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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . November 7th, 2004

Non-Subscriber - Summaries Only

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

Brain Cancer - N-ethyl-N-nitrosourea increases brain mutations in neonatal mice

HIV/AIDS Therapy - Critical reporting elements for quality of study methods reported

Pneumococcal Vaccine - Murine model of immunity induced by pneumococcal vaccine developed

Poliomyelitis - Change in polio vaccine policy eliminates cases of vaccine-associated polio

West Nile Fever - Clinicopathologic study of West Nile Virus encephalomyelitis reported

AIDS/HIV Diagnosis - HIV-1 superinfections assessed by autologous heteroduplex mobility

AIDS/HIV Epidemiology - Current state of HIV and AIDS in Sub-Saharan Africa reviewed

Abdominal Aortic Aneurysm - FDA approves medical device to treat AAA

Acinetobacter Baumannii - Multiresistant Acinetobacter baumannii outbreak occurred in surgical room

Addiction Medicine - U.S. HHS awards grants to treat co-occurring substance abuse/mental disorders

Adverse Drug Events - Study documents adverse events of pneumococcal vaccine in children

Allergy Medicine - Patient knowledge of allergy immunotherapy better than expected

Anthrax - Study of primary care doctors' response to 2001 attacks shows prudent care

Arsenic Pollution - Synthetic zeolites used for arsenate removal from pollutant water

Arthritis - Pharmaceutical company offers its alternative to recalled arthritis medication

Avian Influenza Vaccine - Reassortant influenza vaccines control avian influenza

Awards - Biotech firm lauds Nobel winner, announces olfactory-based government contract

Bacterial Pathogen - Oligonucleotide array technology rapidly detects foodborne pathogenic bacteria

Bioterrorism - District of Columbia EHMSA licenses VisualDx diagnostic software

Bioterrorism - NIH grants awards for the development of human antibody against anthrax

Bipolar Disorder - FDA approves ABILIFY for acute bipolar mania, including manic and mixed episodes

Business Update - Agreement signed for distribution of bacterial detection system in Japan

Business Update - University study affirms efficacy of pheromone-based products, company says

Cancer Research - Companies announce filing of MAA in Europe to inject anticancer drug for MDS

Cancer Screening - DOD awards sole-source contract for the ThinPrep Pap Test

Cancer Therapy - Compounds with MDR1-enhanced anticancer activity identified

Cancer Therapy - Protein biomarkers and drug design for cancer treatments reviewed

Cardiac Monitors - FDA approves marketing a newly developed cardiac monitor

Cardiology - After initial damage, protective mechanisms within the heart were initiated

Cervical Cancer - Infection site and patient ethnicity affect HPV-induced cancer pathways

Cervical Cancer - Socioeconomic disparities affect disease incidence and mortality in U.S.

Childhood Obesity - Prevalence of overweight and obesity among Kuwaiti adolescents reported

Clinical Trials - Clinical investigators review, endorse phase 2 trials for deep vein therapy

Clinical Trials - Company expands consulting services to full service clinical trials

Clinical Trials - Drug improves Huntington disease movement disorder in clinical trial

Cochlear Implant - Bionics cochlear auditory implants recalled worldwide

Cognitive Function - Decision-making brains weigh up evidence

Conjunctivitis Outbreak - E-mail surveys assist investigation and response in conjunctivitis outbreak

Cystic Fibrosis - Company announces final research report on cystic fibrosis treatment

Cystic Fibrosis - Foundation urges newborn screening for CF in test panels

Dental Caries - HIV infection increases risk of dental caries in children

Dermatology - FDA issues 510(k) clearance for Varilite dual wavelength laser

Diabetes Prevention - Researchers study sixth-graders to prevent type 2 diabetes

Diabetes Therapy - FDA approval granted for Metformin Hydrochloride 500 mg

Diagnostics - U.S. NIH grant to fund human asthma testing with Breathmeter

Drug Delivery - U.S. FDA approves new and easy way to take ENBREL

Drug Development - Pharmaceutical receives U.S. FDA approval of GI disease and hepatitis drugs

