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Biomarkers for MS: Unpuzzling the progressive multiple sclerosis puzzle
The past 20 years have seen dramatic advances in our understanding and treatment of multiple sclerosis (MS). Diagnostic criteria have been refined, imaging has been applied to both MS diagnosis and longitudinal assessment, and 10 treatments have received US Food and Drug Administration approval, with more on the way. Neurologists can now make an MS diagnosis quickly and accurately. They can apply effective treatments to curtail inflammation, precisely monitor for continued inflammatory disease activity, and change treatments if active disease persists. Treatment paradigms now target no evident disease activity, also called...
Source: Neurology - October 20, 2014 Category: Neurology Authors: Fox, R. J. Tags: All Demyelinating disease (CNS), Multiple sclerosis EDITORIALS Source Type: research

Rechanneling the cardiac proarrhythmia safety paradigm: A meeting report from the Cardiac Safety Research Consortium
Publication date: March 2014 Source:American Heart Journal, Volume 167, Issue 3 Author(s): Philip T. Sager , Gary Gintant , J. Rick Turner , Syril Pettit , Norman Stockbridge This white paper provides a summary of a scientific proposal presented at a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/Food and Drug Administration–sponsored Think Tank, held at Food and Drug Administration's White Oak facilities, Silver Spring, MD, on July 23, 2013, with the intention of moving toward consensus on defining a new paradigm in the field of cardiac safety in which proarrhythmic risk would be primar...
Source: American Heart Journal - October 20, 2014 Category: Cardiology Source Type: research

Impact of Levonorgestrel Intrauterine Device on Endometrial Ablation Utilization for Treatment of Menorrhagia
To determine changes in endometrial ablation utilization following Food and Drug Administration (FDA) approval of the levonorgestrel intrauterine device (IUD) for treatment of menorrhagia. (Source: The Journal of Minimally Invasive Gynecology)
Source: The Journal of Minimally Invasive Gynecology - October 19, 2014 Category: OBGYN Authors: M.N. Wasson, H.T.H. Yuen, M.K. Hoffman Source Type: research

A New Application for Barbed Suture: Repair of Cystotomy and Enterotomy
Barbed suture has been approved by the Food and Drug Administration (FDA) since 2004. Here, we show examples where a unidirectional barbed suture was used for closure of intentional cystotomy and enterotomy after resection of endometriotic nodules. (Source: The Journal of Minimally Invasive Gynecology)
Source: The Journal of Minimally Invasive Gynecology - October 19, 2014 Category: OBGYN Authors: A.M. Ecker, T.T.M. Lee Source Type: research

[Perspectives] Robotic surgery: where are we now?
Robotic surgery has fascinated surgeons since its inception almost 30 years ago. US Food and Drug Administration (FDA) approval of the Da Vinci surgical system in 2000 led to the expansion of robotic-assisted laparoscopic surgery—most rapidly in urology but also in gynaecology, cardiothoracics, head and neck, and general surgery. But has this innovation in surgery translated to benefits for patients? (Source: LANCET)
Source: LANCET - October 18, 2014 Category: Journals (General) Authors: Naomi Lee Tags: Perspectives Source Type: research

Expanding Public-Private Collaborations to Enhance Cancer Drug Development: A Report of the Institute of Medicine's Workshop Series, "Implementing a National Cancer Clinical Trials System for the 21st Century"
This report identified a need to reinvigorate the cooperative groups and provided recommendations for improving their effectiveness. Follow-up workshops to monitor progress were conducted by the IOM's National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) in 2011 and 2013. One of the key recommendations of the IOM report was a call for greater collaboration among stakeholders in cancer research. In particular, more active engagement and better alignment of incentives among the cooperative groups, the National Cancer Institute, the U.S. Food and Drug Administration, and the biopharmaceutical indus...
Source: The Oncologist - October 17, 2014 Category: Cancer & Oncology Authors: Bertagnolli MM, Canetta R, Nass SJ Tags: Oncologist Source Type: research

CDC's Tom Frieden to face Congress as two representatives call for his resignation
CDC head Dr. Thomas Frieden is expected to appear before a committee of the House of Representatives Oct. 16, as two congressmen are calling for his resignation. A subcommittee of the Energy & Commerce Committee of the House of Representatives is scheduled to hold a hearing Thursday at noon to examine the U.S. public health response to the Ebola outbreak. Frieden and officials from the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) will be among the hearing witnesses. “Ebola… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 15, 2014 Category: Biotechnology Authors: David Allison Source Type: research

