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Cyclic depsipeptides as potential cancer therapeutics
Cyclic depsipeptides are polypeptides in which one or more amino acid is replaced by a hydroxy acid, resulting in the formation of at least one ester bond in the core ring structure. Many natural cyclic depsipeptides possessing intriguing structural and biological properties, including antitumor, antifungal, antiviral, antibacterial, anthelmintic, and anti-inflammatory activities, have been identified from fungi, plants, and marine organisms. In particular, the potent effects of cyclic depsipeptides on tumor cells have led to a number of clinical trials evaluating their potential as chemotherapeutic agents. Although many o...
Source: Anti-Cancer Drugs - January 30, 2015 Category: Cancer & Oncology Tags: Review Articles Source Type: research

New treatment paradigms in psoriatic arthritis: an update on new therapeutics approved by the U.S. Food and Drug Administration
Purpose of review: The purpose of this study is to give an overview of the new treatments approved by the U.S. Food and Drug Administration (FDA) for use in psoriatic arthritis (PsA). Recent findings: FDA has approved three new drugs for PsA: Certolizumab-pegol: a PEGylated Fc-free tumour necrosis factor inhibitor (TNFi); ustekinumab: an anti interleukin (IL)-12 and IL-23 mAb; and apremilast and oral phosphodiesterase 4 inhibitor. On well designed and extensive developing programmes, all three drugs proved to be effective for the treatment of most PsA manifestations, including peripheral arthritis, skin involvement, enthes...
Source: Current Opinion in Rheumatology - January 30, 2015 Category: Rheumatology Tags: EPIDEMIOLOGY AND HEALTH-RELATED SERVICES: Edited by M. Elaine Husni Source Type: research

Product quality for nanomaterials: current U.S. experience and perspective
In recent years, there has been an increased focus on developing novel drug delivery systems and targeted therapies through the use of nanotechnology and nanomaterials. Such focus is translating to an increasing number of investigational new drug (IND) applications, new drug applications (NDAs), and abbreviated new drug applications (ANDAs) for drug products containing nanomaterials to the United States Food and Drug Administration (FDA). Although subject to the same rigorous regulatory standards and regulatory pathways as any drug product, unique properties that arise from the small size, large surface area, and polydispe...
Source: Wiley Interdisciplinary Reviews: Nanomedicine and Nanobiotechnology - January 30, 2015 Category: Nanotechnology Authors: Katherine M. Tyner, Peng Zou, Xiaochuan Yang, Hailing Zhang, Celia N. Cruz, Sau L. Lee Tags: Advanced Review Source Type: research

EMA recommended approval for 40 new drugs in 2014
Nature Reviews Drug Discovery 14, 82 (2015). doi:10.1038/nrd4548 Author: Asher Mullard The European Medicines Agency (EMA) approved 40 new agents in 2014, up from 34 in 2013. This left the European regulators only one approval behind the US Food and Drug Administration (FDA) last year (see Nature Rev. Drug Discov. 14, 77–81; (Source: Nature Reviews Drug Discovery)
Source: Nature Reviews Drug Discovery - January 30, 2015 Category: Drugs & Pharmacology Authors: Asher Mullard Tags: News and Analysis Source Type: research

The Tamiflu fiasco and lessons learnt
This article takes a comprehensive relook on the subject, and we proceed to suggest some ways and means to avoid a similar situation in the future. (Source: Indian Journal of Pharmacology)
Source: Indian Journal of Pharmacology - January 30, 2015 Category: Drugs & Pharmacology Authors: Yogendra Kumar GuptaMeenakshi MeenuPrafull Mohan Source Type: research

The Current Role of Retropubic Suspensions
Abstract Various surgical techniques are available to treat stress urinary incontinence (SUI). Recent data analysis revealed that both Burch colposuspension and mid-urethral sling (MUS) are valid treatment options. Both the US Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have reported risks of complications of MUS and it is crucial that pre-operative patients’ counselling should include these. New treatment modalities are also emerging, including bioengineering and nanomaterials; however, these are limited in their current applicability and conventional su...
Source: Current Bladder Dysfunction Reports - January 29, 2015 Category: Urology & Nephrology Source Type: research

