Susan Hasty, Publisher
Table of Contents . . . October 9th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Dracunculiasis - Analysis of 18S rRNA gene distinguishes Dracunculus species
Environmental Health - Effects of environmental agents on puberty investigated
Salmonella - Multidrug-resistant Salmonella in four animal facilities reported
Smallpox Vaccine - Vaccinia and eczema vaccinatum are rare following smallpox vaccination
West Nile Virus - Epidemiology and transmission dynamics of West Nile virus reviewed
Addiction Medicine - Possible new class of psychoactive medications identified
Adolescent Health - Malaria therapy promotes healthy growth in Vietnamese minority commune
Age-Related Macular Degeneration - Biotech plans to file a BLA for Lucentis for the treatment of AMD
Alzheimer Disease - Efficacy of acetylcholinesterase inhibitors clarified
Alzheimer Disease - sNDA submitted to U.S. FDA for Aricept for treatment of severe AD
Angina - New medicine for angina has same ingredient as MSV 60
Malaria Vaccines - Researchers detail new studies and findings in the area of malaria vaccines
Anthrax Vaccine Development - Edible crop transformed with pagA gene of Bacillus anthracis
Anthrax Vaccines - New data illuminates research in anthrax vaccines
Antimicrobial Resistance - Trends of antimicrobial resistance in Europe are difficult to gauge
Asthma Therapy - Microbes and products have potential in management of allergic asthma
Avian Influenza - Methods to contain pandemic influenza at the source examined
Tuberculosis Vaccines - Research in tuberculosis vaccines provides new insights
Bacterial Meningitis - Risk factors for pneumococcal meningitis in France outlined
Baylisascaris Outbreaks - Larva migrans outbreak fatal to macaques in Japan safari-style zoo
Biowarfare - Thermostable phosphotriesterase from Sulfolobus solfataricus cloned
Breast Cancer - U.S. FDA 501(k) clearance for en-bloc breast biopsy system
Business & Finance - Arrhythmia-focused company reports Q2 revenue of $201,000, updates trials
Business Update - Generic drug maker placed in Official Action Indicated status by U.S. FDA
Tuberculosis Vaccines - Researchers provide details of new studies and findings in the area of tuberculosis vaccines
Business Update - IND application submitted for cholesterol-lowering drug, FM-VP4
Business Update - Immunodiagnostics company released from U.S. FDA's application integrity policy
Business Update - MIV Technologies research note on two new patent filings issued
Business Update - Recombinant protein therapeutics firm gets U.S. FDA licensure for facilities
Cardiology - Article demonstrates heterodimerization of beta1 AR and beta2 AR
Cerebrospinal Meningitis - Chromosomally integrated prophage may promote N. meningitidis clones
Dendritic Cells - Phenotype and function of intestinal dendritic cells investigated
Dengue Fever - Dengue virus vaccine candidates evaluated in rhesus macaque model
Dengue Infection Outbreaks - Prominent GI symptoms/increased symptomatic cases characterize dengue outbreak
Developmental Medicine - Decapentaplegic gene of Drosophila melanogaster analyzed
Diabetes Therapy - Studies advance knowledge in diabetes therapy research
Diagnostics - Antibiotic resistance test discriminates Lactobacillus spp
Diagnostics - Delay in bacterial meningitis treatment associated with poorer prognosis
Diagnostics - Gel Microdrop Growth Assay accurate/sensitive/rapid TB susceptibility test
Diagnostics - Immunoblot test detects antiToxoplasma gondii IgG in saliva
Diagnostics - PRA method accurately identifies mycobacteria culture isolates at species level
Diagnostics - Pneumonia severity associated with Legionella urinary antigen test
Diagnostics - Researchers' findings advance diagnostics research
Diagnostics - Simple colorimetric method detects exposure to microcystins
Diagnostics - Spoligotyping alone overestimates the number of recent MTB transmissions
Diagnostics - Spoligotyping useful for rapid clinical diagnosis of M. tuberculosis
Diagnostics - U.S. FDA okays expanded ThinPrep Pap Test for detecting glandular lesions
Diet & Nutrition - Birth defect organization restates position on folic acid consumption
Drug Development - Extended-release version of Ambien receives U.S. FDA approval
Drug Development - Final U.S. FDA approval granted for generic version of Glucophage XR
Drug Development - IND filed with U.S. FDA for AVN944 for the treatment of cancer
Drug Development - Phase II trial initiated for overactive bladder therapy
Drug Development - Study shows Aclasta is superior to risedronate for Paget disease of the bone
Drug Development - Tramadol ER receives U.S. FDA approval