CDC's Tom Frieden to face Congress as two representatives call for his resignation
CDC head Dr. Thomas Frieden is expected to appear before a committee of the House of Representatives Oct. 16, as two congressmen are calling for his resignation. A subcommittee of the Energy & Commerce Committee of the House of Representatives is scheduled to hold a hearing Thursday at noon to examine the U.S. public health response to the Ebola outbreak. Frieden and officials from the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) will be among the hearing witnesses. “Ebola… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - October 15, 2014 Category: Hospital Management Authors: David Allison Source Type: research

Drug delivery to the ischemic brain.
Abstract Cerebral ischemia occurs when blood flow to the brain is insufficient to meet metabolic demand. This can result from cerebral artery occlusion that interrupts blood flow, limits CNS supply of oxygen and glucose, and causes an infarction/ischemic stroke. Ischemia initiates a cascade of molecular events in neurons and cerebrovascular endothelial cells including energy depletion, dissipation of ion gradients, calcium overload, excitotoxicity, oxidative stress, and accumulation of ions and fluid. Blood-brain barrier (BBB) disruption is associated with cerebral ischemia and leads to vasogenic edema, a primary c...
Source: Advances in Pharmacology - October 15, 2014 Category: Drugs & Pharmacology Authors: Thompson BJ, Ronaldson PT Tags: Adv Pharmacol Source Type: research

iTraumaCare reaches another regulatory milestone
Canadian early-stage medical device company iTraumaCare, which has its global commercialization headquarters in San Antonio, has cleared another important regulatory hurdle for its initial product, the iTClamp Hemorrhage Control System. The U.S. Food and Drug Administration has expanded the indications for the iTClamp to include the temporary control of severe bleeding of the neck. Previously, the product’s indications for use in the U.S. included the extremities (arms and legs), axilla (arm pit),… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 15, 2014 Category: Pharmaceuticals Authors: W. Scott Bailey Source Type: research

Migraine Headache Prophylaxis in Adolescents
Abstract Migraine headache is estimated to affect up to 28 percent of adolescents, most of whom are female. Chronic migraine in this population has been associated with reduced quality of life and academic disruption due to missed school days. Historically, migraine headache was treated episodically as it occurred. In March 2014 the U.S. Food and Drug Administration approved an existing medication, topiramate (Topamax®), for migraine prophylaxis in adolescents between the ages of 12 and 17. This is the first FDA approval of a drug for migraine prevention in this population. There are several possible adverse effects of ta...
Source: AWHONN Lifelines - October 14, 2014 Category: Nursing Authors: Heidi Collins Fantasia Tags: Rx Source Type: research

The Targeting of Indoleamine 2,3 Dioxygenase ‐Mediated Immune Escape in Cancer
Abstract The era of immunotherapies was unleashed in 2010 with the Food and Drug Administration (FDA) approval of the first therapeutic vaccine sipuleucel‐T as a standard treatment for metastatic prostate cancer. Next, the first immune‐activating anticytotoxic lymphocyte antigen‐4 (CTLA‐4) antibody ipilimumab exhibiting ‘immune checkpoint blockade’ was approved by FDA and European Medical Agency (EMA) for the treatment of patients with metastatic melanoma. New generations of immune checkpoint blockading antibodies targeting programmed cell death 1 (PD‐1) and its ligand (PD‐L1) are now under intense investig...
Source: Basic and Clinical Pharmacology and Toxicology - October 13, 2014 Category: Drugs & Pharmacology Authors: Trine Zeeberg Iversen, Mads Hald Andersen, Inge Marie Svane Tags: MiniReview Source Type: research

POMALIDOMID – nowy immunomodulujący lek w terapii szpiczaka plazmocytowego
Publication date: April–June 2014 Source:Acta Haematologica Polonica, Volume 45, Issue 2 Author(s): Artur Jurczyszyn , Lidia Usnarska-Zubkiewicz , Anna Engel , Aleksandra Butrym , Grzegorz Mazur , Aleksander B. Skotnicki Multiple myeloma (MM) is a haematological disease characterized by plasma cells proliferation in bone marrow associated with damage of organs – mainly kidneys and bones. Previous therapies significantly extended the survival of patients, but still relapse is 100%. In February 2013, in USA, the Food and Drug Administration (FDA) introduced to therapy a new immunomodulatory drug – pomalidomide. In Eu...
Source: Acta Haematologica Polonica - October 12, 2014 Category: Hematology Source Type: research