Amitriptyline Improves Motor Function in a HD Mouse Model [Molecular Bases of Disease]
In this study, we observed profound improvements in the motor coordination of AMI-treated N171-82Q HD model mice. The beneficial effects of AMI treatment were associated with its ability to reduce mHTT aggregation, potentiation of the BDNF-TrkB signaling system, and support of mitochondrial integrity and functionality. Our study not only provides preclinical evidence for the therapeutic potency of AMI in treating HD, but it also represents an important example of the usefulness of additional pharmacogenomic profiling of pre-existing drugs for novel therapeutic effects with often intractable pathological scenarios. (Source:...
Source: Journal of Biological Chemistry - January 28, 2015 Category: Chemistry Authors: Cong, W.-N., Chadwick, W., Wang, R., Daimon, C. M., Cai, H., Amma, J., Wood, W. H., Becker, K. G., Martin, B., Maudsley, S. Tags: Neurobiology Source Type: research

Immune reactivity to food coloring.
Abstract Artificial food dyes are made from petroleum and have been approved by the US Food and Drug Administration (FDA) for the enhancement of the color of processed foods. They are widely used in the food and pharmaceutical industries to increase the appeal and acceptability of their products. Synthetic food colorants can achieve hues not possible for natural colorants and are cheaper, more easily available, and last longer. However, since the use of artificial food coloring has become widespread, many allergic and other immune reactive disorders have increasingly been reported. During the past 50 y, the amount ...
Source: Alternative Therapies in Health and Medicine - January 27, 2015 Category: Complementary Medicine Authors: Vojdani A, Vojdani C Tags: Altern Ther Health Med Source Type: research

'Black box warning' on food and drug administration criteria for drug-induced heart valve disease?
(Source: European Journal of Echocardiography)
Source: European Journal of Echocardiography - January 27, 2015 Category: Cardiology Authors: Cosyns, B., Droogmans, S. Tags: EDITORIALS Source Type: research

Hyperkalemia Controlled With 2 Novel Medications
Three recent randomized clinical trials have shown that 2 distinct oral medications can effectively lower plasma potassium levels in patients with hyperkalemia, a notoriously challenging but common problem in chronic kidney disease and heart failure. The drugs, which haven’t been approved by the US Food and Drug Administration, have different mechanisms of action. Patiromer binds potassium, primarily in the colon. Sodium zirconium cyclosilicate is a highly selective cation exchanger that traps potassium in the intestines. (Source: JAMA)
Source: JAMA - January 27, 2015 Category: Journals (General) Source Type: research

New Modeling Software Evaluates Coronary Artery Blood Flow
A new computer modeling program approved by the US Food and Drug Administration (FDA) will permit clinicians to noninvasively evaluate blood flow in the coronary arteries of patients with symptoms of coronary artery disease (http://1.usa.gov/1FsmVpq). (Source: JAMA)
Source: JAMA - January 27, 2015 Category: Journals (General) Source Type: research

On-label and off-label drug use in the treatment of endometriosis
Endometriosis, characterized by the presence of endometrial glands and stroma in extrauterine locations, is a significant cause of pelvic pain and infertility, as well as a major health care burden. Although Food and Drug Administration (FDA)–approved treatments are available, the use of “off-label” medications for endometriosis is widespread. In this review, we provide an overview of the current FDA-approved treatments, followed by a detailed review of the major “off-label” treatments being used in the United States and worldwide, including efficacy, side effects, drug interactions, contraindications, and anomal...
Source: Fertility and Sterility - January 27, 2015 Category: Reproduction Medicine Authors: Alexander M. Quaas, Elizabeth A. Weedin, Karl R. Hansen Tags: Views and reviews Source Type: research

Workshop focuses on accelerating approval of neonatal therapeutics [FDA UPDATE]
(Source: AAP News)
Source: AAP News - January 26, 2015 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Office of Translational Sciences, Division of Pediatric & Maternal Health Tags: FDA Update, Therapeutics Source Type: research

