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Investigational drugs for treating agitation in persons with dementia.
Authors: Garay RP, Citrome L, Grossberg GT, Cavero I, Llorca PM Abstract INTRODUCTION: Agitation is common and distressing in persons with dementia, but safe, effective treatments remain elusive. In this review, the authors describe investigational compounds in ongoing or recently completed clinical trials for this indication and provide an opinion on how they may meet current therapeutic needs. AREAS COVERED: Phase II and phase III clinical trials for agitation in persons with dementia were searched in US and EU clinical trial registries and in the medical literature for the period January 2013-February 2016 E...
Source: Expert Opinion on Investigational Drugs - May 28, 2016 Category: Drugs & Pharmacology Tags: Expert Opin Investig Drugs Source Type: research

Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study
This study is registered with, number NCT01705574. Findings Between Nov 28, 2012, and March 12, 2014, 575 women were enrolled. 289 were randomly assigned to receive the integrase inhibitor regimen and 286 to receive the protease inhibitor based regimen. 252 (87%) women in the integrase inhibitor group had plasma HIV-1 RNA less than 50 copies per mL at week 48 compared with 231 (81%) women in the protease inhibitor group (adjusted difference 6·5%; 95% CI 0·4–12·6). No participant had virological failure with resistance in the integrase inhibitor group compared with three participants ([1%]; all Met1...
Source: The Lancet HIV - May 28, 2016 Category: Infectious Diseases Source Type: research

Red blood cell antigen genotyping for sickle cell disease, thalassemia and other transfusion complications
Since the discovery of the ABO blood group in the early 20th century, more than 300 blood group antigens have been categorized among 35 blood group systems. The molecular basis for most blood group antigens has been determined and demonstrates tremendous genetic diversity, particularly in the ABO and Rh systems. Several blood group genotyping assays have been developed and one platform has been approved by the Food and Drug Administration (FDA) as a “test of record,” such that no phenotype confirmation with antisera is required. (Source: Transfusion Medicine Reviews)
Source: Transfusion Medicine Reviews - May 28, 2016 Category: Hematology Authors: Ross M. Fasano, Stella T. Chou Source Type: research

Clinical use and applications of histone deacetylase inhibitors in multiple myeloma.
Authors: Tandon N, Ramakrishnan V, Kumar SK Abstract The incorporation of various novel therapies has resulted in a significant survival benefit in newly diagnosed and relapsed patients with multiple myeloma (MM) over the past decade. Despite these advances, resistance to therapy leads to eventual relapse and fatal outcomes in the vast majority of patients. Hence, there is an unmet need for new safe and efficacious therapies for continued improvement in outcomes. Given the role of epigenetic aberrations in the pathogenesis and progression of MM and the success of histone deacetylase inhibitors (HDACi) in other mali...
Source: Clinical Pharmacology: Advances and Applications - May 27, 2016 Category: Allergy & Immunology Tags: Clin Pharmacol Source Type: research

Trabectedin for Soft Tissue Sarcoma: Current Status and Future Perspectives
Abstract Trabectedin (ET743, Yondelis®, manufactured by Baxter Oncology GmbH, Halle/Westfalen, Germany, for Janssen Products, LP, Horsham, PA), derived from the marine ascidian, Ecteinascidia turbinata, is a natural alkaloid with multiple complex mechanisms of action. On 23 October 2015, 15 years after the results of the first Phase 1 clinical trial using trabectedin for chemotherapy-resistant solid malignancies was reported, and 8 years after its approval in Europe, the United States Food and Drug Administration (USFDA) finally approved trabectedin for the treatment of unresectable or metastatic liposarcoma or...
Source: Advances in Therapy - May 27, 2016 Category: Drugs & Pharmacology Source Type: research

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methods are used, with a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. Both are supplemented by accessing the related articles feature of PubMed and by scrutinizing pertinent references cited by the identified...
Source: Gastrointestinal Endoscopy - May 27, 2016 Category: Gastroenterology Authors: ASGE TECHNOLOGY COMMITTEE, Sri Komanduri, Nirav Thosani, Barham K. Abu Dayyeh, Harry R. Aslanian, Brintha K. Enestvedt, Michael Manfredi, John T. Maple, Udayakumar Navaneethan, Rahul Pannala, Mansour A. Parsi, Zachary L. Smith, Shelby A. Sullivan, Subhas Tags: Status evaluation report Source Type: research

