Medical Letter on the CDC & FDA articles from February 2009

Medical Letter on the CDC & FDA archives from February 2009

New asthma study findings reported from Daegu Haany University, Medical Department.
February 1, 2009... According to recent research published in the journal Food and Chemical Toxicology, "Mahwangyounpae-tang (MT), consisting of 22 types of herbal extracts has been used for thousands of years in Korean traditional medicine for the oral treatment...

Research from University of Pennsylvania in the area of breast cancer described.
February 1, 2009... According to a study from the United States, "An estimated $8.1 billion (in 2004 dollars) is spent annually on total health care costs for the treatment of breast cancer in the United States. Breast cancer has traditionally been treated with...

Thomson Reuters White Paper Explores the Role of Biomarkers in Clinical Trials and Drug Development.
February 1, 2009... Thomson Reuters announced that it has published a new white paper on the topic of biomarkers drawing on expert insight from academics and key players in the pharmaceuticals industry. Called "Biomarkers: An Indispensable Addition to the Drug...

New erythropoiesis study results from A.M. Newland et al described.
February 1, 2009... According to recent research published in the journal Annals of Pharmacotherapy, "To evaluate, characterize, compare, and critique trials reporting increased tumor progression in patients with cancer who are receiving erythropoiesis-stimulating...

Study findings on life sciences are outlined in reports from George Mason University.
February 1, 2009... According to recent research published in the American Journal of Economics and Sociology, "The amended Food, Drug and Cosmetics Act requires efficacy certification for a drug's initial uses (''on-label''), but does not require certification...

Reports from R. Shi and co-researchers add new data to research in Escherichia coli.
February 1, 2009... "Three catabolic enzymes, UlaD, UlaE, and UlaF, are involved in a pathway leading to fermentation of L-ascorbate under anaerobic conditions. UlaD catalyzes a beta-keto acid decarboxylation reaction to produce L-xylulose-5-phosphate, which...

Investigators at Columbia University release new data on legionnaire disease.
February 1, 2009... According to recent research from the United States, "RNase R is a processive 3'-5' exoribonuclease with a high degree of conservation in prokaryotes. Although some bacteria possess additional hydrolytic 3'-5' exoribonucleases such as RNase II,...

University of Modena details research in legionnaire disease.
February 1, 2009... According to recent research published in the journal Current Microbiology, "In the ecology of Legionella pneumophila a crucial role may be played by its relationship with the natural flora; thus we investigated the interactions between...

Research conducted at R. Dey and co-authors has provided new information about legionnaire disease.
February 1, 2009... Investigators publish new data in the report 'Free-living freshwater amoebae differ in their susceptibility to the pathogenic bacterium Legionella pneumophila.' "Legionella pneumophila is known as a facultative intracellular parasite of...

Peanut Corporation of America Announces Voluntary Nationwide Recall of Peanut Butter.
February 1, 2009... Peanut Corporation of America (PCA), a peanut processing company and maker of peanut butter for bulk distribution to institutions, food service industries, and private label food companies, announced a voluntary recall of peanut butter produced...

Researchers at Mayo Clinic release new data on adverse drug reactions.
February 8, 2009... "Over 10 years after their approval as cancer supportive and palliative care agents, erythropoietin and the bisphosphonates began to show unexpected, serious adverse events, which resulted in dramatic changes in how they were subsequently...

Findings from Food & Drug Administration advance knowledge in drug delivery.
February 8, 2009... "In the United States (U.S.), drug products are considered therapeutically equivalent if they meet regulatory criteria of pharmaceutical equivalence and bioequivalence. These requirements can be traced back to 1977 when the U.S.," investigators...

General Mills Issues Voluntary Recall of LARABAR and JamFrakas Peanut Butter Snack Bars.
February 8, 2009... General Mills announced a voluntary recall of LARABAR Peanut Butter Cookie flavor snack bars and JamFrakas Peanut Butter Blisscrisp flavor snack bars because peanut butter in the products was sourced from Peanut Corporation of America, and may...

