Food and Drug Administration (FDA) Food and Drug Administration (FDA) RSS feedThis is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

This page shows you the latest research publications in this category.

Experience of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma and relapsed/refractory systemic anaplastic large-cell lymphoma in the Named Patient Program: review of the literature
Brentuximab vedotin (ADCETRIS®; Seattle Genetics, Inc., Bothell, WA, USA, and Takeda Pharmaceuticals International Co., Cambridge, MA, USA), a CD30-targeted antibody-drug conjugate, comprises three components: the anti-CD30 antibody cAC10 [1,2]; the microtubule-disrupting agent monomethyl auristatin E (MMAE) [1,3]; and a protease-cleavable linker that covalently attaches MMAE to cAC10 [1,3,4]. In August 2011, brentuximab vedotin received accelerated approval by the US Food and Drug Administration (FDA) for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after...
Source: Critical Reviews in Oncology Hematology - April 27, 2015 Category: Cancer & Oncology Authors: P.L. Zinzani, S. Sasse, J. Radford, O. Shonukan, V. Bonthapally Source Type: research

Medical Countermeasures for Radiation Exposure and Related Injuries: Characterization of Medicines, FDA-Approval Status and Inclusion into the Strategic National Stockpile
Abstract: World events over the past decade have highlighted the threat of nuclear terrorism as well as an urgent need to develop radiation countermeasures for acute radiation exposures and subsequent bodily injuries. An increased probability of radiological or nuclear incidents due to detonation of nuclear weapons by terrorists, sabotage of nuclear facilities, dispersal and exposure to radioactive materials, and accidents provides the basis for such enhanced radiation exposure risks for civilian populations. Although the search for suitable radiation countermeasures for radiation-associated injuries was initiated more tha...
Source: Health Physics - April 24, 2015 Category: Radiology Tags: Review Paper Source Type: research

Women's experiences with abortion services in Texas in the wake of restrictive legislation
This study assessed women's experiences seeking abortion in Texas after these restrictions were implemented. (Source: Contraception)
Source: Contraception - April 24, 2015 Category: OBGYN Authors: S. Baum, D.A. Grossman, L. Fuentes, K. White, K. Hopkins, J.E. Potter Source Type: research

Safety concerns regarding 5α reductase inhibitors for the treatment of androgenetic alopecia
Purpose of review: To examine the clinical and basic studies regarding persistent adverse effects associated with 5α reductase inhibitor treatment for androgenetic alopecia. Recent findings: Recent postmarketing reports and a US Food and Drug Administration analysis have documented uncommon persistent sexual and nonsexual side-effects in a subset of younger men who have taken finasteride 1 mg for androgenic alopecia. While the mechanisms of the sexual side-effects in humans is incompletely understood, one study found lower cerebrospinal fluid concentrations of dihydrotestosterone, progesterone, dihydroprogesterone and a...
Source: Current Opinion in Endocrinology, Diabetes and Obesity - April 24, 2015 Category: Endocrinology Tags: Special Commentary Source Type: research

The Times They Are A-Changin’: New Antibacterials for Skin and Skin Structure Infections
Abstract Twenty-one agents are approved by the US Food and Drug Administration (FDA) for the therapy of skin and soft tissue infections. Of these, the five newest agents, tedizolid, telavancin, oritavancin, dalbavancin, and ceftaroline, are active against and “non-inferior” to vancomycin against methicillin-resistant Staphylococcus aureus (MRSA). Oritavancin is indicated as a single-dose intravenous regimen, while dalbavancin is a two-dose intravenous regimen given 1 week apart. Telavancin has multiple mechanisms of action. A 6-day regimen of once-daily intravenous or oral dose of tedizolid was compared with 1...
Source: American Journal of Clinical Dermatology - April 24, 2015 Category: Dermatology Source Type: research

Subcutaneous Implantable Cardioverter Defibrillator for Dialysis Patients: A Strategy to Reduce Central Vein Stenoses and Infections
In this report, we present 4 long-term hemodialysis patients treated successfully with an SICD. 3 patients received the device for primary prevention of sudden cardiac death (cardiomyopathy with low ejection fraction). The patient in the fourth case had a prolonged QT interval and received the device for secondary prevention. 3 patients had an arteriovenous fistula, whereas 1 patient was dialyzing with a tunneled dialysis catheter. Insertion of an SICD is a minimally invasive procedure. By virtue of leaving the venous system untouched, this approach might offer the advantage of reduced risk of central venous stenosis and i...
Source: American Journal of Kidney Diseases - April 24, 2015 Category: Urology & Nephrology Source Type: research