[Editorial] Health technologies and computer security
Fans of the American television drama Homeland may remember a scene in which the US vice-president is killed by an assassin who hacks into his wireless pacemaker and induces a fatal electric shock. This premise might sound fantastical, but the publication by the US Food and Drug Administration on Oct 2 of guidance on cybersecurity for medical devices suggests that such scenarios have moved beyond the realm of fiction and are of practical (albeit improbable) concern. The guidance is hardly sophisticated; mainly that manufacturers should include authentication, such as passwords, to restrict access to legitimate users, but m...
Source: LANCET - October 11, 2014 Category: Journals (General) Authors: The Lancet Tags: Editorial Source Type: research

Pharmacological Treatment of Chronic Non-Cancer Pain in Pediatric Patients.
This article reviews the major medications used for pediatric chronic pain conditions. PMID: 25304005 [PubMed - as supplied by publisher] (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 11, 2014 Category: Pediatrics Authors: Mathew E, Kim E, Goldschneider KR Tags: Paediatr Drugs Source Type: research

Pharmacological Treatment of Chronic Non-Cancer Pain in Pediatric Patients
This article reviews the major medications used for pediatric chronic pain conditions. (Source: Pediatric Drugs)
Source: Pediatric Drugs - October 11, 2014 Category: Pediatrics Source Type: research

Gilead's next-generation hepatitis C pill wins FDA approval
Regulators approved Gilead Sciences Inc.'s next-generation hepatitis C drug Friday as the company's controversial breakthrough treatment continues to rack up sales. Harvoni — combining Sovaldi, the hep C drug that won Food and Drug Administration approval in December, with the drug ledipasvir — will cost $94,500 for a 12-week course of treatments for patients with genotype 1 infection or about $63,000 for an eight-week course, according to reports. Genotype 1 is the most common type of hepatitis… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 10, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

Gilead's next-generation hepatitis C pill wins FDA approval
Regulators approved Gilead Sciences Inc.'s next-generation hepatitis C drug Friday as the company's controversial breakthrough treatment continues to rack up sales. Harvoni — combining Sovaldi, the hep C drug that won Food and Drug Administration approval in December, with the drug ledipasvir — will cost $94,500 for a 12-week course of treatments for patients with genotype 1 infection or about $63,000 for an eight-week course, according to reports. Genotype 1 is the most common type of hepatitis… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - October 10, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

Evaluating Cardiovascular Safety of Novel Therapeutic Agents for the Treatment of Type 2 Diabetes Mellitus
Abstract Type 2 diabetes increases the risk of developing cardiovascular (CV) complications such as myocardial infarction, heart failure, stroke, peripheral vascular disease, and CV-associated mortality. Strict glycemic control in diabetics has shown improvement in microvascular complications related to diabetes but has been unable to demonstrate major effects on macrovascular complications including myocardial infarction and stroke. Conventional therapies for diabetes that include insulin, metformin, sulfonylureas (SU), and alpha-glucosidase inhibitors have limited and/or controversial data on CV safety based on...
Source: Current Cardiology Reports - October 10, 2014 Category: Cardiology Source Type: research

Alcohol involvement in opioid pain reliever and benzodiazepine drug abuse-related emergency department visits and drug-related deaths - United States, 2010.
Abstract The abuse of prescription drugs has led to a significant increase in emergency department (ED) visits and drug-related deaths over the past decade. Opioid pain relievers (OPRs) and benzodiazepines are the prescription drugs most commonly involved in these events. Excessive alcohol consumption also accounts for a significant health burden and is common among groups that report high rates of prescription drug abuse. When taken with OPRs or benzodiazepines, alcohol increases central nervous system depression and the risk for overdose. Data describing alcohol involvement in OPR or benzodiazepine abuse are limi...
Source: MMWR Morb Mortal Wkl... - October 10, 2014 Category: Epidemiology Authors: Jones CM, Paulozzi LJ, Mack KA Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Aluminum contamination in parenteral products
Purpose of reviewIn 1986, the US Food and Drug Administration issued an aluminum mandate in hopes of minimizing patient exposure to aluminum contaminates contained in parenteral nutrition additives. The purpose of this article is to revisit the status of aluminum contamination as it relates to parenteral nutrition and to survey the recent literature to determine if any new findings have emerged. A special emphasis will be placed on the complications associated with aluminum toxicity. Recent findingsIn addition to metabolic bone disease, patients with aluminum toxicity are also prone to other complications such as neurodeve...
Source: Current Opinion in Clinical Nutrition and Metabolic Care - October 9, 2014 Category: Nutrition Tags: MICRONUTRIENTS: Edited by Henry C. Lukaski and Gil Hardy Source Type: research

