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This page shows you the latest research publications in this category.
Raptor Pharma heads into the clinic against another rare disease
Raptor Pharmaceutical Corp. hopes to expand the use of its already-approved drug Procysbi to another rare genetic disease. The Novato company (NASDAQ: RPTP) said Tuesday that it filed an investigational new drug application with the Food and Drug Administration to develop the drug, also known as RP-103, for Leigh syndrome, a condition that typically kills children within a couple of years of birth. Led by CEO Chris Starr, Raptor won FDA approval of delayed-release Procysbi capsules earlier this… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - December 10, 2013 Category: Hospital Management Authors: Ron Leuty Source Type: research
Health Science Center resarchers develop oral application for hepatitis C drug
Researchers at the University of Texas Health Science Center at San Antonio have developed an oral application for drugs recently approved by the U.S. Food and Drug Administration for treatment of hepatitis C. Hepatitis C is one of the most common chronic blood-borne infections in the United States, with more than 3 million people infected. Drs. Fred Poordad and Eric Lawitz developed an all-oral combination of sofosbuvir and one other drug that can cure hepatitis C in as little as eight weeks with… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 10, 2013 Category: Pharmaceuticals Authors: Mike W. Thomas Source Type: research
FDA approves Gilead's potential hepatitis C blockbuster
Gilead Sciences Inc.'s big risk is paying off. The Foster City-based drug developer (NASDAQ: GILD) won Food and Drug Administration approval Friday for its potential blockbuster hepatitis C treatment — even, perhaps, a cure for the liver disease. The drug, which will be marketed as Sovaldi, will cost $84,000 for a 12-week course of treatment. It is the third drug from a Bay Area company in the past six weeks to win approval under the FDA's "breakthrough therapy" designation, which is meant to… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 6, 2013 Category: Pharmaceuticals Authors: Ron Leuty Source Type: research
FDA approves Gilead's potential hepatitis C blockbuster
Gilead Sciences Inc.'s big risk is paying off. The Foster City-based drug developer (NASDAQ: GILD) won Food and Drug Administration approval Friday for its potential blockbuster hepatitis C treatment — even, perhaps, a cure for the liver disease. The drug, which will be marketed as Sovaldi, will cost $84,000 for a 12-week course of treatment. It is the third drug from a Bay Area company in the past six weeks to win approval under the FDA's "breakthrough therapy" designation, which is meant to… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 6, 2013 Category: Biotechnology Authors: Ron Leuty Source Type: research
Mylan markets Cabergoline Tablets
Mylan Inc. has begun to market Cabergoline Tablets USP, 0.5 mg to treat hyperprolactinemic disorders. The Southpointe-based Mylan (Nasdaq: MYL) said it received final approval from the Food and Drug Administration for the Cabergoline Tablets USP, which had about $41.67 million in sales in the 12 months ended Sept. 30. (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - December 6, 2013 Category: Hospital Management Authors: Paul J. Gough Source Type: research
[News of the Week] Around the World
In science news around the world, Israel secures a spot in the Horizon 2020 funding program, a study linking genetically modified maize to disease in rats is retracted, the U.S. Food and Drug Administration issues a warning to genetic testing company 23andMe, and more. (Source: Science: Current Issue)
Source: Science: Current Issue - December 6, 2013 Category: Science Authors: Stewart Wills (mailto:swills at aaas.org) Source Type: research
[News of the Week] Around the World
In science news around the world, Israel secures a spot in the Horizon 2020 funding program, a study linking genetically modified maize to disease in rats is retracted, the U.S. Food and Drug Administration issues a warning to genetic testing company 23andMe, and more. (Source: Science: This Week)
Source: Science: This Week - December 6, 2013 Category: Science Authors: Stewart Wills (mailto:swills at aaas.org) Source Type: research
New Antiobesity Agents: Lorcaserin (Belviq) and Phentermine/Topiramate ER (Qsymia)
This article reviews the pharmacology and clinical efficacy and safety of each of these agents. The differences among the three available agents for long-term management of obesity will also be examined. (Source: Cardiology in Review)
Source: Cardiology in Review - December 5, 2013 Category: Cardiology Tags: Review Article Source Type: research
U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia.
