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Federal judge slaps down Massachusetts governor's bid to block Zohydro
A federal judge today struck down Gov. Deval Patrick's administration's ban on the sale of the powerful painkiller Zohydro ER in Massachusetts. In granting a request for an emergency order preventing the state from blocking sales of Zohydro ER, Judge Rya Zobel ruled that federal law governing the sale of prescription drugs pre-empts state law, so a drug that has been approved by the federal Food and Drug Administration can't be pushed from the marketplace by the Commonwealth of Massachusetts. In… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 15, 2014 Category: Biotechnology Authors: Eric Convey Source Type: research

Federal judge slaps down Massachusetts governor's bid to block Zohydro
A federal judge today struck down Gov. Deval Patrick's administration's ban on the sale of the powerful painkiller Zohydro ER in Massachusetts. In granting a request for an emergency order preventing the state from blocking sales of Zohydro ER, U.S. District Court Judge Rya Zobel ruled that federal law governing the sale of prescription drugs pre-empts state law, so a drug that has been approved by the federal Food and Drug Administration can't be pushed from the marketplace by the Commonwealth… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - April 15, 2014 Category: Hospital Management Authors: Eric Convey Source Type: research

Nothing to sneeze at: Merck hay fever drug approved
The Food and Drug Administration has granted marketing approval for Grastek, a drug developed by Merck & Co. Inc. to treat people with grass allergies. More than 40 million people in the United States suffer from allergies, according to the American College of Allergy, Asthma and Immunology. (The organization could not provide stats on grass allergies.) The Merck drug, taken in tablet form, will provide an alternative to allergy shots for some patients suffering from grass allergies, also known… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 15, 2014 Category: American Health Authors: John George Source Type: research

Congressional report says e-cigarette industry should be regulated
A Congressional report issued Monday recommends that the electronic cigarette industry be regulated. In 2009, the U.S. Food and Drug Administration was given authority to regulate e-cigarettes but has yet to do so. The fast-growing industry has led to concerns that there are no age restrictions or warning labels for the cigarettes, which create a nicotine vapor that is inhaled. The report was authored by the staff of Illinois Sen. Dick Durbin, California Rep. Henry Waxman and others, according… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 15, 2014 Category: Biotechnology Authors: Rebecca Troyer Source Type: research

Oregon brewers: Composting rules would cost the beer industry millions
An Oregon senator asked the U.S. Food and Drug Administration today to tweak a proposed rule on brewery byproducts that include livestock feed. Wyden, in a letter to USDA Commissioner Margaret Hamburg, said the spent grain rule as currently written “would be onerous, costly and even wasteful” and urged her to adjust it in favor of something more workable for both brewers and farmers while protecting public health. “After the brewing process the remaining materials, commonly known as spent… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 14, 2014 Category: Biotechnology Authors: Andy Giegerich Source Type: research

Oregon brewers: Composting rules would cost the beer industry millions
An Oregon senator asked the U.S. Food and Drug Administration today to tweak a proposed rule on brewery byproducts that include livestock feed. Wyden, in a letter to USDA Commissioner Margaret Hamburg, said the spent grain rule as currently written “would be onerous, costly and even wasteful” and urged her to adjust it in favor of something more workable for both brewers and farmers while protecting public health. “After the brewing process the remaining materials, commonly known as spent… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - April 14, 2014 Category: Hospital Management Authors: Andy Giegerich Source Type: research

GE Healthcare gains FDA approval for new CT system
GE Healthcare, which spent hundreds of millions of dollars at its Waukesha and West Milwaukee operations developing a next-generation computed tomography (CT) unit, said Monday it received clearance from the U.S. Food and Drug Administration to begin marketing the device. GE Healthcare calls its latest product “Revolution,” which the company says tackles the challenges of getting images of patients who have a high heart rate, have metallic implants or are otherwise “non-compliant.” I wrote… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 14, 2014 Category: American Health Authors: Rich Kirchen Source Type: research