New antiepileptic medication linked to blue discoloration of the skin and eyes
Ezogabine is an antiepileptic medication approved in June 2011 by the US Food and Drug Administration (FDA) as an adjunctive treatment for partial seizures. Minimal drug interactions and a novel mechanism of action made ezogabine an appealing new treatment option. However, adverse effects reported during clinical trials and following drug approval have been alarming. A Risk Evaluation Mitigation Strategy (REMS) program has been established for urinary retention. A safety alert was published in April 2013 warning ezogabine may cause retinal pigment abnormalities and/or blue-gray discoloration, most notably on or near the li...
Source: Therapeutic Advances in Drug Safety - January 26, 2015 Category: Drugs & Pharmacology Authors: Clark, S., Antell, A., Kaufman, K. Tags: Reviews Source Type: research

ER/LA Opioids: Achieving Safe Use While Improving Patient Care (P19)
The US Food and Drug Administration (FDA) has determined that a risk evaluation and mitigation strategy (REMS) is required for extended-release (ER) and long-acting (LA) opioid medications to ensure that their benefits outweigh their risks. AAHPM has been a strong advocate of availability of these medications for use in palliative and hospice care settings while acknowledging the significant increase of unintentional deaths, emergency department visits, and admissions to substance abuse treatment due to abuse of pain relievers. (Source: Journal of Pain and Symptom Management)
Source: Journal of Pain and Symptom Management - January 25, 2015 Category: Palliative Care Source Type: research

Estimated cost efficacy of systemic treatments that are approved by the US Food and Drug Administration for the treatment of moderate to severe psoriasis
Newer psoriasis treatments tout higher efficacy but are generally more expensive. (Source: Journal of the American Academy of Dermatology)
Source: Journal of the American Academy of Dermatology - January 25, 2015 Category: Dermatology Authors: Logan S. D'Souza, Michael J. Payette Tags: Original article Source Type: research

Evaluation of Patients' Perceptions of Mesh Usage in Female Pelvic Medicine and Reconstructive Surgery
To evaluate if new patients presenting to a female pelvic medicine and reconstructive surgery clinic are aware of the US Food and Drug Administration (FDA) announcement regarding transvaginal mesh placement for pelvic organ prolapse repair and do they believe there is a mesh recall. (Source: Urology)
Source: Urology - January 24, 2015 Category: Urology & Nephrology Authors: Christopher F. Tenggardjaja, Courtenay K. Moore, Sandip P. Vasavada, Jianbo Li, Howard B. Goldman Tags: Female Urology Source Type: research

Editorial Comment
Tenggardjaja et al1 report on a survey instrument, developed by 3 experts in female pelvic health, administered to new patients presenting to tertiary referral center for incontinence (73%) or pelvic organ prolapse. They conclude that 2 of 3 patients were aware of the US Food and Drug Administration's warning and half of those who answered the particular question believed there was a recall related to the mesh. They further state that 108 of 156 listed television (TV) advertisements as the source of the information. (Source: Urology)
Source: Urology - January 24, 2015 Category: Urology & Nephrology Authors: Gopal H. Badlani Tags: Female Urology Source Type: research

Contemporary Comparison Between Retropubic Midurethral Sling and Autologous Pubovaginal Sling for Stress Urinary Incontinence After the FDA Advisory Notification
To compare the efficacy and safety in a contemporary cohort of women who were offered either a pubovaginal sling (PVS) or a synthetic midurethral sling (MUS) after the US Food and Drug Administration notification and made an informed decision on procedure option. (Source: Urology)
Source: Urology - January 24, 2015 Category: Urology & Nephrology Authors: Stephen Mock, Jonathan Angelle, William Stuart Reynolds, David J. Osborn, Roger R. Dmochowski, Alexander Gomelsky Tags: Female Urology Source Type: research

Editorial Comment
This article1 describes the dissemination of TT and its impact on rates of cytoreductive nephrectomy (CN) among privately insured patients aged (Source: Urology)
Source: Urology - January 24, 2015 Category: Urology & Nephrology Authors: Hubert R. Kübler Tags: Medical Oncology Source Type: research

