Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . February 27th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Allergy Medicine - Extraction buffers evaluated using allergenic food protein detection
Anti-Infectives - Human health impact from antimicrobial use in food animals reviewed
Bioterrorism - Advances in responding to bioterrorism and emerging diseases outlined
Endocrinology - New findings in the area of endocrinology described
Meningitis Vaccine - Serogroup A meningococcal vaccines evaluated in Africa
Tuberculosis Vaccine - Mycobacterial heparin-binding hemagglutinin protects against TB
Allergy & Immunology - FDA gives nod to sublingual-oral immunotherapy safety and dosing trials
Allergy Medicine - Methods to estimate allergenicity of novel proteins in mice reviewed
Alzheimer Disease - Enrollment for approved study of implant to treat Alzheimer disease completed
Anti-Infectives - Antimicrobial drug development reviewed
Antimicrobial Resistance - Bayesian model predicts risk of emerging resistance to antimicrobials
Antioxidants - New data illuminates research in antioxidants
Avian Influenza - Bird flu kills 10-year-old girl in southern Vietnam, 12th victim in a month
Bacillus Calmette-Guerin Vaccine - Lymphadenopathy from BCG vaccine reported in child with granulomatous disease
Bioterrorism - Highly efficient Francisella shuttle plasmid constructed
Breast Cancer - Research in breast cancer provides new insights
Business & Finance - Drug development company reports fourth quarter and 2004 results
Business & Finance - Medical device company reports financial performance for 4Q and year 2004
Business & Finance - Science-based pharmaceutical company reports Q4, full-year 2004 results
Business Update - Corgenix announces establishment of bioterrorism defense development program
Business Update - GSA awards construction contract for physics lab at White Oak facility
Business Update - Health products developer and marketer provides R&D update
Business Update - Imaging informatics company relocated headquarters
Business Update - Report: Cholesterol drugs still poised for OTC switch despite Mevacor setback
Business Update - VNS developer submits response to FDA warning letter
Cancer Therapy - FDA grants orphan drug designation to TOCOSOL Paclitaxel in urothelial cancer
Cancer Therapy - Phase III data shows Tarceva plus gemcitabine significantly improves survival
Cancer Vaccine - T cell tumor destruction results from specific triggering at tumor site
Carcinogens - U.S. government list of cancer-causing agents grows
Cardiology - beta1 -AR stimulation increases PI3K activity in adult rat cardiomyocytes
Cardiovascular Disease - Effects of adrenergic agents on post-defibrillation arrest time studied
Chagas Disease - Response to Trypanosoma antigen differentially modulated in mouse strains
Contraception - FDA decision on Plan B OTC status delayed
Cryptosporidium Parvum - Two Cryptosporidium parvum genotypes caused recreational water outbreak
Diagnostics - FDA approves gene-based test for hematuria patients' bladder cancer
Diagnostics - New data shows feasibility of combidex-enhanced MRI
Diet & Nutrition - Folic acid organization announces awareness week
Diet & Nutrition - Youth need training to interpret nutrition labels
Dietary Supplements - Method to determine choline in dietary supplements developed
Digestion - Phytostanyl ferulate esters are hydrolyzed by pancreatic cholesterol esterase
Disease Associations - Prion protein toxicity studied, translocation-medicated protection revealed
Disease Risk - Preventable diseases kill 1.3 million children each year, health experts say
Drug Delivery - FDA approves syringes that let physicians inject and aspirate with one hand
Drug Development - Study offers additional experimental paradigm for analyzing NO-donor metabolism
Drug Development - U.S. FDA approves oral spray for treatment of mouth ulcers
Drug Development - U.S., European regulatory submissions made for Humira
Duchenne Muscular Dystrophy - Biopharma company granted orphan drug designation by FDA for PTC124
Encephalomyelitis Vaccine - Anti-IL-12 p40 auto-vaccine developed
Environmental Exposure - Industrial residues from household-wax manufacturing are mutagenic
Environmental Health - Method to measure 8:2 fluorotelomer alcohol in animal tissues developed
Environmental Health - Mucosal toxicity screening method for chlorinated benzenes developed