Digest
US new drug approvals The US Food and Drug Administration has granted marketing approval to several compounds ahead of their European regulatory counterpart. Lacosamide (Vimpat) is now approved as monotherapy for partial onset seizures in patients aged over 17. In Europe it is currently limited to adjunctive therapy, though a monotherapy indication will be pursued pending the outcome of a comparative trial against carbamazepine. Peginterferon beta‐1a (Plegridy), administered as a fortnightly subcutaneous injection, has been approved for relapsing forms of multiple sclerosis. Eliglustat (Cerdelga) has been approved for th...
Source: Progress in Neurology and Psychiatry - October 9, 2014 Category: Neurology Tags: Digest Source Type: research

A validated LC-MS/MS assay for simultaneous quantification of methotrexate and tofacitinib in rat plasma: application to a pharmacokinetic study.
Abstract A highly sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for simultaneous quantification of methotrexate (MTX) and tofacitinib (TFB) in rat plasma (50 μL) using phenacetin as an internal standard (IS), as per the US Food and Drug Administration guidelines. After a solid-phase extraction procedure, the separation of the analytes and IS was performed on a Chromolith RP18e column using an isocratic mobile phase of 5 mm ammonium acetate (pH 5.0) and acetonitrile at a ratio of 25:75 (v/v) using flow-gradient with a total run time of 3.5 min. The detection was performed in mul...
Source: Biomedical Chromatography : BMC - October 9, 2014 Category: Biomedical Science Authors: Sharma K, Giri K, Dhiman V, Dixit A, Zainuddin M, Mullangi R Tags: Biomed Chromatogr Source Type: research

Dimethyl fumarate protection against collagen II degradation.
In this study, we found that DMF ameliorated collagen type II degradation by inhibiting the expression of MMP-1, MMP-3, and MMP-13 caused by TNF-α. Mechanistically, DMF attenuated MMPs expression by suppressing JAK/STAT3 pathway. These findings imply that DMF treatment might be a potential therapeutic strategy for chondroprotective therapy. PMID: 25305493 [PubMed - as supplied by publisher] (Source: Biochemical and Biophysical Research communications)
Source: Biochemical and Biophysical Research communications - October 8, 2014 Category: Biochemistry Authors: Li Y, Tang J, Hu Y Tags: Biochem Biophys Res Commun Source Type: research

A synthetic stimulant never tested in humans, 1,3‐dimethylbutylamine (DMBA), is identified in multiple dietary supplements
A synthetic stimulant never before studied in humans, 1,3‐dimethylbutylamine (DMBA), was suspected of being present in dietary supplements. DMBA is an analogue of the pharmaceutical stimulant, 1,3‐dimethylamylamine (DMAA), which was recently banned by the US Food and Drug Administration. We obtained all dietary supplements sold by US distributors that listed an ingredient on the label, such as AMP Citrate, that might be a marketing name for DMBA. Supplements were analyzed for the presence and quantity of DMBA. Fourteen supplements met our inclusion criteria and were analyzed by two separate laboratories using ultra hig...
Source: Drug Testing and Analysis - October 8, 2014 Category: Drugs & Pharmacology Authors: Pieter A. Cohen, John C. Travis, Bastiaan J. Venhuis Tags: Short communication Source Type: research

Durham's Chimerix offers potential drug to fight Ebola
At the request of physicians fighting Ebola, North Carolina drug developer Chimerix Inc. will offer an experimental drug as potential treatment for the deadly virus. The U.S. Food and Drug Administration granted Chimerix (NASDAQ:CMRX) Emergency Investigational New Drug Applications, in which a drug that has not received FDA approval may be used in an emergency situation if physicians make the request. Durham-based Chimerix will work to develop a clinical trial to test the safety, tolerability and… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 7, 2014 Category: American Health Authors: Jason deBruyn Source Type: research