Researchers from George Washington University detail new studies and findings in the area of health policy.(Clinical report)
February 8, 2009... "This installment of Law and the. public's Health reviews a federal appeals court decision in Colaricco v Apotex Inc.(1) and considers its implications for public health policy and practice. The Colacicco decision is emblematic of it...

Studies from Rush University update current data on life sciences.
February 8, 2009... "In May 2006, the US Food and Drug Administration approved the first metal-on-metal total hip resurfacing. Surgeons wanting to implant this device were required to undergo formal industry-sponsored training before performing their first case...

New life sciences findings from A. Lueking and co-researchers published.
February 8, 2009... Data detailed in 'Determination and validation of off-target activities of anti-CD44 variant 6 antibodies using protein biochips and tissue microarrays' have been presented. According to recent research from Dortmund, Germany, "We describe a...

New legionnaire disease research from B. Chang and co-researchers described.
February 8, 2009... "Legionella organisms are prevalent in manmade water systems and cause legionellosis in humans. A rapid detection method for viable Legionella cells combining ethidium monoazide (EMA) and PCR/real-time PCR was assessed," scientists writing in...

Food and Drug Law Institute Announces Writing Award Winners.(Awards list)
February 8, 2009... The Food and Drug Law Institute has announced the winners of the 2007-2008 H. Thomas Austern Memorial Writing Competition (see also Food and Drug Law Institute). In the Short Paper Competition, Michael Kolber, a Harvard Law School Student,...

CLSI Publishes Approved Guideline for Continuous Interstitial Glucose Monitoring.
February 15, 2009... Clinical and Laboratory Standards Institute (CLSI) recently published Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline (POCT05-A), which provides recommendations for methods for determining analytical and...

Data from Columbia Laboratories' Study for the Prevention of Preterm Birth to be Presented at the Society for Maternal-Fetal Medicine SMFM 2009 Annual Meeting.
February 15, 2009... Columbia Laboratories, Inc. (Nasdaq: CBRX) announced that the PREGNANT Study, ColumbiaEs ongoing study to prevent preterm birth in pregnant women with a short cervical length, will be discussed at a scientific session of the SMFM Annual Meeting...

Research on HIV/AIDS published by scientists at Baylor College of Medicine, College of Medicine.
February 15, 2009... "Numerous studies suggest that the residual risk of transfusion-transmitted hepatitis B virus (HBV) is significantly greater than that for hepatitis C virus (HCV) or human immunodeficiency virus (HIV),(1,2) yet there is no requirement in the...

Data on breast cancer described by V.J. Croog et al.(Report)
February 15, 2009... "Whole breast irradiation (WBI) is the standard of care for patients with early-stage breast cancer who opt for breast conservation. After a randomized trial demonstrated equivalent cosmesis and disease control with accelerated WBI (AWBI), our...

New life sciences research from R. Zimmermann et al outlined.
February 15, 2009... "There exists only very few data on in vitro and in vivo effects of gamma irradiation of red blood cells (RBCs) that have been leukoreduced by filtration before a subsequent irradiation. Reported studies reflect neither the current Food and...

Researchers at University of Arizona publish new data on Escherichia coli.
February 15, 2009... "Enterohemorrhagic Escherichia coli (EHEC) O157:H7 produces long bundles of polar type 4 pili (T4P) called HCP (for hemorrhagic coli pili) that form physical bridges between bacteria associating with human and animal epithelial cells. Here, we...

Study data from Yale University provide new insights into legionnaire disease.
February 15, 2009... "The immune system must discriminate between pathogenic and nonpathogenic microbes in order to initiate an appropriate response. Toll-like receptors (TLRs) detect microbial components common to both pathogenic and nonpathogenic bacteria,...

Peter Pan Safe to Enjoy; ConAgra Foods Reaffirms None of Its Products Involved in Peanut Butter Salmonella Investigation.
February 15, 2009... ConAgra Foods, Inc., today reaffirmed that Peter Pan peanut butter is not associated with the federal government's ongoing Salmonella investigation and expanding recall. In addition, none of the companyEs other products containing any peanut or...