Longitudinal study of long-term smoking behaviour by biomarker-supported determination of exposure to smoke
DiscussionThe planned study is anticipated to contribute to understanding smokers' behaviours and their consequent exposure to smoke constituents. It will also allow assessment of compensatory changes in their behaviour following spontaneous switching of cigarette product smoked. Data from this study are expected to provide insights into study design and conduct for non-clinical assessment of smokers' exposure as part of post marketing surveillance programmes.Trial registration: Current Controlled Trials Database reference ISRCTN95019245. (Source: BioMed Central)
Source: BioMed Central - April 12, 2014 Category: Journals (General) Authors: Anthony CunninghamJohan SommarströmAjit S SisodiyaGraham ErringtonKrishna Prasad Source Type: research

Overcautious FDA has lost its way
Five years after the passage of the Family Smoking Prevention and Tobacco Control Act, little progress has been made in the effort to regulate the US tobacco industry and advance the public health goals of tobacco control. Legal challenges by the tobacco industry, and evidence of political interference from the White House have resulted in the US Food and Drug Administration's (FDA) overcautious approach toward advancing a meaningful regulatory agenda. While the White House bears final responsibility, it is incumbent upon the FDA and its Center for Tobacco Products to become more aggressive and seize the extraordinary oppo...
Source: Tobacco Control - April 12, 2014 Category: Respiratory Medicine Authors: Gottlieb, M. Tags: Editorial Source Type: research

Chronic myeloid leukemia: 2014 update on diagnosis, monitoring, and management
Disease overview: Chronic Myeloid Leukemia (CML) is a myeloproliferative neoplasm with an incidence of 1–2 cases per 100,000 adults, and accounts for ∼15% of newly diagnosed cases of leukemia in adults. Diagnosis: CML is characterized by a balanced genetic translocation, t(9;22)(q34;q11.2), involving a fusion of the Abelson oncogene (ABL) from chromosome 9q34 with the breakpoint cluster region (BCR) gene on chromosome 22q11.2. This rearrangement is known as the Philadelphia chromosome. The molecular consequence of this translocation is the generation of a BCR‐ABL fusion oncogene, which in turn translates into a Bcr...
Source: American Journal of Hematology - April 12, 2014 Category: Hematology Authors: Elias Jabbour, Hagop Kantarjian Tags: Annual Clinical Updates in Hematological Malignancies Source Type: research

A regulatory perspective on the abuse potential evaluation of novel stimulant drugs in the United States.
This article is part of a special issue 'CNS Stimulants'. PMID: 24727212 [PubMed - as supplied by publisher] (Source: Neuropharmacology)
Source: Neuropharmacology - April 12, 2014 Category: Drugs & Pharmacology Authors: Calderon SN, Klein M Tags: Neuropharmacology Source Type: research

Medical device firm Baxano receives FDA clearance on surgical screw
Raleigh medical device company Baxano Surgical, Inc. received clearance for its Avance MIS Pedicle Screw System, meaning it may now work towards a commercial launch of the product. Receiving clearance from the U.S. Food and Drug Administration is sort of the regulatory finish line for medical device companies like Baxano (Nasdaq:BAXS). These kinds of companies can spend years putting together an application package to prove to the FDA that their product is safe and effective. This screw will be… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 10, 2014 Category: Biotechnology Authors: Jason deBruyn Source Type: research

A phase 1 clinical trial of long-term, low-dose treatment of WHIM syndrome with the CXCR4 antagonist plerixafor
Warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome is a rare immunodeficiency disorder caused by gain-of-function mutations in the G protein–coupled chemokine receptor CXCR4. The CXCR4 antagonist plerixafor, which is approved by the US Food and Drug Administration (FDA) for stem cell mobilization in cancer and administered for that indication at 0.24 mg/kg, has been shown in short-term (1- to 2-week) phase 1 dose-escalation studies to correct neutropenia and other cytopenias in WHIM syndrome. However, long-term safety and long-term hematologic and clinical efficacy data are lacking. Here we r...
Source: Blood - April 10, 2014 Category: Hematology Authors: McDermott, D. H., Liu, Q., Velez, D., Lopez, L., Anaya-O'Brien, S., Ulrick, J., Kwatemaa, N., Starling, J., Fleisher, T. A., Priel, D. A. L., Merideth, M. A., Giuntoli, R. L., Evbuomwan, M. O., Littel, P., Marquesen, M. M., Hilligoss, D., DeCastro, R., Gr Tags: Free Research Articles, Phagocytes, Granulocytes, and Myelopoiesis, Clinical Trials and Observations Source Type: research