Abstract On October 26, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval to omacetaxine mepesuccinate (Synribo; Teva Pharmaceuticals USA, Inc., North Wales, PA, http://www.tevausa.com) for the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). The approval was based on the FDA review of data from 111 patients with CML in CP or in AP who had received two or more prior TKIs, including imatinib. Major cytogenetic response was achieved in 18% of pat...
Source: The Oncologist - December 5, 2013 Category: Cancer & Oncology Authors: Alvandi F, Kwitkowski VE, Ko CW, Rothmann MD, Ricci S, Saber H, Ghosh D, Brown J, Pfeiler E, Chikhale E, Grillo J, Bullock J, Kane R, Kaminskas E, Farrell AT, Pazdur R Tags: Oncologist Source Type: research
Gilead CEO John Martin pockets $19 million in stock sale
Gilead Sciences Inc. Chairman and CEO John Martin netted nearly $19 million by selling 282,242 shares Monday at nearly 10 times the price at which he exercised options to buy the shares. Martin's stock flip comes on the eve of a Food and Drug Administration decision on a potential blockbuster hepatitis C treatment from the Foster City-based drug developer (NASDAQ: GILD). Martin bought Gilead stock at $7.6323 per share. He then sold a tranche of 264,500 shares at $73.62 to $74.60 and a cohort of… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 4, 2013 Category: Biotechnology Authors: Ron Leuty Source Type: research
Gilead CEO John Martin pockets $19 million in stock sale
Gilead Sciences Inc. Chairman and CEO John Martin netted nearly $19 million by selling 282,242 shares Monday at nearly 10 times the price at which he exercised options to buy the shares. Martin's stock flip comes on the eve of a Food and Drug Administration decision on a potential blockbuster hepatitis C treatment from the Foster City-based drug developer (NASDAQ: GILD). Martin bought Gilead stock at $7.6323 per share. He then sold a tranche of 264,500 shares at $73.62 to $74.60 and a cohort of… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - December 4, 2013 Category: Hospital Management Authors: Ron Leuty Source Type: research
Quantitative evaluation of initial symptoms as predictors to detect adverse drug reactions using bayes' theory: expansion and evaluation of drug-adverse drug reaction-initial symptom combinations using adverse event reporting system database.
In this study, using the Adverse Event Reporting System (AERS) database of the U.S. Food and Drug Administration (FDA), we evaluated 132 drug-ADR-IS combinations that were considered to be potentially clinical significant. Regarding bezafibrate-associated rhabdomyolysis and cibenzoline-associated hypoglycemia, these ADR were not detected in cases involving monotherapy. For 58 combinations, no events that were considered to be IS of the target ADR developed. Fever, nausea, and decreased appetite were the IS of many ADR, making them very useful predictors. In contrast, pruritus and rash were not very useful. Fever might be a...
Source: Biological and Pharmaceutical Bulletin - December 4, 2013 Category: Drugs & Pharmacology Authors: Kobayashi D, Hosaka S, Inoue E, Ohshima K, Kutsuma N, Oshima S, Okuno Y Tags: Biol Pharm Bull Source Type: research
The subcutaneous implantable cardioverter-defibrillator
Purpose of review: To consider the case of need that underpinned the development of the subcutaneous implantable cardioverter-defibrillator (SICD), the preclinical and clinical data obtained so far, its current role and likely future. Recent findings: The data from prospective clinical evaluation of the device demonstrated safety and efficacy leading to Food and Drug Administration approval. This superseded earlier reports from Europe that raised some clinical concerns, previously anticipated through the introduction of new technology. Recent estimates indicate maybe 55% of patients in routine clinical practice needing an ...
Source: Current Opinion in Cardiology - December 4, 2013 Category: Cardiology Tags: ARRHYTHMIAS: Edited by David Birnie Source Type: research
Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals
by Carolina Riveros, Agnes Dechartres, Elodie Perrodeau, Romana Haneef, Isabelle Boutron, Philippe Ravaud Background The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration–approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals. Methods and Findings We searched ClinicalTrials.gov on March 27, 2012, for randomized controlled trials of drugs with posted results. For a random sample of these trials, we searched ...
