, D. Azoulay Surgery using a robotic platform is expanding rapidly today, with a notable surge since its authorization on the international medical market by the US Food and Drug Administration in 2000. The first hepatectomy by a robotic approach was reported in 2002, 10 years after the first laparoscopic hepatectomy. Yet, in hepatic surgery, series are scarce and the lack of relevant data in the literature is an obstacle to the development of robot-assisted laparoscopic hepatectomy ...
Source: Journal of Visceral Surgery - September 22, 2016 Category: Surgery Source Type: research

Assessment of the Risk of Suicide-Related Events Induced by Concomitant Use of Antidepressants in Cases of Smoking Cessation Treatment with Varenicline and Assessment of Latent Risk by the Use of Varenicline
by Hayato Akimoto, Shinji Oshima, Akio Negishi, Kousuke Ohara, Shigeru Ohshima, Naoko Inoue, Daisuke Kobayashi Smoking Cessation Treatment (SCT) is a policy that has to be promoted for health economics, and expectations for the success of treatments with varenicline (VAR) are large. However, the Food and Drug Administration (FDA) have issued a warning on VAR-induced depression and suicide. In the present s tudy, utilizing the FDA Adverse Event Reporting System (FAERS), we searched for antidepressants (ADs) used during SCT that cause fewer suicide-related events (SRE) (Study 1). We also investigated whether VAR concomitant...
Source: PLoS One - September 22, 2016 Category: Biomedical Science Authors: Hayato Akimoto Source Type: research

Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device. Final order.
Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device. Final order. Fed Regist. 2016 Sep 22;81(184):65279-81 Authors: Food and Drug Administration, HHS Abstract The Food and Drug Administration (FDA) is classifying the strabismus detection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the strabismus detection device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safet...
Source: Fed Regist - September 22, 2016 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Reply
We thank Dr Ding for his interest in our article.1 The Bascom Palmer Eye Institute established a computerized patient database in 1985 with coding by diagnosis and procedure, and this database was used to identify patients for our study. Dr Ding is correct that the Baerveldt glaucoma implant did not receive approval by the Food and Drug Administration until 1991.2 Mitomycin C (MMC) was introduced as an adjunct to trabeculectomy at an earlier date.3 Therefore, it is not surprising that eligible patients who underwent trabeculectomy with MMC were identified in the early years of the database, whereas those who underwent plac...
Source: Ophthalmology - September 21, 2016 Category: Opthalmology Authors: Joseph F. Panarelli, Michael R. Banitt, Steven J. Gedde, Wei Shi, Joyce C. Schiffman, William J. Feuer Tags: Correspondence Source Type: research

Tolerability of Repeat Use of Blue Light Cystoscopy with Hexaminolevulinate for Patients with Urothelial Cell Carcinoma
In this study we examine the tolerability of the repeat use of WLC+BLC. (Source: The Journal of Urology)
Source: The Journal of Urology - September 21, 2016 Category: Urology & Nephrology Authors: Giulia I. Lane, Tracy M. Downs, Ayman Soubra, Amrita Rao, Lauren Hemsley, Christopher Laylan, Fangfang Shi, Badrinath Konety Source Type: research

Tavaborole, a Novel Boron-Containing Small Molecule Pharmaceutical Agent for Topical Treatment of Onychomycosis: I. Reproductive and Developmental Toxicity Studies
Tavaborole is a topical antifungal agent approved by the US Food and Drug Administration for the treatment of toenail onychomycosis. As part of the nonclinical development program, reproductive and developmental toxicity studies were conducted (rat oral fertility and early embryonic development, rat (oral) and rabbit (dermal) embryo–fetal development). There were no effects on fertility or reproductive performance at doses up to 300 mg/kg/d (107 times the maximum recommended human dose [MRHD] based on mean area under the plasma concentration–time curve comparisons). In the rat embryo–fetal development tox...
Source: International Journal of Toxicology - September 21, 2016 Category: Toxicology Authors: Ciaravino, V., Coronado, D., Lanphear, C., Hoberman, A., Chanda, S. Tags: Drug Development and Safety Evaluation Source Type: research

