Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . September 25th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Antimicrobial Resistance - Cefoxitin test correlates with mecA presence in Staphylococcus
Environmental Health - Acute illnesses associated with pesticide exposure at schools reported
Immunology - CD4-CD8- T cells control intracellular bacterial infections
Immunotoxicity - Biomarkers assess potential developmental immunotoxicity in children
Smallpox Vaccine Development - Monitoring health care workers after smallpox vaccination described
Alcohol Use - Acamprosate for treatment of alcohol dependence reviewed
Allergy & Immunology - ELISA to detect raw and processed egg developed
Amyloid A Amyloidosis - New drug application initiated for Fibrillex
Angiology - Company reports on successful use of CLiRpath 2.5 Turbo Catheter
Anthrax - New method detects anthrax proteins at ultra-low concentrations
Anthrax - Researchers report details of new studies and findings in the area of anthrax
HIV/AIDS Vaccines - Studies add new findings to HIV/AIDS vaccines body of knowledge
Anthrax Vaccines - Recent findings illuminate research in anthrax vaccines
Atrial Flutter - Company reports progress in U.S. FDA review of atrial flutter PMA
Avian Influenza - Avian flu in Russia may be resistant to amantadine
Avian Influenza - Bird flu claims critically endangered mammal
Avian Influenza - U.S. adults only moderately concerned about avian flu, but endorse preparation
Blood Safety - Exposure levels of di(2-ethylhexyl) phthalate from blood bags reported
Malaria Vaccines - Researchers provide details of new studies and findings in the area of malaria vaccines
Business & Finance - Alzheimer drug maker reports clinical update, $0.05 per share loss
Business Update - Humana Military Healthcare Services receives URAC accreditation
Business Update - U.S. FDA clears SET LNOP Blue sensor for cyanotic babies
Business Update - VNS therapy hits milestone: More than 100,000 patient years of experience
Cancer Research - U.S. FDA approves special protocol assessment for phase III PRECISE trial
Cancer Vaccine Development - Dendritic cell vaccine accelerates CD8+ memory and prime-boost response
Tuberculosis Vaccines - New data illuminates research in tuberculosis vaccines
Cancer Vaccine Development - Human carcinoembryonic antigen-based cancer vaccines reviewed
Candidemia Risk Factors - Risk factors for candidemia among newborn infants determined
Cardiology - Catheter-delivered pacing lead for placement in right heart chambers introduced
Cardiology - First U.S. double implant of new heart valve reported
Cardiology - Heart failure guidelines support use of drug recently approved by U.S. FDA
Cardiology - U.S. FDA clears catheter for long total occlusions in superficial femoral artery
Tuberculosis Vaccines - Recent findings illuminate research in tuberculosis vaccines
Cardiology - U.S. FDA grants approval of IDE to begin enrollment in ESCAPE migraine study
Cholera Vaccine Development - Immune response kinetics after immunization with cholera toxin reported
Clinical Trials - Study shows docetaxel injection with paclitaxel improves breast cancer survival
Clinical Trials - U.S. FDA agrees on design of Viprinex trial, Xerecept trial enrollment announced
Coronary Artery Disease - Company gets approval to expand U.S. drug-eluting stent trial
Coronary Artery Disease - U.S. FDA approves ACEON to reduce risk of cardiovascular mortality
Tuberculosis Vaccines - Reports add new data to tuberculosis vaccines research
Crohn Disease - High MAP prevalence in gut tissues from patients with Crohn disease
Dengue Fever - Recombinant multi-epitope protein as dengue diagnostic reagent designed
Dental Care - U.S. FDA 510(k) clearance granted for DynaGraft II dental
Diabetes Complications - Race and ethnicity a factor in diabetics' risk for complications
Diabetes Epidemiology - Glucose intolerance in United Arab Emirates investigated
Diabetes Epidemiology - Type 1 diabetes incidence in children in Caceres, Spain, reported
Tuberculosis Vaccines - Researchers report details of new studies and findings in the area of tuberculosis vaccines
