Medical Letter on the CDC & FDA articles from January 2009

Medical Letter on the CDC & FDA archives from January 2009

Reports summarize life sciences research from P. Cole and co-authors.
January 4, 2009... "Targeting glucagon-like peptide 1 (GLP-1) is an attractive strategy for the treatment of type 2 diabetes, as this incretin hormone enhances postprandial insulin secretion in a manner dependent on glycemia. Evidence also indicates that GLP-1...

Oncology Biomarker KRAS to be Discussed at FDA Panel Meeting.
January 4, 2009... Amgen (NASDAQ: AMGN) announced they will discuss the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-epidermal growth factor receptor (EGFr) antibody Vectibix(R)...

Fujirebio Diagnostics and Roche Diagnostics Sign Agreement for New Ovarian Cancer Test.
January 4, 2009... Fujirebio Diagnostics, Inc. and Roche Diagnostics announced a worldwide license and supply agreement for the HE4 ovarian cancer test. Under the agreement, Roche will develop an assay kit utilizing Fujirebio Diagnostics' HE4 test on its...

Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote(R).
January 4, 2009... Cumberland Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Acetadote(R) (acetylcysteine) Injection, the company's intravenous treatment for acetaminophen overdose. The revised package...

New schizophrenia study results from Medical College of Georgia, Medical College described.
January 4, 2009... According to recent research from the United States, "The role of brain-derived neurotrophic factor (BDNF) has been implicated in the pathophysiology as well as treatment outcome of schizophrenia. Rodent studies indicate that several...

Research from R.W. Depaolo and colleagues has provided new data on life sciences.
January 4, 2009... According to recent research from the United States, "Educating dendritic cells (DC) to become tolerogenic DC, which promote regulatory IL-10 immune responses, represents an effective immune evasion strategy for pathogens. Yersinia pestis...

PureCircle Set to Lead USA Supply of High-Purity Reb A.
January 4, 2009... PureCircle , the world's leading developer and producer of high-purity Rebaudioside A (Reb A)* announces that the United States Food & Drug Administration (FDA) issued a no objection letter with respect to Reb A. This indicates the FDA has no...

Researchers at New York Blood Center release new data on HIV/AIDS.
January 11, 2009... "T20 (generic name: Enfuvirtide, brand name: Fuzeon) is the only FDA-approved HIV fusion inhibitor that is being used for treatment of HIV/AIDS patients who have failed to respond to current antiretroviral drugs. However, it rapidly induces...

Study findings from University of Colorado provide new insights into phototherapy.
January 11, 2009... "Obstructive non-small cell lung cancer and obstructive esophageal cancer are US FDA approved indications of photodynamic therapy (PDT). The usefulness of PDT for the treatment of cholangiocarcinoma is currently under clinical investigation,"...

Findings from University Medical Center advance knowledge in life sciences.
January 11, 2009... A report, 'Medical abortion practices: a survey of National Abortion Federation members in the United States,' is newly published data in Contraception. According to a study from Groningen, Netherlands, "Little is known about clinical...

Findings in pharmacology reported from M.K Pendergast and co-researchers.
January 11, 2009... Researchers detail in 'Regulatory agency consideration of pharmacogenomics,' new data in pharmacology. According to recent research published in the journal Experimental Biology and Medicine, "This article discusses the current ambiguous state...

Data from University of Texas advance knowledge in aortic aneurysms.(Report)
January 11, 2009... According to recent research published in the journal Annals of Vascular Surgery, "Prior to approval by the U. S. Food and Drug Administration of larger endografts (main body diameters up to 36 mm), small abdominal aortic aneurysms (AAAs, = 5.5...

Researchers from Food & Drug Administration publish findings in amyotrophic lateral sclerosis.
January 18, 2009... According to recent research published in the journal Pharmacoepidemiology and Drug Safety, " We detected disproportionate reporting of amyotrophic lateral sclerosis (ALS) with HMG-CoA-reductase inhibitors (statins) in the Food and Drug...

