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Food and Drug Administration (FDA)

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[Correspondence] Cardiovascular outcome trials of glucose-lowering strategies in type 2 diabetes
There is a wave of cardiovascular intervention trials with antidiabetes drugs, largely driven by regulatory requirements of the US Food and Drug Administration (FDA). Rury Holman and colleagues underline that, because of their placebo-controlled design and short duration, these studies are unlikely to provide a clear answer about comparative efficacy and the risk–benefit balance of the cardiovascular effects of antidiabetes drugs. (Source: LANCET)
Source: LANCET - September 20, 2014 Category: Journals (General) Authors: Olga Vaccaro, Maria Masulli, Enzo Bonora, Stefano Del Prato, Gabriele Riccardi, on behalf of the TOSCA.IT Study Group Tags: Correspondence Source Type: research

Controversies and Complications in the Perioperative Management of Transcatheter Aortic Valve Replacement.
Abstract Transcatheter aortic valve replacement (TAVR) is performed with increasing frequency in the United States since Food and Drug Administration approval in 2011. The procedure involves the replacement of a severely stenosed native or bioprosthetic aortic valve with a specially constructed valvular prosthesis that is mounted onto a stent, without the use of cardiopulmonary bypass and the complications of a major open surgical procedure. TAVR has been performed mostly in elderly patients with multiple comorbidities or who have undergone previous cardiac surgery. The most commonly used access routes are the femo...
Source: Anesthesia and Analgesia - September 19, 2014 Category: Anesthesiology Authors: Klein AA, Skubas NJ, Ender J Tags: Anesth Analg Source Type: research

FDA told more study on testosterone treatments needed; AbbVie's AndroGel a leading product in that niche
An expert panel recommended that the Food and Drug Administration tighten restrictions on the use of testosterone drugs, a move that could put a dent in sales of one of AbbVie’s billion-dollar drugs. Bloomberg explained that North Chicago-based AbbVie (NYSE: ABBV) pulled in about $1.04 billion in sales of its testosterone therapy AndroGel last year. But the panel of FDA advisers voted 20-1 in favor of new trials to learn more about heart risks from various testosterone drugs, the report said,… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 18, 2014 Category: Pharmaceuticals Source Type: research

Shares of Burlington biotech Flexion drop after-hours due to FDA trial halt
Just two weeks after shares in the newly-public biotech firm Flexion Therapeutics spiked after surprise good news from the FDA, its shares fell 28 percent in after-hours trading Wednesday after the company said it’s temporarily halting a trial of its main drug due to safety concerns. After the close of markets Wednesday, the Burlington company said that the U.S. Food and Drug Administration has placed a clinical hold on a 300-patient Phase 2b trial of its non-opioid, long-acting injected painkiller… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - September 18, 2014 Category: Hospital Management Authors: Don Seiffert Source Type: research

FDA delays decision on Impax Parkinson's drug
An FDA decision on a treatment for Parkinson's disease symptoms — the first non-generic drug developed by Impax Laboratories Inc. — has been pushed back three months to January. The Hayward-based drug maker (NASDAQ: IPXL) blamed the delay on changes it made to its new drug application to the Food and Drug Administration after the agency inspected Impax's Taiwan facility. The FDA's new decision date on Rytary, an extended-release capsule of carbidopa and levodopa aimed at the jerky movements… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 17, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

Outflow graft thrombectomy during HeartMate II left ventricular assist device exchange
This report highlights a thrombectomy technique and reuse of the outflow graft during subcostal pump exchange in a patient with relative contraindications to repeat sternotomy. (Source: Interactive CardioVascular and Thoracic Surgery)
Source: Interactive CardioVascular and Thoracic Surgery - September 17, 2014 Category: Cardiovascular & Thoracic Surgery Authors: Berg, K. B., Klodell, C. T. Tags: Electrophysiology - arrhythmias, Myocardial protection, Peripheral vascular ADULT CARDIAC Source Type: research