Problems in addition to stroke and bleeding after left atrial appendage closure
We read the article by Waksman et al. about the discussions between the US Food and Drug Administration (FDA) and the sponsor regarding approval of the WATCHMAN-device for interventional left atrial appendage closure (LAAC).[1] We would like to stimulate the discussion by the following contribution: LAAC is primarily intended as an alternative for stroke prevention in patients with atrial fibrillation (AF) in whom oral anticoagulation (OAC) is not possible because of contraindications about a high bleeding risk. (Source: The American Journal of Cardiology)
Source: The American Journal of Cardiology - April 24, 2015 Category: Cardiology Authors: Claudia Stöllberger, Josef Finsterer, Birke Schneider Source Type: research

FDA issues final guidance on abuse‐deterrent opioids
On April 1, the Food and Drug Administration issued final guidance on the development of opioids with abuse‐deterrent properties. The FDA is encouraging manufacturers to develop drugs that work when taken as prescribed but deter misuse or abuse, including making it difficult to snort or inject the drugs. While deterrence is not “abuse‐proof,” the FDA said, it is a step toward balancing access to needed medications with the reduction of abuse. (Source: The Brown University Child and Adolescent Psychopharmacology Update)
Source: The Brown University Child and Adolescent Psychopharmacology Update - April 24, 2015 Category: Psychiatry Tags: From the FDA Source Type: research

Reply
We appreciate the interest in our article, “Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN Left Atrial Appendage Closure Therapy,” and that it stimulated provocative discussion in a letter to the editor. First, the WATCHMAN device was approved with the indication to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation, who are at an increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores; are deemed by their physicians to be suitable for warfarin; and have an appropriat...
Source: The American Journal of Cardiology - April 23, 2015 Category: Cardiology Authors: Ron Waksman Source Type: research

Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study
The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. Failure to protect subject safety and to report adverse events to IRBs was found ...
Source: Journal of Medical Ethics - April 23, 2015 Category: Medical Ethics Authors: Shetty, Y. C., Saiyed, A. A. Tags: Press releases Research ethics Source Type: research

The TREAT-NMD advisory committee for therapeutics (TACT): an innovative de-risking model to foster orphan drug development
We present our experience in the establishment and operation of the TACT. TACT provides a unique resource of recognized experts from multiple disciplines. The goal of each TACT review is to help the sponsor to position the candidate compound along a realistic and well-informed plan to clinical trials, and eventual registration. The reviews and subsequent recommendations are focused on generating meaningful and rigorous data that can enable clear go/no-go decisions and facilitate longer term funding or partnering opportunities. The review process thereby acts to comment on viability, de-risking the process of proceeding on ...
Source: BioMed Central - April 22, 2015 Category: Journals (General) Authors: Emma HeslopCristina CsimmaVolker StraubJohn McCallKanneboyina NagarajuKathryn R WagnerDidier CaizerguesRudolf KorinthenbergKevin M FlaniganPetra KaufmannElizabeth McNeilJerry MendellSharon HesterleeDominic J WellsKate Bushbyon behalf of TACT Source Type: research

Counterpoint: Dose Selection for rasH2 Mouse Carcinogenicity Studies.
Abstract Dose selection for the 6-month rasH2 mouse carcinogenicity studies depends heavily on the maximum tolerated dose (MTD) obtained from 1-month range-finding studies. A retrospective evaluation of range-finding studies and pivotal 6 month rasH2 mouse studies for 11 compounds demonstrated that the MTD based on at least a 10% decrease in body weight gain, mortality, and target organ toxicity in range-finding studies appropriately identified high doses for pivotal studies for 8 of 11 compounds. Two of the selected high doses were based on decreased body weight gain alone, while 7 were based on mortality at highe...
Source: Toxicologic Pathology - April 22, 2015 Category: Pathology Authors: Nambiar PR, Morton D Tags: Toxicol Pathol Source Type: research

Applications of In Vitro – In Vivo Correlations in Generic Drug Development: Case Studies
ABSTRACT In vitro–in vivo correlation (IVIVC) is a predictive mathematical model describing the relationship between an in vitro property and a relevant in vivo response. The main objective of an IVIVC is to serve as a surrogate for human bioequivalence (BE) studies, which may reduce the number of BE studies performed during the initial approval process as well as with certain scale-up and postapproval changes. The US Food and Drug Administration (FDA) published a regulatory guidance related to development, evaluation, and applications of IVIVC for extended-release (ER) oral dosage forms in September ...
Source: The AAPS Journal - April 21, 2015 Category: Drugs & Pharmacology Source Type: research