Source: PLoS Medicine - December 3, 2013 Category: Internal Medicine Authors: Carolina Riveros et al. Source Type: research
AcelRx targets fall 2014 FDA decision on pain drug system
An automated pain drug delivery system developed by AcelRx Pharmaceuticals Inc. was accepted for regulatory review, putting its potential approval date in September 2014. Redwood City-based AcelRx (NASDAQ: ACRX) said Monday that the Food and Drug Administration accepted its application to sell the handheld, pre-programmed Zalviso system. It submitted the application in September. Zalviso is AcelRx's first product candidate. SEE ALSO: Size matters: A cautionary tale for small businesses Zalviso… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 2, 2013 Category: Biotechnology Authors: Ron Leuty Source Type: research
AcelRx targets fall 2014 FDA decision on pain drug system
An automated pain drug delivery system developed by AcelRx Pharmaceuticals Inc. was accepted for regulatory review, putting its potential approval date in September 2014. Redwood City-based AcelRx (NASDAQ: ACRX) said Monday that the Food and Drug Administration accepted its application to sell the handheld, pre-programmed Zalviso system. It submitted the application in September. Zalviso is AcelRx's first product candidate. SEE ALSO: Size matters: A cautionary tale for small businesses Zalviso… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - December 2, 2013 Category: Hospital Management Authors: Ron Leuty Source Type: research
Linking the human response to unplanned radiation and treatment to the nonhuman primate response to controlled radiation and treatment.
Abstract A key difficulty in developing countermeasures against radiation-induced health impairments is the clear lack of controlled clinical studies, due to the relatively low number of radiation victims worldwide. Instead, established and accepted animal models, as well as the recommendations of national and international expert panels and committees, are the main sources of information. Therefore, the development of countermeasures requires comparison of data from many sources and accumulation of information consistent with the U. S. Food and Drug Administration's "Animal Rule." A new approach is the comparative...
Source: Health Physics - December 2, 2013 Category: Physics Authors: Dörr H, Lamkowski A, Graessle DH, Bennett A, Shapiro A, Farese AM, Garofalo M, Macvittie TJ, Meineke V Tags: Health Phys Source Type: research
The Delayed Pulmonary Syndrome Following Acute High-dose Irradiation: A Rhesus Macaque Model.
Abstract Several radiation dose- and time-dependent tissue sequelae develop following acute high-dose radiation exposure. One of the recognized delayed effects of such exposures is lung injury, characterized by respiratory failure as a result of pneumonitis that may subsequently develop into lung fibrosis. Since this pulmonary subsyndrome may be associated with high morbidity and mortality, comprehensive treatment following high-dose irradiation will ideally include treatments that mitigate both the acute hematologic and gastrointestinal subsyndromes as well as the delayed pulmonary syndrome. Currently, there are n...
Source: Health Physics - December 2, 2013 Category: Physics Authors: Garofalo M, Bennett A, Farese AM, Ward A, Taylor-Howell C, Cui W, Gibbs A, Lasio G, Jackson W, Macvittie TJ Tags: Health Phys Source Type: research
pH-Sensitive Nano-Systems for Drug Delivery in Cancer Therapy.
Abstract Nanotechnology has been widely used in the development of new strategies for drug delivery and cancer therapy. Compared to traditional drug delivery systems, nano-based drug delivery system have greater potential in a variety of areas, such as multiple targeting functionalization, in vivo imaging, combined drug delivery, extended circulation time, and systemic control release. Nano-systems incorporating stimulus-responsive materials have remarkable properties which allow them to bypass biological barriers and achieve targeted intracellular drug delivery. As a result of the active metabolism of tumor cells,...
Source: Biotechnology Advances - December 2, 2013 Category: Biotechnology Authors: Liu J, Huang Y, Kumar A, Tan A, Jin S, Mozhi A, Liang XJ Tags: Biotechnol Adv Source Type: research
Cervical disc arthroplasty for cervical spondylosis has been pursued for over a decade. The purpose of this study was to evaluate the safety and effectiveness of the PCM cervical disc compared with anterior cervical disectomy and fusion with single-level disease between C3 and T1. The authors performed a prospective multicenter randomized Food and Drug Administration-approved, investigational device exemption clinical trial. (Source: Seminars in Spine Surgery)
Source: Seminars in Spine Surgery - December 1, 2013 Category: Orthopaedics Authors: Scott D. Boden Source Type: research
Neoadjuvant therapy as a platform for drug development and approval in breast cancer.