Drug Development - Study results of treatment for leukemia with arsenic trioxide presented

Drug Development - U.S. FDA grants orphan status to drug for treatment of soft tissue sarcoma

Emerging Pathogens - Emerging pathogen suggests amphibian trade should be closely monitored

Environmental Health - Diesel exhaust enhances expression of IL-13 in bronchial epithelium

Esophageal Cancer - Company announces clinical hold on TNFerade trials

Finance - Company raises $12 million to fund gene therapy

Finance - NIH funds first national SNP genotyping center

Food Safety - Food-borne illness strikes at least 2 billion people a year

Food-Borne Illness - Biogenic amines and bacteria analyzed in recalled canned anchovies

Generic Drugs - Pharma company recieves FDA approval for nicotine gum and ibuprofen suspension

Genomics - Comparative study of Legionnaire's disease published

Glaucoma - FDA gives final approval for Brimonidine Tartrate Ophthalmic Solution, 0.2% ANDA

Glioblastoma Multiforme - Protein patterns can be used to identify GBM subtypes

Glycopeptide-Resistant Enterococci - Debate-guidelines for glycopeptide-resistant enterococci control have not worked

HIV/AIDS Epidemiology - HIV-1 non-B subtypes from heterosexual transmission predominate in Scotland

HIV/AIDS Prevention - Primary hotline questions in Netherlands regard HIV transmission/risk/testing

HIV/AIDS Research - APOBEC3G incorporated into HIV-1 virions through viral/nonviral RNA interactions

HIV/AIDS Research - Host cell gene expression varies during HIV-1 latency or reactivation

HIV/AIDS Treatment - Study: Fuzeon plus active boosted PI doubles long-term response

Healthcare Access - New PAHO fact sheets on HIV reflect differences in cost, care, coverage

Heart Disease - Canadian biotech company begins two studies on cholesterol combination therapy

Heart Disease - Clinical trials slated for choelsterol drug

Hepatitis/HIV Coinfection - FDA grants priority review to Pegasys with Copegus for HCV in HIV patients

Hepatocellular Carcinoma - Gene expression patterns with prognostic value identified

Hodgkin's Disease - Drug receives orphan designation

Imaging - FDA extends review period for contrast agent MS-325 by 3 months

Imaging - Lung image database consortium established for medical imaging researchers

Immunology - IL-7 has dose-dependent effects on T-cell development

Infection Control - Disinfection, and sterilization adherence reduce hospital-related infections

Infectious Disease - Company awarded SIBR grant for infectious disease detection

Influenza - Drug-DNA combination could offer longer-lasting, more efficient flu vaccine

Influenza - Experts: Good hygiene can ward off flu

Influenza - Study to test flu shot and nasal spray flu vaccine side by side

Influenza - Survey of hospitals quantifies flu vaccine price gouging

Influenza - Thirty million doses of influenza vaccine shipped to healthcare providers

Influenza - U.S. CDC urges high-risk groups to get vaccinated, healthy people to wait

Influenza - U.S. funding granted for new influenza drug

Influenza - U.S. health services department releases statement regarding Chiron flu vaccine

Influenza Vaccine - Hospital visit prevention by influenza vaccine during pregnancy studied

Influenza Vaccine - Remaining flu shots directed to high-risk patients

Information Technology - Software designer receives NIH grant to develop nutrition education software

Legal Issues - Maker of skin lightening creams responds to TV statement on product dangers

Leptospirosis - Unique Leptospira strain isolated from patient with pulmonary hemorrhage

Listeria -  Listeria monocytogenes tracked in cheese processing plants

Listeriosis - New biosensor rapidly detects deadly food-borne pathogen

Macular Degeneration - U.S. FDA gives fast-track status for antiangiogenic

Malaria Vaccine - Antibodies to P. vivax protein studied in malaria-exposed subjects