Medical Therapy in Idiopathic Pulmonary Fibrosis
Semin Respir Crit Care Med 2016; 37: 368-377DOI: 10.1055/s-0036-1582010Medical therapy for idiopathic fibrosis remains controversial. Idiopathic pulmonary fibrosis (IPF) was uniformly a disease that progressed inexorably, typically leading to death within 3 to 5 years from onset of symptoms. Until recently, lung transplantation was the only effective transplant option. Within the past decade, several placebo-controlled trials failed to show benefit in patients with IPF. However, within the past 2 years, two novel antifibrotic agents (pirfenidone and nintedanib) were approved by the Food and Drug Administration (FDA) in the...
Source: Seminars in Respiratory and Critical Care Medicine - May 27, 2016 Category: Respiratory Medicine Authors: Antoniou, Katerina M.Wuyts, WimWijsenbeek, MarliesWells, Athol U. Source Type: research

20% subcutaneous immunoglobulin dosed biweekly for primary immunodeficiency
Approval of 20% subcutaneous immunoglobulin (SCIG) (Hizentra, CSL Behring LLC, Kankakee, Illinois) by the US Food and Drug Administration in 2013 for biweekly (every 2 weeks) administration in patients with primary immunodeficiency disease (PIDD) was based on a pharmacometric model and simulation.1 To examine biweekly dosing of SCIG in a clinical setting, we conducted a retrospective record review of patients with PIDD treated with 20% SCIG biweekly from June 24, 2010, through July 3, 2014, at 5 clinical practices. (Source: Annals of Allergy, Asthma and Immunology)
Source: Annals of Allergy, Asthma and Immunology - May 27, 2016 Category: Allergy & Immunology Authors: Richard L. Wasserman, Mark R. Stein, M. Elizabeth M. Younger, Shahnaz Fatteh, Elie Haddad Tags: Letter Source Type: research

Heart Failure Considerations of Antihyperglycemic Medications for Type 2 Diabetes.
Abstract Prevalent and incident heart failure (HF) is increased in people with type 2 diabetes mellitus, with risk directly associated with the severity of hyperglycemia. Furthermore, in patients with type 2 diabetes mellitus, mortality is increased ≈10-fold in patients with versus without HF. Reducing HF with antihyperglycemic therapies, however, has been unsuccessful until recently. In fact, HF as an important outcome in patients with type 2 diabetes mellitus seems to be heterogeneously modulated by antihyperglycemic medications, as evidenced by results from cardiovascular outcome trials (CVOTs) and large obser...
Source: Circulation Research - May 27, 2016 Category: Cardiology Authors: Standl E, Schnell O, McGuire DK Tags: Circ Res Source Type: research

What's in the Literature?
Abstract: One of the first questions asked by patients and family members when a diagnosis of amyotrophic lateral sclerosis is made is “what about stem cells?” The term “stem cells” has attractiveness to it, with the assumption that stem cell treatment (stem nerve cells) can replace lost nerve cells. There are perhaps 2 types of stem cell trials, those that are vetted by the Food and Drug Administration and those that have no official oversight and whose results are infrequently published. The issue of the latter was discussed in the last edition of this column. The results of one of the formal stem cell trials now...
Source: Journal of Clinical Neuromuscular Disease - May 26, 2016 Category: Neurology Tags: Literature Review Source Type: research

FDA panel recommends two new combo injectables for diabetes
In back-to back advisory committee hearings, the Food and Drug Administration received recommendations for approval of two new combination medications to treat type 2 diabetes. The two medications... (Source: Internal Medicine News)
Source: Internal Medicine News - May 26, 2016 Category: Internal Medicine Source Type: research

An experimental study of the effects of electronic cigarette warnings on young adult nonsmokers’ perceptions and behavioral intentions
Electronic cigarette (“e-cigarette”) manufacturers use warning labels on their advertising that vary widely in content and the U.S. Food and Drug Administration has issued a warning label requirement for e-cig... (Source: Tobacco Induced Diseases)
Source: Tobacco Induced Diseases - May 26, 2016 Category: Global & Universal Authors: Darren Mays, Clayton Smith, Andrea C. Johnson, Kenneth P. Tercyak and Raymond S. Niaura Source Type: research

