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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . October 9th, 2005

Non-Subscriber - Summaries Only

Related 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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