Tavaborole, a Novel Boron-Containing Small Molecule Pharmaceutical Agent for Topical Treatment of Onychomycosis: II. Prenatal and Postnatal Developmental Toxicity and Maternal Function Study
Tavaborole is a topical antifungal agent approved by the US Food and Drug Administration for the treatment of toenail onychomycosis. The effects of tavaborole on gestation, parturition (delivery, labor), offspring development, and survival during the perinatal and postnatal periods were assessed in mated female rats. Females (F0 generation) were administered single daily oral (gavage) doses of 15, 60, or 100 mg/kg/d from gestation day 6 through lactation day 20. The females were allowed to deliver naturally and rear their offspring until lactation day 21, at which time the F0 females were euthanized. One male and female fr...
Source: International Journal of Toxicology - September 21, 2016 Category: Toxicology Authors: Ciaravino, V., Coronado, D., Lanphear, C., Hoberman, A., Chanda, S. Tags: Drug Development and Safety Evaluation Source Type: research

Characterization of a Mouse Model of Oral Potassium Cyanide Intoxication
Potassium cyanide (KCN) is an inhibitor of cytochrome C oxidase causing rapid death due to hypoxia. A well-characterized model of oral KCN intoxication is needed to test new therapeutics under the Food and Drug Administration Animal Rule. Clinical signs, plasma pH and lactate concentrations, biomarkers, histopathology, and cyanide and thiocyanate toxicokinetics were used to characterize the pathology of KCN intoxication in adult and juvenile mice. The acute oral LD50s were determined to be 11.8, 11.0, 10.9, and 9.9 mg/kg in water for adult male, adult female, juvenile male, and juvenile female mice, respectively. The time ...
Source: International Journal of Toxicology - September 21, 2016 Category: Toxicology Authors: Sabourin, P. J., Kobs, C. L., Gibbs, S. T., Hong, P., Matthews, C. M., Patton, K. M., Sabourin, C. L., Wakayama, E. J. Tags: Regular Articles Source Type: research

Neurobehavioral and Cardiovascular Effects of Potassium Cyanide Administered Orally to Mice
This study describes the short- and long-term sensory, motor, cognitive, and behavioral changes associated with oral dosing of a sublethal but toxic dose of KCN utilizing functional observation battery and Tier II CNS testing in adult and juvenile mice of both sexes. Selected tissues (histopathology) were evaluated for changes associated with KCN exposure with special attention to brain regions. Telemetry (adult mice only) was used to evaluate cardiovascular and temperature changes. Neurobehavioral capacity, sensorimotor responsivity or spontaneous locomotor activity, and rectal temperature were significantly reduced in ad...
Source: International Journal of Toxicology - September 21, 2016 Category: Toxicology Authors: Hawk, M. A., Ritchie, G. D., Henderson, K. A., Knostman, K. A. B., Roche, B. M., Ma, Z. J., Matthews, C. M., Sabourin, C. L., Wakayama, E. J., Sabourin, P. J. Tags: Regular Articles Source Type: research

Bone Tissue Regeneration - Application of Mesenchymal Stem Cells and Cellular and Molecular Mechanisms.
Abstract The regeneration of damaged bone tissues to a pre-disease state has been a major goal for both clinicians and researchers worldwide. However, critical-sized bone defects which are unable to heal completely are a major clinical concern because effective, evidence-based regenerative therapy is still missing. Bone tissue engineering, aiming at providing novel and effective materials to promote bone regeneration, has been considered as a promising alternative to the traditional use of autografts, allografts and xenografts based on the fact that engineered bone tissue has limitless supply and has no disease tr...
Source: Current Stem Cell Research and Therapy - September 21, 2016 Category: Stem Cells Authors: Zhang J, Chen J Tags: Curr Stem Cell Res Ther Source Type: research