{alpha}1 Antitrypsin deficiency: current best practice in testing and augmentation therapy
α1 Antitrypsin deficiency (AATD) increases the risk of chronic obstructive pulmonary disease (COPD), liver disease and other conditions. Although it is not a rare disease, it is a condition rarely diagnosed because of unawareness by most healthcare providers who manage subjects at risk. Testing recommendations have been published and strongly suggest testing all subjects with confirmed COPD, cryptogenic liver cirrhosis, subjects with incompletely reversible airflow obstruction and siblings of affected individuals. Testing strategies usually imply a combination of measures of α1 antitrypsin (AAT) levels, phenoty...
Source: Therapeutic Advances in Respiratory Disease - September 17, 2014 Category: Respiratory Medicine Authors: Campos, M. A., Lascano, J. Tags: Review Source Type: research

Aptiom (Eslicarbazepine acetate) as a Dual Inhibitor of β-Secretase and Voltage-Gated Sodium Channel: Advancement in Alzheimer's Disease-Epilepsy Linkage Via an Enzoinformatics Study.
This study explores the molecular interactions between a new Food and Drug Administration approved antiepileptic drug Aptiom (Eslicarbazepine acetate) with BACE and VSC to explore a possible link between the treatment of AD and epilepsy. Docking study was performed using 'Autodock4.2'. Hydrophobic and pi-pi interactions play an important role in the correct positioning of Eslicarbazepine acetate within the catalytic site of VSC and BACE enzyme to permit docking. Free energy of binding (ΔG) of 'Eslicarbazepine acetate-VSC' interaction and 'Eslicarbazepine acetate-CAS domain of BACE' interaction were found to be -5.97 and -...
Source: CNS and Neurological Disorders Drug Targets - September 17, 2014 Category: Drugs & Pharmacology Authors: Shaikh S, Rizvi SM, Hameed N, Biswas D, Khan M, Shakil S, Kamal MA Tags: CNS Neurol Disord Drug Targets Source Type: research

FDA may have cracked down, but 23andMe exec hopeful
Ten months after the Food and Drug Administration ordered a direct-to-consumer genetic testing firm to stop selling its service, the company’s medical director sounded an upbeat note at the Oregon Bioscience Association conference. “People want prevention and personalized medicine,” said Dr. Jill Hagenkord, chief medical officer for Mountain View-based 23andMe Inc. “Sequencing is getting cheaper and cheaper, to a consumer price point.” Take our poll below. 23andMe (named for the… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - September 16, 2014 Category: Hospital Management Authors: Elizabeth Hayes Source Type: research

FDA may have cracked down, but personalized genetics testing exec is hopeful
Ten months after the Food and Drug Administration ordered a direct-to-consumer genetic testing firm to stop selling its service, the company’s medical director sounded an upbeat note at the Oregon Bioscience Association conference. “People want prevention and personalized medicine,” said Dr. Jill Hagenkord, chief medical officer for Mountain View, California-based 23andMe. “Sequencing is getting cheaper and cheaper, to a consumer price point.” Take our poll below. 23andMe (named… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 16, 2014 Category: Biotechnology Authors: Elizabeth Hayes Source Type: research

risk assessment for new surgical procedures
Medical devices such as total joint replacements are considered high risk and as such are described as class III medical devices. In North America, these devices require approval from the Food and Drug Administration's Center for Devices and Radiological Health, and in Europe, CE Marking certification is needed for them to be sold. These measures attest to the verification by the manufacturer that the product meets safety, health, or environmental requirements. (Source: Journal of Shoulder and Elbow Surgery)
Source: Journal of Shoulder and Elbow Surgery - September 16, 2014 Category: Orthopaedics Authors: Tressa D. Amirthanayagam, Roger J.H. Emery Tags: Editorial Source Type: research

Nektar stands to win big bucks as drug decision nears
Nektar Therapeutics Inc. and partner AstraZeneca will discover Tuesday if regulators have approved their treatment for opioid-induced constipation. One thing, however, is already clear: Don't play poker with Nektar President CEO Howard Robin . On the eve of the drug starting its way through the Food and Drug Administration's approval process, Robin in August 2013 renegotiated Nektar's deal with AstraZeneca to get an additional $35 million if the drug is approved. But Robin didn't stop there: He… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 16, 2014 Category: Pharmaceuticals Authors: Ron Leuty Source Type: research