Nonhormonal strategies for hot flushes
A wide choice is available for women who do not wish to use estrogen. Paroxetine, fluoxetine, citalopram, venlafaxine and desvenlafaxine have been found to be effective in several studies. In 2013 the U.S. Food and Drug Administration approved paroxetine to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Clonidine is a centrally acting alpha-adrenoceptor agonist that was developed originally for the treatment of hypertension. It is licensed for the treatment of hot flushes in some countries. (Source: Maturitas)
Source: Maturitas - April 21, 2015 Category: Primary Care Authors: Margaret Rees Tags: INV2 Source Type: research

Clinical Association Between Pharmacogenomics and Adverse Drug Reactions
This article updates our knowledge on how genetic polymorphisms of important genes alter the risk of ADR occurrence after an extensive literature search. To date, at least 244 pharmacogenes identified have been associated with ADRs of 176 clinically used drugs based on PharmGKB. At least 28 genes associated with the risk of ADRs have been listed by the Food and Drug Administration as pharmacogenomic biomarkers. With the availability of affordable and reliable testing tools, pharmacogenomics looks promising to predict, reduce, and minimize ADRs in selected populations. (Source: Drugs)
Source: Drugs - April 21, 2015 Category: Drugs & Pharmacology Source Type: research

“ResQCPR” Could Help Prevent Cardiac Arrest Deaths
The Food and Drug Administration (FDA) last month approved a 2-device system that may help first responders improve patients’ chances of surviving cardiac arrest. (Source: JAMA)
Source: JAMA - April 21, 2015 Category: Journals (General) Source Type: research

First Biosimilar Product Approved
The first biosimilar product in the United States recently gained approval from the Food and Drug Administration (FDA). (Source: JAMA)
Source: JAMA - April 21, 2015 Category: Journals (General) Source Type: research

New Chantix Warnings
Chantix, a prescription medication for smoking cessation, can reduce people’s tolerance for alcohol, the Food and Drug Administration (FDA) warned last month in a safety announcement (http://1.usa.gov/1xd9GLH). (Source: JAMA)
Source: JAMA - April 21, 2015 Category: Journals (General) Source Type: research

Emerging Options for Treating Hepatitis C Infection
Abstract Hepatitis C infection can cause chronic liver disease and liver carcinoma and can necessitate liver transplantation. Of the more than 3 million people infected with hepatitis C, more than two‐thirds were born between 1945 and 1965. Many individuals are unaware that they're infected, which can delay treatment and lead to disease progression. Once infection is diagnosed, typical treatment regimens can involve multiple medications and side effects that can make it challenging for some people to complete therapy. In October 2014 the U.S. Food and Drug Administration (FDA) approved Harvoni®, a fixed dose combination...
Source: AWHONN Lifelines - April 21, 2015 Category: Nursing Authors: Heidi Collins Fantasia Tags: Rx Source Type: research

Response to letter to the Editor regarding 'Classification algorithms for the identification of structural injury in TBI using brain electrical activity'
The articles referred to by Bloom and colleagues in their letter to the Editor, were based on a long period of data acquisition and algorithm development work supported by BrainScope Co., Inc. The articles are fundamental to the signal processing and algorithm methodology used in the development of the Ahead 100 device that received clearance from the United States (US) Food and Drug Administration (FDA) in November 2014. The intent of these articles was to describe the underlying innovative methods which resulted in the classification strategy used for development of this system based on brain electrical activity recorded...
Source: Computers in Biology and Medicine - April 21, 2015 Category: Bioinformatics Authors: Leslie S. Prichep, Samanwoy Ghosh Dastidar, Arnaud Jacquin, William Koppes, Jonathan Miller, Brian O'Neil, Roseanne Naunheim, J. Stephen Huff Tags: Letter to the Editor Source Type: research

Electronic nicotine delivery systems: executive summary of a policy position paper from the american college of physicians.
Abstract Electronic nicotine delivery systems (ENDS), which include electronic cigarettes, or e-cigarettes, are growing in popularity, but their safety and efficacy as a smoking cessation aid are not well understood. Some argue that they have the potential to reduce tobacco-related morbidity and mortality and could be a useful tool for reducing tobacco-related harm. Others express concern that the health effects of ENDS use are unknown, that they may appeal to young people, and that they may encourage dual use of ENDS and traditional tobacco products. Although ENDS are a new and unregulated product, the U.S. Food a...
Source: Annals of Internal Medicine - April 21, 2015 Category: Internal Medicine Authors: Crowley RA, Health Public Policy Committee of the American College of Physicians Tags: Ann Intern Med Source Type: research