CardioPulse Articles * Training of cardiologists in China: catching up with the rest of the world * The Great Wall International Congress of Cardiology 2014 * Firehawk(R) sirolimus target-eluting coronary stent approved by China Food and Drug Administration * Hybrid coronary revascularization for treatment of multivessel coronary artery disease * The burden of cardiovascular disease and its impact on life expectancy in China
(Source: European Heart Journal)
Source: European Heart Journal - October 7, 2014 Category: Cardiology Tags: CardioPulse Source Type: research

Questioning the association between bisphosphonates and atypical femoral fractures
Bisphosphonates are the first‐line treatment for osteoporosis. Structurally, they are stable analogues of pyrophosphate and therefore exhibit a high affinity for bone mineral. They reduce bone loss by attenuating the ability of the osteoclast to resorb bone, decreasing activation frequency, and the rate of remodeling. Large prospective randomized placebo‐control trials provide unequivocal evidence for a reduction in the incidence of fractures. Impressively, 40 years since their first use in patients, the safety profile of bisphosphonates has been equally reassuring. Questions have arisen lately as to whether bisphospho...
Source: Annals of the New York Academy of Sciences - October 7, 2014 Category: Science Authors: Michael Pazianas, Se‐min Kim, Tony Yuen, Li Sun, Sol Epstein, Mone Zaidi Tags: Commentary Source Type: research

Overview of the 2014 food and drug administration cardiovascular and renal drugs advisory committee meeting about vorapaxar.
PMID: 25287768 [PubMed - in process] (Source: Circulation)
Source: Circulation - October 7, 2014 Category: Cardiology Authors: Baker NC, Lipinski MJ, Lhermusier T, Waksman R Tags: Circulation Source Type: research

Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop
Abstract Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [www.c-path.org], FDA, and International Society of Pharmacometrics...
Source: Journal of Pharmacokinetics and Pharmacodynamics - October 7, 2014 Category: Drugs & Pharmacology Source Type: research

The concordance of HPV DNA detection by Hybrid Capture 2 and HPV on clinician- and self-collected specimens
Testing for high-risk human papillomavirus (HPV) is now being recommended for cervical cancer screening in both higher-resource settings [1] and lower-resource settings [2]. For the latter, careHPV™ (QIAGEN, Gaithersburg, MD, USA), a lower-cost, signal-amplification DNA test for a pool of 14 HPV types, was developed. careHPV is based on the same biochemistry as Hybrid Capture 2 (HC2; QIAGEN), a DNA test for a pool of 13 HPV types (the same as careHPV minus HPV66) that was U.S. Food and Drug Administration approved in 2003. (Source: Journal of Clinical Virology)
Source: Journal of Clinical Virology - October 7, 2014 Category: Virology Authors: Wen Chen, Jose Jeronimo, Fang-Hui Zhao, You-Lin Qiao, Melissa Valdez, Xun Zhang, Le-Ni Kang, Pooja Bansil, Proma Paul, Ping Bai, Roger Peck, Jing Li, Feng Chen, Mark H. Stoler, Philip E. Castle Source Type: research

HIV neuropathy
Purpose of review: To present an overview of HIV-associated distal symmetric polyneuropathy (HIV-DSP) and other HIV-related peripheral neuropathies in the post-highly active retroviral therapy era. Recent findings: HIV-DSP has become the most common neurologic complication of HIV largely due to the prolonged survival of HIV-positive patients with the advent of highly active retroviral therapy. HIV-DSP can be attributed to the disease itself or to secondary effects of certain HAART agents, and often the two disease entities cannot be distinguished. HIV-DSP can lead to significant morbidity and interfere with daily activitie...
Source: Current Opinion in HIV and AIDS - October 6, 2014 Category: Infectious Diseases Tags: HIV NEUROLOGY: Edited by Christopher Power and Bruce J. Brew Source Type: research

