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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . July 30th, 2006

Non-Subscriber - Summaries Only

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

Food Poisoning - U.S. FDA issues guidance to help prevent introduction of allergens or toxins into food and feed

Newborn Screening - Use of residual dried blood spots from newborn screening programs is examined

Pneumonia Risk Factors - Severe pneumonia due to Staphylococcus aureus was linked to methicillin-resistance

Proteomics - Epstein-Barr virus nuclear antigen 2 induces Fc-receptor homolog 5 expression through CBF1 protein

Public Health - Violence against women is more likely during pregnancy than after delivery

Addiction Medicine - Assessment method affects dosage estimate in recreational ecstasy users

Addiction Medicine - New drug application submitted for studies of subdermal implant for treating opioid addiction

Anthrax Vaccine - Antibiotic prophylaxis plus vaccine protects against anthrax

Anthrax Vaccine - Topical E. coli-vectored vaccine elicits protective immunity

Arthritis Therapy - Sports activity increases after ankle replacement in arthritis patients

Avian Infectious Bronchitis Coronavirus - Genetically diverse avian infectious bronchitis coronavirus strains are circulating in China

Avian Influenza Vaccine - Newcastle disease virus expressing H5 hemagglutinin protects against bird flu

Avian Influenza Vaccine - Viral vaccine constructs have been engineered against bird flu and Newcastle disease

Bacterial Conjunctivitis - InSite Vision announces submission of AzaSite new drug application for conjunctivitis

Biomedical Engineering - Orthovita receives U.S. FDA approval to market Vitagel surgical hemostat

Burns -  Haemophilus influenzae contributes to morbidity but not mortality in burn patients

Business Update - B. Braun Medical launches Duplex for use with Cefoxitin

Business Update - Endo receives FDA approval for extended- and immediate-release Opana for pain control

Business Update - Escalon and PointCare Technologies Inc. sign manufacturing, distribution and co-marketing agreement

Business Update - Hollis-Eden updates status of Neumune RFP for acute radiation syndrome

Business Update - Stryker submits application to U.S. FDA for human protein compound for lumbar spine fusion

Cancer Therapy - Researchers develop novel anti-cancer drugs to treat solid tumors

Carcinogenesis - Oncogenic potential of galactic cosmic rays reviewed

Cardiac Medical Devices - Enrollment complete in safety trial of Medtronic's drug-eluting coronary stent system

Cardiac Medical Devices - U.S. FDA approves Abiomed's IDE for IMPELLA 5.0 minimally invasive cardiac support systems

Cardiac Medical Devices - U.S. FDA approves embolic debris removal device for vein graft, stent placement procedures

Cardiology - Enrollment exceeded in sterol, carotid intima media thickness relationship study

Cholera Therapy - Single-dose azithromycin was effective for treatment of cholera in adults

Cholera Vaccine - Oral cholera vaccines are not recommended for travelers' diarrhea

Chronic Myeloid Leukemia - U.S. FDA approves Sprycel (dasatinib) with two indications

Classic Kaposi Sarcoma - Classic Kaposi sarcoma risk associated with IL8RB and IL13 diplotypes in seropositive Italians

Cochlear Implants - Cochlear receives U.S. FDA approval for next generation of Nucleus Freedom cochlear implant system

Colitis Pathogenesis - Specific amino acids increase mucin synthesis and microbiota in dextran sulfate-treated rats

Critical Care Medicine - Glutamine regulates heat shock protein expression

DNA Plasmid Vaccine - DNA plasmid vaccines against HIV-1, Ebola, SARS and West Nile virus have similar safety profiles

Diabetes Therapy - Gene transfer strategies for beta cell cytoprotection are focus of review

Drug Abuse - Training opportunities in substance abuse are needed for social workers

Drug Development - New gem diether nucleoside with anti-orthopoxvirus activity has been developed

Drug Resistance - Drug-resistant tuberculosis prevalence decreased in New York City from 1991-2003

Drug Safety - Aluminum contamination of parenteral nutrition products is focus of review

Drug Safety - PGXL Laboratories provides DNA testing for Warfarin patients

Drug Safety - Prescribing practices at public health facilities in Laos are described