Consistency and Standardization of Color in Medical Imaging: a Consensus Report
This article summarizes the consensus reached at the Summit on Color in Medical Imaging held at the Food and Drug Administration (FDA) on May 8–9, 2013, co-sponsored by the FDA and ICC (International Color Consortium). The purpose of the meeting was to gather information on how color is currently handled by medical imaging systems to identify areas where there is a need for improvement, to define objective requirements, and to facilitate consensus development of best practices. Participants were asked to identify areas of concern and unmet needs. This summary documents the topics that were discussed at the meeting and re...
Source: Journal of Digital Imaging - January 24, 2015 Category: Radiology Source Type: research

A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation
This article is not meant to further deter gynecologists from using laparoscopic power morcellators, but to provide an interpretation of the FDA statement as to which patients the use of power morcellators may still be permitted under the FDA guidelines. This article also offers protective measures from a legal perspective for those who choose to continue to use power morcellators in the face of the recent FDA warning and litigation. (Source: Journal of Minimally Invasive Gynecology)
Source: Journal of Minimally Invasive Gynecology - January 24, 2015 Category: OBGYN Source Type: research

Risky behaviors, e-cigarette use and susceptibility of use among college students
Since 2007, electronic cigarettes (e-cigarettes) have gained popularity in the U.S. In April 2014, the Food and Drug Administration (FDA) proposed regulations restricting e-cigarette sales to minors. One public health concern is that e-cigarettes may be a “gateway,” leading e-cigarette users to begin smoking (Cobb and Abrams, 2011). E-cigarettes are often believed by users to be less harmful than cigarettes (Choi and Forster, 2013; Pearson et al., 2012). A recent review supports beliefs about reduced harmfulness, concluding “Health professionals may consider advising smokers unable or unwilling to quit through other ...
Source: Drug and Alcohol Dependence - January 24, 2015 Category: Addiction Authors: M.L. Saddleson, L.T. Kozlowski, G.A. Giovino, L.W. Hawk, Murphy Jm, M.G. MacLean, M.L. Goniewicz, G.G. Homish, B.H. Wrotniak, M.C. Mahoney Tags: Full length article Source Type: research

New Thoughts on the “Forgotten” Aspect of Antimicrobial Stewardship: Adverse Event Reporting
Antimicrobial stewardship is an activity that optimizes patient care through selection of the most appropriate antimicrobial therapy. Antimicrobial stewardship programs strive to enhance patient care and reduce preventable consequences of antimicrobial use. They are also vital in monitoring for the development of adverse events occurring as a result of antimicrobial therapy, although literature reviews of this activity are scarce. Although randomized controlled trials are considered the gold standard to study the efficacy of a medication, these trials are not designed to test safety end points and often are only able to id...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - January 23, 2015 Category: Drugs & Pharmacology Authors: Charles Hoffmann, Tina Khadem, Anne Schweighardt, Jack Brown Tags: Practice Insights Source Type: research

A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation
Minimally invasive gynecological surgeons who perform laparoscopic intraperitoneal morcellation should be aware of the recent US Food and Drug Administration (FDA) warning and litigation arising from use of morcellation devices with claims of intraperitoneal dissemination of cancerous cells. On November 24, 2014 the FDA issued a statement warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Despite best intentions in regards to their patients, gynecologists who continue to use power morcellation devices expose themselves to liability. (So...
Source: The Journal of Minimally Invasive Gynecology - January 23, 2015 Category: OBGYN Authors: Raquel Ton, Gokhan S. Kilic, John Y. Phelps Source Type: research