Response to letter to the Editor regarding ‘Classification algorithms for the identification of structural injury in TBI using brain electrical activity’
The articles referred to by Bloom et al. in their letter to the Editor, were based on a long period of data acquisition and algorithm development work supported by BrainScope Co., Inc. The articles are fundamental to the signal processing and algorithm methodology used in the development of the Ahead 100 device that received clearance from the United States (US) Food and Drug Administration (FDA) in November 2014. The intent of these articles was to describe the underlying innovative methods which resulted in the classification strategy used for development of this system based on brain electrical activity recorded from a ...
Source: Computers in Biology and Medicine - April 21, 2015 Category: Bioinformatics Authors: Leslie S. Prichep, Samanwoy Ghosh Dastidar, Arnaud Jacquin, William Koppes, Jonathan Miller, Brian O׳Neil, Roseanne Naunheim, J. Stephen Huff Tags: Letter to the Editor Source Type: research

Targeted Therapy in Advanced Bladder Cancer: What Have We Learned?
This article outlines representative trials of targeted therapies in UC and discusses the significance of genetic preselection in trial design as a method to optimize responses to these agents, thus, hopefully expanding the armamentarium of treatment options against this lethal disease. PMID: 25882566 [PubMed - as supplied by publisher] (Source: The Urologic Clinics of North America)
Source: The Urologic Clinics of North America - April 20, 2015 Category: Urology & Nephrology Authors: Jordan EJ, Iyer G Tags: Urol Clin North Am Source Type: research

Shortage of Peritoneal Dialysis Solution and the Food and Drug Administration's Response.
Abstract Although the number of new drug shortages has been lower in recent years than in the past, severe shortages have occurred that have affected large numbers of patients. A new law entitled the Food and Drug Administration Safety and Innovation Act was enacted in July of 2012, which requires companies to notify the Food and Drug Administration of anticipated shortages. This notification requirement has allowed the Food and Drug Administration to work closely with manufacturers earlier to mitigate and, often, prevent shortages. However, not all shortages are able to be prevented, and the shortage of peritoneal...
Source: Clinical Journal of the American Society of Nephrology : CJASN - April 20, 2015 Category: Urology & Nephrology Authors: Jensen V, Throckmorton DC Tags: Clin J Am Soc Nephrol Source Type: research

Responding to the Pandemic of Falsified Medicines.
Abstract Over the past decade, the number of countries reporting falsified (fake, spurious/falsely labeled/counterfeit) medicines and the types and quantities of fraudulent drugs being distributed have increased greatly. The obstacles in combating falsified pharmaceuticals include 1) lack of consensus on definitions, 2) paucity of reliable and scalable technology to detect fakes before they reach patients, 3) poor global and national leadership and accountability systems for combating this scourge, and 4) deficient manufacturing and regulatory challenges, especially in China and India where fake products often orig...
Source: The American Journal of Tropical Medicine and Hygiene - April 20, 2015 Category: Tropical Medicine Authors: Nayyar GM, Attaran A, Clark JP, Culzoni MJ, Fernandez FM, Herrington JE, Kendall M, Newton PN, Breman JG Tags: Am J Trop Med Hyg Source Type: research

Pharmacogenomics and personalized medicine: a review focused on their application in the Chinese population.
Abstract The field of pharmacogenomics was initiated in the 1950s and began to thrive after the completion of the human genome project 10 years ago. Thus far, more than 100 drug labels and clinical guidelines referring to pharmacogenomic biomarkers have been published, and several key pharmacogenomic markers for either drug safety or efficacy have been identified and subsequently adopted in clinical practice as pre-treatment genetic tests. However, a tremendous variation of genetic backgrounds exists between different ethnic groups. The application of pharmacogenomics in the Chinese population is still a long way o...
Source: Acta Pharmacologica Sinica - April 20, 2015 Category: Drugs & Pharmacology Authors: Shu WY, Li JL, Wang XD, Huang M Tags: Acta Pharmacol Sin Source Type: research

Special Commentary: Food and Drug Administration and American Academy of Ophthalmology Sponsored
The pace of medical research and development, estimated at $85 billion in research and development by industry plus the National Institutes of Health in 2010 alone, has brought about significant breakthroughs in medical care in the United States. Yet, there has been widespread concern that this investment has not yielded novel product applications to the Food and Drug Administration (FDA) or the diffusion of innovative medical technologies into the marketplace. The factors slowing medical innovation and keeping devices from the hands of clinicians in this country are complex. (Source: Ophthalmology)
Source: Ophthalmology - April 18, 2015 Category: Opthalmology Authors: Flora Lum, Michelle E. Tarver, Malik Y. Kahook, Thomas A. Oetting, Eva Rorer, Gene Hilmantel, Don Calogero, Tina Kiang, John P. Berdahl, Anne L. Coleman, Malvina B. Eydelman Source Type: research