Abstract The traditional drug development process in breast cancer based on large phase III studies has serious limitations and needs a major overhaul. Searching for new approaches, the testing of novel agents in the preoperative (neoadjuvant) setting approach offers a potentially rapid and efficient strategy for drug development utilizing pathologic complete response (path CR), a surrogate marker for survival, as the primary endpoint. In addition, neoadjuvant studies allow the assessment of drug effects on the target (pharmacodynamic response) and the development of predictive biomarkers of response. Molecular pro...
Source: Clinical Cancer Research - December 1, 2013 Category: Cancer & Oncology Authors: Bardia A, Baselga J Tags: Clin Cancer Res Source Type: research
Elements of concern in fillets of bighead and silver carp from the Illinois River, Illinois.
Abstract Efforts to control invasive bighead (Hypophthalmichthys nobilis) and silver carp (H. molitrix) may include harvest for human consumption. We measured concentrations of arsenic (As), mercury (Hg), and selenium (Se) in fillets from silver and bighead carp collected from the lower Illinois River, Illinois, USA, to determine whether concentrations were of health concern and differed by species, size, and location. Concentrations of total As were below detection limits in most bighead (92%) and silver (77%) carp fillets, whereas inorganic As was below detection limits in all samples. Mean Hg concentrations were...
Source: Chemosphere - November 30, 2013 Category: Chemistry Authors: Levengood JM, Soucek DJ, Sass GG, Dickinson A, Epifanio JM Tags: Chemosphere Source Type: research
The Incidence and Outcome of DVT After Endovenous Laser Ablation
Endovenous ablation of the saphenous vein (EVLT) has become the preferred treatment for treating saphenous reflux, which results in symptomatic lower extremity venous insufficiency or varicose veins. This office-based ambulatory procedure was noted during initial Food and Drug Administration trials to have a low incidence of postoperative deep vein thrombosis (DVT). Later clinical experience suggested that the actual incidence of DVT may be much higher. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - November 28, 2013 Category: Surgery Authors: William P. Shutze, Katherine Kane, Taylor Hicks, John Kedora, Steve Hohmann, Toby Dunn, Brad Grimsley, Dennis Gable, Greg Pearl, Bertram Smith Tags: Abstracts from the 2014 Southern Association for Vascular Surgery Annual Meeting Source Type: research
Comparison of outcomes following endovascular repair of abdominal aortic aneurysms based on size threshold
In April 2012, the Food and Drug Administration approved a fenestrated endoprosthesis to treat the visceral aorta. Therefore, the existing Category III CPT codes that were used for fenestrated endovascular repair of the visceral aorta (FEVAR) were replaced with Category I CPT codes in the 2014 manual. One set of codes was created for treatment of the visceral aorta alone, and a parallel set was created to report concomitant repair of the visceral aorta and the infrarenal aorta. Simultaneous to this, the four Category III CPT codes were deleted. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - November 28, 2013 Category: Surgery Authors: Sean P. Roddy Tags: CPT advisor Source Type: research
Therapeutic proteins: a to z.
Abstract In recent years, therapeutic proteins have become an important growing class of drugs in the pharmaceutics industry. The development of recombinant DNA technology has caused to appreciation of therapeutic value of many proteins and peptides in medicine. Currently, approximately 100 therapeutic proteins obtained approval from Food and Drug Administration (FDA) and they are widely used in the treatment of various diseases such as cancer, diabetes, anemia and infections. This paper will summarize the production processes, pharmaceuticals and physicochemical properties and important classes of therapeutic prot...
Source: Protein and Peptide Letters - November 27, 2013 Category: Biochemistry Authors: Ozgur A, Tutar Y Tags: Protein Pept Lett Source Type: research
Therapeutic proteins in tumors and targeted therapeutic agents for cancer patients.
Abstract The identification of novel molecular targets has paved the way for new treatment options in cancer patients. A number of agents targeting molecules that are crucial both for the tumor and its microenvironment have already been approved by the U.S. Food and Drug Administration for clinical use. The monoclonal antibodies and the small molecule kinase inhibitors constitute two major classes of targeted therapeutic agents, which have apparently different mechanisms of action, toxicity profiles, routes of administration, timing and dosing. Moreover, individual differences in genes regulating the distribution a...