Effects of the prospective payment system on anemia management in maintenance dialysis patients: implications for cost and site of care
The 2011 expanded Prospective Payment System (PPS) and contemporaneous Food and Drug Administration label revision for erythropoiesis-stimulating agents (ESAs) were associated with changes in ESA use and mean ... (Source: BMC Nephrology)
Source: BMC Nephrology - May 26, 2016 Category: Urology & Nephrology Authors: James B. Wetmore, Spiros Tzivelekis, Allan J. Collins and Craig A. Solid Source Type: research

FDA warns about rare but serious skin reactions to olanzapine
The Food and Drug Administration (FDA) last month warned that olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. The FDA is adding a new warning to the drug labels for all olanzapine‐containing products that describes this severe condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). (Source: The Brown University Child and Adolescent Psychopharmacology Update)
Source: The Brown University Child and Adolescent Psychopharmacology Update - May 26, 2016 Category: Psychiatry Tags: From the FDA Source Type: research

Drug discrimination: A versatile tool for characterization of CNS safety pharmacology and potential for drug abuse
Publication date: Available online 25 May 2016 Source:Journal of Pharmacological and Toxicological Methods Author(s): Michael D.B. Swedberg Drug discrimination studies for assessment of psychoactive properties of drugs in safety pharmacology and drug abuse and drug dependence potential evaluation have traditionally been focused on testing novel compounds against standard drugs for which drug abuse has been documented, e.g. opioids, CNS stimulants, cannabinoids etc. (e.g. Swedberg & Giarola, 2015), and results are interpreted such that the extent to which the test drug causes discriminative effects similar to tho...
Source: Journal of Pharmacological and Toxicological Methods - May 26, 2016 Category: Drugs & Pharmacology Source Type: research

Safety of gefitinib in non-small cell lung cancer treatment.
Authors: Hsiue EH, Lee JH, Lin CC, Yang JC Abstract INTRODUCTION: The development of EGFR TKI and the subsequent identification of activating EGFR mutations have dramatically changed how NSCLC is treated. With its recent approval by the US Food and Drug Administration, gefitinib adds to the list of recommended first-line treatments for lung cancer harboring EGFR mutations, which hitherto includes erlotinib and afatinib. Areas covered: This review summarizes the pharmacological property, clinical efficacy, and safety of gefitinib in major clinical trials and post-marketing studies. Expert opinion: Gefitinib is a wel...
Source: Expert Opinion on Drug Safety - May 25, 2016 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Reversal of newer direct oral anticoagulant drugs (DOACs).
Authors: Hussain SS, Tyroch AH, Mukherjee D Abstract Anticoagulation therapy is indicated for management of various clinical conditions to prevent adverse events and introduction of direct oral anticoagulants (DOACs) has ushered in a new era in anticoagulation therapy. Major advantages of DOACS include fewer drug interactions and that they do not need periodic monitoring. Several patients who were not on anticoagulation before due to older age, polypharmacy/drug interaction concerns, and logistics of periodic monitoring are now on anticoagulation with DOACs. Despite their many advantages, a challenge while prescrib...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - May 25, 2016 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

Comparison of allergenic extracts from different origins: the value of the FDA's bioequivalent allergy unit (BAU).
Authors: Passalacqua G, Sastre J, Pfaar O, Wahn U, Demoly P Abstract INTRODUCTION: Allergy immunotherapy (AIT) is the only disease-modifying intervention for the treatment of allergic diseases. The clinical effectiveness of AIT is clearly dose-dependent, so it is important that clinicians can assess and compare the potency of the various products available. However, this is not possible in practice, because manufacturers use different methods to determine potency. Therefore, a clear need exists for adoption of a 'gold-standard' measure of allergenicity. The bioequivalent allergy unit (BAU) is thus far the only alle...
Source: Expert Review of Clinical Immunology - May 25, 2016 Category: Allergy & Immunology Tags: Expert Rev Clin Immunol Source Type: research

The treatment of CML at an environment with limited resources.
This article reviews clinical experiences in the treatment of chronic myeloid leukemia (CML) in an environment of limited resources. METHODS: We reviewed recent publications on Pub med and abstracts from mayor congresses relevant to the disease. RESULTS: CML is a hematological neoplasm observed more frequently in adults, regardless of their socioeconomic status. Until recently, available treatments improved patients' quality of life but did not modify survival. It was not until interferon appeared that patients received a drug that reduced and even eliminated Philadelphia chromosome-positive (Ph+) cells. DISCUS...
Source: Hematology - May 25, 2016 Category: Hematology Tags: Hematology Source Type: research