Specialty Pharmaceuticals: Policy Initiatives To Improve Assessment, Pricing, Prescription, And Use [Spending On Specialty Pharmaceuticals]
This article analyzes the five principal stages through which a specialty drug must pass on its journey from the laboratory to the bedside. These include regulatory approval by the Food and Drug Administration for market access, insurance coverage, pricing and payment, physician prescription, and patient engagement. If structured appropriately, each stage improves performance and supports continued research and development. If structured inappropriately, however, each stage adds to administrative burdens, distorts clinical decision making, and weakens incentives for innovation. Cautious optimism is in order, but neither th...
Source: Health Affairs - October 6, 2014 Category: Global & Universal Authors: Robinson, J. C., Howell, S. Tags: Access To Care, Ethical Issues, Health Promotion/Disease Prevention, Insurance Coverage, Legal/Regulatory Issues, Pharmaceuticals, Physicians, Public Health, Public Opinion, Quality Of Care, Health Spending, Politics Spending On Specialty Pharmaceutical Source Type: research

Despite High Costs, Specialty Drugs May Offer Value For Money Comparable To That Of Traditional Drugs [Spending On Specialty Pharmaceuticals]
Specialty drugs are often many times more expensive than traditional drugs, which raises questions of affordability and value. We compared the value of specialty and traditional drugs approved by the Food and Drug Administration (FDA) in the period 1999–2011. To do this, we identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) and increased costs of drug and health care resource use that were associated with fifty-eight specialty drugs and forty-four traditional drugs, compared to preexisting care. We found that specialty drugs offered greater QALY gains (0.183 ...
Source: Health Affairs - October 6, 2014 Category: Global & Universal Authors: Chambers, J. D., Thorat, T., Pyo, J., Chenoweth, M., Neumann, P. J. Tags: Access To Care, Health Care Finance, Health Promotion/Disease Prevention, Health Reform, Hospitals, Insurance Coverage, Legal/Regulatory Issues, Pharmaceuticals, Physicians, Chronic Care, Quality Of Care, Health Spending, Consumer Issues, Affordable Care Source Type: research

Existing FDA Pathways Have Potential To Ensure Early Access To, And Appropriate Use Of, Specialty Drugs [Policy Issues For Pharmaceuticals]
Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical t...
Source: Health Affairs - October 6, 2014 Category: Global & Universal Authors: Kesselheim, A. S., Tan, Y. T., Darrow, J. J., Avorn, J. Tags: Access To Care, Legal/Regulatory Issues, Pharmaceuticals Policy Issues For Pharmaceuticals Source Type: research

Editorial: unlocking the potential of stem cells in cell therapy, drug delivery and drug discovery.
Abstract In metazoans, adult, tissue-specific stem cells function to naturally replace and regenerate components of organ systems during life. The restorative power of adult stem cells has been best exploited clinically in bone marrow transplantation to treat blood cancers and other disorders. With the discovery and characterisation of other adult stem cell types and pluripotent stem cells capable of generating all tissues in the body, it has been postulated that stem cells may be of utility in replacing other tissues which have stopped functioning due to age or disease. However, the potential application of stem c...
Source: Current Drug Delivery - October 4, 2014 Category: Drugs & Pharmacology Authors: Boyd AS Tags: Curr Drug Deliv Source Type: research

Endovascular stroke intervention in the very young
Stroke remains the leading cause of adult permanent disability and the third-leading cause of death in United States [1]. In USA, the incident of new or recurrent stroke is approximately 795,000 per year [2], and is predicted to increase to 1.2 million per year by 2025 [3]. It is not surprising, giving these numbers, that the management of stroke is consistently evolving and includes medical treatment as well as interventional management such as open and endovascular surgery. Medical treatment consists of intravenous (IV) recombinant tissue plasminogen activator (rtPA), which is the only therapy approved by the Food and Dr...
Source: Clinical Neurology and Neurosurgery - October 3, 2014 Category: Neurosurgery Authors: Mario Zanaty, Nohra Chalouhi, Robert M. Starke, Stavropoula Tjoumakaris, David Hasan, Shannon Hann, Norman Ajiboye, Kenneth C. Liu, Robert H. Rosenwasser, Philip Manasseh, Pascal Jabbour Source Type: research

Virginia Mason’s new computerized sedation system finds middle ground between asleep and awake
Virginia Mason Medical Center is using a new technology to make sure patients who leave the hospital after a procedure remember important details and instructions from their doctors. Computer-assisted propofol sedation, or CAPS, administers a drug to patients via a computer to achieve conscious sedation, approved by the Food and Drug Administration for use in colonoscopies and endoscopies. As a result, patients fall into a middle ground between asleep and awake during these procedures, and it's… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 1, 2014 Category: Biotechnology Authors: Annie Zak Source Type: research