Epiglottitis Epidemiology - Hib conjugate vaccines change epidemiology of epiglottitis in England

Finance - Health centers trying to rebuild after Katrina get a boost from tax credits

Finance - Lifeblood Medical raises $1.2 million in series B round of funding

Generic Drugs - U.S. FDA approves first generic simvastatin

Generic Drugs - Warner Chilcott receives certification notice on filing of ANDA for oral contraceptive

Glaucoma - Allergan reports U.S. FDA approval of Lumigan for elevated eye pressure

Government Policy - Pharmavite applauds Senate introduction of serious adverse event reporting bill

HIV Testing - U.S. FDA approves fully automated human immunodeficiency test

HIV/AIDS Epidemiology - U.S. HIV prevention spending correlates with HIV testing and awareness

HIV/AIDS Therapy - U.S. FDA approves boosted protease inhibitor that enables HIV drug combination with Fuzeon

HIV/AIDS Therapy - U.S. FDA approves new HIV treatment for patients who do not respond to existing drugs

Healthcare Costs - Cost for antiretroviral drugs determined for low and middle-income developing countries

Healthcare Coverage - Medical care needs were commonly unmet among cancer survivors, particularly uninsured survivors

Heart Failure - Mortality risk score for heart failure admission is validated

Heart Failure - Ortho-Clinical Diagnostics announces U.S. FDA clearance of VITROS NT-proBNP assay

Hepatitis C Virus - Recovery from hepatitis C involves virus-specific memory T cells

Hypertension - U.S. FDA grants approval to Lupin Pharmaceuticals for generic hypertension tablets

Immunology - Maternal immunization can help prevent infections in children

Immunotherapy - Understanding CD8+ cell differentiation needed to develop effective immunotherapies

Macular Degeneration - Macular degeneration drug receives U.S. Food and Drug Administration approval

Malaria Therapy - Suicide was linked with mefloquine use

Medical Devices - Celsion files process change supplement with U.S. FDA for Prolieve Thermodilatation

Medicare - Medicare Part D driving changes in where seniors shop, says study.

Meningitis Epidemiology - Epidemiology of bacterial meningitis is changing among adults in U.K.

Meningitis Epidemiology - Social behavior influences meningococcal carriage in British teenagers

Meningitis Vaccine -  Haemophilus influenzae type b reemerges after DTaP-Hib immunization

Non-Hodgkin Lymphoma - Non-Hodgkin lymphoma risk linked to cytokine polymorphisms in the Tb1/Th2 pathway

Ophthalmology - Visiogen Inc. receives European CE Mark for dual-optic accommodating intraocular lens

Oral Contraceptives - Wyeth receives approvable letter from U.S. FDA for combination oral contraceptive

Organ Transplant - Pharming receives orphan drug designations for rhC1INH from U.S. FDA

Osteoarthritis - Gene therapy approaches for osteoarthritis are focus of review

Osteoporosis - Full-length parathyroid hormone is under review for osteoporosis treatment

Overactive Bladder - Antares reports on phase II meeting with U.S. FDA for Anturol, an incontinence therapy

Patents - Rockwell Medical Technologies receives Hong Kong patent for iron delivery dialysis product

Pertussis Epidemiology - Seroepidemiology of diphtheria and pertussis in Luxembourg is outlined

Product Labeling - Reed Technology and QeL to provide SPL-PLR services for pharmaceutical manufacturers

Product Recall - Triaminic Vapor Patch product recalled in U.S. by Novartis

Prostate Medical Devices - SurModics, AbbeyMoor Medical agree to develop drug-device products for diseases of prostate

Pruritus Therapy - Rational symptomatic therapy for chronic pruritus is focus of review

Pulmonary Embolism - Migration of recovery filter wire causes pericardial tamponade

Rheumatoid Arthritis - Abbott receives U.S. FDA approval for new Humira delivery device

Salmonella Vaccine - Vaccination of sows decreases Salmonella infection in offspring

Schizophrenia - Shared decision-making about antipsychotic medications is examined

Sexual & Reproductive Health - OTC availability of Plan B in Canada reduces health care costs; U.S. FDA opposed to approving