Source: Protein and Peptide Letters - November 27, 2013 Category: Biochemistry Authors: Kesikli SA, Kilickap S Tags: Protein Pept Lett Source Type: research
Ultrasound Skin Tightening
Ultrasound skin tightening is a noninvasive, nonablative method that allows for energy deposition into the deep dermal and subcutaneous tissue while avoiding epidermal heating. Ultrasound coagulation is confined to arrays of 1-mm3 zones that include the superficial musculoaponeurotic system and connective tissue. This technology gained approval from the Food and Drug Administration as the first energy-based skin “lifting” device, specifically for lifting lax tissue on the neck, submentum, and eyebrows. Ultrasound has the unique advantage of direct visualization of treated structures during treatment. Ultrasound is a sa...
Source: Dermatologic Clinics - November 27, 2013 Category: Dermatology Authors: Kira Minkis, Murad Alam Source Type: research
[Comment] Can we improve ABVD in Hodgkin's lymphoma?
Brentuximab vedotin is an antibody–drug conjugate—the antibody targets CD30 and is linked to the microtubule-disrupting agent auristatin. Although the unconjugated antibody had little, if any, activity in Hodgkin's lymphoma, when the conjugate was given as a single agent to patients with relapsed or refractory Hodgkin's lymphoma, 76 (75%, 95% CI 64·9–82·6) of 102 patients achieved an objective response, and 35 (34%, 95% CI 25·2–44·4) patients had complete remission. Brentuximab vedotin was registered with the European Medicines Agency and US Food and Drug Administration; the first conjugated antibody approved f...
Source: The Lancet Oncology - November 26, 2013 Category: Cancer & Oncology Authors: Christian Gisselbrecht Tags: Comment Source Type: research
Genetic jungle: Trying to make sense of FDA's 23andMe warning
According to results from a 23andMe genetic test I took a couple of years ago, I run a higher-than-average risk of coronary heart disease, prostate cancer, gout, restless legs syndrome and celiac disease. It's laid out in a simple-to-read, personalized report on the website of the Google Inc.-backed, Mountain View-based company. That is, if the report is accurate. In a scathing warning letter to the company, the Food and Drug Administration said Friday that it is "concerned about the public health… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - November 26, 2013 Category: American Health Authors: Ron Leuty Source Type: research
FDA halts sales of 23andMe DNA kits
On Monday the Food and Drug Administration blocked genetic testing company 23andMe, funded in part by Google, from continuing to sell its personalized DNA test kits. In a Nov. 22 letter to 23andMe CEO Anne Wojcicki, the FDA sternly stated that the company's saliva collection kits may not be safe or effective, and could lead to consumers seeking medical care that may not be needed or effective. The letter states that "you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - November 25, 2013 Category: Hospital Management Authors: James Dunn Source Type: research
FDA Was Right To Block 23andMe
A few techno-libertarians are up in arms over the FDA’s letter warning the genetics company 23andMe to stop selling its personalized genome services kit. But a quick search of the Food and Drug Administration’s admittedly user-unfriendly website shows federal regulators have been targeting various low-cost genetic testing ventures to provide the necessary analysis that goes along with a proper genetic screening for at least the past three years.At present, getting raw data about your personal genome is worse than useless, as Nancy Shute pointed out in a Scientific American article that I edited back in 2012. ...
Source: Scientific American - Official RSS Feed - November 25, 2013 Category: Science Tags: Health Source Type: research
Cardiovascular drugs among 500 products with new pediatric information [FDA UPDATE]
(Source: AAP News)
Source: AAP News - November 25, 2013 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Pediatric & Maternal Health Staff, Division of Cardiovascular and Renal Products Tags: FDA Update, Pharmacology, Cardiology Source Type: research
Reply: Possible Confounding by Mefloquine in the Association of Emergence Delirium With PTSD and TBI Among Combat Veterans
The letter by Dr. Nevin to the Journal of PeriAnesthesia Nursing regarding the possible confounding variability that mefloquine hydrochloride prophylaxis may contribute to the incidence of and risk factors for emergence delirium (ED) is not only intriguing but also very timely. The U.S. Food and Drug Administration recently published a safety announcement on the prescriptive use of mefloquine to include a black box warning. As Dr. Nevin clearly described, the potential irreversible psychiatric and neurologic problems associated with its use must drive the scientific community to conduct further research in this area. (Sour...