Inhibiting Glycogen Synthase Kinase-3 Mitigates the Hematopoietic Acute Radiation Syndrome in Mice.
In this study, we performed anin vitroscreen using irradiated bone marrow mononuclear cells (BM-MNCs) to test the effects of four GSK-3 inhibitors: CHIR99021; 6-Bromoindirubin-3'-oxime (BIO); SB415286; and SB216763. This screen showed that SB216763 significantly increased the frequency of c-Kit(+) Lin(-) Sca1(+) (KLS) cells and hematopoietic colony-forming cells in irradiated BM-MNCs. Importantly, administration of a single dose of SB216763 to C57BL/6J mice by subcutaneous injection 24 h after total-body irradiation significantly improved hematopoietic recovery and mitigated hematopoietic ARS. Collectively, our results dem...
Source: Radiation Research - April 10, 2014 Category: Physics Authors: Lee CL, Lento WE, Castle KD, Chao NJ, Kirsch DG Tags: Radiat Res Source Type: research

Remote monitoring of the progression of primary pneumonic plague in Brown Norway rats in high‐capacity, high‐containment housing
This article is protected by copyright. All rights reserved. (Source: FEMS Immunology and Medical Microbiology)
Source: FEMS Immunology and Medical Microbiology - April 9, 2014 Category: Microbiology Authors: Eric A. Coate, Andrew G. Kocsis, Kristen N. Peters, Paul E. Anderson, Mark R. Ellersieck, Deborah M. Fine, Deborah M. Anderson Tags: Research Paper Source Type: research

Patients, investors react to Genzyme’s retry for approval of MS drug Lemtrada
While yesterday’s news that Genzyme plans to resubmit an application for its previously-rejected multiple sclerosis drug couldn't have come too soon for patients, it came a little late for some investors. Melissa Burdick, a 49-year-old patient from Waterford, Conn., said she was “thrilled” to hear the news. Burdick testified before the U.S. Food and Drug Administration in favor of the once-a-year drug, called Lemtrada, last year, and said in an interview Tuesday morning that she plans to do… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - April 8, 2014 Category: Pharmaceuticals Authors: Don Seiffert Source Type: research

A survey of breakthrough therapy designations
Nature Biotechnology 32, 323 (2014). doi:10.1038/nbt.2864 Author: Saurabh (Rob) Aggarwal As of last month, 41 products have been granted breakthrough therapy designations by the US Food and Drug Administration—drugs against cancer, hepatitis C and monogenetic diseases predominate. (Source: Nature Biotechnology)
Source: Nature Biotechnology - April 8, 2014 Category: Biotechnology Authors: Saurabh (Rob) Aggarwal Tags: Feature Source Type: research

Genzyme to resubmit application for multiple sclerosis drug, Lemtrada, to FDA
Genzyme announced today it plans to submit its once-a-year drug, which is approved outside the U.S. for multiple sclerosis, to U.S. regulators after it was rejected in December. The Cambridge biotech’s drug, named Lemtrada, was turned down by the U.S. Food and Drug Administration on Dec. 27 due to disagreements over the design of the trial. While the FDA does not comment on rejected drugs, Genzyme said the rejection was in part because the trials of 1,600 patients compared Lemtrada to EMD Serono’s… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - April 7, 2014 Category: Hospital Management Authors: Don Seiffert Source Type: research

The current issues on development and clinical use of companion diagnostics and prospects of personalized medicine for the future.
Abstract   Recently companion diagnostics (CoDx) have been getting more importance to promote personalized medicine which can improve not only the efficacy and safety of treatments but also increase the cost-effectiveness of medication. In July 2011, the U.S. Food and Drug Administration (FDA) notified the draft guidance for development of CoDx that recommends co-development of CoDx and a new drug as the best practice. The Ministry of Health, Labour and Welfare in Japan also issued on July 1, 2013, their official notification regarding considerable items on co-development of CoDx if the drug needs its dedicate di...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 6, 2014 Category: Drugs & Pharmacology Authors: Tazawa Y Tags: Yakugaku Zasshi Source Type: research