Intranasal Inactivated Influenza Vaccines: a Reasonable Approach to Improve the Efficacy of Influenza Vaccine?
Abstract Influenza is a contagious, acute respiratory disease caused by the influenza virus. The mucosal lining in the host respiratory tract is not only the site of virus infection, but also the site of defense; it is at this site that the host immune response targets the virus and protects against reinfection. One of the most effective methods to prevent influenza is to induce specific antibody (Ab) responses in the respiratory tract by vaccination. Two types of influenza vaccines, intranasal live attenuated influenza virus (LAIV) vaccines and parenteral (injectable) inactivated vaccines, are currently used world...
Source: Japanese Journal of Infectious Diseases - May 25, 2016 Category: Infectious Diseases Authors: Tamura S, Ainai A, Suzuki T, Kurata T, Hasegawa H Tags: Jpn J Infect Dis Source Type: research

Recombinant bone morphogenetic protein in patients under 18 years of age
In January 2015, the US Food and Drug Administration (FDA) issued a drug safety communication warning related to the use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients under 18 years of age. The safety communication cited reports of serious injuries such as excess bone growth, fluid accumulation, inhibited bone healing, swelling, and pressure on the adjacent vital organs following the use of bone graft substitutes containing proteins or synthetic peptides. (Source: International Journal of Oral and Maxillofacial Surgery)
Source: International Journal of Oral and Maxillofacial Surgery - May 25, 2016 Category: ENT & OMF Authors: K. Kumar, M. Nagarjuna, R. Raut, H. Pipalia Tags: Letter to the Editor Source Type: research

Drug Approvals in Oncology: Striking the Right Balance Between Saving Lives and Patient Safety
In 1962, the Kefauver-Harris Amendment to the United States Federal Food, Drug, and Cosmetic Act mandated for the first time that pharmaceutical companies seeking drug approval must provide proof of clinical benefit (efficacy) from well-controlled studies.1 Before this amendment, drug companies mainly needed to document the safety of the drug they intended to market, per the requirements of the 1938 Federal Food, Drug, and Cosmetic Act.2 The Kefauver-Harris Amendment also removed time constraints on the US Food and Drug Administration (FDA) adjudication and approval of new drug applications, which was previously restricted...
Source: Mayo Clinic Proceedings - May 25, 2016 Category: Internal Medicine Authors: S. Vincent Rajkumar Tags: Editorial Source Type: research

Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs
To determine the strength of the surrogate-survival correlation for cancer drug approvals based on a surrogate. (Source: Mayo Clinic Proceedings)
Source: Mayo Clinic Proceedings - May 25, 2016 Category: Internal Medicine Authors: Chul Kim, Vinay Prasad Tags: Original article Source Type: research

Cardiovascular Devices; Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids. Final order.
Cardiovascular Devices; Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids. Final order. Fed Regist. 2016 May 25;81(101):33128-34 Authors: Food and Drug Administration, HHS Abstract The Food and Drug Administration (FDA) is issuing a final order to reclassify external cardiac compressors (ECC) (under FDA product code DRM), a preamendments class III device, into class II (special controls). FDA is also creating a separate classification regulation for a subgroup of devices previously included within this classification regulation, to be called cardio...
Source: Fed Regist - May 25, 2016 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

RES-529: a PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes
We present a review of the PI3K/AKT/mTOR pathway, its role in tumorigenesis, and the potential of RES-529 in cancer treatment. RES-529 inhibits mTORC1/mTORC2 activity in various cancer cell lines, as noted by decreased phosphorylation of substrates including ribosomal protein S6, 4E-BP1, and AKT, leading to cell growth inhibition and death, with activity generally in the range of 5–15 μmol/l. In animal tumor models where the PI3K/AKT/mTOR pathway is abnormally activated (i.e. glioblastoma, prostate cancer, and breast cancer), RES-529 reduces tumor growth by as much as 78%. RES-529 treatment is synergistic with radiati...
Source: Anti-Cancer Drugs - May 24, 2016 Category: Cancer & Oncology Tags: Review Articles Source Type: research