[Comment] Pre-exposure prophylaxis works—it's time to deliver
The science is now clear: oral pre-exposure prophylaxis (PrEP) with a coformulation of tenofovir disoproxil fumarate and emtricitabine (Truvada) significantly reduces the risk of HIV infection among individuals at high risk of HIV infection. The news that PrEP has shown consistent efficacy among those who take it as prescribed should be a cause for celebration, and galvanise action to ensure access to PrEP for those who could benefit the most. But almost 3 years since the US Food and Drug Administration approved tenofovir–emtricitabine for PrEP,1 little is being done on implementation. (Source: LANCET)
Source: LANCET - April 17, 2015 Category: Journals (General) Authors: Chris Beyrer, Linda-Gail Bekker, Anton Pozniak, Françoise Barré-Sinoussi Tags: Comment Source Type: research

Update on indoor tanning legislation in the United States
The incidence of melanoma has been increasing over the past several decades, with notable increases in the pediatric and adolescent population. Indoor tanning has been proven carcinogenic and is associated with an increased risk of melanoma, especially when used at a young age. The incidence and frequency of usage of indoor tanning in the United States is high, particularly among adolescents, with roughly 20% reporting using a tanning bed at least once. The Food and Drug Administration recently made changes to its regulation of indoor tanning devices, reclassifying them as class II devices necessitating stricter premarket ...
Source: Clinics in Dermatology - April 17, 2015 Category: Dermatology Authors: Michael Pan, Lauren Geller Source Type: research

Clinical round-up
HPV vaccination As we write, the Food and Drug Administration (USA) has approved the use of the 9-valent human papilloma virus (HPV) vaccine. Questions remain, however, about who to vaccinate. Should we be vaccinating boys/men, and how old is too old to be vaccinated? Skinner et al1 go some way to answering the second question with their interim analysis. The VIVIANE study is a multicentre double-blinded randomised controlled trial looking at the efficacy of the bivalent HPV 16/18 vaccine in women >25 years. (The PATRICIA study previously looked at this vaccine in women <25 years).2 In total, 15% of women i...
Source: Sexually Transmitted Infections - April 17, 2015 Category: Sexual Medicine Authors: Herbert, S., Haddow, L. Tags: Clinical trials (epidemiology), Drugs: infectious diseases, HIV/AIDS, Vaccination / immunisation, HIV / AIDS, Chlamydia, HIV infections, Screening (epidemiology), Screening (public health) Clinical round-up Source Type: research

Tobacco use among middle and high school students - United States, 2011-2014.
Abstract Tobacco use and addiction most often begin during youth and young adulthood. Youth use of tobacco in any form is unsafe. To determine the prevalence and trends of current (past 30-day) use of nine tobacco products (cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, tobacco pipes, snus, dissolvable tobacco, and bidis) among U.S. middle (grades 6-8) and high school (grades 9-12) students, CDC and the Food and Drug Administration (FDA) analyzed data from the 2011-2014 National Youth Tobacco Surveys (NYTS). In 2014, e-cigarettes were the most commonly used tobacco product among middle (3.9%) and hig...
Source: MMWR Morb Mortal Wkl... - April 17, 2015 Category: Epidemiology Authors: Arrazola RA, Singh T, Corey CG, Husten CG, Neff LJ, Apelberg BJ, Bunnell RE, Choiniere CJ, King BA, Cox S, McAfee T, Caraballo RS Tags: MMWR Morb Mortal Wkly Rep Source Type: research

After 10 Years of Clinical Trials with Liraglutide in Diabetes, what do we Know about its Effects on Clinical Cardiovascular Outcomes?
Abstract Type 2 diabetes remains an escalating world-wide problem, despite a range of treatments. The revelation that insulin secretion is under the control of a gut hormone, glucagon-like peptide 1 (GLP-1), led to a new paradigm in the management of type 2 diabetes. Liraglutide is a long acting GLP-1 receptor agonist used in the treatment of type 2 diabetes. The review considers the clinical trials with liraglutide. There are many comparator trials between liraglutide and other medicines for the treatment of type 2 diabetes, and these trials have shown that liraglutide lowers HbA1c and body weight, and is well tol...
Source: Reviews on Recent Clinical Trials - April 17, 2015 Category: Cancer & Oncology Authors: Doggrell SA Tags: Rev Recent Clin Trials Source Type: research

Lenalidomide in non-Hodgkin lymphoma: biological perspectives and therapeutic opportunities
Lenalidomide is an immunomodulatory drug (IMiD) with activity in lymphoid malignancies occurring primarily through immune modulation (eg, T-cell immune synapse enhancement and NK-cell/T-cell effector augmentation) and antiproliferative effects. Food and Drug Administration–approved for bortezomib-resistant, relapsed/refractory mantle-cell lymphoma, lenalidomide has demonstrated efficacy in several additional lymphoma subtypes. There are many ongoing clinical trials examining the use of lenalidomide alone or in combinatorial therapy. It will be important in these studies to delineate reliable, predictive biomarkers to...
Source: Blood - April 16, 2015 Category: Hematology Authors: Kritharis, A., Coyle, M., Sharma, J., Evens, A. M. Tags: Free Research Articles, Lymphoid Neoplasia, Blood Spotlight, Clinical Trials and Observations Source Type: research