Source: Journal of PeriAnesthesia Nursing - November 23, 2013 Category: Nursing Authors: Jason M. McGuire, John Tyler Wilson Tags: Letters to the Editor Source Type: research
Mathematical Modeling and Microbiological Verification of Ohmic Heating of a Multicomponent Mixture of Particles in a Continuous Flow Ohmic Heater System with Electric Field Parallel to Flow
Abstract To accomplish continuous flow ohmic heating of a low‐acid food product, sufficient heat treatment needs to be delivered to the slowest‐heating particle at the outlet of the holding section. This research was aimed at developing mathematical models for sterilization of a multicomponent food in a pilot‐scale ohmic heater with electric‐field‐oriented parallel to the flow and validating microbial inactivation by inoculated particle methods. The model involved 2 sets of simulations, one for determination of fluid temperatures, and a second for evaluating the worst‐case scenario. A residence time distributio...
Source: Journal of Food Science - November 19, 2013 Category: Food Science Authors: Pitiya Kamonpatana, Hussein M. H. Mohamed, Mykola Shynkaryk, Brian Heskitt, Ahmed E. Yousef, Sudhir K. Sastry Tags: E: Food Engineering & Physical Propertie Source Type: research
Dexamethasone Intravitreal Implant Trapped at the Macula in a Silicone Oil-filled Eye
We describe an unusual retinal finding that developed when the implant became trapped at the macular surface under silicone oil. (Source: Ophthalmology)
Source: Ophthalmology - November 18, 2013 Category: Opthalmology Authors: Armin R. Afshar, Allison R. Loh, Pear Pongsachareonnont, Daniel M. Schwartz, Jay M. Stewart Tags: Reports Source Type: research
Endothelial Keratoplasty: Prospective, Randomized, Masked Clinical Trial Comparing an Injector With Forceps for Tissue Insertion
In regard to the recent paper by Terry and associates, I would like to point out a potential mitigating factor that limits the clinical applicability of the paper. Although the authors state, “All other steps of the surgical procedure were exactly the same,” this is not precisely correct. The authors utilized viscoelastic protection for the Charlie II forceps (Bausch & Lomb Surgical, St. Louis, Missouri, USA) group and did not utilize any viscoelastic for the Neusidl Cornea Inserter (Fischer Surgical, Imperial, Missouri, USA) group, stating that viscoelastic is not part of the standard operating procedure for the Neusi...
Source: American Journal of Ophthalmology - November 18, 2013 Category: Opthalmology Authors: Michael W. Belin, Sadeer B. Hannush Tags: Correspondence Source Type: research
Clinical translation of autologous Schwann cell transplantation for the treatment of spinal cord injury.
Abstract PURPOSE OF REVIEW: To describe the current status of testing Schwann cell transplantation as a therapy for human spinal cord injury (SCI). RECENT FINDINGS: Transplanted Schwann cells have reparative effects in the damaged spinal cord. A few clinical studies have reported that Schwann cell transplantation appears safe. Compared with allogeneic cell transplants, autologous cells do not require immune suppression, but the workload of cell manufacturing is greater. Preclinical Schwann cell transplant studies conducted at the University of Miami in 2009-2012 supported an investigational new drug approved by...
Source: Current Opinion in Organ Transplantation - November 18, 2013 Category: Transplant Surgery Authors: Guest J, Santamaria AJ, Benavides FD Tags: Curr Opin Organ Transplant Source Type: research
Antihepatitis B therapy: a review of current medications and novel small molecule inhibitors
Abstract There are approximately 350 million hepatitis B virus (HBV) carriers worldwide. Chronic HBV infection increases the risk of liver cirrhosis and hepatocellular carcinoma. To date, two classes of antiviral drugs have been approved by the Food and Drug Administration for the treatment of hepatitis B, immunomodulators (interferon [IFN]‐α and pegylated‐interferon [PEG‐IFN]‐α) and nucleos(t)ide analogs (lamivudine, telbivudine, adefovir, tenofovir [TDF], and entecavir [ETV]). Of these, ETV, TDF, and PEG‐IFN‐α are the most effective and are currently recommended for anti‐HBV therapy. However, these thera...
Source: Fundamental and Clinical Pharmacology - November 18, 2013 Category: Drugs & Pharmacology Authors: Li‐Peng Qiu, Liang Chen, Ke‐Ping Chen Tags: Review Article Source Type: research
U.s. Food and drug administration approves Paclitaxel protein-bound particles (abraxane®) in combination with gemcitabine as first-line treatment of patients with metastatic pancreatic cancer.
