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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 25th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Dengue Virus - Fourplex real-time RT-PCR assay to detect dengue viruses is developed

Measles Vaccine - More sclerosing panencephalitis prevented by measles vaccine than previously recognized

Rotavirus Vaccine - Vaccination reduces disease burden and health costs of rotavirus diarrhea in Vietnam

Smallpox Vaccine - Maxi-Vac software aids in planning mass smallpox vaccination clinics

Vaccine Registries - Electronic billing systems need improvement to maintain accurate vaccine registries

Acinetobacter Baumannii - Integrons are useful markers for epidemic strains of Acinetobacter baumannii

Addiction Medicine - Medications show effectiveness in reducing drug use in addicted patients

Adipose Tissue - Nnat increases CREB phosphorylation and enhances adipogenic differentiation in rat model

Adverse Drug Effects - Relative disparities should be measured in terms of adverse events

Asthma - Drug maker expresses disagreement with U.S. FDA proposed labeling change for Serevent and Advair

Atopic Eczema - Current aspects of therapy with topical calcineurin inhibitors are reviewed

Avian Influenza - Researchers' findings advance avian influenza research

Avian Influenza - Viral inactivation method being explored for development of bird flu vaccine

Awards - U.S. NIH grant will support research of potent anti-inflammatory effects of incyclinide

Bioterrorism - Multiplex PCR microarray assay screens multiple bioterror pathogens in blood

Breast Cancer - Company files 510(k) application with U.S. FDA on microendoscope for breast exams

Business & Finance - Maker of gene-transfer therapy products reports third-quarter revenues of $21,000

Chromatography - LC-MS sensitivity improved through increases in chromatographic performance

Clinical Trials - Positive final results reported from phase II study of diabetic nephropathy therapy

Cognition - Phosphodiesterase type 5 inhibitors enhance cognitive abilities

Community-Acquired Pneumonia - New drug application submitted to U.S. FDA for Factive's use in sinusitis and pneumonia

Depression - Eight percent of adults experienced major depression in past year, according to report

Diabetes Complications - Geographic variation in diabetes complications is linked to health care performance

Diabetes Epidemiology - Diabetes and associated disorders are common in Cambodia

Diagnostics - Diagnostic tests provider engages Partner International to strengthen European distribution network

Diagnostics - Integrating multiantigen ELISA with AFB smear improves sensitivity for active TB screening

Diagnostics - Nucleic acid amplification tests in absence of a gold standard test are reviewed

Diagnostics - Reports add new data to diagnostics research

Diet & Nutrition - Hemoglobin and ferritin are most efficient indicators of response to iron interventions

Disease Associations - Relationship between obesity and pediatric oncology discussed

Disease Control - Oral fluid dried onto filter paper suitable for detection of measles virus strains

Disease Control - Provider awareness education increases reporting of syphilis cases and decreases reporting delays

Disease Control - Public awareness campaign resulted in community involvement in syphilis control efforts

Disease Control - Screening programs conducted during outbreak do not detect many persons with syphilis

Disease Control - WHO DOTS strategy not adopted in Russia due to inadequate understanding

Drug Development - Biomedical Diagnostics gets CLIA certification

Drug Development - Regulatory status update provided for decitabine injection for MDS

Drug Development - U.S. FDA approves Avelox for the treatment of complicated intra-abdominal infections

Drug Development - U.S. FDA approves a new higher dose formulation of Fosrenol

Drug Development - U.S. FDA grants fast track status to drug for head and neck squamous cell carcinoma

Drug Development - U.S. NIAID awards phase I SBIR to develop siRNA technology for influenza treatment

Drug Resistance - Resistance to antituberculosis drugs increasing in Botswana

Drug Resistance - Virulent MRSA strains carrying Panton-Valentine leucocidin genes prevalent in the Netherlands

Drug Safety - Methods for clearing viruses and TSE agents from biologicals are under development

Environmental Health - Contaminated soil and water exposure associated with leptospirosis outbreak in Japan

Environmental Health - Somatic and germ cell DNA damage in acrylamide-treated mice depends upon CYP2E1 activity