Nektar stands to win big bucks as drug decision nears
Nektar Therapeutics Inc. and partner AstraZeneca will discover Tuesday if regulators have approved their treatment for opioid-induced constipation. One thing, however, is already clear: Don't play poker with Nektar President CEO Howard Robin . On the eve of the drug starting its way through the Food and Drug Administration's approval process, Robin in August 2013 renegotiated Nektar's deal with AstraZeneca to get an additional $35 million if the drug is approved. But Robin didn't stop there: He… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 16, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

Pitt researcher helps develop new kidney test
The Food and Drug Administration has approved a lab test that helps determine if certain hospitalized patients are at risk of developing kidney injury, an advancement over current tests, which only tell whether an injury has already occurred. University of Pittsburgh researcher Dr. John Kellum was the lead investigator in assessing the effectiveness of the test. The NephroCheck Test System is manufactured by Astute Medical, which is based in San Diego. NephroCheck detects the presence of a protein… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 15, 2014 Category: Biotechnology Authors: Kris B. Mamula Source Type: research

How Taxol/paclitaxel kills cancer cells.
Abstract Taxol (generic name paclitaxel) is a microtubule-stabilizing drug that is approved by the Food and Drug Administration for the treatment of ovarian, breast, and lung cancer, as well as Kaposi's sarcoma. It is used off-label to treat gastroesophageal, endometrial, cervical, prostate, and head and neck cancers, in addition to sarcoma, lymphoma, and leukemia. Paclitaxel has long been recognized to induce mitotic arrest, which leads to cell death in a subset of the arrested population. However, recent evidence demonstrates that intratumoral concentrations of paclitaxel are too low to cause mitotic arrest and r...
Source: Mol Biol Cell - September 15, 2014 Category: Molecular Biology Authors: Weaver BA Tags: Mol Biol Cell Source Type: research

Viamet snags orphan drug status for in-development brain treatment
Durham-based Viamet Pharmaceuticals, the drug discovery firm co-founded by former UNC Chancellor Holden Thorp, has snagged orphan drug status for an in-development antifungal treatment. The drug candidate, dubbed VT-1129, is a pill that aims to treat what’s called cryptococcal meningitis, a rare, life-threatening fungal infection that targets the brain and spinal cord. The U.S. Food and Drug Administration grants orphan drug status as an incentive to companies developing treatments for conditions… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 12, 2014 Category: American Health Authors: Lauren K. Ohnesorge Source Type: research

FDA's OK completes GE product suite
Approval of General Electric’s three-dimensional breast cancer screening technology by the U.S. Food and Drug Administration means more than simply allowing the company to market and sell the technology in the U.S. It enables GE to sell its entire 3D mammography product line as a package. Before the FDA approved the technology last week, hospitals, imaging centers and treatment centers in the U.S. could only purchase the 2-D technology. “GE likes to offer what we call a suite of solutions,”… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 12, 2014 Category: Pharmaceuticals Authors: Krystle S. Morey Source Type: research

FDA could be source of innovation, Hamburg says
U.S. Food and Drug Administration (FDA) chief Margaret Hamburg has heard the talk of her agency being a tough regulator that makes life hard for small businesses in the bioscience and medical industries. She sees the FDA as something else — a potential partner for new innovations and a regulator that brings value to the companies it oversees. “Regulation, when done right is a meaningful pathway to furthering innovation,” Hamburg said in a visit to Denver. The FDA, in the course of approving… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - September 12, 2014 Category: Hospital Management Authors: Greg Avery Source Type: research

Liver injury associated with ketoconazole: Review of the published evidence.
Abstract The azole antifungal agent ketoconazole has been available since 1981 for the treatment of fungal infections. In 2013 the American Food and Drug Administration and the European Medicines Agency issued warnings or prohibitions against the clinical use of oral ketoconazole due to the risk of liver injury which may lead to liver transplantation or death. From the available published evidence it is difficult to determine the actual incidence or prevalence of liver injury during clinical use of ketoconazole as an antifungal. Hepatic injury, when it occurs, is generally evident as asymptomatic and reversible abn...
Source: The Journal of Clinical Pharmacology - September 12, 2014 Category: Drugs & Pharmacology Authors: Greenblatt HK, Greenblatt DJ Tags: J Clin Pharmacol Source Type: research