Drug Development - U.S. FDA allows IND for phase III trial of antifungal agent
Drug Development - U.S. FDA approvable letter issued for Dacogen (decitabine) injection
Drug Development - U.S. FDA issues OTC drug status for a new saliva-stimulating lozenge
Drug Development - U.S. FDA panel recommends approval of rheumatoid arthritis drug
Drug Safety - Study shows faster FDA approval has not increased drugs withdrawn due to safety
Environmental Health - PBDEs and PCBs affect intracellular signaling differently
Epidemiology - L. donovani is predominant pathogen in localized cutaneous leishmaniasis
Epidemiology - Fluoroquinolone-resistant N. gonorrhoeae incidence increasing worldwide
Epidemiology - Origin of SIVmac and SIVstm unraveled
Epidemiology - West Nile virus infection increases with age
Erectile Dysfunction - Reports describe recent advances in erectile dysfunction research
Food-Borne Illness - LC/MS/MS method to analyze chloramphenicol in crab meat developed
Generic Drugs - ANDA for generic levalbuterol hydrochloride inhaled form submitted to U.S. FDA
Generic Drugs - Pharmaceutical companies launch generic version of Aventis' Allegra tablets
Genetics & Genomics - Collaborating scientists illuminate small RNA component of transcriptome
Gonorrhea Therapy - Treatment of drug-resistant Neisseria gonorrhoeae optimized
HIV/AIDS Coinfection - IL-6 and HIV RNA predict anorexia/wasting in adults with pulmonary tuberculosis
HIV/AIDS Infection - Outbreak of West African HIV recombinant in Uzbekistan reported
HIV/AIDS Pathogenesis - Myeloid/plasmacytoid DCs transfer HIV-1 preferentially to Ag-specific CD4+ cells
HIV/AIDS Pathogenesis - Vpr-mediated cell cycle arrest important for HIV replication and pathogenesis
HIV/AIDS Prevention - Postexposure prophylaxis compliance low for sexual assault in South Africa
HIV/AIDS Transmission - Reports add new data to HIV/AIDS transmission research
HIV/AIDS Vaccine Development - Antigen-presenting cells do not modulate immune responses
HIV/AIDS Vaccine Development - Glycosylation affected the efficacy of vaccine against SIV
HIV/AIDS Vaccine Development - Immunogenicity of HIV-1 envelope glycoprotein complex evaluated
HIV/AIDS Vaccine Development - Mucosal alloimmunization inhibits SIV infectivity
HIV/AIDS Vaccine Development - Properties of peptide mimotopes of HIV carbohydrate antigens reported
HIV/AIDS Vaccine Development - Replicating adenovirus-HIV vaccines are better at eliciting immunity
HIV/AIDS Vaccine Development - Virions with HIV Env induce high-titer neutralizing antibody responses
HIV/AIDS Vaccines - Researchers' findings advance HIV/AIDS vaccines research
HIV/AIDS-Associated Cryptococcosis - Cryptococcosis incidence decreased in HIV+ persons prior to HAART era
HIV/AIDS-Associated Mycobacteriosis - Parotid mycobacteriosis frequently caused by MTB in advanced AIDS
HIV/AIDS-Herpes Simplex Virus Type 2 Coinfection - Treating HSV-2 in HIV-coinfected persons delays need for HAART
HIV/AIDS-Related Herpes Simplex Virus Type 2 - Macaque dendritic cells can become infected by herpes simplex virus type 2
Haemophilus Vaccine Development - Epiglottitis incidence reduced after Haemophilus influenzae vaccine
Haemophilus Vaccine Development - Hib vaccine failure linked to multiple copies of capsulation b locus
Heart Disease Risk Factors - No confounder found for alcohol and coronary heart disease risk
Hepatic Veno-Occlusive Disease - Defibrotide maker to commence phase III trial following discussions with FDA
Influenza - Agency approves new influenza vaccine for upcoming flu season
Influenza - GlaxoSmithKline announces U.S. FDA approval of Fluarix
Influenza - Highly pathogenic H5N1 viruses in ducks are a serious threat to humans/animals
Influenza Epidemiology - Need for effective influenza vaccine in infants demonstrated
Influenza Outbreaks - Influenza H3N2 viruses continue to drift from vaccine strains in Nepal
Influenza Vaccine Development - Method for nasal influenza vaccine delivery using chitosan developed
Influenza Vaccine Development - Respiratory vaccination of mice against influenza virus examined
Influenza Vaccine Efficacy - Influenza vaccines are safe and effficacious in HIV-positive patients
Influenza Vaccines - New findings in the area of influenza vaccines detailed
Information Technology - Contract awarded to provide data to U.S. Food and Drug Administration
Information Technology - Data management provider announced development agreement with the FDA
Information Technology - Foundation releases report on health information exchange efforts, progress
Iron Supplements - Hypersensitivity reactions linked to intravenous iron preparations