Escherichia Coli - Diversity and host range of Shiga toxin-encoding phage reported
Filariasis Therapy - Strategic plan for research to eliminate lymphatic filariasis outlined
Finance - Angina-focused company reports strong Q4 and 2004 results
Finance - Dermatology company reports Q4 net income of $6.4M; product revenues up 128%
Finance - Sun Pharmaceutical sub reports positive third quarter
Finance - Thalomid maker reports strong revenue growth and profits
Finance - Vaccine maker reports 2004 pro forma earnings down more than 50% from 2003
Fitness - Walking or biking to elementary school not an option for most students
Flavivirus Vaccine - Flavivirus envelope glycoprotein cross-reactive epitopes characterized
Food-Borne Illness - Beta-agonists found in bovine retina and liver
Genomics - Report describes expression of tilapia extracellular Ca2+-sensing receptor
Genomics - Study identified biochemical and genetic defect in L-2-hydroxyglutaric aciduria
HIV/AIDS Coinfection - HAART immune reconstitution trigger adverse effects in M. leprae coinfection
HIV/AIDS Epidemiology - Report: AIDS on the rise among blacks
HIV/AIDS Prevention - HIV-infected gay men acknowledge risky sex behavior
HIV/AIDS Screening - HIV screening based on patient complaint is cost-effective in low-resource areas
HIV/AIDS Therapy - FDA grants tentative approval to generic AIDS drug regimen
HIV/AIDS Therapy - P-TEFb kinase inhibitor flavopiridol inhibits HIV transcription elongation
HIV/AIDS Therapy - Patient enrollment in phase 3 trial of somatropin injection for HARS complete
HIV/AIDS Vaccines - Recent findings in HIV/AIDS vaccines provide new insights
Haemophilus - Cuban children develop natural immunity to Haemophilus influenzae type b
Health Promotion - Women's reproductive rights lacking in Indonesia
Healthcare Access - Healthcare system struggling to treat basic ailments in tsunami-hit areas
Healthcare Access - Kenyan government admits it failed to distribute international aid
Healthcare Coverage - Fallon Community Health Plan to offer Medicare beneficiaries a PPO option
Hemorrhagic Fever - Crimean-Congo hemorrhagic fever outbreak spread via contact with animal blood
Hepatitis B - Drug for treatment of chronic hepatitis B up for approval
Herpes Virus - Company conducts pre-IND FDA conference for CY301 antiherpes cream
Herpesvirus - HHV-8 transmission is independent of antibody levels of infected transmitter
Infant Mortality - Expert says Aboriginal infant mortality can be reduced with government help
Infectious Disease - WHO warns of increased risk of vector-borne diseases in tsunami-affected areas
Influenza Vaccine - Influenza in Thailand studied as model for middle-income countries
Information Technology - NIH selects Sunrise Surgical Manager
Injury Prevention - Highest average rate of U.S. road deaths on Independence Day
Lactobacillus - Aminoglycoside sensitivity in Lactobacillus due to cholic acid
Legionella - Method simultaneously detects genes and epidemiologically types Legionella
Leishmaniasis - Leishmania guyanensis cause of disseminated cutaneous leishmaniasis
Lung Cancer - Mutant K-ras(V12) increases COX-2/peroxides/DNA damage in lung cells
Lupus - Innovative research receives increased funding
Lyme Disease Vaccine - Outer surface protein E structural domains involved in antibody binding
Malaria Therapy - Impact of antimalarial drug withdrawal on parasite resistance reported
Medical Devices - Device for bioaerosol monitoring of viruses described
Medical Ethics - U.S. National Institutes of Health announces tighter ethics rules
Medicare - Medicare prescription benefit to cover Viagra, other 'lifestyle' drugs
Medicare - Rx plan pushed for disabled Nevadans
Melanoma Vaccine - Growth of T cell clones from melanoma tumor-infiltrating lymphocytes studied
Microbial Resistance - Carbapenem & ciprofloxacin most effective antimicrobials for ESBL-EK bacteremia
Mosquito-Borne Disease - Infection patterns of o'nyong nyong virus in mosquitoes reported
Mosquito-Borne Disease - Mosquito saliva enhances Plasmodium parasite development in chickens
Mycobacteria Vaccine - Mycophage therapy, drugs, and vaccines to control M. avium compared
Mycotoxin - Thermal food processing affects structure and toxicity of fumonisin mycotoxins
Myelodysplastic Syndrome - Altered gene expression characterized in MDS hematopoietic progenitors
