Medical Letter on the CDC & FDA articles from December 2008

Medical Letter on the CDC & FDA archives from December 2008

Research on HIV/AIDS discussed by scientists at University of Massachusetts, Medical Department.
December 7, 2008... According to recent research from the United States, "The current effectiveness of HAART in the management of HIV infection is compromised by the emergence of extensively cross-resistant strains of HIV-1, requiring a significant need for new...

Research from Hamline University broadens understanding of pharmacology.
December 7, 2008... "This paper explores events surrounding the US Food and Drug Administration's formal approval of the heart failure drug BiDil in 2005. BiDil is the first drug ever to be approved with a race-specific indication, in this case to treat heart...

Investigators at University Diego Portales release new data on schizophrenia therapy.
December 7, 2008... Data detailed in 'Glutamatergic dysfunction in schizophrenia: from basic neuroscience to clinical psychopharmacology' have been presented. According to a study from Santiago, Chile, "The underlying cellular mechanisms leading to frontal...

Studies by D.R. Sanders and co-authors describe new findings in astigmatism.(Clinical report)
December 7, 2008... In this recent study, researchers in the United States conducted a study "To compare the results of wavefront-guided custom LASIK and the Toric Implantable Collamer Lens (TICL) in the correction of myopic astigmatism. This observational,...

Findings from C.M. Toscano and co-authors broaden understanding of diabetes.(Report)
December 7, 2008... According to recent research from Porto Alegre, Brazil, "In 2001 Brazilian citizens aged 40 or older were invited to participate in a nationwide population screening program for diabetes. Capillary glucose screening tests and procedures for...

New yersinia study findings reported from University of Washington.
December 7, 2008... "Lipid A isolated from several bacteria (Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica, and various strains of Yersinia) showed abundant formation of pyrophosphate anions upon ion dissociation," scientists in the United States...

New data from University of California illuminate research in clinical trial research.
December 14, 2008... According to recent research from the United States, " The United States ( US) Food and Drug Administration (FDA) approves new drugs based on sponsor-submitted clinical trials. The publication status of these trials in the medical literature...

Gilead Sciences Announces Notification of ANDA Filing for Truvada.
December 14, 2008... Gilead Sciences, Inc. (Nasdaq:GILD) announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA)...

Cephalon and Eurand File Patent Infringement Lawsuit Against Mylan Pharmaceuticals and Barr Pharmaceuticals.
December 14, 2008... Cephalon, Inc. (NASDAQ:CEPH) and Eurand, Inc. (NASDAQ:EURX) announced that they have filed a lawsuit in U.S. District Court in Delaware against Mylan Pharmaceuticals, Inc. and its subsidiary, Mylan, Inc., and Barr Pharmaceuticals, Inc. and its...

Lilly Withdraws Application for Additional U.S. Indication for Cymbalta(R) for Chronic Pain.
December 14, 2008... Eli Lilly and Company (NYSE:LLY) has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain. Lilly plans to resubmit the...

Scientists at Katholieke University Leuven, Rega Institute for Medical Research publish new data on HIV/AIDS therapy.
December 14, 2008... Researchers detail in 'A genotypic assay for the amplification and sequencing of integrase from diverse HIV-1 group M subtypes,' new data in HIV/AIDS. "Recently, the Food and Drug Administration (FDA) of the USA approved the first integrase...

New west nile virus study findings have been reported by T. Balenghien and co-researchers.
December 14, 2008... According to recent research from Montpellier, France, "To identify the mosquito species able to sustain the transmission of West Nile Virus (WNV) in the Camargue region (the main WNV focus of southern France), we assessed the vector competence...

Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab).
December 21, 2008... Roche announced that the U.S. Food and Drug Administration (FDA) has provided further guidance on the requirements for the Biologics License Application (BLA) for ACTEMRA(R) (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting...

Research from University of Texas in the area of colon cancer published.
December 21, 2008... "Vascular endothelial growth factor (VEGF) is the most potent proangiogenic factor and has been identified as an important target of cancer therapy. Blocking endothelial cell VEGF activity inhibits tumor angiogenesis normalizes tumor...

Researchers from Tufts University describe findings in regulatory actions.
December 21, 2008... "Section 114 of the 1997 Food and Drug Administration Modernization Act (FDAMA) effective February 19, 1998, permitted some additional flexibility for drug companies to provide ''health care economic information'' to ''a formulary committee or...

