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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

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

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

Roche to pay rich price for one-drug InterMune
Roche — the Swiss parent of Genentech Inc. — will buy Brisbane’s InterMune Inc. for $8.3 billion, according to a deal disclosed Sunday. The $74-per-share, all-cash deal really is no surprise. Rumors of a buyout by any one of a handful of Big Pharma players surged as InterMune’s experimental treatment for a fatal lung-scarring disease neared an approval-decision date with the Food and Drug Administration. But InterMune’s (NASDAQ: ITMN) price tag — a 38 percent premium to Friday’s… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - August 25, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

New labeling added to 19 neurology drugs studied in pediatric patients [FDA UPDATE]
(Source: AAP News)
Source: AAP News - August 25, 2014 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Pediatric & Maternal Health Staff, Division of Neurology Products Tags: FDA Update, Neurology Source Type: research

The use of natural and synthetic phospholipids as pharmaceutical excipients
In pharmaceutical formulations, phospholipids obtained from plant or animal sources and synthetic phospholipids are used. Natural phospholipids are purified from, e.g., soybeans or egg yolk using non‐toxic solvent extraction and chromatographic procedures with low consumption of energy and minimum possible waste. Because of the use of validated purification procedures and sourcing of raw materials with consistent quality, the resulting products differing in phosphatidylcholine content possess an excellent batch to batch reproducibility with respect to phospholipid and fatty acid composition. The natural phospholipids are...
Source: European Journal of Lipid Science and Technology - August 25, 2014 Category: Lipidology Authors: Peter van Hoogevest, Armin Wendel Tags: Review Article Source Type: research

Transjugular Liver Biopsy in a Patient with a Total Artificial Heart
Although orthotopic cardiac transplantation is the definitive treatment for heart failure, an increasing number of patients are undergoing insertion of an artificial heart for mechanical circulatory support as a bridge to transplantation. Technologic developments have allowed patients with an artificial heart to leave the hospital while they await organ transplant. The devices were approved more recently for destination therapy by the U.S. Food and Drug Administration under a humanitarian use exemption. (Source: Journal of Vascular and Interventional Radiology : JVIR)
Source: Journal of Vascular and Interventional Radiology : JVIR - August 23, 2014 Category: Radiology Authors: Joseph M. Miller, Richard J. Van Allan, Alagappan A. Annamalai, Marc L. Friedman Tags: Letters to the Editor Source Type: research

A Vascular Surgeon Plays a Critical Role in the Development of a Successful TAVR Program
Transcatheter aortic valve replacement (TAVR) is a Food and Drug Administration-approved means of treating symptomatic aortic stenosis in high-risk patients. A number of techniques to deliver valve prostheses are currently in practice, including transfemoral (TF), transapical, and transaortic approaches. Various disciplines are involved throughout this complex process. Our team includes a vascular surgeon, bringing greater experience in aortoiliac imaging, vascular access, and repair. We analyzed the role of a vascular surgeon during the selection process and throughout safe device delivery. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - August 22, 2014 Category: Surgery Authors: Jeffrey Ranaudo, Ossama Reslan, Marc Cohen, Bruce Haik, Mark Russo, Paul Burns, Bruce J. Brener, Cindy Sturt Tags: Abstracts from the 2014 New England Society for Vascular Surgery/Eastern Vascular Society Joint Annual Meeting Source Type: research