Rethinking the Food and Drug Administration's 2013 guidance on developing drugs for early-stage Alzheimer's disease.
Authors: Schneider LS Abstract The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical...
Source: The Journal of Alzheimers Association - April 6, 2014 Category: Psychiatry Tags: Alzheimers Dement Source Type: research

Comments on: Are Food and Drug Administration prescription drug safety plans working? A case study of isotretinoin
(Source: Pharmacoepidemiology and Drug Safety)
Source: Pharmacoepidemiology and Drug Safety - April 5, 2014 Category: Drugs & Pharmacology Authors: Carla M. Van Bennekom, Allen A. Mitchell Tags: Letter to the Editor Source Type: research

Chapel Hill's Pozen anticipates FDA ruling on two drugs this month
Chapel Hill drug developer Pozen submitted an additional study to the FDA and says it is on track to hear a ruling on two drug applications by the April 25 deadline. These applications have had a bit of a bumpy road. Pozen (Nasdaq: POZN) first filed a new drug application with the Food and Drug Administration for two products in March, 2013, and in May the FDA accepted the application, initially saying it would decide on the drugs by Jan. 24. After discussions with the FDA, however, Pozen said… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 4, 2014 Category: American Health Authors: Jason deBruyn Source Type: research

Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings
This study investigated the utilisation patterns of rosiglitazone and pioglitazone in Australia before and after warnings of major drug authorities. Methods: We evaluated rosiglitazone and pioglitazone dispensing using the Pharmaceutical Benefit Scheme (PBS) subsidised drug dispensing data for the Australian population from February 2004 to July 2012. The World Health Organisation Anatomic Therapeutic Chemical (ATC)/Defined Daily Dose (DDD) system was used to compare the drug utilisation patterns following the announcements of EMA, FDA, and TGA safety warnings, which first occurred in May 2007. The DDD/1000population/day w...
Source: BMC Health Services Research - April 4, 2014 Category: Journals (General) Authors: Suvimol NiyomnaithamAndrew PageAdam La CazeKaren WhitfieldAlesha Smith Source Type: research

Response to: 'When is it not ethical to withhold treatment for rheumatoid arthritis?' by Dr Yusuf Yazici
The ethical consideration in placebo-controlled studies of antirheumatic drugs is of primary importance. We thank Dr Yazici1 for his questions regarding the ethical aspect of our study.2 The GO-MONO study was designed to have placebo crossover to methotrexate (MTX) at week 16, as a Registration Study to Japan Health Authority, following the MHLW Guideline for the Clinical Study and Evaluation of Drugs for Rheumatoid Arthritis (RA), which is similar to the US Food and Drug Administration's Guidance for Industry RA.3 The US guidance recommends sponsors to limit the use of placebo as a control and consider the use of an activ...
Source: Annals of the Rheumatic Diseases - April 4, 2014 Category: Rheumatology Authors: Takeuchi, T. Tags: Electronic pages Source Type: research