Clinical Trials Registration and Results Information Submission. Final rule.
Abstract This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act o...
Source: Fed Regist - September 21, 2016 Category: American Health Authors: National Institutes of Health, Department of Health and Human Services Tags: Fed Regist Source Type: research

Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.
Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order. Fed Regist. 2016 Sep 21;81(183):64761-3 Authors: Food and Drug Administration, HHS Abstract The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in orde...
Source: Fed Regist - September 21, 2016 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

The Food and Drug Administration Approves a Multitude of Medical Device Products
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 20, 2016 Category: Medical Equipment Tags: DEPARTMENTS: Washington Scene Source Type: research

Laser and Other Light-Emitting Medical Devices Used in Healthcare Settings—Considerations Regarding Device Safety
This article is intended to provide some technical background, applications, and common safety considerations for these devices. It also touches on the mechanisms for reporting serious adverse effects and medical device malfunctions involving these devices to the US Food and Drug Administration. (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 20, 2016 Category: Medical Equipment Tags: Feature Articles: Online Only Source Type: research

FDA gives orphan drug designation to BIV201 for ascites treatment
The Food and Drug Administration has given an orphan drug designation to the compound BIV201 for the treatment of ascites, according to a press release from the drug’s manufacturer, BioVie. The FDA... (Source: Hospitalist News)
Source: Hospitalist News - September 20, 2016 Category: Hospital Management Source Type: research

[Correspondence] Should testing of donors be restricted to active Zika virus areas?
Jean Michel Mansuy and colleagues1 report the detection of Zika virus in the semen of a patient returning from a non-epidemic area, even while usual recommendations limit testing to only those returning from epidemic areas.1 However, categorisation of Zika-virus-affected countries by WHO, US Centers for Disease Control and Prevention (CDC), US Food and Drug Administration (FDA), European Centre for Disease Prevention and Control (ECDC), and others differ and are often discordant and their update cycles for recommendations for those exposed in endemic and epidemic areas vary in timeliness (appendix). (Source: The Lancet Infectious Diseases)
Source: The Lancet Infectious Diseases - September 20, 2016 Category: Infectious Diseases Authors: Didier Musso, David Baud, David O Freedman Tags: Correspondence Source Type: research

Current management and future directions in metastatic pancreatic adenocarcinoma
This article will review the current treatment standards and emerging targets for metastatic pancreatic cancer. Cancer 2016. © 2016 American Cancer Society. (Source: Cancer)
Source: Cancer - September 20, 2016 Category: Cancer & Oncology Authors: Anna M. Varghese, Maeve A. Lowery, Kenneth H. Yu, Eileen M. O'Reilly Tags: Review Article Source Type: research

Immunotherapy for prostate cancer: False promises or true hope?
Prostate cancer is the most commonly diagnosed cancer, and the second leading cause of cancer‐related death for men in the United States. Despite the approval of several new agents for advanced disease, each of these has prolonged survival by only a few months. Consequently, new therapies are sorely needed. For other cancer types, immunotherapy has demonstrated dramatic and durable treatment responses, causing many to hope that immunotherapies might provide an ideal treatment approach for patients with advanced prostate cancer. However, apart from sipuleucel‐T, prostate cancer has been conspicuously absent from the lis...
Source: Cancer - September 20, 2016 Category: Cancer & Oncology Authors: Brian T. Rekoske, Douglas G. McNeel Tags: Review Article Source Type: research

A Multiplexed High-Content Screening Approach Using the Chromobody Technology to Identify Cell Cycle Modulators in Living Cells
This study demonstrates that CCC imaging is a versatile high-content screening approach to identify cell cycle modulators, which can be multiplexed with cytotoxicity assays for early elimination of toxic compounds during screening. (Source: Journal of Biomolecular Screening)
Source: Journal of Biomolecular Screening - September 20, 2016 Category: Molecular Biology Authors: Schorpp, K., Rothenaigner, I., Maier, J., Traenkle, B., Rothbauer, U., Hadian, K. Tags: Original Research Source Type: research