For Medication Abortion, Science Should Guide Policy
The U.S. Food and Drug Administration (FDA) approval of an updated label for the abortion drug Mifeprex in March 2016 (FDA, 2016a) marked an important step for access for abortion care and for evidence-based policy. Since the drug's initial approval in 2000, a strong and growing body of research has demonstrated the safety of medication abortion and supported several advances in medication abortion procedures, including changes to medication dosages and requirements for in-person office visits (Borkowski, Strasser, Allina, & Wood, 2015). (Source: Womens Health Issues)
Source: Womens Health Issues - May 24, 2016 Category: Primary Care Authors: Susan F. Wood, Liz Borkowski, Julia Strasser, Amy Allina Tags: Commentary Source Type: research

Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval.
Abstract In the United States, new surgical heart valves can be approved on the basis of objective performance criteria (OPC). In contrast, the US Food and Drug Administration traditionally requires stricter criteria for transcatheter heart valve (THV) approval, including randomized, clinical trials. Recent US Food and Drug Administration approval of new-generation THVs based on single-arm studies has generated interest in alternative study approaches for THV device approval. This review evaluates whether THV device approval could follow a pathway analogous to that of surgical heart valves by incorporating OPC and ...
Source: Circulation - May 24, 2016 Category: Cardiology Authors: Head SJ, Mylotte D, Mack MJ, Piazza N, van Mieghem NM, Leon MB, Kappetein AP, Holmes DR Tags: Circulation Source Type: research

US FDA approves first PD-1/PD-L1 inhibitor for most common bladder cancer
The US Food and Drug Administration has approved the immunotherapy atezolizumab (Tecentriq) to treat urothelial carcinoma, the most common form of bladder cancer. (Source: The Pharmaceutical Journal)
Source: The Pharmaceutical Journal - May 23, 2016 Category: Drugs & Pharmacology Source Type: research

Artificial sweeteners as a sugar substitute: Are they really safe?
Arun Sharma, S Amarnath, M Thulasimani, S RamaswamyIndian Journal of Pharmacology 2016 48(3):237-240Nonnutritive sweeteners (NNS) have become an important part of everyday life and are increasingly used nowadays in a variety of dietary and medicinal products. They provide fewer calories and far more intense sweetness than sugar-containing products and are used by a plethora of population subsets for varying objectives. Six of these agents (aspartame, saccharine, sucralose, neotame, acesulfame-K, and stevia) have previously received a generally recognized as safe status from the United States Food and Drug Administration, a...
Source: Indian Journal of Pharmacology - May 23, 2016 Category: Drugs & Pharmacology Authors: Arun SharmaS AmarnathM ThulasimaniS Ramaswamy Source Type: research

Atypical post-finasteride syndrome: A pharmacological riddle
Anita K Gupta, Neetu Sharma, Prashant ShuklaIndian Journal of Pharmacology 2016 48(3):316-317Finasteride and dutasteride are commonly used 5-alpha reductase inhibitors. While finasteride is a selective inhibitor of 5-alpha reductase Type II, dutasteride inhibits 5- alpha reductase Type I and II. The United States Food and Drug Administration approved the use of finasteride for benign prostatic hypertrophy (BPH) as well as androgenic alopecia (AGA) while dutasteride is approved only for BPH. Off-label use of dutasteride is not uncommon in AGA as well. Although the postfinasteride syndrome (PFS) is a well-established entity,...
Source: Indian Journal of Pharmacology - May 23, 2016 Category: Drugs & Pharmacology Authors: Anita K GuptaNeetu SharmaPrashant Shukla Source Type: research

The (Con-) Fusion in ALK Diagnostics: When Food and Drug Administration-Approved Algorithms Fail [CORRESPONDENCE]
(Source: Journal of Clinical Oncology)
Source: Journal of Clinical Oncology - May 23, 2016 Category: Cancer & Oncology Authors: Jurgens, Engel-Riedel, Stoelben, Schildgen, Schildgen, Brockmann Tags: CORRESPONDENCE Source Type: research

Lumacaftor-ivacaftor (Orkambi) for cystic fibrosis: behind the 'breakthrough
This article aims to help this process. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - May 23, 2016 Category: Internal Medicine Authors: Mayer, M. Tags: Pancreas and biliary tract, Editor's choice, Cystic fibrosis Perspective Source Type: research