Medivation snags $90M from Astellas as FDA expands use of prostate cancer drug
An expanded label on Medivation Inc.’s signature prostate cancer drug will net the San Francisco company an additional $90 million from partner Astellas Pharma Inc. The Food and Drug Administration said Xtandi, which the agency approved in August 2012 to treat men with metastatic castration-resistant prostate cancer who previously received the chemotherapy drug docetaxel, now can be used before chemotherapy, the companies said Wednesday. The new indication means more than the addition of a few… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 11, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

Development and validation of an LC-APCI-MS/MS method for the determination of phenethyl isothiocyanate in human plasma.
Abstract Phenethyl isothiocyanate (PEITC) is a promising chemopreventive agent present in cruciferous vegetables. This paper describes the development of a method for the determination of PEITC in human plasma by liquid chromatography/tandem mass spectrometry (LC-MS/MS). Atmospheric-pressure chemical ionization was found more suitable for ionization of PEITC than electrospray ionization. Because of the lability of PEITC, a combination of low temperature and acidification was applied to minimize the degradation during the sample collection and preparation procedure. A simple protein precipitation with acetonitrile w...
Source: Biomedical Chromatography : BMC - September 11, 2014 Category: Biomedical Science Authors: Zheng L, Zheng F Tags: Biomed Chromatogr Source Type: research

The Targeting of IDO‐Mediated Immune Escape in Cancer
This article is protected by copyright. All rights reserved. (Source: Basic and Clinical Pharmacology and Toxicology)
Source: Basic and Clinical Pharmacology and Toxicology - September 10, 2014 Category: Drugs & Pharmacology Authors: Trine Zeeberg Iversen, Mads Hald Andersen, Inge Marie Svane Tags: MiniReview Source Type: research

The Targeting of IDO-Mediated Immune Escape in Cancer.
This article is protected by copyright. All rights reserved. PMID: 25207460 [PubMed - as supplied by publisher] (Source: Clinical Prostate Cancer)
Source: Clinical Prostate Cancer - September 10, 2014 Category: Cancer & Oncology Authors: Iversen TZ, Andersen MH, Svane IM Tags: Basic Clin Pharmacol Toxicol Source Type: research

Duke spinout gets $125M and a 10% stock bounce
Duke University spinoff Aerie Pharmaceuticals saw a 10 percent stock bump on news that it secured $125 million in convertible debt. Aerie (Nasdaq: AERI) chief executive Vicente Anido says this financing will be enough cash to allow Aerie to finish clinical trials on two experimental drugs as well as commercialize one of those drugs, if the trials show successful results. In drug development, companies can’t sell their new drugs until they receive approval from the U.S. Food and Drug Administration,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 9, 2014 Category: Biotechnology Authors: Jason deBruyn Source Type: research

Duke spinout gets $125M and a 10% stock bounce
Duke University spinoff Aerie Pharmaceuticals saw a 10 percent stock bump on news that it secured $125 million in convertible debt. Aerie (Nasdaq: AERI) chief executive Vicente Anido says this financing will be enough cash to allow Aerie to finish clinical trials on two experimental drugs as well as commercialize one of those drugs, if the trials show successful results. In drug development, companies can’t sell their new drugs until they receive approval from the U.S. Food and Drug Administration,… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - September 9, 2014 Category: Hospital Management Authors: Jason deBruyn Source Type: research

Colony-stimulating factors for the treatment of the hematopoietic component of the acute radiation syndrome (H-ARS): A review.
Abstract One of the greatest national security threats to the United States is the detonation of an improvised nuclear device or a radiological dispersal device in a heavily populated area. As such, this type of security threat is considered to be of relatively low risk, but one that would have an extraordinary high impact on health and well-being of the US citizenry. Psychological counseling and medical assessments would be necessary for all those significantly impacted by the nuclear/radiological event. Direct medical interventions would be necessary for all those individuals who had received substantial radiatio...
Source: Cytokine - September 9, 2014 Category: Molecular Biology Authors: Singh VK, Newman VL, Seed TM Tags: Cytokine Source Type: research

