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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 19th, 2004

Non-Subscriber - Summaries Only

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

Ebola Virus - Ebola amino acid motif required for interferon antagonism

Influenza Virus - H2N2 and early H3N2 influenza viruses exhibit genetic divergence

Occupational Health - Respiratory protection against bioaerosols reviewed

SARS Diagnosis - Laboratory diagnosis of SARS in Guangdong Province, China, described

AIDS/HIV Vaccine - Depo-Provera before SIV challenge eliminates lentivirus-induced protection

AIDS/HIV Vaccine - Non-neutralizing anti-HIV-1 antibody becomes neutralizing antibody

Addiction Medicine - Neuroscience research on addictions reviewed

Adrenergic Receptors - Beta1 AR stimulation activates dual signaling pathways

Alcohol Abuse - Mouse responses to ethanol after food shortage are strain-specific

Alcoholism - Adult drinking risk jumps 12% per year as youths drink younger and younger

Anthrax - U.S. government to procure BioThrax for nation's stockpile

Anti-Infectives - Antimicrobial activity of Mahonia aquifolium extract examined

Asthma - Effect of BCG vaccination in asthmatic schoolchildren determined

Avian Influenza - Biostatisticians tackle potential avian flu outbreak in computer modeling effort

Avian Influenza - Bird flu vaccine expected to be ready by 2007

Brucellosis & Q Fever - Brucellosis/Q fever seroprevalence determined in Central African Republic cattle

Business Update - Emerging Enterprise Solutions plans to change name, discusses sub's new products

Business Update - U.S. FDA inspects company's API manufacturing plant in Macau

Cancer Genomics and Genetics - CDC50A, CDC50B, and CDC50C genes in silico characterized

Cancer Therapy - U.S. FDA approves Tarceva for patients with advanced non-small-cell lung cancer

Cancer Therapy - U.S. FDA grants fast track status to glufosfamide for treating pancreatic cancer

Cardiology - Biotech announces Libracol availability in Canada

Cervical Dysplasia - Positive phase 2 data in high grade cervical dysplasia drug trial reported

Clinical Trials - Ukraine AF Medical Center begins clinical trial of tissue bonding technology

Collaborations - Alliance formed to develop melanoma product MDX-010

Collaborations - Alliance made for drug screening facility

Collaborations - Third pandemic influenza vaccine agreement signed

Contraception - Contraceptive efficacy and safety of DMPA-SC reviewed

Cytomegalovirus - Two pasteurization methods inactivate CMV in breast milk

DNA Research - A three step process delineates the handoff of UvrA to UvrB during DNA repair

DNA Research - H-1 paramagnetic relaxation enhancement characterizes protein-DNA interactions

Depression - FDA approval granted for Citalopram Hydrobromide tablets

Depression - Pharmaceutical company receives FDA approval for citalopram hydrobromide tablets

Diabetes Epidemiology - New study shows diabetes higher on U.S.-Mexico border

Diabetes Survival and Mortality - Daily diabetes mortality linked to outdoor air pollution in Shanghai

Diagnostics - More pregnant women learn their HIV status under Botswana's HIV testing policy

Drug Delivery - Spray dried PLGA/amifostine nanoparticles for oral delivery developed

Drug Development - Abbreviated new drug application for antitumor cancer drug granted by U.S. FDA

Drug Development - European pharmaceutical company gets E.U. approval for bone marrow disorder drug

Drug Development - Study: Follow-on drugs improve patient safety and help reduce costs

Drug Marketing - U.S. cholesterol drug marketing activity increases with new product release

Ebola Virus - Neugene antisense drug demonstrates efficacy against Ebola virus

Employee Health - CorSolutions and DIRECTV Group focus of CDC Grant Study

Environmental Health - Toxicity of PCB126 and PCB169 in ovalbumin-immunized mice reported

Environmental Toxins - Flawed pesticide studies in humans could result in higher allowable exposures

Environmental Toxins - Scientists warn of toxins in fish

Epidemiology - Inability to gain access to information keeps women, girls ignorant of HIV/AIDS

Epidemiology - UNAIDS issues annual HIV/AIDS update for 2004

Escherichia Coli - Toxin-producing E. coli survive in foods stored at wide temperature range