Effect of Cromolyn Sodium on A{beta} Aggregation and Cerebral A{beta} [Molecular Bases of Disease]
Interfering with the assembly of Amyloid β (Aβ) peptides from monomer to oligomeric species and fibrils or promoting their clearance from the brain are targets of anti-Aβ-directed therapies in Alzheimer disease. Here we demonstrate that cromolyn sodium (disodium cromoglycate), a Food and Drug Administration-approved drug already in use for the treatment of asthma, efficiently inhibits the aggregation of Aβ monomers into higher-order oligomers and fibrils in vitro without affecting Aβ production. In vivo, the levels of soluble Aβ are decreased by over 50% after only 1 week of daily intraperitoneally administered cromo...
Source: Journal of Biological Chemistry - January 22, 2015 Category: Chemistry Authors: Hori, Y., Takeda, S., Cho, H., Wegmann, S., Shoup, T. M., Takahashi, K., Irimia, D., Elmaleh, D. R., Hyman, B. T., Hudry, E. Tags: Neurobiology Source Type: research

Progesterone Receptor Chaperone Complex-Based High-Throughput Screening Assay: Identification of Capsaicin as an Inhibitor of the Hsp90 Machine
We report here the development of a novel high-throughput screening assay platform to identify small-molecule inhibitors of Hsp90 and its co-chaperones. This assay quantitatively measures the ability of Hsp90 and its co-chaperones to refold/protect the progesterone receptor, a physiological client of Hsp90, in a 96-well plate format. We screened the National Institutes of Health clinical collection drug library and identified capsaicin as a hit molecule. Capsaicin is a Food and Drug Administration–approved drug for topical use in pain management. Cell survival assays showed that capsaicin selectively kills cancer cel...
Source: Journal of Biomolecular Screening - January 22, 2015 Category: Molecular Biology Authors: Patwardhan, C. A., Alfa, E., Lu, S., Chadli, A. Tags: Original Research Source Type: research

Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.
Abstract BACKGROUND: On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recomme...
Source: Breast Cancer - January 22, 2015 Category: Cancer & Oncology Authors: Tazawa Y Tags: Breast Cancer Source Type: research

Treatment of hepatitis C, then, now and tomorrow
Commentary on: Kohli A, Shaffer A, Kottilil S. Treatment of hepatitis C: a systematic review. JAMA 2014;312:631–40. Context Hepatitis C virus (HCV) infects over 185 million people worldwide and can lead to progressive liver fibrosis, cirrhosis, hepatocellular carcinoma and death. Antiviral treatment can prevent these complications and improve survival. Interferon has been the backbone of anti-HCV therapy, but has been plagued by side effects, treatment failure and relapse. HCV treatment has seen significant changes with the advent of directly acting antiviral agents with nearly 100% cure rate with all oral, interfero...
Source: Evidence-Based Medicine - January 21, 2015 Category: Internal Medicine Authors: Sterling, R. K., Dharel, N. Tags: Liver disease, Clinical trials (epidemiology), Epidemiologic studies, Immunology (including allergy), Hepatitis and other GI infections, Hepatitis (sexual health) Therapeutics/Prevention Source Type: research

Practical aspects of treatment with target specific anticoagulants: initiation, payment and current market, transitions, and venous thromboembolism treatment
Abstract Target specific anticoagulants (TSOACs) have recently been introduced to the US market for multiple indications including venous thromboembolism (VTE) prevention in total hip and knee replacement surgeries, VTE treatment and reduction in the risk of stroke in patients with non-valvular atrial fibrillation (NVAF). Currently, three TSOACs are available including rivaroxaban, apixaban, and dabigatran with edoxaban currently under Food and Drug Administration review for VTE treatment and stroke prevention in NVAF. The introduction of these agents has created a paradigm shift in anticoagulation by considerably...
Source: Journal of Thrombosis and Thrombolysis - January 21, 2015 Category: Hematology Source Type: research

Transcutaneous electrical nerve stimulation for chronic post‐herpetic neuralgia
Abstract Postherpetic neuralgia remains a therapeutic challenge for the clinician. Many modalities have been utilized with limited success. In this pilot randomized study of patients who were refractory to previous medicinal treatment, the patients were treated with transcutaneous nerve stimulation with a biofeedback capability. After every two treatments with the sham and true device, the patients were required to fill out a standard neuropathic pain scale score. The patients were allowed to select the other device after three consecutive treatments if they felt an inadequate decrease in their pain. The true device was ch...
Source: International Journal of Dermatology - January 20, 2015 Category: Dermatology Authors: Malcolm R. Ing, Philip D. Hellreich, Douglas W. Johnson, John J. Chen Tags: Clinical Trial Source Type: research