The Hidden Cost Of Low Prices: Limited Access To New Drugs In India [Access To Drugs]
We examined data on the sales of 184 drugs approved by the US Food and Drug Administration between 2000 and 2009. We found that 50 percent of those 184 drugs went on sale in India only after lags of more than five years from their first worldwide introduction. More than half of the drugs that became newly available in India during the study period were produced and sold by multiple manufacturers in the country within one year of their introduction. The presence of multiple manufacturers indicates sharp competition and weak patent protection—factors that are disincentives to manufacturers to incur the costs of ga...
Source: Health Affairs - September 8, 2014 Category: Global & Universal Authors: Berndt, E. R., Cockburn, I. M. Tags: Insurance Coverage, International Issues, Legal/Regulatory Issues, Business Of Health, Pharmaceuticals, Public Health, Quality Of Care, Health Spending Access To Drugs Source Type: research

Nano-LC-MS/MS for the quantitation of prostanoids in immune cells.
Abstract Prostanoids, derivatives of arachidonic acid, are involved in inflammation and immune reactions. To understand the role of prostanoids produced by diverse immune cells, a highly sensitive quantitation method for prostaglandin E2 (PGE2), prostaglandin D2 (PGD2), 6-keto prostaglandin F1α (6-keto PGF1α), prostaglandin F2α (PGF2α), and thromboxane B2 (TXB2) by means of nano-liquid chromatography-tandem mass spectrometry has been developed. It was validated according to the guidelines of the Food and Drug Administration (FDA) in terms of linearity, precision, accuracy, recovery, stability, and lower limit o...
Source: Analytical and Bioanalytical Chemistry - September 6, 2014 Category: Chemistry Authors: Thomas D, Suo J, Ulshöfer T, Jordan H, de Bruin N, Scholich K, Geisslinger G, Ferreirós N Tags: Anal Bioanal Chem Source Type: research

San Antonio’s START gains more recognition in global cancer fight
The U.S. Food and Drug Administration has approved a new treatment option for patients with advanced melanoma. The clearance of MK-3475, or pembrolizumab, further underscores the impact San Antonio-based START is having on cancer research. The approved drug, a Merck compound, was initially tested at START, which is located in the South Texas Medical Center and operates one of the world’s largest Phase I clinical trial programs for new anti-cancer agents. Dr. Amita Patnaik, associate director… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - September 5, 2014 Category: Hospital Management Authors: W. Scott Bailey Source Type: research

OncoMed moves forward on drug trials halted due to side effects
For the second time in a week, the Food and Drug Administration lifted a hold on three early-stage clinical trials of an experimental cancer-fighting drug by OncoMed Pharmaceuticals Inc. The studies are important for Redwood City-based OncoMed (NASDAQ: OMED) because partner Bayer HealthCare has the option under a 2010 deal to an exclusive license of the drugs after the trials are completed. Enrollment in both programs, halted in June, is expected to be under way again soon, OncoMed Chairman and… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 5, 2014 Category: American Health Authors: Ron Leuty Source Type: research

GE receives U.S. approval to sell 3-D digital imaging technology to detect breast cancer
GE Healthcare has received federal approval to begin selling its three-dimensional imaging technology for breast cancer detection in the United States. The company makes detectors at its Digital X-ray manufacturing plant which opened in North Greenbush, New York in 2009. The North Greenbush plant employed 135 workers as of July. General Electric announced Wednesday that the U.S. Food and Drug Administration granted approval to market and sell its 3-D imaging technology in the United States. The… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 4, 2014 Category: Biotechnology Source Type: research

Rebasing the Medicare Payment for Dialysis: Rationale, Challenges, and Opportunities.
Abstract After Medicare's implementation of the bundled payment for dialysis in 2011, there has been a predictable decrease in the use of intravenous drugs included in the bundle. The change in use of erythropoiesis-stimulating agents, which decreased by 37% between 2007, when its allowance in the bundle was calculated, and 2012, was because of both changes in the Food and Drug Administration labeling for erythropoiesis-stimulating agents in 2011 and cost-containment efforts at the facility level. Legislation in 2012 required Medicare to decrease (rebase) the bundled payment for dialysis in 2014 to reflect this dec...
Source: Clinical Journal of the American Society of Nephrology : CJASN - September 4, 2014 Category: Urology & Nephrology Authors: Wish D, Johnson D, Wish J Tags: Clin J Am Soc Nephrol Source Type: research