Reports outline carcinoma study findings from C. Campas and colleagues.
January 18, 2009... "BIBW-2992 is a potent, irreversible, orally active inhibitor of the epidermal growth factor receptor EGFR and HER2 tyrosine kinases," scientists in Barcelona, Spain report (see also Carcinoma). "In preclinical studies, BIBW-2992 showed...

Researchers from Henry Ford Hospital publish findings in heart disease.
January 18, 2009... According to recent research published in the journal Formulary, "Prasugrel is athienopyndine prodrug under FDA review for the treatment of acute coronary syndrome (ACS) managed with percutanelous coronary intervention (PCI). This, agent...

Reports outline life sciences study results from S.L. Andes et al.
January 18, 2009... "To effectively gauge the potential clinical and economic impact of drug and biologic therapies that are pending FDA approval, the monitoring of pharmaceutical pipelines has become an essential function of pharmacy benefit management (PBM)...

Studies from S.Q. Wang and co-researchers yield new data on life sciences.
January 18, 2009... "The importance of adequate ultraviolet A (UVA) protection has become apparent with improved understanding of the mechanism of UVA-induced damage to tissues. Currently in the United States, there is no regulation on testing and labeling; Of...

Research reports from Charite University provide new insights into DNA research.
January 18, 2009... According to recent research published in the journal Cellular Microbiology, "Intracellular bacteria and cytosolic stimulation with DNA activate type I IFN responses independently of Toll-like receptors, most Nod-like receptors and RIG-like...

Reports by C. Ragaz and co-researchers describe recent advances in legionnaire disease.
January 18, 2009... According to recent research from Zurich, Switzerland, "Legionella pneumophila, the causative agent of Legionnaires' disease, uses the intracellular multiplication/defective organelle trafficking (Icm/Dot) type IV secretion system to establish...

Scientists at Dalhousie University target legionnaire disease.
January 18, 2009... "The intracellular bacterial pathogen Legionella pneumophila follows a developmental cycle in which replicative forms (RFs) differentiate into infectious stationary-phase forms (SPFs) in vitro and in vivo into highly infectious mature...

Study results from A. Edagawa and colleagues broaden understanding of legionnaire disease.
January 18, 2009... According to recent research published in the Journal of Applied Microbiology, "To investigate the prevalence of culturable and nonculturable Legionella species in hot water systems of public buildings in Japan and assess the risk factors...

Researchers from University of California report details of new studies and findings in the area of clinical trial research.(Report)
January 25, 2009... According to a study from the United States, " Previous studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results. The objective of this study is to determine the...

Research from G.V. Glinsky and co-authors in the area of life sciences published.
January 25, 2009... According to a study from the United States, "We report the results of a disease phenocode analysis interrogating the relationships between structural features and gene expression patterns of disease-linked SNPs, microRNAs and mRNAs of...

Research on life sciences described by R. Ramakrishnan and colleagues.
January 25, 2009... "Hip surfacing devices require a new radiographic evaluation technique owing to femoral components with short or no stems. Fourteen US surgeons implanted 1148 metal-on-metal hip resurfacing (HR) devices in a US-FDA-IDE clinical trial, which...

Star Scientific Announces Successful Completion of Product Satisfaction Study - Results Show Potential for Development and Manufacturing of New Pharmaceutical Product for Smoking and Smokeless Tobacco Cessation.
January 25, 2009... Star Scientific (NASDAQ :STSI) announced that its subsidiary, Rock Creek Pharmaceuticals, Inc., in conjunction with its Star Tobacco, Inc. subsidiary, recently completed a study to determine the ability of Stonewall(R) dissolvable smokeless...

Study data from University of North Carolina update understanding of toxic epidermal necrolysis.
January 25, 2009... According to recent research from the United States, "Recently, the USA FDA has made a labeling change to the drug information contained in carbamazepine. Owing to recent data implicating the HLA allele B*1502 as a marker for...

Study results from E. Strauch and colleagues update understanding of Escherichia coli.
January 25, 2009... "The production of Shiga toxin (Stx) (verocytotoxin) is a major virulence factor of Escherichia coli O157: H7 strains (Shiga toxin-producing E. coli [STEC] O157). Two types of Shiga toxins, designated Stx1 and Stx2, are produced in STEC O157,"...