Malaria Vaccine - Incidence of severe malaria useful as endpoint for vaccine trials

Malaria Vaccine - Molecular analysis of antibody response to malaria sporozoite reported

Malaria Vaccine - Quantitative PCR used to test vaccines in human experimental malaria

Medical Devices - Company is awarded ISO certification for in vitro diagnostic medical devices

Medical Devices - Patent for stroke diagnostic device to measure protein biomarkers issued to SynX

Medicare - HHS seeks to expand Medicare coverage

Meningitis Outbreak - Nosocomial meningitis outbreak caused by Acinetobacter baumannii

Meningococcal Disease - Domestic clones of N. meningitidis circulated in meningococcal disease outbreak

Meningoencephalitis - Invasion of CNS by cryptococcal yeast cells characterized

Menopause - New campaign promotes benefits of hormone therapy

Menopause - Tentative approval granted for generic version of Femhrt tablets

Mental Health - APA applauds passage of Mentally Ill Offender Treatment and Crime Reduction Act

Metabolic Syndrome - Incidence of metabolic syndrome among Moroccan Sahraoui women reported

Multiple Myeloma - U.S. FDA grants Aplidin orphan drug status for the treatment of multiple myeloma

Obesity - Company wins phase I SBIR grant for obesity program

Obesity Surgery - Surgery effective for extremely obese Americans

Oncogenesis - Viruses, chemicals, and co-carcinogenesis reviewed

Oncology - FDA grants fast-track designation for metastatic melanoma treatment

Oncology - Phase II trial slated for renal cancer treatment

Opthalmology - Treatment for wet age-related macular degeneration receives new brand name

Osteoporosis - Study shows once-monthly Boniva increases bone density and reduces breakdown

Osteoporosis - U.S. Surgeon General: Immediate action needed to prevent osteoporotic fractures

Otitis Media - Nasopharyngeal pathogens in Danish children with otitis media studied

Patents - Periostat maker files patent infringement claim against IVAX, CorePharma

Pharmacology - P-glycoprotein rapidly regulated at the blood-brain barrier by endothelin-1

Poliomyelitis - Vaccine-caused cases of polio have been eliminated in the United States

Poxvirus Vaccine - Structural proteomics of the poxvirus family reviewed

Prion Disease - Yeast prions not involved in transcriptional activity

Professional Education - Cleveland consortium to share $14 million federal grant

Proteomics - Helical forms of peptides determined by NMR and molecular dynamics

Research Expertise - Strategies addressed to discourage brain drain of international scientists

SARS Infection Control - Providing SARS infection control information to outpatients increases compliance

SARS Vaccine - Antibody responses against SARS-coronavirus studied in SARS patients

Salmonella Outbreak -  Salmonella outbreak traced to unshelled peanuts originating from one country

Sarcopenia - Impaired muscle protein synthesis linked to S6K1 dysregulation

Smallpox - FDA fast track status granted for modified vaccinia ankara program

Smallpox - U.S. HHS awards $232 million in biodefense contracts for vaccine development

Smallpox Research - California scientists help bring study of smallpox virus into 'molecular age'

Smallpox Vaccine - Positive side effects of smallpox vaccination described

Swine Fever Virus - Optimized protocol developed for detection of classical swine fever virus

Systemic Lupus Erythematosus - Preliminary results of Prestara trial on BMD in women with lupus not positive

T Cell Lymphoma - U.S. FDA grants Fast Track designation for FK228 in cutaneous T cell lymphoma

Tobacco Use - Smoking but not areca quid chewing increase micronuclei formation

Tuberculosis -  M. tuberculosis antigen structures confirm binding orientation

Tuberculosis Vaccine - "M. tuberculosis-induced IFN-gamma expression lower in TB patients

Tuberculosis Vaccine - BCG heat-shock proteins protect against tuberculosis challenge

Tularemia - Genetic relations among Francisella tularensis isolates analyzed

Vaccines - Study finds demand for vaccines in U.S. will increase 8.6% annually

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