Pharmacokinetic Assessment in Patients Receiving Continuous RRT: Perspectives from the Kidney Health Initiative.
Abstract The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembled a work group composed of clinicians and scientists representing academia, the FDA, and the pharmaceutical and ...
Source: Clinical Journal of the American Society of Nephrology : CJASN - September 4, 2014 Category: Urology & Nephrology Authors: Nolin TD, Aronoff GR, Fissell WH, Jain L, Madabushi R, Reynolds K, Zhang L, Huang SM, Mehrotra R, Flessner MF, Leypoldt JK, Witcher JW, Zineh I, Archdeacon P, Roy-Chaudhury P, Goldstein SL Tags: Clin J Am Soc Nephrol Source Type: research

Medical devices; hematology and pathology devices; classification of early growth response 1 gene fluorescence in-situ hybridization test system for specimen characterization. Final order.
Abstract The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectivene...
Source: Fed Regist - September 3, 2014 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Advanced prostate cancer - patient survival and potential impact of enzalutamide and other emerging therapies.
Abstract The advent of exponential growth of novel agents tested and approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) has brought about a need for understanding of the mechanism of action, side-effects, and clinical efficacy of these drugs as they relate to these patients. This review will provide a synopsis of the treatment landscape in mCRPC as varying agents such as abiraterone acetate, cabazitaxel, sipuleucel-T, radium, and selected emerging agents are presented. A distinct focus on the utilization of enzalutamide, its mechanism of action, key pivotal trials th...
Source: Clinical Prostate Cancer - September 2, 2014 Category: Cancer & Oncology Authors: Patel NK, Finianos A, Whitaker KD, Aragon-Ching JB Tags: Ther Clin Risk Manag Source Type: research

VentiRx gets FDA fast-track designation for drug aimed at ovarian cancer
Seattle biopharmaceutical VentiRx Pharmaceuticals Inc. said it's been given fast-track designation by the U.S. Food and Drug Administration for its drug targeting ovarian cancer in women. VentiRx said its motolimod drug is aimed at cancer that disease has progressed on or recurred after platinum-based chemotherapy. Fast-track designation by the FDA expedites clinical development of new drugs. "We look forward to emerging clinical data and to the possibility of providing a meaningful treatment for… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 2, 2014 Category: American Health Authors: Ben Miller Source Type: research

Pharmacokinetics of Fluoride in Toddlers After Application of 5% Sodium Fluoride Dental Varnish
The objective of this research is to examine the safety of use in toddlers by characterizing the absorption and distribution profile of a currently marketed fluoride varnish. We measured urinary fluoride for 5 hours after application of fluoride varnish to teeth in 6 toddlers aged 12 to 15 months. Baseline levels were measured on a separate day. The urine was extracted from disposable diapers, measured by rapid diffusion, and extrapolated to plasma levels. The mean estimated plasma fluoride concentration was 13 μg/L (SD, 9 μg/L) during the baseline visit and 21 μg/L (SD, 8 μg/L) during the 5 hours after treatme...
Source: PEDIATRICS - September 2, 2014 Category: Pediatrics Authors: Milgrom, P., Taves, D. M., Kim, A. S., Watson, G. E., Horst, J. A. Tags: Case Report Source Type: research

Treatment with the Matricellular Protein CCN3 (nov) Blocks and/or Reverses Fibrosis Development in Obesity with Diabetic Nephropathy.
This study demonstrates the potential efficacy of recombinant human CCN3 treatment in DN and points to mechanisms operating at multiple levels or pathways, upstream (eg, protecting against cell injury) and downstream (eg, regulating CCN2 activity and extracellular matrix metabolism). PMID: 25193594 [PubMed - as supplied by publisher] (Source: The American Journal of Pathology)
Source: The American Journal of Pathology - September 2, 2014 Category: Pathology Authors: Riser BL, Najmabadi F, Garchow K, Barnes JL, Peterson DR, Sukowski EJ Tags: Am J Pathol Source Type: research