Diabetes Therapy - Beta cell function and therapy response in diabetic Nigerians examined
Diagnostics - Acute dengue fever diagnosed by both RT-PCR and IgM detection
Diagnostics - BDProbeTec ET assay more sensitive than COBAS AMPLICOR MTB for MTB detection
Diagnostics - Gel microdrop growth assay, flow cytometry rapidly test MTB drug susceptibility
Diagnostics - Hybrid capture for HPV-related cervical infection in HIV/AIDS sensitive/specific
Diagnostics - One processing method used for mycobacterial detection by microscopy/culture/PCR
Diagnostics - Self-collected samples accurately diagnose chlamydia/gonorrhea in NAATs
Diagnostics - Single-specimen processing for mycobacterial detection sensitive, specific
Diagnostics - TaqMan real-time PCR may be used to measure HIV RNA in resource-limited settings
Diagnostics - U.S. FDA clears Duet System for automated FISH scanning
Diet & Nutrition - Article provides overview of database of research on dietary supplements
Diet & Nutrition - Family education leads to healthier diet for disease-prone children
Diet & Nutrition - Prevalence of high intake of vitamin E in U.S. adults reported
Diet & Nutrition - Recent findings in diet & nutrition described
Diffuse Lamellar Keratitis Epidemic - Silicone oil contamination of surgical gloves associated with epidemic DLK
Disease Control - Lipophilic antifolate trimetrexate inhibits Trypanosoma cruzi
Disease Control - MTB-infected dogs may be a permanent source of infection to humans and animals
Drosophila Genomics & Genetics - Decapentaplegic gene of Drosophila melanogaster examined
Drug Addiction - Teenage drug use can lead to adult addiction and heart attack
Drug Delivery - Company cleared to market Turbo-Flo PICC lines for delivery of contrast media
Drug Development - Anticancer compound cleared to advance into human clinical trials
Drug Development - Antisoma granted U.S. orphan drug status for AS1411 in renal cancer
Drug Development - Indications for Singulair expand with approval for perennial allergic rhinitis
Drug Development - Intravenous iclaprim granted fast track status by U.S. FDA
Drug Development - Marketing applications to be submitted for Xyotax in U.S, Europe
Drug Development - NDA filed for anidulafungin for treatment of invasive candidiasis/candidemia
Drug Development - Nebulization of SLP-based antitubercular drugs improves bioavailability
Drug Development - Nevanac gets U.S. FDA approval for pain associated with cataract surgery
Drug Development - Orphan drug designations granted for AP23573
Drug Development - U.S. FDA grants approval for additional Clozapine strength
Drug Development - U.S. FDA issues explanation on phase II study of ALS drug
Drug Resistance - Ciprofloxacin failure against tuberculosis due to rapid emergence of resistance
Dysentery Outbreaks - Ceftriaxone-resistant Shigella sonnei associated with dysentery outbreak
Environmental Health - Childhood exposure to second-hand smoke has long-lasting effects
Environmental Health - Partial smoke-free policies will exempt more than 500 pubs in English region
Epidemiology - A/H3N2/Panama/2000/99 is the predominant influenza serotype in Chennai
Epidemiology - Cystic fibrosis P. aeruginosa strain has enhanced virulence, resistance
Epidemiology - Enterotoxigenic E. coli, Vibrio cholerae cause epidemic diarrhea
Epidemiology - Family physicians in Hong Kong, Canada did not differ in handling SARS epidemic
Epidemiology - Rainfall and sea surface temperatures are early warning indicators for malaria
Epidemiology - Similarity shown between two bacterial meningitis strains
Feline Immunodeficiency Virus - IgG from acutely infected cats blocks mucosal FIV infection
Finance - Chinese pharmaceutical company reports first and second quarter 2005 results
Finance - Instrumentation/biotech company will miss 5-day extension for filing of Q2 10Q
Food Safely - Agency: Untreated juices may pose health risk
Food-Borne Illness - Semicarbazide in bread products measured by LC-MS
Glaucoma - New formulation of Alphagan P receives U.S. FDA approval
HIV/AIDS Diagnostics - VIDAS HIV DUO Ultra improved specificity for early HIV seroconversion detection