Theoretical Impact of Florbetapir (18F) Amyloid Imaging on Diagnosis of Alzheimer Dementia and Detection of Preclinical Cortical Amyloid
AbstractIn 2012, florbetapir (18F) (Amyvid) received US Food and Drug Administration approval as a diagnostic agent for detecting neuritic (β-amyloid) plaques in living patients. Although such approval is specifically not extended to the use of florbetapir as a single definitive diagnostic test for Alzheimer disease dementia (ADD), it is of considerable importance to examine its potential in this regard. To estimate the ability of florbetapir amyloid imaging to detect specified densities of postmortem-identified neuritic plaques, we used the data of Clark et al [Clark CM, Pontecorvo MJ, Beach TG, et al. Cerebral PET with ...
Source: Journal of Neuropathology and Experimental Neurology - October 1, 2014 Category: Neurology Tags: Original Articles Source Type: research

A(nother) scientific strategy to prevent breast cancer in postmenopausal women by enhancing estrogen-induced apoptosis?
AbstractThe innovation of combining bazedoxifene with conjugated estrogens provides a new opportunity for women’s health. The finding by the Women’s Health Initiative—that the administration of conjugated equine estrogens alone to women in their 60s who have had hysterectomy results in a decrease in breast cancer incidence and a drop in mortality—was unanticipated but can now be exploited for another gain in women’s health. The issue to be considered is how postmenopausal women can improve their lifestyle to take advantage of conjugated equine estrogens–alone therapy. Food and Drug Administration approval of th...
Source: Menopause - October 1, 2014 Category: OBGYN Tags: Personal Perspective Source Type: research

Consensus Report of a Joint NCI Thoracic Malignancies Steering Committee: FDA Workshop on Strategies for Integrating Biomarkers into Clinical Development of New Therapies for Lung Cancer Leading to the Inception of “Master Protocols” in Lung Cancer
On February 2, 2012, the National Cancer Institute (NCI) sponsored a 2-day workshop with the NCI Thoracic Malignancies Steering Committee and the Food and Drug Administration to bring together leading academicians, clinicians, industry and government representatives to identify challenges and potential solutions in the clinical development of novel targeted therapies for lung cancer. Measures of success are rapidly evolving from a scientific and regulatory perspective and the objectives of this workshop were to achieve initial consensus on a high priority biomarker-driven clinical trial designed to rapidly assess the activ...
Source: Journal of Thoracic Oncology - October 1, 2014 Category: Cancer & Oncology Tags: Special Article Source Type: research

Electronic Cigarettes: A Safer Alternative or Potential Poison?
This article will review the mechanism of action and what is currently known about the safety of electronic cigarettes. The risk of poisoning for children will also be identified, as well as the implications for home healthcare clinicians. (Source: Home Healthcare Nurse)
Source: Home Healthcare Nurse - October 1, 2014 Category: Nursing Tags: Feature Source Type: research

Magnetic Sphincter Augmentation with the LINX Device for Gastroesophageal Reflux Disease after U.S. Food and Drug Administration Approval.
Abstract Magnetic sphincter augmentation (MSA) of the gastroesophageal junction with the LINX Reflux Management System is an alternative to fundoplication for gastroesophageal reflux disease (GERD) that was approved by the U.S. Food and Drug Administration (FDA) in March 2012. This is a prospective observational study of all patients who underwent placement of the LINX at two institutions from April 2012 to December 2013 to evaluate our clinical experience with the LINX device after FDA approval. There were no intraoperative complications and only four mild postoperative morbidities: three urinary retentions and on...
Source: The American Surgeon - October 1, 2014 Category: Surgery Authors: Reynolds JL, Zehetner J, Bildzukewicz N, Katkhouda N, Dandekar G, Lipham JC Tags: Am Surg Source Type: research

Fecal microbiota transplantation: from practices to legislation before considering industrialization
This article is protected by copyright. All rights reserved. (Source: Clinical Microbiology and Infection)
Source: Clinical Microbiology and Infection - October 1, 2014 Category: Microbiology Authors: Jean‐Christophe Lagier Tags: Invited Review Source Type: research