Update on recommendations for use of herpes zoster vaccine.
Abstract Herpes zoster vaccine (Zostavax [Merck & Co., Inc.]) was licensed in 2006 and recommended by the Advisory Committee on Immunization Practices (ACIP) in 2008 for prevention of herpes zoster (shingles) and its complications among adults aged ≥60 years. The Food and Drug Administration (FDA) approved the use of Zostavax in 2011 for adults aged 50 through 59 years based on a large study of safety and efficacy in this age group. ACIP initially considered the use of herpes zoster vaccine among adults aged 50 through 59 years in June 2011, but declined to recommend the vaccine in this age group, citing shor...
Source: MMWR Morb Mortal Wkl... - August 22, 2014 Category: Epidemiology Authors: Hales CM, Harpaz R, Ortega-Sanchez I, Bialek SR, Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, CDC Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Direct Flow Medical heart valve device wins approval in Europe
Direct Flow Medical won European regulatory approval of an aortic valve system, the Santa Rosa company said Thursday, as it pushes forward on a pivotal U.S. study. The European CE Mark allows Direct Flow Medical to sell its 23-milligram valve as well as other valve sizes in its portfolio, and it comes as the company tries to win the U.S. Food and Drug Administration's OK of the system. Pivotal to U.S. approval is an ongoing 500-person trial at 30 sites that is designed to help patients, many in… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 21, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

Direct Flow Medical heart valve device wins approval in Europe
Direct Flow Medical won European regulatory approval of an aortic valve system, the Santa Rosa company said Thursday, as it pushes forward on a pivotal U.S. study. The European CE Mark allows Direct Flow Medical to sell its 23-milligram valve as well as other valve sizes in its portfolio, and it comes as the company tries to win the U.S. Food and Drug Administration's OK of the system. Pivotal to U.S. approval is an ongoing 500-person trial at 30 sites that is designed to help patients, many in… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - August 21, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

Seattle biotech startup raises more than $2M, hopes to soon begin human trials
Seattle biotech startup Immusoft Corp. has raised $2.37 million from investors, including FF Science, a San Francisco venture fund that targets early stage technology and science companies. Founder and CEO Matthew Scholz, who launched Immusoft in 2009, said the funding will allow his company to scale up research, including approaching the U.S. Food and Drug Administration about doing human clinical trials. “It won’t get us through our Phase 1, but hopefully it gets us right up to it,” Scholz… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 21, 2014 Category: Pharmaceuticals Authors: Greg Lamm Source Type: research

Sprout raises $15M war chest to develop 'female Viagra'
A North Carolina company looking to produce the first FDA-approved drug for female sexual dysfunction retooled its war chest and now has enough cash to test its experimental drug and file a new application for approval. Since facing some regulatory hurdles from the U.S. Food and Drug Administration, Sprout Pharmaceuticals has raised $15 million from private investors, enough to bring it through a new application with FDA for flibanserin, a drug that would treat Hypoactive Sexual Desire Disorder… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 21, 2014 Category: American Health Authors: Jason deBruyn Source Type: research

IRS can’t figure out medical-device tax, U.S. Treasury says
The Internal Revenue Service is struggling to determine which businesses must pay an excise tax on medical devices, according to a U.S. Treasury report. The Affordable Care Act created a 2.3 percent tax on medical device sales that went into effect at the beginning of 2013. Not all device-makers must pay the tax, however. For instance, products like contact lenses sold at retail stores are exempt. The IRS has tried to identify which companies should pay based on Food and Drug Administration registrations,… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - August 21, 2014 Category: Hospital Management Authors: Katharine Grayson Source Type: research

Whole Foods, Trader Joe’s affected by peanut-, almond-butter recall
A nationwide recall of peanut butter and almond butter could affect Whole Foods Market and Trader Joe’s shoppers in the Charlotte area. The U.S. Food and Drug Administration announced Tuesday that nSpired Natural Foods Inc. is voluntarily recalling those products because they could be contaminated with salmonella. That includes certain lots of Arrowhead Mills peanut butter, MaraNath almond butter and private-label peanut and nut butters, including Whole Foods and Trader Joe's brands. To date,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 21, 2014 Category: Biotechnology Authors: Jennifer Thomas Source Type: research