New reversal agent for factor Xa inhibitors shows promise
Commentary on: Siegal DM, Curnette JT, Connolly SJ, et al.. Andexanet alfa for the reversal of Factor Xa inhibitor activity. N Engl J Med 2015;373:2413–24. Context Direct oral anticoagulants (DOACs) have emerged as alternatives to vitamin K-antagonists (eg, warfarin) for the long-term management of stroke prevention for non-valvular atrial fibrillation or venous thromboembolic disease. Favourable side-effect profiles and absence of therapeutic monitoring are important benefits of these newer agents. Warfarin is readily reversed with fresh frozen plasma (FFP) or prothrombin complex concentrates.1 The first reversal ag...
Source: Evidence-Based Medicine - May 23, 2016 Category: Internal Medicine Authors: Ghadimi, K., Welsby, I. J. Tags: Clinical trials (epidemiology), Immunology (including allergy), Drugs: cardiovascular system, Stroke, Venous thromboembolism, Unwanted effects / adverse reactions Therapeutics/Prevention Source Type: research

Native tissue repair for central compartment prolapse: a narrative review
The objective and subjective results of different procedures are reviewed. Functional outcomes of native tissue repair procedures have not been studied sufficiently, though existing data present those procedures as favorable and not categorically inferior to sacrocolpopexy. Apical compartment prolapse repair using native tissue is not a compromise. Functional outcomes of native tissue repair procedures are favorable, have a high rate of success, improve women’s quality of life (QoL), and result in high rates of patient satisfaction. This subject requires further long-term, standardized prospective studies following the I...
Source: International Urogynecology Journal - May 21, 2016 Category: OBGYN Source Type: research

Cardiovascular MRI with ferumoxytol
The practice of contrast-enhanced magnetic resonance angiography (CEMRA) has changed significantly in the span of a decade. Concerns regarding gadolinium (Gd)-associated nephrogenic systemic fibrosis in those with severely impaired renal function spurred developments in low-dose CEMRA and non-contrast MRA as well as efforts to seek alternative MR contrast agents. Originally developed for MR imaging use, ferumoxytol (an ultra-small superparamagnetic iron oxide nanoparticle), is currently approved by the US Food and Drug Administration for the treatment of iron deficiency anaemia in adults with renal disease. (Source: Clinical Radiology)
Source: Clinical Radiology - May 21, 2016 Category: Radiology Authors: J.P. Finn, K.-L. Nguyen, F. Han, Z. Zhou, I. Salusky, I. Ayad, P. Hu Tags: Review Source Type: research

A Better Solution to the Management of Pararenal/Visceral Aortic Aneurysms: The Fenestrated Aortic Endograft
Abdominal aortic aneurysms (AAA) are relatively common and can be life threatening. Currently, over 70% of aneurysms are repaired with endovascular techniques. Approximately 20% of patients, however, are not candidates for conventional endovascular repair mainly due to renal artery involvement. Although fenestrated and branched endografts have been used in Europe for several decades, it was not until April of 2012 that the Food and Drug Administration approved the Cook Zenith Fenestrated Aortic Endograft (ZFEN) in the United States. (Source: Journal of Vascular Nursing)
Source: Journal of Vascular Nursing - May 20, 2016 Category: Nursing Authors: Ann Lopez Source Type: research

Interleukin-12-expressing oncolytic virus: A promising strategy for cancer immunotherapy
Publication date: Available online 27 April 2016 Source:Journal of Taibah University Medical Sciences Author(s): Almohanad A. Alkayyal, Ahmad B. Mahmoud, Rebecca C. Auer Oncolytic viruses (OVs) are an emerging class of novel anti-cancer therapeutic agents that selectively infect and destroy cancerous tissues without damaging normal cells. With the recent US Food and Drug Administration (FDA) approval of Herpes Virus (T-VEC) for the treatment of advanced melanoma, oncolytic virotherapy has gained more attention for further development as a novel form of immunotherapy. A viable approach to maximize the efficacy of OVs i...
Source: Journal of Taibah University Medical Sciences - May 20, 2016 Category: Universities & Medical Training Source Type: research

Understanding the biosimilar approval and extrapolation process—A case study of an epoetin biosimilar
The World Health Organization defines a biosimilar as “a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.” Biosimilars are biologic medical products that are very distinct from small-molecule generics, as their active substance is a biological agent derived from a living organism. Approval processes are highly regulated, with guidance issued by the European Medicines Agency and US Food and Drug Administration. (Source: Critical Reviews in Oncology Hematology)
Source: Critical Reviews in Oncology Hematology - May 20, 2016 Category: Cancer & Oncology Authors: Amit B. Agarwal, Ali McBride Source Type: research