Electronic Cigarette Toxicity.
Abstract Electronic cigarettes (e-cigarettes) are often advertised as a healthier product when compared with traditional cigarettes. Currently, there are limited data to support this and only a threat of federal regulation from the US Food and Drug Administration. Calls to poison control centers about e-cigarette toxicity, especially in children, and case reports of toxic exposures have increased over the past 3 years. This research letter reports the frequency of hazardous exposures to e-cigarettes and characterizes the reported adverse health effects associated with e-cigarette toxicity. PMID: 27650036 [Pub...
Source: Primary Care - September 20, 2016 Category: Primary Care Authors: Payne JD, Michaels D, Orellana-Barrios M, Nugent K Tags: J Prim Care Community Health Source Type: research

A new paediatric formulation of valaciclovir: development and bioequivalence assessment
A paediatric formulation of valaciclovir with acceptable palatability, good pharmaceutical quality and stability, and with the possibility of flexible dosing is currently not available. A preparation of valaciclovir liquid using crushed tablets as described in the US Food and Drug Administration label information was found not to be adequate for use in daily practice.1 The mean relative bioavailability of this liquid compared with the tablets was reported to be 91.1% (SD, 33.1%), but was not investigated following the regulatory guidance for bioequivalence testing.2 Aim of this study was to develop a new paediatric formula...
Source: Archives of Disease in Childhood - September 19, 2016 Category: Pediatrics Authors: Bastiaans, D. E. T., Bartels-Wilmer, C. M., Colbers, A. P. H., Heijens, C. A. W., Velthoven-Graafland, K., Smeets, O. S. N. M., Vink, N., Harbers, V. E. M., Warris, A., Burger, D. M. Tags: ADC Drug Therapy, Headache (including migraine), Pain (neurology), Diet, Medicines regulation, Research and publication ethics Source Type: research

Bias in the reporting of harms in clinical trials of second-generation antidepressants for depression and anxiety: A meta-analysis
Previous research has shown that reporting bias has inflated the apparent efficacy of antidepressants. We investigated whether apparent safety was also affected. We included 133 trials, involving 31,296 patients, of second-generation antidepressants for the treatment of major depressive disorder (MDD) or anxiety disorders, obtained from Food and Drug Administration (FDA) reviews. We extracted data on overall discontinuation, discontinuation due to adverse events, and serious adverse events (SAEs). (Source: European Neuropsychopharmacology)
Source: European Neuropsychopharmacology - September 19, 2016 Category: Psychiatry & Psychology Authors: Ymkje Anna de Vries, Annelieke M. Roest, Lian Beijers, Erick H. Turner, Peter de Jonge Source Type: research

A Critical Review of Biosimilars in IBD: The Confluence of Biologic Drug Development, Regulatory Requirements, Clinical Outcomes, and Big Business
Abstract: On February 9, 2016, the Food and Drug Administration Arthritis Advisory Committee recommended by a vote of 21 to 3, that the biosimilar to infliximab, CT-P13, be approved for rheumatoid arthritis and ankylosing spondylitis and, by extrapolation, for all the indications for which infliximab is currently approved, including adult and pediatric ulcerative colitis and Crohn's disease. On April 5, 2016, the Food and Drug Administration concurred with this recommendation and approved CT-P13 (Inflectra; Pfizer Inc.) for all diseases for which infliximab had previously been approved, including adult and pediatric modera...
Source: Inflammatory Bowel Diseases - September 16, 2016 Category: Gastroenterology Tags: Clinical Review Articles Source Type: research