When Does FDAMA Section 114 Apply? Ten Case Studies
Section 114 of the Food and Drug Administration Modernization Act of 1997 regulates the promotion of health economic information by pharmaceutical companies to US health plans. Greater clarity is important given demands by payers and other stakeholders for evidence of value. (Source: Value in Health)
Source: Value in Health - April 16, 2015 Category: Global & Universal Authors: Peter J. Neumann, Cayla J. Saret Source Type: research

Salmonella Serotype Determination Utilizing High-Throughput Genome Sequencing Data [Epidemiology]
Serotyping forms the basis of national and international surveillance networks for Salmonella, one of the most prevalent foodborne pathogens worldwide (1–3). Public health microbiology is currently being transformed by whole-genome sequencing (WGS), which opens the door to serotype determination using WGS data. SeqSero (www.denglab.info/SeqSero) is a novel Web-based tool for determining Salmonella serotypes using high-throughput genome sequencing data. SeqSero is based on curated databases of Salmonella serotype determinants (rfb gene cluster, fliC and fljB alleles) and is predicted to determine serotype rapidly and ...
Source: Journal of Clinical Microbiology - April 16, 2015 Category: Microbiology Authors: Zhang, S., Yin, Y., Jones, M. B., Zhang, Z., Deatherage Kaiser, B. L., Dinsmore, B. A., Fitzgerald, C., Fields, P. I., Deng, X. Tags: Epidemiology Source Type: research

Drug Shortages and Patient Safety: An Overview of Essential Information for the Infusion Nurse
Drug shortages present a growing problem in the United States, with the majority of shortages occurring among sterile injectable medications. Although the impact of shortages has been shown to adversely affect patient care in a variety of settings, those who are dependent on outpatient or home infusion therapy are especially vulnerable. Legislative action and the efforts of the U.S. Food and Drug Administration have helped reduce the occurrence of new shortages; however, the problem is not likely to be eliminated in the short term and requires effective management strategies. (Source: Journal of Infusion Nursing)
Source: Journal of Infusion Nursing - April 15, 2015 Category: Nursing Tags: Features Source Type: research

Topiramate's effects on alcohol use similar to FDA‐approved drugs
A meta‐analysis of seven randomized controlled trials, comprising 1,125 patients, has found that the antiepileptic drug topiramate is moderately effective compared with placebo in reducing alcohol consumption in individuals with alcohol use disorders. Effect sizes in the examined trials were comparable to those for naltrexone and acamprosate, the most frequently studied of the medications approved by the Food and Drug Administration (FDA) for alcohol dependence. (Source: The Brown University Psychopharmacology Update)
Source: The Brown University Psychopharmacology Update - April 15, 2015 Category: Psychiatry Tags: What's New in Research Source Type: research

Long-term survival as a treatment benchmark in melanoma: latest results and clinical implications
Historically, stage III–IV melanoma patients have had few options to achieve long-term survival. For patients with stage III disease, surgery alone may be curative for approximately 50%. Adjuvant treatment with a slightly greater impact on relapse-free survival at the cost of substantial toxicity, and studies are ongoing to test the adjuvant benefit of other immunotherapies that appear more active and less toxic in advanced melanoma. Achieving long term survival for stage IV patients had been rare until recently and progress was painfully slow with traditional cytotoxic chemotherapy; review of multiple phase II studi...
Source: Therapeutic Advances in Medical Oncology - April 15, 2015 Category: Cancer & Oncology Authors: Grossmann, K. F., Margolin, K. Tags: Reviews Source Type: research

Histone Deacetylase Inhibitors: Potent Anti-leukemic Agents.
Abstract Leukemia is a life threatening disease that has become increasingly common. Many categories of anti-leukemic agents have been developed by probing into the nature of leukemia. Nevertheless, the needs for potent molecules with few side effects are still not satisfied in the current anti-leukemic therapy. Targeted therapy has been developed for the advantage of relatively high efficiency and safety in the anticancer chemotherapy. Among the targeted antitumor therapies, inhibition of histone deacetylases has been intensively studied. Three histone deacetylase inhibitors (HDACIs) have been approved by US Food ...
Source: Current Medicinal Chemistry - April 15, 2015 Category: Chemistry Authors: Bian J, Zhang L, Han Y, Wang C, Zhang L Tags: Curr Med Chem Source Type: research