New pharmacokinetics findings from Naresuan University, Faculty of Pharmaceutical Sciences published.(Report)
December 21, 2008... Investigators publish new data in the report 'Bioequivalence of generic lamotrigine 100-mg tablets in healthy Thai male volunteers: a randomized, single-dose, two-period, two-sequence crossover study.' "Lamotrigine is an antiepileptic drug...

Research findings from University of Texas update understanding of colon cancer.
December 21, 2008... According to a study from the United States, "Cetuximab and panitumumab, monoclonal antibodies used to target the epidermal growth factor receptor (EGFR), were recently approved by the United States Food and Drug Administration for use as...

Philip T. Sager, M.D., Joins NewCardio's Scientific Advisory Board.
December 28, 2008... NewCardio, Inc., (BULLETIN BOARD: NWCI) a cardiac diagnostic and services company, announced that Philip T. Sager, M.D., FACC, FAHA, FHRS, has joined the Company's Scientific Advisory Board (see also Cardiology). Dr. Sager is currently the...

Reports outline depression study findings from R.G. Wenzel and colleagues.
December 28, 2008... "In 2006 the Food and Drug Administration (FDA) issued an alert, based on 27 case reports gathered over a 5-year span, regarding serotonin syndrome resulting from concurrent use of either a selective serotonin-reuptake inhibitor (SSRI) or a...

Research from N. Taudon et al has provided new information about malaria.
December 28, 2008... "A new class of antimalarial drugs targeting phospholipid metabolism of the malarial parasite is now in development. In the strategy of this development, two mono-thiazolium salts, T1 and T2, need to be monitored," investigators in Montpellier,...

Research on pulmonary hypertension detailed by S.L. Hrometz and co-authors.
December 28, 2008... "To review the role of ambrisentan in the treatment of pulmonary arterial hypertension (PAH). Literature was accessed through MEDLINE (1950-June 2008), Iowa Drug Information Service (1966-March 2008), EMBASE (1966-June 2008), bibliographies of...

Study findings from Washington State University broaden understanding of type 2 diabetes.
December 28, 2008... According to a study from the United States, "inhibition of the enzyme dipeptidyl peptidase-4 represents the latest pharmacologic intervention to become available to assist patients with Type 2 diabetes to achieve glycemic control. A...

Research from E. Franz and colleagues has provided new data on Escherichia coli.(Report)
December 28, 2008... According to a study from Netherlands, "A growing number of foodborne illnesses has been associated with the consumption of fresh produce. In this study, the probability of lettuce contamination with Escherichia coli O157:H7 from manure-amended...

Researchers at University of Aberdeen target Escherichia coli.
December 28, 2008... According to recent research published in the Journal of Applied Microbiology, "Development of a novel inoculation technique to improve the current methods of determining the leaching of Escherichia coli O157:H7 from faeces. Ruminant faeces...

Scientists at University of Montreal target Escherichia coli.
December 28, 2008... "Escherichia coli O157:H7 is an important food-borne pathogen that specifically binds to the follicle-associated epithelium in the intestine, which rapidly brings this bacterial pathogen in contact with underlying human macrophages. Very little...

Studies from University of Texas in the area of Escherichia coli described.
December 28, 2008... According to recent research from the United States, "The expression of the long polar fimbriae (LPF) of enterohemorrhagic Escherichia coli (EHEC) O157:H7 is controlled by a tightly regulated process, and, therefore, the role of these fimbriae...

New legionnaire disease research reported from University of Louisville.
December 28, 2008... "The Dot/Icm type IV secretion system of Legionella pneumophila translocates numerous bacterial effectors into the host cell and is essential for bacterial proliferation within macrophages and protozoa. We have recently shown that L....

New findings reported from Institute of Biological Science describe advances in life sciences.
December 28, 2008... Investigators publish new data in the report 'Structure of a Shigella effector reveals a new class of ubiquitin ligases.' "Bacterial pathogens have evolved effector proteins with ubiquitin E3 ligase activities through structural mimicking. Here...

Intellx Bails Out Safe Sex.
December 28, 2008... Intellx Inc. announces a 50% price cut effective immediately on its top-rated condoms through online direct buying. Intellx is one of four major condom makers in the USA, distributing the #1 consumer-rated condom in the USA, Inspiral(R) (see...