Hematopoietic Stem Cell Transplantation for MS Extraordinary Evidence Still Needed
Multiple sclerosis (MS) is a central nervous system disorder characterized by inflammation, loss of the insulating tissue (myelin) surrounding and protecting nerve axons, and multifocal scarring. Multiple sclerosis is a prototypic autoimmune disease likely mediated by pathogenic T and B lymphocytes. There has been substantial progress in the management of MS during the past decade, with 10 variably effective therapies now available and approved by the US Food and Drug Administration (FDA). These therapies suppress the early relapsing-remitting form of MS; however, the late neurodegenerative phase of the disease, progressiv...
Source: JAMA - January 20, 2015 Category: Journals (General) Source Type: research

FDA Regulation of Adult Stem Cell Therapies as Used in Sports Medicine
This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval.[...]Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.Article in Thieme eJournals:T...
Source: Journal of Knee Surgery - January 20, 2015 Category: Orthopaedics Authors: Chirba, Mary AnnSweetapple, BerkleyHannon, Charles P.Anderson, John A. Tags: Special Focus Section Source Type: research

Hypersensitivity Reaction in the US Food and Drug Administration-Approved Second-Generation Drug-Eluting Stents: Histopathological Assessment With Ex Vivo Optical Coherence Tomography.
PMID: 25601953 [PubMed - in process] (Source: Circulation)
Source: Circulation - January 20, 2015 Category: Cardiology Authors: Otsuka F, Yahagi K, Ladich E, Kutys R, Alexander R, Fowler D, Virmani R, Joner M Tags: Circulation Source Type: research

A Meeting Report from the Cardiac Safety Research Consortium
Publication date: Available online 15 January 2015 Source:American Heart Journal Author(s): Philip T. Sager , Jonathan Seltzer , J. Rick Turner , Jeffrey L. Anderson , William R. Hiatt , Peter Kowey , Judith J. Prochaska , Norman Stockbridge , William B. White This White Paper provides a summary of presentations and discussions at a Cardiovascular Safety Outcome Trials Think Tank co-sponsored by the Cardiac Safety Research Consortium (CSRC), the US Food and Drug Administration (FDA), and the American College of Cardiology (ACC), held at ACC's Heart House, Washington, DC, on 19 February 2014. Studies to assess cardiovascu...
Source: American Heart Journal - January 19, 2015 Category: Cardiology Source Type: research

Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: Treatments in urologic oncology
Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA׳s role in the development of investigational new drugs, with an emphasis on the regulatory...
Source: Urologic Oncology: Seminars and Original Investigations - January 19, 2015 Category: Urology & Nephrology Authors: Yang-Min Ning, V. Ellen Maher Tags: Seminar article Source Type: research

Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: Treatments in urologic oncology.
Abstract Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA׳s role in the development of investigational new drugs, with an emphasis ...
Source: Urologic Oncology - January 19, 2015 Category: Urology & Nephrology Authors: Ning YM, Maher VE Tags: Urol Oncol Source Type: research

Discussion and Challenges in the Use and Interpretation of Utility Assessment
The importance of Patient-Reported Outcome (PRO) measures in the evaluation of drugs, technologies, and treatments has been recently recognized by clinicians, policy makers, and regulators (eg the U. S. Food and Drug Administration). PROs assess the patient's experience and include domains such as quality of life, functional status, well-being, and satisfaction with care (1). These measures complement the usual clinical measures such as survival, toxicity, and efficacy. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - January 17, 2015 Category: Radiology Authors: Karen E. Bremner Tags: Editorial Source Type: research