HIV/AIDS Epidemiology - Diversity and divergence of HIV in chronically infected women examined
HIV/AIDS Epidemiology - HIV C77G polymorphism in exon 4 of CD45 gene is prevalent in Spanish population
HIV/AIDS Epidemiology - HSV-2 is a primary cofactor in facilitating the spread of HIV infection
HIV/AIDS Genomics & Genetics - Prevalence of resistant mutations in Greek HIV-1 patients reported
HIV/AIDS Pathogenesis - CD4 binding partially locks gp120 bridging sheet, leaves BETA2/3 strand flexible
HIV/AIDS Prevention - Intention to use condoms increased in theory-based HIV risk reduction program
HIV/AIDS Vaccine Development - CD8+ depletion reduced virus levels of virus in SIV-vaccinated macaques
HIV/AIDS Vaccine Development - DNA prime and adenovirus boost enhance immunity to HIV immunogens
HIV/AIDS Vaccine Development - DNA vaccines expressing SIV antigens decrease viremia upon challenge
HIV/AIDS Vaccine Development - Factors affecting retention in HIV vaccine clinical trials examined
HIV/AIDS Vaccine Development - Glycosylation affects efficacy of an Env-based vaccine against SIV
HIV/AIDS Vaccine Development - HIV vaccine reduces CD8+ expansion but improves virus control
HIV/AIDS Vaccine Development - Priming-boosting regimen enhance plasmid DNA microparticle HIV vaccines
HIV/AIDS Vaccine Development - Properties of peptide mimotopes of HIV carbohydrate antigens outlined
HIV/AIDS Vaccine Development - Replicating adenovirus-HIV vaccines elicit high cellular immunity
HIV/AIDS Vaccines - Researchers' work adds to HIV/AIDS vaccines body of knowledge
HIV/AIDS-Associated Infection - Cotrimoxazole prophylaxis reduces morbidity/mortality among HIV- family members
Haemophilus Influenzae - rRNA gene diversity in Haemophilus influenzae useful for subtyping
Healthcare Coverage - Quality of primary health care in Saudi Arabia reviewed
Herpes Vaccine Development - Parents' willingness to vaccinate children against herpes examined
Imaging - Flat panel display added to PACS display solutions
Imaging - Studies conclude MS-325 (Vasovist) improves imaging in MRA
Immunology - New findings in the area of immunology described
Infectious Bronchitis Virus - Gene 5 of infectious bronchitis virus not needed for replication
Influenza - CMS proposal would require nursing homes to vaccinate residents against the flu
Influenza - Donation of 3 million treatments of oseltamivir will help in event of pandemic
Influenza Vaccines - New research in the area of influenza vaccines detailed
Influenza Virus - Attenuated mutant influenza strain developed for vaccine use
Information Technology - U.S. FDA's CDER to use and evaluate Resolver System
Information Technology - U.S. VA Medical Center awards contract for acute nurse staffing services
Insulin Resistance - Recent findings in insulin resistance provide new insights
Insulin Sensitivity - QUICKI is accurate surrogate index for measuring insulin sensitivity
Legal Issues - Medical devices company notified that U.S. FDA lawsuit trial start postponed
Liver Cancer - Deaths related to hepatocellular carcinoma are on the rise in Japan
Magnetic Resonance Imaging - CR bolus-tracking shows evidence for shutter-speed variation in human pathology
Malaria Vaccines - Recent findings illuminate research in malaria vaccines
Medical Devices - CLIA waived status reported for analytes when used with Piccolo analyzer
Methanol Poisoning Outbreaks - Late diagnosis caused increased morbidity in methanol poisoning outbreak
Methicillin-Resistant S. Aureus Outbreaks - MRSA outbreaks occurred in two nursing homes in central Norway
Mycobacteria Abscessu Outbreaks - Mycobacteria abscessu outbreak in U.S. linked to offshore surgicenter
Mycobacterium Bovis - Mycobacterium bovis P36 gene mutation provokes attenuation of the bacillus
Mycobacterium Tuberculosis - Intramembrane proteolysis regulates MTB cell envelope composition and virulence
Mycobacterium Tuberculosis-Related Meningitis - MTB virulence in meningitis depends on bacilli-produced phenolic glycolipid
Neosporosis Vaccine Development - Microneme antigen NcMIC1 protects against cerebral neosporosis