Sickle Cell Anemia - Sickle cell disease in Germany was the focus of investigation

Smallpox Vaccine - siRNA-targeting vaccinia virus double-stranded RNA binding protein is antiviral

Stem Cell Research - Bone marrow-derived keratinocytes not detected in normal skin

Stem Cell Research - Notch controls stem cell proliferation and differentiation in dose-dependent manner

Stem Cell Research - ViaCell announces U.S. FDA conditional approval of plans for trial of cryopreservation device

Stress Reduction - Program reduces parenting stress in families with irritable infants

Tobacco Use - Drug priming reinstates nicotine-conditioned place preference

Tuberculosis Vaccine -  Streptomyces acts as host for production of Mycobacterium tuberculosis proteins

Tuberculosis Vaccine - DNA vaccine was evaluated in guinea pig aerosol tuberculosis infection model

Tuberculosis Vaccine - Tuberculosis antigen ESAT-6 is expressed in Nicotiana tabacum

Tuberculosis Vaccine - Virus-vectored tuberculosis vaccines are effective for mucosal immunization

Vector Development - Adenovirus types attach to and infect lymphocytes and monocytes

Xenotransplantation - Lentiviral CTLA4Ig expression inhibits cytokine responses

Alzheimer Disease - Researchers from the United States detail new studies and findings in the area of Alzheimer disease

Antibiotics - Studies from the United States and Canada describe new findings in antibiotics research

Brucellosis - Researchers from the United States and Italy detail new studies and findings in the area of Brucellosis

Candida - Reports from the United States add new data to candida research

Cholera - Researchers' findings from the United Kingdom and Sweden advance cholera research

Eating Disorders - Researchers' data from the United Kingdom and United States advance eating disorders research

Ebola - Studies from the United States and Germany describe new findings in ebola research

Encephalitis - New findings from Japan, Taiwan and India in the area of encephalitis described

Gastroenterology - Data from the United States, Japan and Poland advance knowledge in gastroenterology research

Genetics - Findings from the United States and Iceland describe new data in genetics research

Genetics - Researchers from the United States and People's Republic of China report details of new studies and findings in the area of genetics

HIV/AIDS - New data from the United States, Japan and Iran lluminates research in HIV/AIDS

HIV/AIDS - Recent findings in HIV/AIDS described by researchers from the United States

HIV/AIDS - Researchers' findings from Thailand, the United Kingdom and the United States advance HIV/AIDS research

Healthcare - Researchers from Canada and the United States provide details of new studies and findings in the area of healthcare

Hypertension - Researchers from the United States and Australia detail new studies and findings in the area of hypertension

Influenza - New data from the United States and Australia lluminates research in influenza

Influenza - Researchers' work from Russia and the United States adds to influenza body of knowledge

Leishmania - New data from Spain, Iran and Israel lluminates research in leishmania

Leishmania - Researchers from India publish new studies and findings in the area of leishmania

Leishmania - Researchers from Iran, the the Netherlands and Brazil report details of new studies and findings in the area of leishmania

Measles - New findings in measles described from the United Kingdom, Saudi Arabia and United States

Neurology - Recent findings from the United States and Canada illuminate research in neurology

Papillomavirus - Findings from the United States, Germany and South Africa advance knowledge in papillomavirus research

Papillomavirus - Research from the United Kingdom, France and Belgium add new data to papillomavirus body of knowledge

Pneumococcal - Researchers from the United Kingdom, Greece and Finland publish new studies and findings in the area of pneumococcal

Pneumococcal - Researchers from the United States report recent findings in pneumococcal

Prostate Cancer - Reports from the United States add new data to prostate cancer research

Prostate Cancer - Researchers from the United States and Netherlands detail new studies and findings in the area of prostate cancer

Streptococcus - Researchers' findings from the United States and Brazil advance streptococcus research

Stroke - Findings from the United States and Italy describe new data in stroke research

Tuberculosis - Researchers from the United States report details of new studies and findings in the area of tuberculosis

Tuberculosis - Studies from the United States and Mexico add new findings to tuberculosis body of knowledge

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