FDA approves first PI3K inhibitor
Nature Reviews Drug Discovery 13, 644 (2014). doi:10.1038/nrd4425 But better biomarkers and rational combinations are still needed for the class to achieve its full potential.The lowdown: After many fits and starts for phosphoinositide 3-kinase (PI3K) drugs, the US Food and Drug Administration (FDA) has approved Gilead's first-in-class idelalisib in combination with (Source: Nature Reviews Drug Discovery)
Source: Nature Reviews Drug Discovery - September 1, 2014 Category: Drugs & Pharmacology Tags: News and Analysis Source Type: research

FDA approves second transgenic milk drug
Nature Reviews Drug Discovery 13, 644 (2014). doi:10.1038/nrd4426 Despite regulatory success for Pharming's conestat alfa, 'farmaceuticals' continue to face an uphill battle.The lowdown: The US Food and Drug Administration (FDA) approved Pharming's conestat alfa for the treatment of hereditary angioedema, providing a second complete case study for developers of drugs from (Source: Nature Reviews Drug Discovery)
Source: Nature Reviews Drug Discovery - September 1, 2014 Category: Drugs & Pharmacology Tags: News and Analysis Source Type: research

[Comment] Future of ALK inhibition in non-small-cell lung cancer
Progress in defining molecular targets of oncogenesis and drugs to inhibit cancer growth in specific populations has led to augmented outcomes for patients and new expectations in the development of treatments. The EML4–ALK fusion protein was identified in patients with non-small-cell lung cancer (NSCLC) in 2007. Rearrangements in the ALK gene lead to constitutive signalling, triggering transforming properties. Up to now, two drugs have been approved by the US Food and Drug Administration for ALK-rearranged NSCLC—crizotinib and ceritinib. (Source: The Lancet Oncology)
Source: The Lancet Oncology - September 1, 2014 Category: Cancer & Oncology Authors: Karen L Reckamp Tags: Comment Source Type: research

[Correspondence] Drug–drug interactions with tyrosine-kinase inhibitors
In their Review, Roelof van Leeuwen and colleagues recommend various dose adjustments during concomitant use of tyrosine-kinase inhibitors and drugs that inhibit or induce cytochrome P450 3A4 (CYP3A4). Most information is taken from the US Food and Drug Administration (FDA)'s drug label or the European Medicines Agency (EMA)'s Summary of Product Characteristics. However, we could not find support for their advice regarding concomitant use of pazopanib and strong CYP3A4 inducers such as carbamazepine. (Source: The Lancet Oncology)
Source: The Lancet Oncology - September 1, 2014 Category: Cancer & Oncology Authors: Sander Croes, Frank de Vries Tags: Correspondence Source Type: research

Transoral incisionless fundoplication: is it as safe and efficacious as a nissen or toupet fundoplication?
This study was undertaken to compare outcomes for patients with GERD undergoing TIF versus laparoscopic Nissen or Toupet fundoplications. We undertook a case-controlled study of three cohorts of 20 patients undergoing TIF or laparoscopic Nissen or Toupet fundoplications from 2010 to 2013 controlling for age, body mass index, and preoperative DeMeester scores. All patients were prospectively followed. Median data are reported. Patients undergoing TIF had significantly shorter operative times (in minutes: 71 vs 119 and 85, respectively, P < 0.001) and length of stay (in days: 1, 2, and 1, respectively, P < 0.001). No m...
Source: The American Surgeon - September 1, 2014 Category: Surgery Authors: Toomey P, Teta A, Patel K, Ross S, Sukharamwala P, Rosemurgy AS Tags: Am Surg Source Type: research

Primary human papillomavirus screening for cervical cancer in the United States—US Food and Drug Administration approval, clinical trials, and where we are today
The US Food and Drug Administration recently approved the additional indication of Primary Screening for the Roche cobas human papillomavirus test. This commentary includes an overview of the supporting clinical trial data, issues this approval will present for laboratorians, and proposed clinical management guidelines for abnormal screening results. (Source: Cancer Cytopathology)
Source: Cancer Cytopathology - September 1, 2014 Category: Pathology Authors: Ritu Nayar, Robert A. Goulart, Patricia G. Tiscornia‐Wasserman, Diane Davis Davey Tags: Commentary Source Type: research

