Medical Letter on the CDC & FDA articles from October 2008

Medical Letter on the CDC & FDA archives from October 2008

New life sciences research from S.V. Rao et al outlined.
October 5, 2008... According to a study from the United States, "Cardiovascular procedures performed in the United States have more than tripled in the last decade, a trend that is expected to continue with the aging of the population, coupled with epidemics of...

New life sciences study findings have been published by J.P. Reichmann and colleagues.
October 5, 2008... According to recent research from the United States, "The current paradigm in obstetrics has shifted toward evidence-based medicine, and yet in clinical practice physicians continue to use interventions for which there exists no credible...

New pharmacology study results from Food & Drug Administration described.(Clinical report)
October 5, 2008... "Ethnicity is one factor that may account for the observed differences in both pharmacokinetics (PK) and pharmacodynamics (PD) of drugs, resulting in variability in response to drug therapy. Given that the applicability of clinical study...

Study results from C.I. Starner and colleagues update understanding of regulatory actions.
October 5, 2008... According to recent research from the United States, "Rosiglitazone was approved by the U.S. Food and Drug Administration (FDA) for type 2 diabetes in 1999." "The unique mechanism of action and low risk of hypoglycemia contributed to rapid...

Data from Indiana University advance knowledge in vomiting.
October 5, 2008... According to recent research published in the journal Current Opinion in Investigational Drugs, "Casopitant, an inhibitor of the neurokinin-1 receptor, and its mesylate salt, are being developed by GlaxoSmithKline plc for the potential...

Researchers at Johnson & Johnson target life sciences.(Report)
October 5, 2008... Research findings, 'Real life juvenile toxicity case studies: the good, the bad and the ugly,' are discussed in a new report. "With the growing experience in the conduct of juvenile toxicity studies for multiple classes of compound, the...

New legionnaire disease research from INSERM discussed.
October 5, 2008... "Legionella pneumophila is the causative agent of Legionnaires' disease. This bacterium is ubiquitous in aqueous environments and uses amoebae as an intracellular replicative niche," scientists writing in the journal Applied and Environmental...

Mosquito Season Won't End with Summer.
October 5, 2008... Just because summer is over, don't assume mosquito season is, too. The National Pest Management Association (NPMA) has warned that mosquitoes will be active through fall this year. Although mosquitoes are typically thought of as a summer pest,...

The American Legion's NEF Assists Ike, Gustav Victims.
October 5, 2008... The American Legion has speeded up its process to assist Legionnaires and Sons of the American Legion members who have been victimized by Hurricanes Ike or Gustav. Financial grants are available through the organization's National Emergency...

Baxter Initiates Phase III Trial for the Treatment of Alzheimer's Disease.
October 12, 2008... Baxter Healthcare Corporation announced initiation of a Phase III clinical trial following U.S. Food and Drug Administration (FDA) review of its investigational new drug application to evaluate GAMMAGARD LIQUID [Immune Globulin Intravenous...

Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression.
October 12, 2008... Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act to the U.S. Food and Drug Administration (FDA) for DDS-04A, a once-daily...

First Reported Head-to-Head Study Showed BYETTA[R] (exenatide) Injection Provided Greater Reduction in Post-Meal Glucose Levels Than Januvia (sitagliptin) in Patients With Type 2 Diabetes Patients Taking BYETTA Also Reduced Food Intake.(Clinical report)
October 12, 2008... Patients Taking BYETTA Also Reduced Food Intake Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) and Eli Lilly and Company (NYSE: LLY) announced results from a randomized, double-blind, cross-over, four-week head-to-head study demonstrating that...

Major Adult Vaccine Clinical Trial for Pneumonia Prevention Begins.
October 12, 2008... Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced the initiation of the Community Acquired Pneumonia Immunization Trial in Adults a major study in adults of an investigational 13-valent conjugate vaccine designed to help prevent...

Reports outline breast cancer clinical trial research from University of Oklahoma, Health Science Center.(Report)
October 12, 2008... New research, 'Lapatinib: a dual inhibitor of human epidermal growth factor receptor tyrosine kinases,' is the subject of a report. According to a study from the United States, "Lapatinib, the first dual inhibitor of epidermal growth factor...

Research from I.C. Munro and co-researchers provides new data on life sciences.
October 12, 2008... New investigation results, 'The Threshold of Toxicological Concern (TTC) in risk assessment,' are detailed in a study published in Toxicology Letters. According to recent research published in the journal Toxicology Letters, "The Threshold of...