A multicentre study of meticillin-resistant in acute bacterial skin and skin-structure infections in China: susceptibility to ceftaroline and molecular epidemiology
Ceftaroline is a new cephalosporin with potent activity against Gram-positive organisms, including meticillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Streptococcus pneumoniae. It has been approved by the US Food and Drug Administration (FDA) (October 2010) and the European Medicines Agency (August 2012) for acute bacterial skin and skin-structure infections (ABSSSIs) and community-acquired bacterial pneumonia. (Source: International Journal of Antimicrobial Agents)
Source: International Journal of Antimicrobial Agents - January 16, 2015 Category: Drugs & Pharmacology Authors: Hui Zhang, Meng Xiao, Fanrong Kong, Matthew V.N. O'Sullivan, Lei-Li Mao, Hao-Ran Zhao, Ying Zhao, He Wang, Ying-Chun Xu Source Type: research

Reactions to graphic health warnings in the United States
This study reports consumer reactions to the graphic health warnings selected by the Food and Drug Administration to be placed on cigarette packs in the United States. We recruited three sets of respondents for an experimental study from a national opt-in e-mail list sample: (i) current smokers aged 25 or older, (ii) young adult smokers aged 18–24 and (iii) youth aged 13–17 who are current smokers or who may be susceptible to initiation of smoking. Participants were randomly assigned to be exposed to a pack of cigarettes with one of nine graphic health warnings or with a text-only warning statement. All three a...
Source: Health Education Research - January 16, 2015 Category: Research Authors: Nonnemaker, J. M., Choiniere, C. J., Farrelly, M. C., Kamyab, K., Davis, K. C. Tags: ORIGINAL ARTICLES Source Type: research

Awareness of FDA-mandated cigarette packaging changes among smokers of 'light' cigarettes
Previous research has clearly demonstrated that smokers associate cigarette descriptors such as ‘light’, ‘ultra-light’ and ‘low tar’ with reduced health risks, despite evidence showing that cigarettes with these descriptor terms do not present lower health risk. In June 2010, regulations implemented by the US Food and Drug Administration went into effect to ban the use of ‘light’, ‘mild’ and ‘low’ on cigarette packaging. We surveyed smokers participating in human laboratory studies at our Center in Philadelphia, PA, USA shortly after the ban went into ...
Source: Health Education Research - January 16, 2015 Category: Research Authors: Falcone, M., Bansal-Travers, M., Sanborn, P. M., Tang, K. Z., Strasser, A. A. Tags: ORIGINAL ARTICLES Source Type: research

GSK3{beta} Regulates Podocyte Microtubules [Molecular Bases of Disease]
Reminiscent of neural repair, following podocyte depletion, remnant-surviving podocytes exhibit a considerable adaptive capacity to expand and cover the denuded renal glomerular basement membrane. Microtubules, one of the principal cytoskeletal components of podocyte major processes, play a crucial role in podocyte morphogenesis and podocyte process outgrowth, branching, and elongation. Here, we demonstrated that the microtubule-associated proteins Tau and collapsin response mediator protein (CRMP) 2, key regulators of microtubule dynamics, were abundantly expressed by glomerular podocytes in vivo and in vitro, interacted ...
Source: Journal of Biological Chemistry - January 16, 2015 Category: Chemistry Authors: Xu, W., Ge, Y., Liu, Z., Gong, R. Tags: Cell Biology Source Type: research

Neoliberal technocracy: Explaining how and why the US Food and Drug Administration has championed pharmacogenomics
Publication date: Available online 15 January 2015 Source:Social Science & Medicine Author(s): Stuart Hogarth By 2004 the FDA had emerged as a champion of pharmacogenomics as an exemplar for novel approaches to drug development. This was made clear in 2004 when the agency released a wide-ranging report which positioned pharmacogenomics at the heart of a broader regulatory reform agenda. The Critical Path initiative addressed declining productivity of drug development by suggesting that the problem was a mismatch between the rapid pace of discovery in post-genomic biomedicine and the antiquated development process...
Source: Social Science and Medicine - January 15, 2015 Category: Psychiatry & Psychology Source Type: research