[This Week in Medicine] August 30–Sept 5, 2014
The US Food and Drug Administration (FDA) plans to ensure representation of demographic subgroups (eg, age, ethnic origin, and sex) in clinical trials of drugs and medical products, with an action plan to improve data collection by study funders, identify barriers to subgroup enrolment in trials, and make subgroup data more available. (Source: LANCET)
Source: LANCET - August 30, 2014 Category: Journals (General) Authors: The Lancet Tags: This Week in Medicine Source Type: research

Endovascular Aortoiliac Aneurysm Repair: Surgical Progress Through New Treatment Paradigms and Innovative Endograft Design
Effective treatment for patients with an abdominal aortic aneurysm (AAA) began more than 50 years ago through the development of prosthetic grafts, which were used to replace aneurysmal segments of diseased arteries. Open surgical repair of AAAs became the gold standard for treating this disease. In 1999, two device manufacturers received US Food and Drug Administration approval for their endovascular aneurysm repair (EVAR) devices to treat selected patients with AAA. During the next 10 years, multiple other EVAR devices received US Food and Drug Administration approval, and, now, EVAR rivals open surgical repair as the st...
Source: AORN Journal - August 28, 2014 Category: Nursing Authors: Shirley D. Buckley, Clifford J. Buckley Tags: Featured Articles Source Type: research

FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non-Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements.
Abstract On August 26, 2011, crizotinib received accelerated approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by a test approved by the U.S. Food and Drug Administration (FDA). Approval was based on two single-arm trials demonstrating objective response rates (ORRs) of 50% and 61% and median response durations of 42 and 48 weeks. On November 20, 2013, crizotinib received regular approval based on confirmation of clinical benefit in study A8081007, a randomized trial in 347 patients with ALK-positive advanced NSCLC who had ...
Source: The Oncologist - August 28, 2014 Category: Cancer & Oncology Authors: Kazandjian D, Blumenthal GM, Chen HY, He K, Patel M, Justice R, Keegan P, Pazdur R Tags: Oncologist Source Type: research

Ceftriaxone-Induced Immune Hemolytic Anemia.
Abstract OBJECTIVES: To describe a case of ceftriaxone-induced immune hemolytic anemia (CIIHA) in a 6 year-old boy with sickle cell disease (SCD) and perform a systematic literature review to delineate the clinical and laboratory features of this condition. DATA SOURCES: EMBASE (1947-January 2014), MEDLINE (1946-January 2014), and databases from the US Food and Drug Administration and Health Canada were searched, using anemia, hemolytic anemia, hemolysis, and ceftriaxone as search terms. Additional references were identified from a review of literature citations. STUDY SELECTION AND DATA EXTRACTION: All cas...
Source: The Annals of Pharmacotherapy - August 27, 2014 Category: Drugs & Pharmacology Authors: Neuman G, Boodhan S, Wurman I, Koren G, Bitnun A, Kirby-Allen M, Ito S Tags: Ann Pharmacother Source Type: research

Coverage of certain preventive services under the Affordable Care Act. Interim final rules.
Abstract This document contains interim final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by ...
Source: Fed Regist - August 27, 2014 Category: American Health Authors: Internal Revenue Service, Department of the Treasury, Employee Benefits Security Administration, Department of Labor, Centers for Medicare & Medicaid Services, Department of Health and Human Services Tags: Fed Regist Source Type: research

Erratum
The article “Severely Restricted Diets in the Absence of Medical Necessity: The Unintended Consequences,” in the July 2014 issue of the Journal of the Academy of Nutrition and Dietetics (pp 986-994), erroneously implied on page 990 that soy milk is not fortified with vitamin D. Since 2009, the US Food and Drug Administration has allowed manufacturers to fortify soy milk with vitamin D. Mary Anne Burkman, MPH, RDN, has confirmed that her quote should have stated, “If soy milk is not fortified with vitamin D, it may affect bone health and strength.” The Journal regrets this unintended error. (Source: Journal of the ...
Source: Journal of the American Dietetic Association - August 25, 2014 Category: Nutrition Tags: Erratum Source Type: research