Homoharringtonine delivered by high proportion PEG of long- circulating liposomes inhibits RPMI8226 multiple myeloma cells in vitro and in vivo.
This study suggests that our developed LCL-HHT-H-PEG may be regarded as a promising nano-device to deliver anti-MM drug HHT for treatment of MM patients. PMID: 27186264 [PubMed] (Source: American Journal of Translational Research)
Source: American Journal of Translational Research - May 19, 2016 Category: Research Tags: Am J Transl Res Source Type: research

FDA: No oral ketoconazole for skin, nail fungus
The Food and Drug Administration is warning health care professionals not to prescribe oral ketoconazole for patients with fungal infections of the skin and nails, because of "the risks of... (Source: Hospitalist News)
Source: Hospitalist News - May 19, 2016 Category: Hospital Management Source Type: research

FDA: No oral ketoconazole for skin, nail fungus
The Food and Drug Administration is warning health care professionals not to prescribe oral ketoconazole for patients with fungal infections of the skin and nails, because of "the risks of... (Source: Internal Medicine News)
Source: Internal Medicine News - May 19, 2016 Category: Internal Medicine Source Type: research

PCSK9 inhibitors: monoclonal antibodies for the treatment of hypercholesterolemia.
Authors: Paton DM Abstract In 2015 the U.S. Food and Drug Administration approved the first two proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, alirocumab (Praluent[R]; Sanofi/ Regeneron) and evolocumab (Repatha[R]; Amgen), for use in patients with heterozygous and homozygous familial hypercholesterolemia and for patients intolerant of statins or those with a major risk of cardiovascular disease (CVD) but unable to lower their LDL cholesterol (LDL-C) to optimal levels with statins and ezetimibe. Numerous randomized clinical trials have demonstrated that these inhibitors cause a fall in LDL-C level...
Source: Drugs of Today - May 19, 2016 Category: Drugs & Pharmacology Tags: Drugs Today (Barc) Source Type: research

Liquid Biopsy in Lung Cancer.
Abstract Liquid biopsy has received extensive media coverage and has been called the holy grail of cancer detection. Attempts at circulating tumor cell and genetic material capture have been progressing for several years, and recent financially and technically feasible improvements of cell capture devices, plasma isolation techniques, and highly sensitive polymerase chain reaction- and sequencing-based methods have advanced the possibility of liquid biopsy of solid tumors. Although practical use of circulating RNA-based testing has been hindered by the need to fractionate blood to enrich for RNAs, the detection of ...
Source: Archives of Pathology and Laboratory Medicine - May 19, 2016 Category: Laboratory Medicine Authors: Sholl LM, Aisner DL, Allen TC, Beasley MB, Cagle PT, Capelozzi VL, Dacic S, Hariri LP, Kerr KM, Lantuejoul S, Mino-Kenudson M, Raparia K, Rekhtman N, Roy-Chowdhuri S, Thunnissen E, Tsao M, Vivero M, Yatabe Y Tags: Arch Pathol Lab Med Source Type: research

What Is the Value of Three-Parent IVF?
Abstract In February 2016, the Institute of Medicine released a report, commissioned by the United States Food and Drug Administration, on the ethical and social-policy implications of so-called three-parent in vitro fertilization. The IOM endorses commencement of clinical trials on three-parent IVF, subject to some initial limitations. Also called mitochondrial replacement or transfer, three-parent IVF is an intervention comprising two distinct procedures in which the genetic materials of three people-the DNA of the father and mother and the mitochondrial DNA of an egg donor-can be used to create a child. Three-pa...
Source: The Hastings Center Report - May 19, 2016 Category: Medical Ethics Authors: Rulli T Tags: Hastings Cent Rep Source Type: research

EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus.
Abstract During the last decade, the armamentarium for glucose-lowering drugs has increased enormously by the development of DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors, allowing individualization of antidiabetic therapy for patients with type 2 diabetes (T2DM). Some combinations can now be used without an increased risk for severe hypoglycemia and weight gain. Following a request of the US Food and Drug Administration, many large cardiovascular (CV) outcome studies have been performed in patients with longstanding disease and established CV disease. In the majority of CV outcome studies, CV risk...
Source: Clinical Therapeutics - May 19, 2016 Category: Drugs & Pharmacology Authors: Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH Tags: Clin Ther Source Type: research