PMID: 24216565 [PubMed - in process] (Source: JOP)
Source: JOP - November 16, 2013 Category: Gastroenterology Authors: Saif MW Tags: JOP Source Type: research
New mammography technologies and their impact on radiation dose.
This article reviews new mammography technologies resulting from advances in digital detectors and processing techniques. Most are just starting to be commercialized or are in the clinical trial phase. The results of clinical trials with the new 2D techniques (contrast-enhanced techniques or stereotactic techniques) show they are useful for diagnosing cancer. However, the greater complexity of the image acquisition process suggests that their use will be limited to particular cases such as inconclusive lesions or women with high risk for developing breast cancer. Among the 3D technologies (breast tomography and breast tomo...
Source: Radiologia - November 16, 2013 Category: Radiology Authors: Chevalier Del Rio M Tags: Radiologia Source Type: research
International Union of Pharmacology. LXXXIX. Update on the Extended Family of Chemokine Receptors and Introducing a New Nomenclature for Atypical Chemokine Receptors.
ie O, Zlotnik A Abstract Sixteen years ago, the Nomenclature Committee of the International Union of Pharmacology approved a system for naming human seven-transmembrane (7TM) G protein-coupled chemokine receptors, the large family of leukocyte chemoattractant receptors that regulates immune system development and function, in large part by mediating leukocyte trafficking. This was announced in Pharmacological Reviews in a major overview of the first decade of research in this field [Murphy PM, Baggiolini M, Charo IF, Hébert CA, Horuk R, Matsushima K, Miller LH, Oppenheim JJ, and Power CA (2000) Pharmacol Rev 52:14...
Source: Pharmacological Reviews - November 15, 2013 Category: Drugs & Pharmacology Authors: Bachelerie F, Ben-Baruch A, Burkhardt AM, Combadiere C, Farber JM, Graham GJ, Horuk R, Sparre-Ulrich AH, Locati M, Luster AD, Mantovani A, Matsushima K, Murphy PM, Nibbs R, Nomiyama H, Power CA, Proudfoot AE, Rosenkilde MM, Rot A, Sozzani S, Thelen M, Yos Tags: Pharmacol Rev Source Type: research
Quantitative Structure-Activity Relationship Models for Predicting Drug-Induced Liver Injury Based on FDA-Approved Drug Labeling Annotation and Using a Large Collection of Drugs
Drug-induced liver injury (DILI) is one of the leading causes of the termination of drug development programs. Consequently, identifying the risk of DILI in humans for drug candidates during the early stages of the development process would greatly reduce the drug attrition rate in the pharmaceutical industry but would require the implementation of new research and development strategies. In this regard, several in silico models have been proposed as alternative means in prioritizing drug candidates. Because the accuracy and utility of a predictive model rests largely on how to annotate the potential of a drug to cause DIL...
Source: Toxicological Sciences - November 15, 2013 Category: Toxicology Authors: Chen, M., Hong, H., Fang, H., Kelly, R., Zhou, G., Borlak, J., Tong, W. Tags: Research Article Source Type: research
Tobacco product use among middle and high school students - United States, 2011 and 2012.
This report describes the results of that analysis, which found that, in 2012, the prevalence of current tobacco product use among middle and high school students was 6.7% and 23.3%, respectively. After cigarettes, cigars were the second most commonly used tobacco product, with prevalence of use at 2.8% and 12.6%, respectively. From 2011 to 2012, electronic cigarette use increased significantly among middle school (0.6% to 1.1%) and high school (1.5% to 2.8%) students, and hookah use increased among high school students (4.1% to 5.4%). During the same period, significant decreases occurred in bidi* and kretek† use among ...
Source: MMWR Morb Mortal Wkl... - November 15, 2013 Category: Epidemiology Authors: Centers for Disease Control and Prevention (CDC) Tags: MMWR Morb Mortal Wkly Rep Source Type: research
Imaging Recommendations for Acute Stroke and Transient Ischemic Attack Patients: A Joint Statement by the American Society of Neuroradiology, the American College of Radiology, and the Society of NeuroInterventional Surgery [WHITE PAPER]
SUMMARY: Stroke is a leading cause of death and disability worldwide. Imaging plays a critical role in evaluating patients suspected of acute stroke and transient ischemic attack, especially before initiating treatment. Over the past few decades, major advances have occurred in stroke imaging and treatment, including Food and Drug Administration approval of recanalization therapies for the treatment of acute ischemic stroke. A wide variety of imaging techniques has become available to assess vascular lesions and brain tissue status in acute stroke patients. However, the practical challenge for physicians is to understand t...