Drinking Water Research Foundation Chairman Calls Environmental Protection Agency Ruling Unacceptable Risk for Americans.
October 12, 2008... The Chairman of the Drinking Water Research Foundation criticized the recent Environmental Protection Agency (EPA) announcement stating that it will not issue a health regulation for perchlorate for public drinking water systems. Even though...

AxioMed Spine Corporation Initiates Pivotal Study.
October 19, 2008... AxioMed(R) Spine Corporation (www.axiomed.com), focused on next-generation devices for the restoration of spinal function, announces the initiation of its pivotal clinical study of the Freedom(R) Lumbar Disc, an elastomeric total disc...

Study results from University of Miami in the area of contact lens published.
October 19, 2008... In this recently published study, investigators in the United States conducted a study "To evaluate and compare the in vitro effectiveness of Multipurpose contact lens solutions (MPDS) to inhibit fungal colonization of Food and Drug...

Research data from Brandeis University update understanding of life sciences.
October 19, 2008... "The medicalisation of life problems has been occurring for well over a century and has increased over the past 30 years, with the engines of medicalisation shifting to biotechnology, managed care, and consumers. This paper examines one strand...

Research conducted at Baylor College of Medicine, College of Medicine has provided new information about lupus.(Report)
October 19, 2008... According to a study from the United States, "Thalidomide is approved by the Food and Drug Administration (FDA) for erythema nodosum leprosum, but has been used in many other dermatological conditions that are refractory to standard therapy....

Watson Notified of OXYTROL(R) Patent Challenge.
October 19, 2008... Watson Pharmaceuticals, Inc. (NYSE:WPI), a leading specialty pharmaceutical company, confirmed the receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug...

Researchers at Yale University have published new data on plague.
October 19, 2008... According to a study from the United States, "External guide sequences (EGSs) targeting virulence genes from Yersinia pestis were designed and tested in vitro and in vivo in Escherichia coli." "Linear EGSs and M1 RNA-linked EGSs were...

Lannett Reports Fiscal 2008 Fourth Quarter, Full-Year Financial Results.(Financial report)
October 19, 2008... Lannett Company, Inc. (AMEX:LCI) reported financial results for the fiscal 2008 fourth quarter and full year ended June 30, 2008 (see also Lannett Company, Inc.). For fiscal 2008, net sales were $72.4 million compared with $82.6 million...

Zep Inc. Provides Solutions for Public Facilities To Defend Against Potentially Deadly Staph Infections.
October 26, 2008... Public facilities, from schools and hospitals to sports facilities and health clubs, can now turn to Zep Inc. for help in combating the spread of Methicillin-Resistant Staphylococcus aureus (MRSA) infections. The dangerous MRSA germ, which has...

Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD.(Report)
October 26, 2008... Shire plc , the global specialty biopharmaceutical company, announced that a study published in the September issue of the Journal of Clinical Psychiatry found once-daily VYVANSE significantly improved Attention Deficit Hyperactivity Disorder...

New Escherichia coli findings from University of Maryland described.
October 26, 2008... "There is considerable heterogeneity among the Shiga toxin type 2 (Stx2) toxins elaborated by Shiga toxin-producing Escherichia coli (STEC). One such Stx2 variant, the Stx2d mucus-activatable toxin (Stx2dact), is rendered more toxic by the...

Investigators at Northwestern University release new data on interstitial cystitis.(Clinical report)
October 26, 2008... In this recently published article, scientists in the United States conducted a study "To evaluate the relationship between symptom reduction and satisfaction with pentosan polysulfate sodium (PPS) therapy in subjects with interstitial...

New life sciences data have been reported by M. Speakman and co-authors.
October 26, 2008... In this recently published article, scientists in the United Kingdom conducted a study "To evaluate the cost-utility of solifenacin, a new generation antimuscarinic, compared with tolterodine in the treatment of overactive bladder syndrome...

Researchers from National Institute of Standards and Technology provide details of new studies and findings in the area of tuberculosis.(Report)
October 26, 2008... New research, 'A comparative biochemical and structural analysis of the intracellular chorismate mutase (Rv0948c) from Mycobacterium tuberculosis H(37)R(v) and the secreted chorismate mutase (y2828) from Yersinia pestis,' is the subject of a...

Investigators at Blood Systems Research Institute target west nile virus.
October 26, 2008... New investigation results, 'Virus and antibody dynamics in acute west nile virus infection,' are detailed in a study published in The Journal of Infectious Diseases. "The dynamics of the early stages of West Nile virus (WNV) infection can be...