Whole Foods, Trader Joe’s affected by peanut-, almond-butter recall
A nationwide recall of peanut butter and almond butter could affect Whole Foods Market and Trader Joe’s shoppers in the Triad. The U.S. Food and Drug Administration announced Tuesday that nSpired Natural Foods Inc. is voluntarily recalling those products because they could be contaminated with salmonella. That includes certain lots of Arrowhead Mills peanut butter, MaraNath almond butter and private-label peanut and nut butters, including Whole Foods and Trader Joe's brands. To date, four reports… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 20, 2014 Category: Pharmaceuticals Authors: Jennifer Thomas Source Type: research

FTY720 (fingolimod) modulates the severity of viral-induced encephalomyelitis and demyelination
Background: FTY720 (fingolimod) is the first oral drug approved by the Food and Drug Administration for treatment of patients with the relapsing-remitting form of the human demyelinating disease multiple sclerosis. Evidence suggests that the therapeutic benefit of FTY720 occurs by preventing the egress of lymphocytes from lymph nodes thereby inhibiting the infiltration of disease-causing lymphocytes into the central nervous system (CNS). We hypothesized that FTY720 treatment would affect lymphocyte migration to the CNS and influence disease severity in a mouse model of viral-induced neurologic disease. Methods: Mice were i...
Source: Journal of Neuroinflammation - August 20, 2014 Category: Neurology Authors: Caroline BlancHugh RosenThomas Lane Source Type: research

UCSF study: Hand-wringing over hospital handwashing
Handwashing using antibacterial soap may expose doctors, nurses and other hospital staffers to "significant and potentially unsafe levels of triclosan," a commonly used chemical that's under review by the U.S. Food and Drug Administration, according to a clinical study led by researchers at UC San Francisco. Triclosan, described by UCSF as a "synthetic antibacterial agent," is also found in thousands of consumer products, researchers said, including soaps, cosmetics, acne creams and some brands… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 19, 2014 Category: Biotechnology Authors: Chris Rauber Source Type: research

UCSF study: Hand-wringing over hospital handwashing
Handwashing using antibacterial soap may expose doctors, nurses and other hospital staffers to "significant and potentially unsafe levels of triclosan," a commonly used chemical that's under review by the U.S. Food and Drug Administration, according to a clinical study led by researchers at UC San Francisco. Triclosan, described by UCSF as a "synthetic antibacterial agent," is also found in thousands of consumer products, researchers said, including soaps, cosmetics, acne creams and some brands… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - August 19, 2014 Category: Hospital Management Authors: Chris Rauber Source Type: research

KC medical device company gets clearance for sales
Epic Medical Concepts & Innovations Inc., a medical device company based in Mission, has gained approval from the Food and Drug Administration to begin selling a product used in dental offices. The product, called the FlexiLume Dental LED System, combines all of the lighting equipment common in dentist exam rooms into one smaller, cheaper and more versatile product. "This is really a time saver and a cost saver for dental suites where they've got $20,000 or $30,000 worth of lighting in each chair,"… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 19, 2014 Category: Pharmaceuticals Authors: Brianne Pfannenstiel Source Type: research

Neuroadaptive changes in marijuana abusers [Neuroscience]
The current watershed in legal status and rising use of marijuana can be traced to a California ballot initiative (Prop. 215, its legal successor SB420), that enabled widespread access to smokeable or edible forms of marijuana for self-reported medical conditions. Circumventing the Food and Drug Administration (FDA) drug approval process,... (Source: Proceedings of the National Academy of Sciences)
Source: Proceedings of the National Academy of Sciences - August 19, 2014 Category: Science Authors: Madras, B. K. Tags: Commentaries Source Type: research

Development of onabotulinumtoxinA for chronic migraine
Discovery of the neuromuscular effects of botulinum toxin began in the early 19th century and has continued to evolve. Currently, onabotulinumtoxinA is approved by the U.S. Food and Drug Administration for two cosmetic and eight medical indications, including chronic migraine (CM). CM is a disabling form of migraine characterized by ≥15 headache days monthly and is believed to result from neuronal hypersensitivity to proinflammatory mediators, upregulation of sensory receptors, and consequent maladaptive pain responses with peripheral and central sensitization. OnabotulinumtoxinA achieves migraine prophylaxis in CM throu...
Source: Annals of the New York Academy of Sciences - August 18, 2014 Category: Science Authors: Scott M. Whitcup, Catherine C. Turkel, Ronald E. DeGryse, Mitchell F. Brin Tags: Original Article Source Type: research