Source: American Journal of Neuroradiology - November 15, 2013 Category: Radiology Authors: Wintermark, M., Sanelli, P. C., Albers, G. W., Bello, J., Derdeyn, C., Hetts, S. W., Johnson, M. H., Kidwell, C., Lev, M. H., Liebeskind, D. S., Rowley, H., Schaefer, P. W., Sunshine, J. L., Zaharchuk, G., Meltzer, C. C. Tags: WHITE PAPER Source Type: research
Medical devices; ophthalmic devices; classification of the scleral plug. Final rule.
Abstract The Food and Drug Administration (FDA or Agency) is classifying the scleral plug into class II (special controls), and exempting the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and continuing to require premarket notification (510(k)) for all other scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The scleral plug is a prescription device used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. PMID: 24236336 [...
Source: Fed Regist - November 15, 2013 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research
Some Danish Advice on the Trans-Fat Ban
When the U.S. Food and Drug Administration proposed to eliminate artery-clogging fats from all foodstuffs last week, they could look across the Atlantic Ocean at one recipe for success. Denmark placed tight restrictions on its own partially hydrogenated oils--the main source of trans fats--a decade ago. [More] (Source: Scientific American - Official RSS Feed)
Source: Scientific American - Official RSS Feed - November 14, 2013 Category: Science Tags: Health,Health Source Type: research
Toward better drug repositioning: prioritizing and integrating existing methods into efficient pipelines.
Abstract Recycling old drugs, rescuing shelved drugs and extendingpatents'lives make drug repositioning an attractive form of drug discovery. Drug repositioning accounts for approximately30% of the newlyUS Food and Drug Administration (FDA)-approved drugs and vaccines in recent years. The prevalence of drug-repositioning studies has resulted in a variety of innovative computational methods for theidentification of new opportunities for the use of old drugs.Questions often arise from customizingor optimizing these methods into efficient drug-repositioning pipelines for alternative applications. It requires a compreh...
Source: Drug Discovery Today - November 14, 2013 Category: Drugs & Pharmacology Authors: Jin G, Wong ST Tags: Drug Discov Today Source Type: research
Ban on Trans Fats Could Accelerate Deforestation
Rainforest campaigners are concerned that a recent Food and Drug Administration proposal to phase out trans fats may boost demand for palm oil, a crop whose large-scale production is linked to deforestation in Southeast Asia. [More] (Source: Scientific American - Official RSS Feed)
Source: Scientific American - Official RSS Feed - November 13, 2013 Category: Science Tags: Energy & Sustainability,Health,Society Policy,Climate,Energy Sustainability,Environment,More Science Source Type: research
Cerebral Oximetry and Cardiac Arrest
Cerebral oximetry is a Food and Drug Administration–approved technology that allows monitoring of brain oxygen saturation in accessible superficial brain cortex regions, which are amongst the most vulnerable in regard to ischemic or hypoxic injury. Since most oxygen in the area of interest is located in the venous compartment, the determined regional brain oxygen saturation approximately reflects the local balance between oxygen delivery and oxygen consumption. Major systemic alterations in blood oxygen content and oxygen delivery will be accompanied by corresponding changes in regional brain saturation. This systema...
Source: Seminars in Cardiothoracic and Vascular Anesthesia - November 13, 2013 Category: Anesthesiology Authors: Skhirtladze-Dworschak, K., Dworschak, M. Tags: Special Collection from the 31st Annual Symposium: Clinical Update in Anesthesiology, Surgery and Perioperative Medicine Source Type: research
Berlin Heart EXCOR Food and Drug Administration Investigational Device Exemption Trial
This study aims to summarize the data from the IDE trial and to provide more updated information with this device by reviewing recent publications and several important abstracts presented at the annual meeting of International Society for Heart and Lung Transplantation (ISHLT) held in April 2013. (Source: Seminars in Thoracic and Cardiovascular Surgery)
Source: Seminars in Thoracic and Cardiovascular Surgery - November 12, 2013 Category: Cardiovascular & Thoracic Surgery Authors: Iki Adachi, Charles D. Fraser Tags: News and Views Source Type: research