Uncontrolled Donation After Circulatory Determination of Death Donors (uDCDDs) as a Source of Lungs for Transplant
In April 2014, the American Journal of Transplantation published a report on the first lung transplant in the United States recovered from an uncontrolled donation after circulatory determination of death donor (uDCDD), assessed by ex vivo lung perfusion (EVLP). The article identified logistical and ethical issues related to introduction of lung transplant from uDCDDs. In an open clinical trial, we have Food and Drug Administration and Institutional Review Board approval to transplant lungs recovered from uDCDDs judged suitable after EVLP. Through this project and other experiences with lung recovery from uDCDDs, we have i...
Source: American Journal of Transplantation - April 14, 2015 Category: Transplant Surgery Authors: T. M. Egan, J. J. Requard Tags: Personal Viewpoint Source Type: research

Use of Cough and Cold Medications in Severe Bronchiolitis before and after a Health Advisory Warning against Their Use
We compared the use of cough and cold medications in 2 multicenter studies of young children hospitalized with bronchiolitis before and after the 2008 Food and Drug Administration cough and cold medications advisory. Although cough and cold medication use decreased after the advisory, nearly 20% of children age 12-23.9 months with severe bronchiolitis received cough and cold medications. (Source: The Journal of Pediatrics)
Source: The Journal of Pediatrics - April 14, 2015 Category: Pediatrics Authors: Katherine O'Donnell, Jonathan M. Mansbach, Frank LoVecchio, John Cheng, Pedro A. Piedra, Sunday Clark, Ashley F. Sullivan, Carlos A. Camargo, Multicenter Airway Research Collaboration (MARC)-25 and MARC-30 investigators Tags: Clinical and Laboratory Observations Source Type: research

Determination of trimethylamine-N-oxide in combination with l-carnitine and γ-butyrobetaine in human plasma by UPLC/MS/MS.
Abstract An ultra-high-performance liquid chromatography-mass spectrometry (UPLC/MS/MS) method was developed and validated for the quantification of trimethylamine-N-oxide (TMAO) simultaneously with TMAO-related molecules l-carnitine and γ-butyrobetaine (GBB) in human blood plasma. The separation of analytes was achieved using a Hydrophilic interaction liquid chromatography (HILIC)-type column with ammonium acetate-acetonitrile as the mobile phase. TMAO determination was validated according to valid US Food and Drug Administration guidelines. The developed method was successfully applied to plasma samples from hea...
Source: Biomedical Chromatography : BMC - April 14, 2015 Category: Biomedical Science Authors: Grinberga S, Dambrova M, Latkovskis G, Strele I, Konrade I, Hartmane D, Sevostjanovs E, Liepinsh E, Pugovics O Tags: Biomed Chromatogr Source Type: research

Rapid analysis of ractopamine in pig tissues by dummy-template imprinted solid-phase extraction coupling with surface-enhanced Raman spectroscopy.
Abstract Ritodrine has similar skeleton structure to ractopamine and it was selected as the dummy-template molecule to synthesize the molecular imprinted polymers (MIPs). The MIPs exhibited better selectivity to ractopamine than to the dummy-template molecule: the imprint factor for ractopamine was 8.9, while 7.6 for ritodrine. The MIPs were used as sorbents in solid-phase extraction for selective enrichment of ractopamine, and some key parameters were optimized. After that, a rapid surface-enhanced Raman spectroscopy method was developed for analysis of ractopamine and isoxuprine in pig tissue samples. Under the o...
Source: Talanta - April 13, 2015 Category: Chemistry Authors: Xiao X, Yan K, Xu X, Li G Tags: Talanta Source Type: research

The new oral anticoagulants: clinical use and reversal agent development
Warfarin has been the centre of oral anticoagulant therapy for over 60 years. Recent development of new oral anticoagulants (NOACs) has provided a safe and effective alternative for stroke prevention in patients with atrial fibrillation and for prevention of venous thromboembolism. Determination of their use in acute coronary syndrome has been hampered by increases in bleeding events in most large trials, especially when used with antiplatelet therapy. NOACs have equal or superior efficacy and safety profiles compared to warfarin, fewer drug interactions; no dietary restrictions; predictable responses that eliminates moni...
Source: ISBT Science Series - April 13, 2015 Category: Hematology Authors: J. Costin, J. Ansell, S. Bakhru, B. Laulicht, S. Steiner Tags: Invited Review Source Type: research