Jenny Craig Announces Nationwide Voluntary Recall of Jenny's Cuisine(R) Anytime Peanut Butter Flavor Nutritional Bars Due to Possible Peanut Corporation of America (PCA) Contamination and Potential Health Risk.
February 15, 2009... Jenny Craig, Inc. one of the nation's leading authorities on weight management, announced a voluntary recall of its Jenny's Cuisine(R) Anytime Peanut Butter Flavor Nutritional Bars (UPC Code 655447009347) for U.S and P.R. distribution with the...

Findings from Emory University broaden understanding of cancer.
February 22, 2009... "Whereas, most cancer research data come from high-profile academic centers, little is known about the outcomes of cancer care in rural communities. We summarize the experience of building a multi-institution partnership to develop a cancer...

Hospira's Precedex(R) Phase IV Study Published in the Journal of the American Medical Association.(Clinical report)
February 22, 2009... The Journal of the American Medical Association (JAMA) has published study results demonstrating Hospira, Inc.'s (NYSE:HSP) alpha-2 agonist Precedex (dexmedetomidine hydrochloride) for intravenous sedation provides comparable effectiveness to...

New drug delivery study findings have been reported by researchers at Isfahan University.
February 22, 2009... According to recent research from Iran, "The large surface area, good vascularization, immense capacity for solute exchange and ultra-thinness of the alveolar epithelium are unique features of the lung facilitating systemic drug delivery via...

Risk-Management Policies Needed Now in Nanotechnology, Insighter Piece Concludes; FDLI Sponsors Nanotechnology Meeting, Publishes Book on FDA-Regulated Products.(Conference news)
February 22, 2009... Companies that manufacture products containing nanomaterials must immediately institute high-quality risk management and product stewardship measures to limit potential liability exposure in the future, assert attorneys Jesse Ash, Antony...

IMPAX Receives Final FDA Approval for Generic SOLODYN Extended-Release Tablets, 45mg, 90mg and 135mg.
February 22, 2009... IMPAX Laboratories, Inc. (OTC: IPXL) confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the CompanyEs Abbreviated New Drug Application (ANDA) for generic versions of SOLODYN(R) (minocycline HCI) 45mg, 90mg...

Research from R. Vaidyanathan and co-researchers provides new data on west nile virus.
February 22, 2009... "Most anautogenous female mosquitoes ingest plant carbohydrates for flight energy and survival, and they imbibe vertebrate blood for egg development. We evaluated the effect of different sucrose meals following a blood meal containing West Nile...

Study data from C.C. Jansen and colleagues update understanding of west nile virus.
February 22, 2009... "Since the establishment of West Nile virus (WNV) into the United States, concern has arisen that this virus may also pose a serious threat to Australian biosecurity. The vector competence of 19 Australian mosquito species for a North American...

AMERIGROUP Names Finley Chief Compliance Officer.
February 22, 2009... AMERIGROUP Corporation (NYSE:AGP) announced that John R. Finley, Esq., MPH has been named Chief Compliance Officer, a position charged with responsibility that all Company operations comply with state and federal laws and regulations (see also...

Hudsonville Ice Cream Announces Recall.
February 22, 2009... Hudsonville Ice Cream today voluntarily recalled the 64 oz. containers of its Candy Bar Whirl Ice Cream (UPC# 70438 10250 8), which is available in Michigan grocers such as Meijer, Family Fare, D&W, Harding's Market, L&L Food centers and others...

The FDA Seeks More Power for Better Regulation of Medical and Healthcare Products.
February 22, 2009... Research and Markets (http://www.researchandmarkets.com/research/fafcf3/the_fda_seeks_more) has announced the addition of GlobalData 's new report "The FDA Seeks More Power for Better Regulation of Medical and Healthcare Products" to their...