Liposome Vaccine Development - PRA International helps complete BLP25 liposome vaccine phase III study
Liver Cancer - Reports describe recent advances in liver cancer research
Lyme Disease - Approaches to host cell adhesion by Lyme disease spirochete examined
Malaria - Recent findings in malaria described
Malaria Genomics and Genetics - Roles of Plasmodium mutations in chloroquine therapy examined
Malaria Outbreaks - Msp1 B-K1/varD genotype associated with severe malaria on French Guiana coast
Malaria Vaccine Development - Full-length cDNA libraries used to develop malaria vaccines
Malaria Vaccines - Research in malaria vaccines provides new insights
Medicaid - EDS awarded $59.1M, 3-year extension of Oklahoma Medicaid contract
Medical Devices - 510k application submitted to U.S. FDA for Oculase MD for ophthalmology
Medical Devices - Device company receives U.S. FDA clearance for MedStar
Medical Devices - European approval granted for drug-eluting stent system
Medication Safety - Pharmacists educate consumers on proper medication use
Meningitis Vaccine Development - Investigational meningitis vaccine immunogenic in children
Mergers & Acquisitions - GlaxoSmithKline to acquire biotech company
Metabolic Syndrome - Integrated approach to tackling metabolic syndrome presented
Metabolic Syndrome - Researchers' findings advance metabolic syndrome research
Myopia - U.S. FDA approves laser system for high myopia with astigmatism
Neisseria Gonorrhoeae Outbreaks - Prolyliminopeptidase-negative N. gonorrhoeae strain circulating in Denmark
Occupational Health - Body composition influences relative metabolic demands of load-carriage
Pain Management - NDA filed for OraVescent fentanyl for management of cancer patients' pain
Pain Management - U.S. FDA approves marketing of sugar-free formulation of ACTIQ
Pediatric Thrombosic Risk Factors - Prothrombotic factors are common in children with stroke, porencephaly
Personnel - Ex-FDA division director joins pain-focused pharmaceutical company
Personnel - George Kuniholm joins regulatory consultancy as New England regional manager
Pertussis Vaccine Development - B. pertussis in countries with different vaccine policies analyzed
Pertussis Vaccines - New findings in the area of pertussis vaccines detailed
Pharmacokinetics - Bioequivalence study of citalopram reported
Pneumococcal Vaccine Development - Pneumococcal infections in population with low HIV prevalence examined
Polio Vaccines - Researchers detail new studies and findings in the area of polio vaccines
Public Health - Kaiser Permanente contributes $2 million for public health response to Katrina
Ross River Disease Outbreaks - Various factors predict Ross River virus disease outbreaks
SARS - New findings in the area of SARS detailed
SARS Vaccine Development - Expression of SARS-CoV spike protein subunit elicits immune responses
Schistosomiasis Vaccine Development - Schistosoma mansoni protein protects against schistosomiasis
Sexually Transmitted Diseases - Researchers publish new studies and findings in the area of sexually transmitted diseases
Smallpox Vaccine Development - Vaccinia virus tropism determined by expression of virus receptor
Surgical Technology - U.S. FDA expands FS30 laser use to include Keratoplasty corneal resections
Tick-Borne Disease - Ixodes scapularis cDNAs protective against infestation characterized
Tick-Borne Disease - Cross-reactive tick cement antigen used for broad-spectrum tick vaccine
Tick-Borne Disease - Methods for preparation of tick-derived stabilates compared
Tissue Engineering - Bone marrow-derived fibroblasts recruited into fibrotic lesions
Tobacco Use - Pharmacotherapy and pharmacogenetics of nicotine dependence reported
Transplant Medicine - U.S. FDA approves Cobas AmpliScreen hepatitis B test
Tuberculosis Diagnosis - Rheumatoid arthritis reduces response to purified protein derivative
Tuberculosis Therapy - Imipenem has antimycobacterial activity in MTB-infected patients
Tuberculosis Vaccine Development - Proteomics identify membrane-associated proteins of M. tuberculosis
Tuberculosis Vaccines - Recent findings in tuberculosis vaccines provide new insights
Vaccine Development - U.S. FDA approves Proquad, a one-shot MMR and chickenpox vaccine
Vaccine Efficacy - Household cost-benefits of sustainable childhood immunization examined
Vibrio Cholerae - V. fluvialis and V. cholerae El Tor hemolysin gene similar
Vision Problems - Improved safety in contemporary LASIK reviewed
Zoonosis - Salmonella outbreak occurred between animals and humans in vet clinics
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