Transfer of Natalizumab into Breast Milk in a Mother with Multiple Sclerosis
Natalizumab (Tysabri) is a recombinant humanized antibody to α4-integrin that is approved by the Food and Drug Administration for the treatment of multiple sclerosis (MS) and Crohn disease. This is a case report of a 28-year-old woman with MS who was taking natalizumab (300 mg intravenously infused over 1 hour every 4 weeks) while breastfeeding her 11.5-month-old daughter 3 times a day. Breast milk samples were collected over a 50-day period after the patient’s first drug infusion. The average concentration of natalizumab was 0.93 µg/mL/d, and the relative infant dose was 1.74% of the weight-adjusted mate...
Source: Journal of Human Lactation - April 13, 2015 Category: Nursing Authors: Baker, T. E., Cooper, S. D., Kessler, L., Hale, T. W. Tags: Case Reports Source Type: research

Pregnancy outcomes in patients exposed to interferon beta-1b
Introduction Multiple sclerosis (MS) is a chronic autoimmune demyelinating disease of the central nervous system that is usually diagnosed in a patient's 20s or 30s and is more common in women than in men.1 Given this typical patient profile, many patients with MS are women in their reproductive years. None of the currently approved disease-modifying therapies (DMTs) for patients with MS are recommended for use during pregnancy. Furthermore, all of these medications have been given a pregnancy category B, C, D or X by the US Food and Drug Administration, indicating that in the best case (category B), animal studies have fa...
Source: Journal of Neurology, Neurosurgery and Psychiatry - April 13, 2015 Category: Neurosurgery Authors: Romero, R. S., Lunzmann, C., Bugge, J.-P. Tags: Open access PostScript Source Type: research

Immunotherapy in Melanoma: Recent Advances and Promising New Therapies
The incidence and mortality of melanoma are on the rise. Historically, patients diagnosed with metastatic melanoma were faced with a grim prognosis, with survival rates of 15% at 5 years. Prior to 2011, no drug or therapeutic regimen had been shown to improve overall survival (OS) in metastatic melanoma. Chemotherapeutic agents, such as dacarbazine or temozolomide, are often given to patients for palliative purposes; high-dose interleukin 2 and biochemotherapy are immunotherapeutic options that could be offered to patients with a good performance status at specialized centers. Neither has been shown to impact OS, but durab...
Source: Journal of Pharmacy Practice - April 12, 2015 Category: Drugs & Pharmacology Authors: Saraceni, M. M., Khushalani, N. I., Jarkowski, A. Tags: Review Articles Source Type: research

Liraglutide Promotes Cortical Neurite Outgrowth via the MEK-ERK Pathway.
Abstract Liraglutide is the glucagon-like peptide-1 (GLP-1) synthetic form which has been approved by the US Food and Drug Administration to be released onto the market. The metabolic benefits of incretin hormone as an anti-diabetic agent are widely recognized, but its potential extra-pancreatic effects of GLP-1 analog (liraglutide) in the central nerve system are less well known. To this purpose, we used immunofluorescence method to examine the effect of liraglutide on neurite outgrowth in primary cortical neuron culture by measuring neurite length and confirmed the promotion effect. Then, we investigated the pot...
Source: Cellular and Molecular Neurobiology - April 11, 2015 Category: Cytology Authors: Li M, Li S, Li Y Tags: Cell Mol Neurobiol Source Type: research

Sequences and combinations of multifaceted therapy in advanced prostate cancer
This report of the Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (PREVAIL) trial led to the Food and Drug Administration approval of this agent. Novel agents such as cabozantinib and custirsen that had shown promising results in phase II trials revealed disappointing results in the phase III setting. The breakthrough report, of the ability of the androgen receptor splice variant mutation, detected in circulating tumor cells, to predict lack of response to abiraterone or enzalutamide, and the remarkable responses of poly(ADP-ribose) polymerase inhibitors in prostate cancer with breast cancer genes 1...
Source: Current Opinion in Oncology - April 10, 2015 Category: Cancer & Oncology Tags: GENITOURINARY SYSTEM: Edited by Arif Hussain Source Type: research

Efficacy of hemcon dental dressing in reducing postsurgical complications following mandibular third molar extractions
The surgical removal of impacted mandibular third molars results in tissue trauma, inflammation, and bleeding and is most often accompanied by moderate to severe pain. The HemCon Bandage is a U.S. Food and Drug Administration-cleared chitosan-based flat bandage that controls severe arterial bleeding from traumatic injuries. HemCon dental dressing material (HemCon Medical Technologies, Portland, OR, USA) improves hemostasis and stabilizes clots in anticoagulated patients. The dressing becomes adherent when in contact with the oral wound environment and provides a protective layer. (Source: Oral Surgery, Oral Medicine, Oral ...
Source: Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics - April 10, 2015 Category: ENT & OMF Authors: Ray English, Alireza Ashrafi, Sepideh Sabooree, Mina Boulos, Archana Viswanath Source Type: research