Peca Labs submits testing data to FDA
An Etna-based medical device startup has submitted preliminary product testing data to the Food and Drug Administration in anticipation of winning marketing approval by late next year. Peca Labs is seeking FDA approval for a combined synthetic vessel and heart valve for children with congenital heart defects under the agency’s humanitarian device exemption. The designation is designed to speed life-saving medical devices to the market by streamlining the review process. Peca Labs was spun out… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 14, 2014 Category: Biotechnology Authors: Kris B. Mamula Source Type: research

Bedaquiline: A novel antitubercular drug for multidrug-resistant tuberculosis
H Nagabushan, HS RoopadeviJournal of Postgraduate Medicine 2014 60(3):300-302Multidrug-resistant and extensively drug-resistant tuberculosis (TB) are emerging global health threats. Bedaquiline is a new antituberculous drug belonging to the diarylquinoline class that efficiently inhibits the adenosine triphosphate synthase enzyme of Mycobacterium tuberculosis. It is a bactericidal and long-acting drug. It inhibits both dormant as well as replicating bacterial sub-populations and thus shortens the duration of TB treatment. This drug has been approved by the Food and Drug Administration in December 2012 for the management of...
Source: Journal of Postgraduate Medicine - August 14, 2014 Category: Internal Medicine Authors: H NagabushanHS Roopadevi Source Type: research

Advancing Regulatory Science to Bring Novel Medical Devices for Use in Emergency Care to Market: The Role of the FDA
This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. (Source: Annals of Emergency Medicine)
Source: Annals of Emergency Medicine - August 13, 2014 Category: Emergency Medicine Authors: Christopher G. Scully, Shawn Forrest, Loriano Galeotti, Suzanne B. Schwartz, David G. Strauss Source Type: research

Colgate defends toothpaste with ingredient banned by Minnesota
Colgate-Palmolive Co. is defending its Colgate Total toothpaste, which contains an antibacterial ingredient linked to cancer and banned by Minnesota lawmakers. Bloomberg obtained the previously unreleased Food and Drug Administration application Colgate filed 17 years ago when it sought approval for the toothpaste, which contains triclosan. The application summarized cancer studies and research showing fetal bone malformations in mice and rats, which is a signal that the chemical could disrupt… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 12, 2014 Category: Biotechnology Authors: Jim Hammerand Source Type: research

Biologic Therapy in Inflammatory Bowel Disease
By the time this issue of Gastroenterology Clinics of North America is released, it will have been 16 years since infliximab was approved by the US Food and Drug Administration for the treatment of moderate to severe Crohn disease. Not only have we come a long way in understanding the efficacy and safety of infliximab, we are beginning to understand how and when to use the drug. Furthermore, as of this writing, we have five other biologic agents approved for either Crohn disease or ulcerative colitis, and there are many more molecules currently in drug development for these indications. In this issue, we have assembled a c...
Source: Gastroenterology Clinics of North America - August 11, 2014 Category: Gastroenterology Authors: Edward V. Loftus Source Type: research

States push FDA for tougher e-cig regulations
Twenty-nine state attorneys general have sent a letter to the federal Food and Drug Administration, urging it to impose tougher restrictions on electronic cigarettes, or e-cigs. North Carolina AG Roy Cooper is not among the 29 who signed the letter. The restrictions the AGs are asking for would include banning television advertising and forbidding companies from offering fruit and candy flavored e-cigs, which the attorneys general believe target minors, according to a report by MarketWatch. Some… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 11, 2014 Category: Pharmaceuticals Source Type: research