Neuroscience - Glucocerebrosidase mutations may correlate with the onset of parkinsonism
Neuroscience - Vanilloid and endocannabinoid receptors coexpressed in brain endothelium
Nicotine Addiction - Racism adds pressure that can lead to youth smoking
Nicotine Addiction - Youth smoking tied to tobacco control spending
Nosocomial Infection - Good infection control practices help prevent nosocomial infections
Obstetrics - Progesterone therapy could prevent thousands of preterm births
Obstetrics - Statins are teratogenic
Oncology - Tumor endothelial marker 7 is overexpressed in tumor endothelium
Pain Management - AT-101 reclassified as therapeutic vibrator requiring 510k submission
Pain Medicine - FDA allows testing of extended release ibuprofen tablets
Papillomavirus Infection - High incidence of HPV in women with normal cytology
Personnel - David Vandertie appointed CFO at pharma consultancy
Personnel - Dr. Edward Arcuri named chief operating officer of vaccine company
Personnel - Drug delivery company appoints Debbie Thomas director of regulatory affairs
Personnel - Stephen J. Fanning named president, CEO of skin-contour device manufacturer
Pneumococcal Vaccine - Vaccination program lowers invasive pneumococcal disease among elderly
Polio Vaccine - Recommendations for ensuring preparedness for polio outbreaks released
Poxvirus - Factors influencing the ability of poxviruses to induce tumors investigated
Product Licensing - Biopharma company gains access to protein expression technology
Prostate Cancer - FDA grants fast-track designation for phenoxodiol in oral dosage form
Psychology - Interventions become treatments in the world of psychology
Public Health - State policies decrease youth smoking, drinking and sex
Public Health - Television drug ads require more understandable language
Respiratory Medicine - Imprinting by E. coli heat-labile toxin protects against lung infections
Resveratrol - Toxicity from resveratrol seen only at the highest dose tested
Rotavirus Vaccine - Intranasal administration of rotavirus VP6 protein induces protection in mice
SARS - Diagnosis and pharmacotherapy of severe acute respiratory syndrome reviewed
SARS - New findings in the area of SARS described
SARS Coronavirus - Findings in SARS coronavirus provide new insights
SARS Vaccine - Severe acute respiratory syndrome reviewed
SARS Vaccines - Researchers publish new studies and findings in the area of SARS vaccines
Schistosomiasis - Recent findings illuminate research in schistosomiasis
Serine Proteinase Inhibitors - Tick larvae are rich source of Kunitz type serine proteinase inhibitors
Sexual & Reproductive Health - Americans more likely to suffer death and disability due to sexual behaviors
Smallpox - Blocking cell signaling can stymie viral infections
Smallpox Vaccine - Poxvirus research still relevant despite eradication of smallpox
Stroke - Migraine-sparked vision loss may increase stroke risk in women
Surgical Technology - FDA clearance granted to market bone cement
Thyroid Cancer - Irradiation is a cause of thyroid cancer in adult victims of Chernobyl
Tissue Engineering - Rotating wall vessel bioreactor generates neural tissue like constructs
Tobacco Use - Cigarette smoke delays clearance of Pseudomonas aeruginosa
Trypanosoma Brucei - Real-time PCR rapid/sensitive for detection of Trypanosoma brucei in blood
Tuberculosis - Retroperitoneal perforation of colon caused by colonic tuberculosis
Tuberculosis Therapy - Rapid, simple screen for tuberculous drugs developed
Tuberculosis Vaccine - Antigens secreted from Mycobacterium tuberculosis identified
Vaccine Development - FDA approves human hookworm vaccine for phase I safety trials
Vaccine Development - HIV Tat protein breaches the skin barrier and elicits neutralizing antibodies
Vaccinia Virus - Vaccinia virus intermediate stage transcription complemented by proteins
Vascular Disease - EGR1 is a target for AhR agonists in lung epithelial cells
Venezuelan Equine Encephalitis Virus - VEE virus subtype IE genotype continuously circulating in southern Mexico
Werner Syndrome - Werner protein analyzed, helicase regulation revealed
West Nile Virus - Genetic alterations in NY99 WNV genotype responsible for crow-virulent phenotype
West Nile Virus - West Nile virus infection of embryo fibroblasts associated with TNF production
Yellow Fever Vaccine - Yellow fever vaccine safe
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