Epidemiology - MLVA reliable for short-term S. aureus epidemiological studies

Facilities - Cancer-focused biotech company relocates headquarters

Finance - Needle-free drug delivery system maker receives Small Business Innovation Research contract

Food Safety - U.S. FDA purchases Bench Top PCT Sample Preparation System

Generic Drugs - U.S. FDA grants approval for generic equivalent of antibiotic Zithromax tablets

Genetics & Genomics -  S. enterica virulence genes required for bacterial attachment to plant tissue

Genetics & Genomics - Small number of genes explains a major proportion of common complex diseases

HIV/AIDS Diagnostics - Results demonstrate importance of reagent selection for monitoring of HIV responses

HIV/AIDS Epidemiology - HIV prevalence increasing among injecting drug users in England and Wales

HIV/AIDS Therapy - U.S. FDA approves updated labeling for LEXIVA

Heartworm - Efficacy of heartworm preventive products was evaluated at U.S. FDA

Hemochromatosis - Dose-response effects of ectopic agouti protein on iron overload were examined

Hepatitis B Therapy - Positive interim data on oral anti-viral compound presented at liver association meeting

Imaging - Pharmaceutical company receives second approvable letter for Vasovist

Imaging - Process begun with U.S. FDA for approval of digital mammography imaging system

Influenza - Community network of reference laboratories developed for influenza surveillance

Influenza - U.S. FDA advisory committee affirms safety of Tamiflu in children

Influenza Vaccine - Macro-epidemiology of influenza vaccination in 56 countries is presented

Influenza Vaccine - Respiratory mucosal immunity from antiviral vaccination is disappointing

Influenza Vaccines - Findings in influenza vaccines provide new insights

Influenza Virus - Equine influenza virus was transmitted to dogs

Information Technology - U.S. FDA renews agreement to provide research access to drug center database

Legal Issues - Drug makers end Tamiflu dispute

Legal Issues - Hospital company resolves two remaining Redding Medical Center settlement issues

Legal Issues - U.S. court decision clarifies launch of clarithromycin 500 mg ER tablets on approval

Lipid Research - U.S. FDA approves SNDA for new dosing regimen, label change of fenofibrate therapy

Malaria Therapy - Researchers' findings advance malaria therapy research

Malaria Vaccines - New findings in the area of malaria vaccines described

Medical Devices - Cardiac safety services unit earns certified partner status for compliance with U.S. FDA standard

Medical Devices - Retinal imaging device receives U.S. FDA 510(k) clearance

Medical Devices - Safe syringe developer signs memo of understanding for U.S. production

Medical Devices - Talent Thoracic stent graft system premarket approval module submitted to U.S. FDA

Mental Health - Final report issued on SSRIs and suicidal behavior in youth

Mental Health - U.S. FDA issues extends goal date for transdermal patch to treat depression

Nocosomial Infection - Septicemia is reported in nursery due to contaminated flush solutions

Orthopedics - Maker of demineralized bone matrix product updates regulatory U.S. FDA status

Osteoarthritis - PRA International to assist with implementation of phase III program for HCT 3012

Osteoarthritis - Two trials presented at rheumatology meeting support use of glucosamine for joint pain

Osteoporosis - Trial results of bone loss therapy show increased BMD with twice yearly injection

Pain Management - New patient-activated pain control device now available in U.S. for difficult-to-treat chronic pain

Pain Management - Trial to evaluate Oxytrex impact on physical dependency hampered by high drop out rates

Pancreatic Cancer - EGFR-inhibitor receives approval in U.S. for pancreatic cancer

Panic Disorder - Effexor XR approved for the treatment of panic disorder

Patents - Connecticut company receives Canadian patent for apparatus and method for isolated pelvic perfusion

Pharmacokinetics - Testing required by U.S. FDA suggests Neoral and Equoral are switchable

Pneumococcal Vaccine - ELISA is developed to detect invasive pneumococcal disease in children

Renal Cell Carcinoma - Coramsine receives orphan drug designation from U.S. FDA

Rubella Epidemiology - Measles and rubella vaccination efforts are needed among young women in Argentina

SARS - Researchers' findings advance SARS research

Vaccine Safety - Reports to vaccine adverse event reporting system are used to track vaccine lots

West Nile Virus - Research add new data to west nile virus body of knowledge

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