Quantification of soy isoflavones and their conjugative metabolites in plasma and urine: an automated and validated UHPLC-MS/MS method for use in large-scale studies.
Abstract The biotransformation of isoflavones by gut microbiota and by drug metabolizing enzymes plays a crucial role in the understanding of their potential health-promoting effects. The purpose of our work was to develop a simultaneous, sensitive, and robust automated ultra high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) method to quantify the soy isoflavones daidzein and genistein, their conjugative metabolites, as well as their major microbial degradation products in order to provide a method for use in large clinical trials or animal studies. An automated, 96-well solid-phase extr...
Source: Analytical and Bioanalytical Chemistry - August 8, 2014 Category: Chemistry Authors: Soukup ST, Al-Maharik N, Botting N, Kulling SE Tags: Anal Bioanal Chem Source Type: research

Colorado to receive payout from Pfizer settlement
Colorado will receive nearly $650,000 as part of a 42-state settlement with pharmaceutical giant Pfizer Inc. for one of its subsidiary company’s off-label marketing and promotion of an immunosuppressive drug for conditions for which it did not have U.S. Food and Drug Administration approval. Wyeth Pharmaceuticals Inc. developed the drug Rapamune to prevent organ rejection after kidney transplant surgery. According to a complaint filed in federal court, however, the company also promoted it off-label… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 6, 2014 Category: American Health Authors: Ed Sealover Source Type: research

Culturally Tailored Smoking Cessation for Adult American Indian Smokers: A Clinical Trial
This collaborative, community-engaged project developed and tested a Culturally Tailored Treatment (CTT) for American Indian/Alaska Native (AI/AN) smokers in the Menominee tribal community. One hundred three adult AI/AN smokers were randomized to receive either Standard Treatment (ST; n = 53) or CTT (n = 50) for smoking cessation. Both treatment conditions included 12 weeks of varenicline and four individual counseling sessions but differed in terms of cultural tailoring of the counseling. The primary outcome was 7-day, biochemically confirmed point-prevalence abstinence (PPA) at the 6-month end-of-study visit. Both intent...
Source: The Counseling Psychologist - August 5, 2014 Category: Psychiatry & Psychology Authors: Smith, S. S., Rouse, L. M., Caskey, M., Fossum, J., Strickland, R., Culhane, J. K., Waukau, J. Tags: Regular Manuscripts Source Type: research

Dabigatran Use in the Real World: A Multihospital System Experience
Dabigatran etexilate, an oral direct thrombin inhibitor, was approved by the Food and Drug Administration to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation based on the outcomes of the Randomized Evaluation of Long-term anticoagulant therapY (RE-LY) study. Although this study provides robust data on the efficacy and safety of dabigatran, there may be differences in the drug use and outcomes in routine clinical practice following drug approval. In this retrospective chart review study, we describe the use of dabigatran in 160 patients in 4 adult hospitals (1 academic and 3 c...
Source: Journal of Pharmacy Practice - August 4, 2014 Category: Drugs & Pharmacology Authors: Kimmons, L. A., Kabra, R., Davis, M., Segars, B. V., Oliphant, C. S. Tags: Research Articles Source Type: research

Levomilnacipran (Fetzima): A New Serotonin-Norepinephrine Reuptake Inhibitor for the Treatment of Major Depressive Disorder
This article provides an overview of the mechanism of action, pharmacokinetic properties, clinical efficacy, safety, and tolerability of levomilnacipran ER. Relevant information was identified through a search of databases using the key word levomilnacipran. Additional information was obtained from fda.gov, by a review of the reference lists of identified articles, and from posters and abstracts from scientific meetings. Levomilnacipran ER, dosed once daily, is generally well tolerated and has demonstrated favorable effects compared to placebo in clinical trials of patients with major depressive disorder. The increased pot...
Source: Journal of Pharmacy Practice - August 4, 2014 Category: Drugs & Pharmacology Authors: Saraceni, M. M., Venci, J. V., Gandhi, M. A. Tags: Review Article Source Type: research

Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals [Prescription Drugs]
We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act’s passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients’ exposure to unsafe drugs, suc...
Source: Health Affairs - August 4, 2014 Category: Global & Universal Authors: Frank, C., Himmelstein, D. U., Woolhandler, S., Bor, D. H., Wolfe, S. M., Heymann, O., Zallman, L., Lasser, K. E. Tags: Access To Care, Legal/Regulatory Issues, Pharmaceuticals, Quality Of Care Prescription Drugs Source Type: research

New Therapeutic Targets in Idiopathic Pulmonary Fibrosis: Aiming to Rein in Runaway Wound Healing Responses.
Abstract Idiopathic pulmonary fibrosis (IPF) is a devastating disease, with a median survival as short as 3 years from the time of diagnosis, and no pharmacological therapies yet approved by the US Food and Drug Administration (FDA). To address the great unmet need for effective IPF therapy, a number of new drugs have recently been, or are now being, evaluated in clinical trials. The rationales for most of these therapeutic candidates are based on the current paradigm of IPF pathogenesis, in which recurrent injury to the alveolar epithelium is thought to drive aberrant wound healing responses, resulting in fibrosis...
Source: American Journal of Respiratory and Critical Care Medicine - August 4, 2014 Category: Respiratory Medicine Authors: Ahluwalia N, Shea BS, Tager AM Tags: Am J Respir Crit Care Med Source Type: research

Overview and Perspective of Proteasome Inhibitor-Based Anti-Cancer Therapies: Bortezomib and Second Generation Proteasome Inhibitors Versus Future Generation Inhibitors of Ubiquitin-Proteasome System.
Abstract Over the past ten years, proteasome inhibition has emerged as an effective therapeutic strategy for treating multiple myeloma (MM) and some lymphomas. In 2003, Bortezomib (BTZ) became the first proteasome inhibitor approved by the U.S. Food and Drug Administration (FDA). BTZ-based therapies have become a staple for the treatment of MM at all stages of the disease. The survival rate of the MM patients has improved significantly since clinical introduction of BTZ and other immunomodulatory drugs. However, BTZ has several limitations. Not all patients respond to BTZ-based therapies and relapse occurs in many ...
Source: Current Cancer Drug Targets - August 4, 2014 Category: Cancer & Oncology Authors: Dou QP, Zonder JA Tags: Curr Cancer Drug Targets Source Type: research

UPMC drops controversial surgical procedure
Western Pennsylvania’s dominant hospital network on Friday suspended using a controversial surgical procedure that has been linked to the spread of cancer in women. UPMC spokeswoman Gloria Kreps said doctors were notified of the policy change Friday afternoon. She said the decision was an "appropriate and prudent course of action" and the hospital giant was looking to the Food and Drug Administration for further guidance. She declined to elaborate. Simultaneously, health insurance giant Highmark… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 3, 2014 Category: Biotechnology Authors: Kris B. Mamula Source Type: research

UPMC drops controversial surgical procedure
Western Pennsylvania’s dominant hospital network on Friday suspended using a controversial surgical procedure that has been linked to the spread of cancer in women. UPMC spokeswoman Gloria Kreps said doctors were notified of the policy change Friday afternoon. She said the decision was an "appropriate and prudent course of action" and the hospital giant was looking to the Food and Drug Administration for further guidance. She declined to elaborate. Simultaneously, health insurance giant Highmark… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 2, 2014 Category: Pharmaceuticals Authors: Kris B. Mamula Source Type: research