Predicting toxicities in humans by nonclinical safety testing: an update with particular reference to anticancer compounds.
Abstract The sensitivity of the various preclinical models used to predict toxicity in humans varies. In this review, we analyze the various models used to predict safety in drug discovery and development with a view to understanding their translational value in humans. Twenty recently approved anticancer drugs were studied and the available nonclinical and clinical adverse effects information available from the US Food and Drug Administration (FDA) was analyzed. We found that gastrointestinal and hematopoietic toxicities were predicted to the maximum extent by nonclinical models, whereas respiratory, integumentar...
Source: Drug Discovery Today - September 16, 2016 Category: Drugs & Pharmacology Authors: Ahuja V, Bokan S, Sharma S Tags: Drug Discov Today Source Type: research

[Letter to the Editor] NaOH concentration and streptavidin bead type are key factors for optimal DNA aptamer strand separation and isolation.
Abstract Address correspondence to Geoffrey K. Kilili or Christine M. Karbiwnyk, Winchester Engineering and Analytical Center, US Food and Drug Administration, Winchester, MA, 01890. E-mail: Geoffrey.Kilili@fda.hhs.gov or Christine.Karbiwnyk@fda.hhs.gov. PMID: 27625204 [PubMed - in process] (Source: BioTechniques)
Source: BioTechniques - September 15, 2016 Category: Biotechnology Authors: Kilili GK, Tilton L, Karbiwnyk CM Tags: Biotechniques Source Type: research

Safety and tolerability review of lorcaserin in clinical trials
Summary Lorcaserin is a novel selective serotonin 2C receptor agonist indicated by the US Food and Drug Administration for chronic weight management in adults with obesity or overweight with ≥1 comorbidity. The safety and efficacy of lorcaserin were established during two Phase III clinical trials in patients without diabetes (BLOOM and BLOSSOM) and one Phase III clinical trial in patients with type 2 diabetes (BLOOM‐DM). Headache was the most common adverse event experienced by patients during all Phase III trials. Additional adverse events occurring in >5% of patients receiving lorcaserin included dizziness, fatig...
Source: Clinical Obesity - September 15, 2016 Category: Eating Disorders and Weight Management Authors: F. L. Greenway, W. Shanahan, R. Fain, T. Ma, D. Rubino Tags: Review Source Type: research

Trabectedin as a chemotherapy option for patients with brca deficiency
Trabectedin (ET743; Yondelis ®) is a semi-synthetic drug originally isolated from the sea squirt Ecteinascidia turbinata. Trabectedin is the first marine-derived antineoplastic drug approved in 2007 in in the European Union and in over 70 countries across the world for the treatment of patients with advanced soft tissue sarcom a (STS) after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents [1]. In October 2015, following the analysis of a phase III trial in patients with advanced liposarcoma or leiomyosarcoma after failure of prior anthracycline-containing chemotherapy, trabectedin was ...
Source: Cancer Treatment Reviews - September 15, 2016 Category: Cancer & Oncology Authors: Bradley J. Monk, Domenica Lorusso, Antoine Italiano, Stan B. Kaye, Miguel Aracil, Adnan Tanovi ć, Maurizio D’Incalci Tags: Anti-Tumour Treatment Source Type: research

What's New in Genetic Testing for Cancer Susceptibility?
Abstract The advent of next-generation sequencing, and its transition further into the clinic with the US Food and Drug Administration approval of a cystic fibrosis assay in 2013, have increased the speed and reduced the cost of DNA sequencing. Coupled with a historic ruling by the Supreme Court of the United States that human genes are not patentable, these events have caused a seismic shift in genetic testing in clinical medicine. More labs are offering genetic testing services; more multigene panels are available for gene testing; more genes and gene mutations are being identified; and more variants of uncertai...
Source: Oncology (Williston Park, N.Y.) - September 15, 2016 Category: Cancer & Oncology Authors: Plichta JK, Griffin M, Thakuria J, Hughes KS Tags: Oncology (Williston Park) Source Type: research