Notes from the field: multistate outbreak of listeriosis linked to soft-ripened cheese - United States, 2013.
Abstract On June 27, 2013, the Minnesota Department of Health notified CDC of two patients with invasive Listeria monocytogenes infections (listeriosis) whose clinical isolates had indistinguishable pulsed-field gel electrophoresis (PFGE) patterns. A query of PulseNet, the national molecular subtyping network for foodborne disease surveillance, identified clinical and environmental isolates from other states. On June 28, CDC learned from the Food and Drug Administration's Coordinated Outbreak Response and Evaluation Network that environmental isolates indistinguishable from those of the two patients had been collec...
Source: MMWR Morb Mortal Wkl... - April 4, 2014 Category: Epidemiology Authors: Choi MJ, Jackson KA, Medu C, Beal J, Rigdon CE, Cloyd TC, Forstner MJ, Ball J, Bosch S, Bottichio L, Cantu V, Melka DC, Ishow W, Slette S, Melka DC, Irvin K, Melka DC, Wise M, Tarr C, Mahon B, Smith KE, Silk BJ, Minnesota Department of Health Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Notes from the field: calls to poison centers for exposures to electronic cigarettes - United States, september 2010-february 2014.
Abstract Electronic nicotine delivery devices such as electronic cigarettes (e-cigarettes) are battery-powered devices that deliver nicotine, flavorings (e.g., fruit, mint, and chocolate), and other chemicals via an inhaled aerosol. E-cigarettes that are marketed without a therapeutic claim by the product manufacturer are currently not regulated by the Food and Drug Administration (FDA) . In many states, there are no restrictions on the sale of e-cigarettes to minors. Although e-cigarette use is increasing among U.S. adolescents and adults, its overall impact on public health remains unclear. One area of concern is...
Source: MMWR Morb Mortal Wkl... - April 4, 2014 Category: Epidemiology Authors: Chatham-Stephens K, Law R, Taylor E, Melstrom P, Bunnell R, Wang B, Apelberg B, Schier JG, EIS officer, CDC Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Establishment, maintenance, and availability of records: amendment to record availability requirements. Final rule.
Abstract The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled "Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.'' This final rule affirms the IFR's change to FDA's records access as required by the FDA Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the Secretary (by delegation FDA) with access to records relating to food that FDA reasonably believes to be adulterated and presents a threat of...
Source: Fed Regist - April 4, 2014 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Autophagic Response to HP{beta}CD Treatment [Molecular Bases of Disease]
This study provides a mechanistic understanding of the cellular response to HPβCD treatment, which will inform the development of safe HPβCD-based therapeutic modalities and may enable engineering HPβCD as a platform technology to reduce the accumulation of lysosomal storage material. (Source: Journal of Biological Chemistry)
Source: Journal of Biological Chemistry - April 3, 2014 Category: Chemistry Authors: Song, W., Wang, F., Lotfi, P., Sardiello, M., Segatori, L. Tags: Cell Biology Source Type: research

FDA to speed up approval process for Tetraphase’s antibiotic
A sign that U.S. regulators are serious about bringing new antibiotics to market quickly came today when Watertown-based Tetraphase Pharmaceuticals said the U.S. Food and Drug Administration has given fast track designation to its most advanced potential drug. The designation affords more frequent communication with the agency in the months leading up to an application for approval for Tetraphase’s drug, eravacycline. It also cuts the time the FDA gives itself to review that application to seven… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 2, 2014 Category: American Health Authors: Don Seiffert Source Type: research

Scioderm close to fully developing new treatment for connective tissue disorder
Durham drug developer Scioderm completed enrollment in a Phase 2b clinical trial, keeping it on track to develop a treatment for Epidermolysis Bullosa. Company CEO Robert Ryan already said he expects the results from the trial “to be quite good,” and Scioderm could put together a new drug application to submit to the U.S. Food and Drug Administration by later this year. Epidermolysis Bullosa is a genetic connective tissue disorder that manifests itself in infants and children and affects the… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 2, 2014 Category: Biotechnology Authors: Jason deBruyn Source Type: research

Intuitive stock price surges 11% after FDA approves surgical robot
Intuitive Surgical's stock shot up more than 11.5 percent early this afternoon after the company received U.S. Food and Drug Administration clearance for the new model of its da Vinci surgical robot,  according to the Wall Street Journal. The machine allows surgeons to operate robotic surgical arms to perform minimally invasive procedures like prostate surgeries from a computer console. The Sunnyvale-based company, currently expanding at its 1266 Kifer Road headquarters, said that the new… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - April 1, 2014 Category: Pharmaceuticals Authors: Eric Van Susteren Source Type: research

Blastic plasmacytoid dendritic cell neoplasm: the first report of two cases treated by 5‐Azacytidine
Abstract Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare hematologic malignancy which was first included as an independent cutaneous lymphoma in the 2008 World Health Organisation (WHO) classification (1). BPDCN usually has an extremely poor prognosis, with quick relapses after chemotherapy (2; 3). Here, we report two cases of patients diagnosed in 2011 with BPDCN and myelodysplasia, and who were treated for the first time with 5‐azacytidine (5‐Aza); a drug approved by the Food and Drug Administration (FDA) and mainly used in the treatment of myelodysplastic syndrome (Kaminskas E, et al. 2005 Clin Cance...
Source: European Journal of Haematology - April 1, 2014 Category: Hematology Authors: Kamel Laribi, Nathalie Denizon, Habib Ghnaya, Mustapha Atlassi, Anne Besançon, Fabienne Pineau‐Vincent, Philippe Gaulard, Tony Petrella Tags: Case Report Source Type: research