Current wound healing procedures and potential care.
Abstract In this review, we describe current and future potential wound healing treatments for acute and chronic wounds. The current wound healing approaches are based on autografts, allografts, and cultured epithelial autografts, and wound dressings based on biocompatible and biodegradable polymers. The Food and Drug Administration approved wound healing dressings based on several polymers including collagen, silicon, chitosan, and hyaluronic acid. The new potential therapeutic intervention for wound healing includes sustained delivery of growth factors, and siRNA delivery, targeting microRNA, and stem cell therap...
Source: Appl Human Sci - January 13, 2015 Category: Physiology Authors: Dreifke MB, Jayasuriya AA, Jayasuriya AC Tags: Mater Sci Eng C Mater Biol Appl Source Type: research

Clarification Needed on Medicare Part B Payment Policy
Medicare and most Medicaid programs and private insurers end up paying for compounded drugs administered in physicians’ offices, even though such drugs and some of their ingredients are not approved by the Food and Drug Administration (FDA), the Government Accountability Office (GAO) found in a report released November 10 (http://1.usa.gov/1sIty04). (Source: JAMA)
Source: JAMA - January 13, 2015 Category: Journals (General) Source Type: research

Outpatient Pharmacotherapy and Modes of Administration for Acute Repetitive and Prolonged Seizures
This article focuses on pharmacotherapy and, in particular, different modes of administering medication for ARS in the outpatient setting. Our aim was to present a review of data from non-randomized and randomized, controlled trials to evaluate the efficacy, safety and tolerability of out-of-hospital ARS treatments. Several of the studies included patients with ARS, as well as patients with prolonged seizures. Prolonged seizures, or seizures lasting greater than 5 min, have similar risks and treatment options to those of ARS; therefore, this discussion also includes treatment trials and recommendations for prolonged seizu...
Source: CNS Drugs - January 13, 2015 Category: Neurology Source Type: research

The Emerging Role of Biosimilar Epoetins in Nephrology in the United States
Publication date: Available online 10 January 2015 Source:American Journal of Kidney Diseases Author(s): Steven Fishbane , Hitesh H. Shah Biologic drugs, including epoetin, continue to play an important role in the management of medical conditions. However, biologics are costly and soon many of the patents on these drugs will expire, making way for non–brand name products (ie, biosimilars). It is only by introducing competition to the marketplace that costs will de-escalate. In Europe, a specific regulatory pathway for approving biosimilars has been in place since 2005. A similar review pathway in the United States has...
Source: American Journal of Kidney Diseases - January 13, 2015 Category: Urology & Nephrology Source Type: research

Epidural Steroid Injections are Safe and Effective: Multisociety Letter in Support of the Safety and Effectiveness of Epidural Steroid Injections
Abstract Background: In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. Results: The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multiso...
Source: Pain Medicine - January 13, 2015 Category: Anesthesiology Authors: , David J. Kennedy, Joshua Levin, Richard Rosenquist, Virtaj Singh, Clark Smith, Milan Stojanovic, Yakov Vorobeychik Tags: Other Source Type: research

Presentation on US Hospital Websites of Risks and Benefits of Transcatheter Aortic Valve Replacement Procedures
Adequate presentation of risks and benefits of medical therapies is essential to informed decision making by patients. Transcatheter aortic valve replacement (TAVR) has been recently approved by the US Food and Drug Administration for the treatment of severe aortic stenosis among carefully selected patients; recent randomized clinical trials have identified important positive and negative outcomes of TAVR in these populations, including twice the risk of stroke for patients undergoing TAVR vs those undergoing open aortic valve replacement. Since 78% of all adults in the United States seek out health information online, we ...
Source: JAMA Internal Medicine - January 12, 2015 Category: Internal Medicine Source Type: research

Germline oncopharmacogenetics, a promising field in cancer therapy
Abstract Pharmacogenetics (PGx) is the study of the relationship between inter-individual genetic variation and drug responses. Germline variants of genes involved in drug metabolism, drug transport, and drug targets can affect individual response to medications. Cancer therapies are characterized by an intrinsically high toxicity; therefore, the application of pharmacogenetics to cancer patients is a particularly promising method for avoiding the use of inefficacious drugs and preventing the associated adverse effects. However, despite continuing efforts in this field, very few labels include information about ge...
Source: Cellular Oncology - January 9, 2015 Category: Cancer & Oncology Source Type: research