Postorthopedic Surgery Joint Replacement Surgery Venous Thromboembolism Prophylaxis
Elective total hip or knee arthroplasty places patients at risk for venous thromboembolism (VTE). As our understanding of the pathophysiology of VTE after joint arthroplasty has increased, pharmacologic strategies have been developed to target different aspects of the coagulation cascade. Various approaches have been used as risk reduction strategies. In 2011 and 2014 the Food and Drug Administration approved rivaroxaban and apixaban as new oral antithrombotic agents. Although controversies remain with regard to the ideal VTE pharmacoprophylactic agent, this class of novel oral anticoagulants has been demonstrated to be sa...
Source: Hematology/Oncology Clinics of North America - September 14, 2016 Category: Cancer & Oncology Authors: Louis M. Kwong, Jon A. Kimball Source Type: research

Design, fabrication and biomedical applications of zein-based nano/micro-carrier systems
Publication date: 20 November 2016 Source:International Journal of Pharmaceutics, Volume 513, Issues 1–2 Author(s): Yong Zhang, Lili Cui, Feng Li, Nianqiu Shi, Chunlei Li, Xianghui Yu, Yan Chen, Wei Kong Nano/micro-carrier systems have shown promising application in the biomedical field as various delivery carriers. The composite material and fabrication method determine their microstructures, properties and thus their potential applications. Since approved as tablet coating material by the U.S. Food and Drug Administration (US-FDA), zein has been widely investigated as one of protein-based materials in the past few dec...
Source: International Journal of Pharmaceutics - September 14, 2016 Category: Drugs & Pharmacology Source Type: research

Disposing of Unused Medications: Have We Been Doing it All Wrong?
Most physicians probably give little thought to the estimated 10-30% of medications that patients don ’t end up consuming (1). On the rare occasion when patients do ask their doctors where to dispose of unused medications, a physician could hardly be criticized for recommending disposal in the household garbage. Indeed, until recently, trash disposal was assumed by most clinicians and patients, as well as the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), to be a safe and environmentally friendly method of disposing of unused pills. (Source: The American Journal of Medicine)
Source: The American Journal of Medicine - September 14, 2016 Category: Journals (General) Authors: Michael E. Hochman Tags: Commentary Source Type: research

[Research Articles] Treatment of otitis media by transtympanic delivery of antibiotics
Otitis media is the most common reason U.S. children receive antibiotics. The requisite 7- to 10-day course of oral antibiotics can be challenging to deliver in children, entails potential systemic toxicity, and encourages selection of antimicrobial-resistant bacteria. We developed a drug delivery system that, when applied once to the tympanic membrane through the external auditory canal, delivers an entire course of antimicrobial therapy to the middle ear. A pentablock copolymer poloxamer 407–polybutylphosphoester (P407-PBP) was designed to flow easily during application and then to form a mechanically strong hydrog...
Source: Science Translational Medicine - September 14, 2016 Category: Biomedical Science Authors: Yang, R., Sabharwal, V., Okonkwo, O. S., Shlykova, N., Tong, R., Lin, L. Y., Wang, W., Guo, S., Rosowski, J. J., Pelton, S. I., Kohane, D. S. Tags: Research Articles Source Type: research

Do not mess with Texas: A landmark victory for abortion access and the road ahead
As an abortion provider and recently returned Texan, I watched with dismay on July 18, 2013 when former Texas Governor Rick Perry signed House Bill 2 (HB2) into law. Despite a powerful 11-h filibuster by then Senator Wendy Davis, a number of acrimonious abortion restrictions became law in a state with 5.4 million people of reproductive age. These provisions included a ban on abortions at 20 weeks postfertilization, requirement that medication abortions be provided according to an outdated Food and Drug Administration protocol, that physicians providing abortion care have admitting privileges at a hospital within 30 miles a...
Source: Contraception - September 14, 2016 Category: OBGYN Authors: Bhavik Kumar Tags: Letter to the editor Source Type: research