Interim Guidance for Zika Virus Testing of Urine - United States, 2016.
Authors: Abstract Diagnostic testing for Zika virus infection can be accomplished using molecular and serologic methods. Real-time reverse transcription-polymerase chain reaction (rRT-PCR) is the preferred test for Zika virus infection because it can be performed rapidly and is highly specific (1,2). However, in most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness (2,3). Recent reports using adaptations of previously published methods (2,4) suggest that Zika virus RNA can be detected in urine for at least 2 weeks after onset of symptoms (3,5-7). Currently, the CDC Triop...
Source: MMWR Morb Mortal Wkl... - May 18, 2016 Category: Epidemiology Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Codeine in paediatrics: pharmacology, prescribing and controversies
Codeine is a drug that until recently was widely used in children. It was endorsed by the WHO as the second step on the analgesic ladder for cancer pain and has been used routinely for postoperative and breakthrough pain. Recently, its safety and efficacy have been called into question, following deaths after adenotonsillectomy was associated with its use. This has led to regulation by the US Food and Drug Administration, European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency to place significant restrictions on its use, and some centres have stopped using it altogether. In this article, w...
Source: Archives of Disease in Childhood - Education and Practice - May 18, 2016 Category: Pediatrics Authors: Andrzejowski, P., Carroll, W. Tags: Oncology, Pharmacy update, Pain (neurology), Hospice, Pain (palliative care), Medicines regulation, Pain (anaesthesia), Ear, nose and throat/otolaryngology Source Type: research

Profile of palbociclib in the treatment of metastatic breast cancer
Moataz Ehab,1 Mohamad Elbaz2,31Department of Pharmacy Practice, 2Department of Pharmacology, Pharmacy School, Helwan University, Egypt; 3Department of Pathology, The Comprehensive Cancer Center, The Ohio State University Wexner Medical Center, Columbus, OH, USAAbstract: Breast cancer is the most common cancer diagnosed in women. Each year, thousands die either because of disease progression or failure of treatment. Breast cancer is classified into different subtypes based on the molecular expression of estrogen receptor (ER), progesterone receptor, and/or human epidermal growth factor receptor 2 (HER2). These receptor...
Source: Vascular Health and Risk Management - May 17, 2016 Category: Cardiology Tags: Breast Cancer: Targets and Therapy Source Type: research

Discovery, Development, and Adoption of Medications to Treat Alcohol Use Disorder: Goals for the Phases of Medications Development
For more than 25 years, advances have been made in developing medications to treat alcohol use disorder (AUD), highlighted by the U.S. Food and Drug Administration's approval of naltrexone (oral and long‐acting) and acamprosate. Despite this progress, more work remains to be done in this area because these medications, although effective for some people, do not work for everyone. A high priority for the National Institute on Alcohol Abuse and Alcohol is to put into place a solid infrastructure to aid in the development of medications that are more effective than those currently available and with few side effects. Medic...
Source: Alcoholism: Clinical and Experimental Research - May 17, 2016 Category: Addiction Authors: Raye Z. Litten, Daniel E. Falk, Megan L. Ryan, Joanne B. Fertig Tags: Critical Review Source Type: research

Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle [Innovations in Care]
Infants with single ventricle require staged cardiac surgery, with stage I typically performed shortly after birth, stage II at 4 to 6 months of age, and stage III at 3 to 5 years of age. There is a high risk of interstage mortality and morbidity after infants are discharged from the hospital between stages I and II. Traditional home monitoring requires caregivers to record measurements of weight and oxygen saturation into a binder and requires families to assume a surveillance role. We have developed a tablet PC–based solution that provides secure and nearly instantaneous transfer of patient information to a cloud-b...
Source: Circulation: Cardiovascular Quality and Outcomes - May 17, 2016 Category: Cardiology Authors: Shirali, G., Erickson, L., Apperson, J., Goggin, K., Williams, D., Reid, K., Bradley-Ewing, A., Tucker, D., Bingler, M., Spertus, J., Rabbitt, L., Stroup, R. Tags: Mortality/Survival, Quality and Outcomes Innovations in Care Source Type: research