The future of oats in the food and health continuum.
Abstract A large body of clinical evidence suggests that the consumption of 3 g or more per d of β-glucan from oats or barley, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD. The unique chemical and physical properties of oats and physiological responses to oat consumption contribute to their demonstrated health benefits; other health attributes are still under evaluation. Many of these benefits, such as those associated with a reduced risk of CVD, are codified in health claims by several regulatory agencies, such as the Food and Drug Administration in the USA and the European ...
Source: The British Journal of Nutrition - October 1, 2014 Category: Nutrition Authors: Clemens R, van Klinken BJ Tags: Br J Nutr Source Type: research

Development and Evaluation of the Nurotron 26-Electrode Cochlear Implant System.
The objective measures show that electrode impedance decreased within the first month of device use, but was stable until a slight increase at the end of two years. The subjective loudness measures show that electric stimulation threshold was stable while the maximal comfort level increased over the 3 years. Mandarin sentence recognition increased from the pre-surgical 0%-correct score to a plateau of about 80% correct with 6-month use of the device. Both indirect and direct comparisons indicate indistinguishable performance differences between the Nurotron system and other commercially available devices. The present 26-el...
Source: Hearing Research - October 1, 2014 Category: Audiology Authors: Zeng FG, Rebscher SJ, Fu QJ, Chen H, Sun X, Yin L, Ping L, Feng H, Yang S, Gong S, Yang B, Kang HY, Gao N, Chi F Tags: Hear Res Source Type: research

Orlistat‐induced fulminant hepatic failure
We present a case of hepatic failure in a patient taking orlistat. A 54‐year‐old African‐American woman with hypertension presented with hepatic failure. She had noticed increasing fatigue, jaundice and confusion. She used alcohol sparingly and denied tobacco or illicit drug use, but had been taking over‐the‐counter orlistat for the past two months. Physical examination revealed scleral icterus, jaundice, asterixis and slow speech. Laboratory testing showed markedly abnormal liver function tests with coagulopathy. Acute viral and autoimmune serologies were negative, as was toxicology screen. Liver biopsy showed n...
Source: Clinical Obesity - October 1, 2014 Category: Eating Disorders and Weight Management Authors: D. Sall, J. Wang, M. Rashkin, M. Welch, C. Droege, D. Schauer Tags: Case Report Source Type: research

Keeping the Genie in the Bottle Growth Hormone and Cardiovascular Disease ∗
Anabolic hormone use is increasingly common and includes replacement in patients with hormone deficiencies, questionable uses in those with borderline-low levels, and clear abuses among athletes aiming to gain a competitive advantage. Recently, direct-to-consumer marketing touting the benefits of “low T” treatment has led to increased testosterone use among middle-aged and older men, despite inadequate cardiovascular safety data. Although the Testosterone in Older Men Trial showed improvements in strength among treated patients, it was prematurely halted due to increased cardiovascular events in the treatment arm (1). ...
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - September 29, 2014 Category: Cardiology Source Type: research

New labeling added to 22 antimicrobial drugs studied in pediatric patients [FDA UPDATE]
(Source: AAP News)
Source: AAP News - September 29, 2014 Category: Pediatrics Authors: Food and Drug Administration, Office of Pediatric Therapeutics, Pediatric & Maternal Health Staff, Division of Anti-Infective Products Tags: FDA Update, Infectious Diseases Source Type: research

Evaluation of a New Handheld Instrument for the Detection of Counterfeit Artesunate by Visual Fluorescence Comparison.
Abstract There is an urgent need for accurate and inexpensive handheld instruments for the evaluation of medicine quality in the field. A blinded evaluation of the diagnostic accuracy of the Counterfeit Detection Device 3 (CD-3), developed by the US Food and Drug Administration Forensic Chemistry Center, was conducted in the Lao People's Democratic Republic. Two hundred three samples of the oral antimalarial artesunate were compared with authentic products using the CD-3 by a trainer and two trainees. The specificity (95% confidence interval [95% CI]), sensitivity (95% CI), positive predictive value (95% CI), and n...
Source: The American Journal of Tropical Medicine and Hygiene - September 29, 2014 Category: Tropical Medicine Authors: Ranieri N, Tabernero P, Green MD, Verbois L, Herrington J, Sampson E, Satzger RD, Phonlavong C, Thao K, Newton PN, Witkowski MR Tags: Am J Trop Med Hyg Source Type: research