Evidence and Access to Biomedical Interventions: The Case of Stem Cell Treatments
The controversy over patients’ access to stem cell interventions is familiar to scholars of the drug regulatory system and the politics of evidence-based medicine. What counts as evidence of a biomedical intervention's safety and effectiveness? Who should define and assess safety and effectiveness, and how? In the first section of the paper we describe the types of stem cells that may be therapeutically effective. We then describe how the US Food and Drug Administration asserted regulatory authority over certain stem cell interventions and the legal challenge to the agency's actions. Next, we place the debate about p...
Source: Journal of Health Politics, Policy and Law - September 12, 2016 Category: Health Management Authors: Maschke, K. J., Gusmano, M. K. Tags: Health Policy & Education, Political Science, General, Public Policy Articles Source Type: research

Bortezomib alleviates experimental pulmonary hypertension by regulating intracellular calcium homeostasis in PASMCs
In this study we aim to determine whether BTZ attenuates the hypoxia-induced elevation of [Ca2+] in PASMCs and the signaling pathway involved in this mechanism. Our results showed that 1) in hypoxia- and monocrotaline-induced rat pulmonary hypertension (PH) models, BTZ markedly attenuated the development and progression of PH, 2) BTZ inhibited the hypoxia-induced increase in cell proliferation, basal [Ca2+]i, and SOCE in PASMCs, and 3) BTZ significantly normalized the hypoxia-upregulated expression of hypoxia-inducible factor-1α, bone morphogenetic protein 4, canonical transient receptor potential isoforms 1 and 6, a...
Source: AJP: Cell Physiology - September 12, 2016 Category: Cytology Authors: Zhang, J., Lu, W., Chen, Y., Jiang, Q., Yang, K., Li, M., Wang, Z., Duan, X., Xu, L., Tang, H., Sun, D., Wang, J. Tags: CALL FOR PAPERS Source Type: research

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.
JR, Turk DC, Twersky RS, Sessler DI Abstract The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public-private partnership with the US Food and Drug Administration, convened a meeting of sedation experts from a variety of clinical specialties and research backgrounds with the objective of developing recommendations for procedural sedation research. Four core outcome domains were recommended for consideration in sedation clinical trials: (1) safety, ...
Source: Anesthesia and Analgesia - September 12, 2016 Category: Anesthesiology Authors: Williams MR, Ward DS, Carlson D, Cravero J, Dexter F, Lightdale JR, Mason KP, Miner J, Vargo JJ, Berkenbosch JW, Clark RM, Constant I, Dionne R, Dworkin RH, Gozal D, Grayzel D, Irwin MG, Lerman J, O'Connor RE, Pandharipande P, Rappaport BA, Riker RR, Tobi Tags: Anesth Analg Source Type: research

Ezetimibe, an NPC1L1 inhibitor, is a potent Nrf2 activator that protects mice from diet-induced nonalcoholic steatohepatitis.
In this study, we found that oxidative stress or inflammatory biomarkers and TUNEL positive cells were markedly increased in NASH patients compared to normal or simple steatosis. In addition, we identified that the hepatic mRNA levels of Nrf2 target genes such as Nqo-1 and GSTA-1 were significantly increased in NASH patients. Ezetimibe, a drug approved by the Food and Drug Administration for the treatment of hypercholesterolemia, improves NAFLD and alleviates oxidative stress. However, the precise mechanism of its antioxidant function remains largely unknown. We now demonstrate that ezetimibe activates Nrf2-Keap1 pathway w...
Source: Free Radical Biology and Medicine - September 12, 2016 Category: Biology Authors: Lee DH, Han DH, Nam KT, Park JS, Kim SH, Lee M, Kim G, Min BS, Cha BS, Lee YS, Sung SH, Jeong H, Ji HW, Lee MJ, Lee JS, Lee HY, Chun Y, Kim J, Komatsu M, Lee YH, Bae SH Tags: Free Radic Biol Med Source Type: research