Epigenetic drugs against cancer: an evolving landscape.
Abstract Alteration of the chromatin orchestra seems to play a critical role in cancer. In recent years, in-depth studies of epigenetic machinery and its deregulation have led to the development and use of a wide range of modulatory molecules directed not only at chromatin enzymes (histone acetyltransferases, histone deacetylases, histone methyltransferases, histone demethylases and DNA methyltransferases) but also toward the emerging class of chromatin-associated proteins, so-called "histone readers." Chromatin modifiers are attractive therapeutic targets for the development of new cancer therapies. Many are curre...
Source: Archives of Toxicology - August 2, 2014 Category: Toxicology Authors: Di Costanzo A, Del Gaudio N, Migliaccio A, Altucci L Tags: Arch Toxicol Source Type: research

N.C. docs recommend e-cigs to stop smoking despite lack of info on them
Despite knowing little about their safety, North Carolina doctors are increasingly recommending e-cigarettes as a way to stop smoking, according to research from UNC-Chapel Hill. Electronic cigarettes still make up a fraction of the overall tobacco industry, though that market is growing. However, scientists know little about their safety because they have not been approved or recommended by the U.S. Food and Drug Administration or various other medical organizations. Still, as many as one-third… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 1, 2014 Category: Biotechnology Authors: Jason deBruyn Source Type: research

FDA approvals for the first 6 months of 2014
Nature Reviews Drug Discovery 13, 565 (2014). doi:10.1038/nrd4409 The US Food and Drug Administration (FDA) approved 17 new drugs before the end of June.The lowdown: The FDA's Center for Drug Evaluation and Research (CDER) is on track for another solid year, with 17 approvals in the first 6 months of 2014 (Source: Nature Reviews Drug Discovery)
Source: Nature Reviews Drug Discovery - August 1, 2014 Category: Drugs & Pharmacology Tags: News and Analysis Source Type: research

Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection
Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at increased risk of severe disease. Since that time, the American Academy of Pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection. The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation...
Source: PEDIATRICS - August 1, 2014 Category: Pediatrics Authors: COMMITTEE ON INFECTIOUS DISEASES AND BRONCHIOLITIS GUIDELINES COMMITTEE Tags: From the American Academy of Pediatrics Source Type: research

Botulinum toxin injection for facial wrinkles.
Abstract Botulinum toxin injection for treatment of facial wrinkles is the most frequently performed cosmetic procedure in the United States, and it is one of the most common entry procedures for clinicians seeking to incorporate aesthetic treatments into their practice. Treatment of frown lines and crow's feet, which are the cosmetic indications approved by the U.S. Food and Drug Administration, and horizontal forehead lines, offers predictable results, has few adverse effects, and is associated with high patient satisfaction. Wrinkles are formed by dermal atrophy and repetitive contraction of underlying facial mu...
Source: American Family Physician - August 1, 2014 Category: Primary Care Authors: Small R Tags: Am Fam Physician Source Type: research

Little filtered cigar, cigarillo, and premium cigar smoking among adults - United States, 2012-2013.
This report expands upon those findings, using data from the 2012-2013 NATS to further characterize cigar smokers by the usual type of cigar smoked using the following categories: little filtered cigars (LFCs), cigarillos/other mass market cigars (cigarillos/MMCs), and premium cigars. The findings indicate that among U.S. adults who smoke cigars, 61.8% usually smoke cigarillos/MMCs, 19.9% usually smoke premium cigars, and the remainder, 18.4%, usually smoke LFCs. These data can help to inform public health interventions to reduce the burden of adverse health effects caused by cigar smoking in the United States, including r...
Source: MMWR Morb Mortal Wkl... - August 1, 2014 Category: Epidemiology Authors: Corey CG, King BA, Coleman BN, Delnevo CD, Husten CG, Ambrose BK, Apelberg BJ, Center for Tobacco Products, Food and Drug Administration Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Race against the clock: Overcoming challenges in the management of anticoagulant-associated intracerebral hemorrhage.
Abstract Patients receiving anticoagulation therapy who present with any type of intracranial hemorrhage-including subdural hematoma, epidural hematoma, subarachnoid hemorrhage, and intracerebral hemorrhage (ICH)-require urgent correction of their coagulopathy to prevent hemorrhage expansion, limit tissue damage, and facilitate surgical intervention as necessary. The focus of this review is acute ICH, but the principles of management for anticoagulation-associated ICH (AAICH) apply to patients with all types of intracranial hemorrhage, whether acute or chronic. A number of therapies-including fresh frozen plasma (F...
Source: Journal of Neurosurgery - August 1, 2014 Category: Neurosurgery Authors: Le Roux P, Pollack CV, Milan M, Schaefer A Tags: J Neurosurg Source Type: research