Intralesional collagenase in the treatment of Peyronie's disease.
The objective of intralesional pharmacotherapy in the treatment of Peyronie's disease is to deliver large doses of pharmacologic agents that can have a local effect on wound remodeling, with minimal side effects. Guidelines for the treatment of peyronie's disease published in the Journal of Sexual Medicine and the European Association of Urology offer no grade A evidence of efficacy with multiple agents such as steroids, verapamil and interferon. Intralesional collagenase is the first drug to be approved by the United States Food and Drug Administration for the treatment of Peyronie's disease. This is based on grade A evid...
Source: Adv Data - April 1, 2014 Category: Epidemiology Authors: Honig SC Tags: Ther Adv Urol Source Type: research

A systematic review of acute pancreatitis as an adverse event of type 2 diabetes drugs.
Summary The question whether antidiabetes drugs can cause acute pancreatitis dates back to the 1970s. Recently, old concerns have reemerged following claims that use of incretins, a new class of drugs for type 2 diabetes, might increase the relative risk of acute pancreatitis up to 30‐fold. Given that diabetes is per se a potent risk factor for acute pancreatitis and that drug‐related acute pancreatitis is rare and difficult to diagnose, we searched the medical databases for information linking acute pancreatitis and type 2 diabetes drugs. Among the biguanides, both phenformin and metformin (the latter in patients with...
Source: Diabetes, Obesity and Metabolism - April 1, 2014 Category: Endocrinology Authors: Carlo B. Giorda, Elisa Nada, Barbara Tartaglino, Lisa Marafetti, Roberto Gnavi Tags: REVIEW ARTICLE Source Type: research

An update on emergency contraception.
Abstract Emergency contraception decreases the risk of unintended pregnancy after unprotected sexual intercourse or after suspected failure of routine contraception (e.g., a condom breaking). Oral methods include combined contraceptive pills (i.e., Yuzpe method), single- or split-dose levonorgestrel, and ulipristal. The Yuzpe method and levonorgestrel are U.S. Food and Drug Administration-approved for use 72 hours postcoitus, whereas the newest method, ulipristal, is approved for up to 120 hours postcoitus. The copper intrauterine device may be used as emergency contraception up to seven days after unprotected inte...
Source: American Family Physician - April 1, 2014 Category: Primary Care Authors: Bosworth MC, Olusola PL, Low SB Tags: Am Fam Physician Source Type: research

A Pharmacogenetic versus a Clinical Algorithm for Warfarin Dosing: Kimmel SE, French B, Kasner SE, et al. N Engl J Med 2013;369:2283–93.
Several observational studies and small clinical trials have suggested an association between the use of genetic algorithms and improved outcomes in the dosing of warfarin. In fact, based on the available data, the Food and Drug Administration has updated the label for warfarin twice, suggesting that certain genetic variants may be taken into account when choosing initial warfarin dosing. However, the Centers for Medicare and Medicaid Services have not found sufficient evidence to cover the cost of genotyping for warfarin dosing. This paper reported data from the Clarification of Optimal Anticoagulation through Genetics st...
Source: The Journal of Emergency Medicine - March 31, 2014 Category: Emergency Medicine Authors: W. Gannon Sungar Tags: Abstracts Source Type: research

Reply
We would like to thank Dr Panasoff for his comment on our report of the EXACT trial (NCT00096954) of omalizumab, which studied patients with atopic asthma with preserved pulmonary function who remained symptomatic on inhaled corticosteroids with or without other controller medications. To clarify, this study was done as a postmarketing commitment from the US Food and Drug Administration in which we were to evaluate patients with atopic asthma and normal lung function. Atopic asthma was not determined solely based on serum IgE levels; patients also had to have positive skin test responses or in vitro (RAST or ImmunoCAP) ...
Source: Journal of Allergy and Clinical Immunology - March 31, 2014 Category: Allergy & Immunology Authors: Karin Rosén, William Busse Tags: Correspondence Source Type: research