Neurotoxicity - Biomarkers of adult and developmental neurotoxicity reviewed
Nevirapine Resistance Mutation - NVP resistance after single dose higher in women with HIV-1 subtype C than A/D
Nicotine Addiction - Nicotine exposure can increase motivation to seek food
Obesity Pathogenesis - Economics of obesity reviewed
Oral Health - New report finds improvements in oral health of Americans
Oral Health - Smokers less likely to visit dentist than nonsmokers
Osteoporosis - U.S. FDA approves prescription risedronate with calcium tabs for osteoporosis
Pain Management - Company announces positive results from its extended-release oxymorphone study
Pandemic Influenza - Positive preclinical results reported on vaccine for pandemic influenza
Pediatric Obesity - Fast-food restaurants cluster around schools
Pediatrics - Outcomes for children with special health care needs compared by state
Pertussis Vaccine Development - Pertussis virulence factor retains properties after production
Pertussis Vaccine Development - Vaccine prevents exacerbation of asthma due to Bordetella pertussis
Pneumococcal Vaccine Development - Universal pneumococcal vaccination of Italian infants is cost effective
Polio - Indonesia launches country's largest-ever immunization campaign
Polio Vaccine - Oral poliovirus strains do not persist after vaccine switch
Presbyopia - Enrollment in final round of SSP clinical trial approved by U.S. FDA
Rectal Cancer - U.S. FDA grants clearance of pharmacogenetic test for in vitro diagnostic use
Respiratory Medicine - Modeling control strategies of respiratory pathogens presented
Retroviral Vectors - Mutations alter cytopathic effects in chimeric avian retroviral vectors
SARS - New research in the area of SARS detailed
SARS - Toronto physicians reveal fears while coping with SARS outbreak
SARS Vaccine Development - SARS-CoV spike protein elicits specific humoral immune responses
SARS Vaccines - Research in SARS vaccines provides new insights
Sexual & Reproductive Health - Predictors of STD vaccine acceptability investigated
Smallpox Vaccine Development - Vaccine shows activity in mouse model of vaccinia virus infection
Smallpox Vaccine Development - Vaccinia virion membrane protein required for cell entry and fusion
Smallpox Vaccine Development - Vaccinia virus tropism determined by unique virus receptor expression
Staphylococcal Vaccine Development - Antibody repertoires against Staphylococcus aureus compared
Stem Cell Research - Embryonic stem cell lines generated from poor quality day 3 embryos
Stem Cell Transplantation - Donor cell allodepletion may reduce severe acute GVHD rate in older patients
Stroke - Neurological disorders institute adds stroke information for seniors to web site
TB Epidemiology - WHO declares TB an emergency in Africa
Tick-Borne Disease - Specific dsRNA silences isac gene in Ixodes scapularis nymphs
Tissue Engineering - Bone is formed by hMSCs in biodegradable scaffolds that release Dex/AsP
Tissue Engineering - Data advance knowledge in tissue engineering research
Tooth Loss - Tooth loss increased risk of death from upper GI cancer, HD, and stroke
Tuberculosis Diagnosis - Mycobacterium glycolipids act as markers for diagnosis of active TB
Tuberculosis Risk Factors - HLA haplotypes related to tuberculosis risk or resistance
Tuberculosis Vaccine Development - Ag85b and MPT64 DNA vaccines in model of tuberculosis examined
Tuberculosis Vaccines - Findings in tuberculosis vaccines provide new insights
Vaccine Development - EPIMHC is database of MHC-binding peptides for vaccinology
Varicella-Zoster Virus - Studies describe new findings in varicella-zoster virus research
Weight Loss - Black and low-income women need tailored weight-loss strategies
West Nile Virus - Focal neurological injury caused by WNV may occur independent of age and health
West Nile Virus - Recent findings illuminate research in west nile virus
Yellow Fever - Two imported cases of yellow fever infection analyzed
Yellow Fever Vaccine Development - Yellow fever viruses expressing foreign epitopes are vaccine candidates
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