New Developments in the Treatment of Pediatric Allergic Rhinitis and Conjunctivitis.
Abstract The primary care physician is the first line of treatment for allergic rhinitis, which affects approximately one-fourth of children in the United States. There is an increasing trend toward self-management by patients or parents due to high-deductible insurance plans and the over-the-counter availability of allergy medications. The primary care physician can offer guidance on appropriate selection of medications and potential adverse effects. Vitamin D deficiency has been proposed as a potential contributing factor in patients with allergic diseases, and studies are underway to determine whether supplement...
Source: Pediatric Annals - August 1, 2014 Category: Pediatrics Authors: Lierl MB Tags: Pediatr Ann Source Type: research

Consequences of feedback in signal transduction for targeted therapies.
Abstract Over the last two decades, many small-molecule inhibitors that target kinase signalling have been developed. More than 20 of these inhibitors are FDA (U.S. Food and Drug Administration)-approved and are now being used in the clinics to treat tumours; even more have entered clinical trials. However, resistance to these inhibitors, either intrinsic to the tumour or acquired during treatment, remains a major problem in targeted therapeutics. One of the mechanisms by which tumours become resistant is the rewiring of the signalling networks via feedback, by which the tumour cells re-activate signalling or activ...
Source: Biochemical Society Transactions - August 1, 2014 Category: Biochemistry Authors: Klinger B, Blüthgen N Tags: Biochem Soc Trans Source Type: research

Why regenerative stem cell medicine progresses slower than expected
Stem cell research has been acclaimed to revolutionize the future of medicine, and to offer new treatments for previously incurable diseases. Despite years of research, however, the therapeutic potential of stem cell research has not yet been fully realized. By June 2014 the US Food and Drug Administration had approved only five stem cell‐based medicinal products, all of which cord blood derived hematopoietic stem cell products for the cure of blood and immunological diseases. © 2014 Wiley Periodicals, Inc. (Source: Journal of Cellular Biochemistry)
Source: Journal of Cellular Biochemistry - July 31, 2014 Category: Biochemistry Authors: Achim Rosemann Tags: View Points Source Type: research

Robustness and Evolvability of the Human Signaling Network
by Junil Kim, Drieke Vandamme, Jeong-Rae Kim, Amaya Garcia Munoz, Walter Kolch, Kwang-Hyun Cho Biological systems are known to be both robust and evolvable to internal and external perturbations, but what causes these apparently contradictory properties? We used Boolean network modeling and attractor landscape analysis to investigate the evolvability and robustness of the human signaling network. Our results show that the human signaling network can be divided into an evolvable core where perturbations change the attractor landscape in state space, and a robust neighbor where perturbations have no effect on the attractor ...
Source: PLoS Computational Biology - July 31, 2014 Category: Biology Authors: Junil Kim et al. Source Type: research

Impax manufacturing problems haunt Parkinson's drug, generics
Manufacturing problems continue to haunt Impax Laboratories Inc.'s experimental Parkinson's Disease treatment, raising concerns about the company's pending drug approvals, pushing the stock sharply lower this week and releasing the securities law vultures. A Food and Drug Administration inspection turned up 10 violations at the Hayward-based company's (NASDAQ: IPXL) Taiwan manufacturing facility. That plant became the primary maker of the Parkinson's drug, called Rytary, after manufacturing concerns… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 30, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research