FDA panel votes in favor of approval for Cubist's new MRSA drug
An advisory committee to the U.S. Food and Drug Administration voted unanimously in favor of approval for the newest antibiotic by Cubist Pharmaceuticals, according to a spokeswoman for the company. The vote this morning on tedizolid — which is planned to be marketed under the name Sivextro in the U.S. — followed a presentation from representatives of the company at the FDA’s headquarters in Silver Springs, Md. A decision by the full FDA is expected by the end of June. While the committee’s… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - March 31, 2014 Category: Hospital Management Authors: Don Seiffert Source Type: research

New pediatric information added to labels of 27 gastroenterology drugs [FDA UPDATE]
(Source: AAP News)
Source: AAP News - March 31, 2014 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Pediatric & Maternal Health Staff, Division of Gastrointestinal and Inborn Errors Products Tags: Gastroenterology, FDA Update Source Type: research

Statin use and incident dementia: A nationwide cohort study of Taiwan
Abstract: Background: Statins are widely used in clinical treatment. However, an U.S. Food and Drug Administration issued health alert has raised concerns for the adverse effects of statin-associated confusion and memory loss in the elderly people. It is necessary to clarify the relationship between statin use and risk of incident dementia as well as whether class effects exist.Methods: In this population-based retrospective cohort study, total 33,398 patients aged≥60years were selected from a subset of the Taiwan National Health Insurance Research Databases and followed up for tracking the occurrence of any type of deme...
Source: International Journal of Cardiology - March 31, 2014 Category: Cardiology Authors: Chian-Ying Chou, Yueh-Ching Chou, Yiing-Jenq Chou, Yi-Fan Yang, Nicole Huang Tags: Original Articles Source Type: research

Medical device recalls soar
A new U.S. Food and Drug Administration report shows medical device recalls have almost doubled in the past 10 years. The most common reason for recalls in that period was device and software design failure, which accounted for 36 percent of the total, according the USDA Center for Device and Radiological Health  recall report for fiscal year 2003 to fiscal year 2012. The number of recalls increased from 604 in FY 2003 to 1,190 in 2012. Faulty material or components resulted in 26 percent of the… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - March 28, 2014 Category: Hospital Management Authors: Jane Meinhardt Source Type: research

AirStrip buys wireless heart monitoring technology from Sense4Baby
AirStrip Technologies has bought the assets of Sense4Baby Inc., a developer of wireless fetal/maternal monitoring system for high-risk pregnancies. Financial terms were not disclosed. San Antonio-based AirStrip licensed the associated technology from the Gary and Mary West Health Institute. Sense4Baby already received clearances from the Food and Drug Administration and the European Union to market the device in clinical settings. The acquisition will allow women to undergo non-stress testings… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - March 28, 2014 Category: Hospital Management Authors: James Aldridge Source Type: research

[Tumor cells in the peripheral blood of patients with urothelial carcinoma of the bladder : Detection and impact of circulating.]
Abstract Circulating tumor cells (CTC) play a crucial role in the natural history of several malignancies and, thus, are the subject of intense research efforts. This review summarizes the most contemporary literature data regarding detection of CTC and their impact on the oncological prognosis of patients with urothelial carcinoma of the bladder (UCB). Despite the availability of different methods for CTC detection and isolation in the peripheral blood, the standardized and Food and Drug Administration-approved CellSearch® assay is currently the most commonly used system for CTC detection. The majority of studies...
Source: Der Urologe. Ausg. A - March 28, 2014 Category: Urology & Nephrology Authors: Rink M, Soave A, Engel O, Fisch M, Riethdorf S, Pantel K Tags: Urologe A Source Type: research

State medicaid coverage for tobacco cessation treatments and barriers to coverage - United States, 2008-2014.
Abstract Medicaid enrollees have a higher smoking prevalence than the general population (30.1% of adult Medicaid enrollees aged <65 years smoke, compared with 18.1% of U.S. adults of all ages), and smoking-related disease is a major contributor to increasing Medicaid costs. Evidence-based cessation treatments exist, including individual, group, and telephone counseling and seven Food and Drug Administration (FDA)-approved medications. A Healthy People 2020 objective (TU-8) calls for all state Medicaid programs to adopt comprehensive coverage of these treatments.* However, most states do not provide such coverag...
Source: MMWR Morb Mortal Wkl... - March 28, 2014 Category: Epidemiology Authors: Singleterry J, Jump Z, Lancet E, Babb S, Macneil A, Zhang L, American Lung Association Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Nutritional constituents and health benefits of wild rice (Zizania spp.)
Wild rice (Zizania spp.) seems to have originated in North America and then dispersed into Eastern Asia and other parts of the world. Nutritional analysis shows that wild rice is rich in minerals, vitamins, protein, starch, dietary fiber, and various antioxidant phytochemicals, while it is low in fat. Wild rice has been recognized as a whole grain by the US Food and Drug Administration; in the North American marketplace it is currently sold as and considered to be a health‐promoting food. Recent scientific studies have revealed antioxidant and lipid‐lowering properties of wild rice, while others have documented cardiov...
Source: Nutrition Reviews - March 28, 2014 Category: Nutrition Authors: Gangadaran Surendiran, Maha Alsaif, Fatemeh Ramezani Kapourchali, Mohammed H Moghadasian Tags: Lead Article Source Type: research

FDA gives doctors more leeway in prescribing Genzyme's thyroid cancer drug
With a decision by the U.S. Food and Drug Administration this week, Genzyme Corp. is now free to tout the results of two large trials showing its the effectiveness at varying dose levels of its drug to treat the fastest-growing cancer in the U.S., thyroid cancer. Abdul Mullick, the vice president and general manager of cardiovascular and endocrinology at Genzyme, said that while the two studies of its drug, Thyrogen, were published in 2012, “we’ve not been allowed to promote them.” That’s… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - March 27, 2014 Category: Biotechnology Authors: Don Seiffert Source Type: research

GlaxoSmithKline recalls weight loss product
GlaxoSmithKline is issuing a voluntary recall of its weigh-loss product alli. The company is reporting that some packages of the product were tampered with and may contain a "product that is not authentic alli," GSK said in a statement.  It says it's working with the U.S. Food and Drug Administration to investigate. Here's more from the company: GSK received inquiries from consumers in seven states about bottles of alli that contained tablets and capsules that were not alli. A range of tablets… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 27, 2014 Category: Pharmaceuticals Authors: Jared Shelly Source Type: research

Kidney health initiative.
Abstract The American Society of Nephrology and the US Food and Drug Administration have set up the Kidney Health Initiative to advance scientific understanding of the kidney, improve patient safety and promote the development of new therapies for patients with kidney disease. Kidney disease is the eighth leading cause of death in the United States. PMID: 24666073 [PubMed - in process] (Source: Nursing Standard)
Source: Nursing Standard - March 26, 2014 Category: Nursing Authors: Barker G Tags: Nurs Stand Source Type: research

UA College of Medicine-Phoenix neurologist's studies at center of FDA approval of biomarkers for Alzheimer’s testing
A Boston-based company has received federal approval for a compound that can be administered to gauge levels of beta-amyloid plaque in the brain, which can indicate the likelihood of a patient having Alzheimer’s disease. The product, named Neuraceq and developed by Piramal Imaging, is what’s called a contrast agent to be used in conjunction with positron emission tomography, or PET scans. It’s the third such agent to be approved by the U.S. Food and Drug Administration in recent months, according… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - March 25, 2014 Category: Hospital Management Source Type: research

UA College of Medicine-Phoenix at center of FDA OK of brain biomarkers to aid in Alzheimer’s efforts
A Boston-based company has received approval for a compound that can be administered to better gauge levels of beta-amyloid plaque in the brain, which can in turn indicate the likelihood of a patient having Alzheimer’s disease. The product, named Neuraceq and developed by Piramal Imaging, is what’s called a contrast agent to be used in conjunction with positron emission tomography imaging. It’s the third such agent to be approved by the U.S. Food and Drug Administration in recent months, according… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - March 25, 2014 Category: Biotechnology Source Type: research