Facilities - U.S. GSA/FDA break ground for central shared-use building

Fasciola - Glycosidase activity in excretory products of liver flukes studied

Finance - Biotech company reports third quarter results

Finance - CVD/CNS-focused company reports Q3 net loss of $12.0

Food Allergy - BCG vaccine modulates intestinal and systemic response to beta-lactoglobulin

Food Poisoning - Polycavernoside A causes fatal food poisoning from red alga Gracilaria edulis

Food-Borne Illness - Disposable immunosensor to measure domoic acid in shellfish developed

Gene Profiling - Canadian genetics company receives certification to updated regulatory standard

Gene Research - LPL N9, S291 alleles are more frequent in men with low HDL-C and heart disease

Genetic Disorders - Mutations in LRP5 associate with familial exudative vitreoretinopathy

Guillain-Barre Syndrome - Study documents decline in paralytic disorder linked to influenza vaccine

HIV/AIDS Epidemiology - HIV increasingly striking women in Asia

HIV/AIDS Epidemiology - Median CD4 lymphocyte counts are low in HIV-uninfected adults in Botswana

HIV/AIDS Funding - WHO awards million-dollar contract for global treatment preparedness activities

HIV/AIDS Prevention - Condom access reduces HIV transmission if preceded by educational workshops

HIV/AIDS Prevention - Women's rights in developing world crucial to victory over AIDS U.N. says

HIV/AIDS Risk - Statistical method to be used by CDC to track HIV risk behavior among drug users

HIV/AIDS Treatment - European CHMP gives positive opinion on Truvada as part of combo HIV therapy

Haemophilus Vaccine - Stochastic model of vaccine trials for endemic infections developed

Haemophilus Vaccine - Transmission of Haemophilus influenzae type b modeled

Health Statistics - Birth rates for U.S. women aged 40-44 rose in 2003

Healthcare Access - Shortage of health workers hampering global health

Heart Failure - U.S. FDA approves V-V timing in Medical Epic HF and Atlas+ HF CRT-Ds

Hereditary Angioedema - Final EDEMA1 results at presented at ACAAI meeting

Herpesvirus Outbreak - Owner likely spreads deadly herpesvirus to colony of captive common marmosets

Histoplasmosis - Functional T cells in primary immune response to histoplasmosis

Hyperlipidemia Therapy - Ezetimibe/simvastatin effective for treatment of hyperlipidemia

Hyperthyroidism - Iodine contaminants responsible for neonatal chemical hyperthyroidism in Nigeria

Immunology - Eosinophils secrete plasminogen activator inhibitor-2

Immunotherapy - Company receives FDA approval to begin sublingual-oral immunotherapy trial

Influenza - Next flu pandemic could kill 7 million people, according to WHO expert

Influenza Vaccine - TCR V beta repertoire directed against influenza CTL epitope reported

Information Technology - Compliance with U.S. FDA, Florida, California drug reporting timelines enabled

Insulin Pump - U.S. FDA alternate site clearance helps blood glucose meter users

Legal Issues - U.S. FDA comments further on complaint against Utah medical devices company

Leishmaniasis - Cutaneous leishmaniasis treated with lipid formulations of amphotericin B

Lyme Disease Diagnosis - C6 Lyme antibody test does not require Western blot for confirmation

Lyme Disease Vaccine - OspA protein of Borrelia burgdorferi vaccination results in neuropathy

Malaria -  Plasmodium falciparum polymorphisms analyzed from Brazilian Amazon region

Malaria - Individual malaria disease susceptibility/outbreak severity varies in Sudan

Malaria Vaccine - Membrane antigen and merozoite protein protect against P. chabaudi malaria

Measles Transmission - Airplane measles exposure offers lessons on disease contact response

Measles Vaccine - Impact of declining vaccination on subclinical measles infections reported

Medical Devices - Doctors perform states' first U.S. FDA-approved artificial disc replacements

Medical Devices - The current status of material used for depot delivery of drugs

Minamata Disease - Effects of methylmercury in neonatal brains determined

Multiple Sclerosis - U.S. FDA approves new drug to treat multiple sclerosis

Mutagenesis - Glycophorin A is potential biomarker for mutagenic effects of pesticides

Nicotine Addiction - Hopkins Institute for Global Tobacco Control receives recognition from PAHO/WHO

Norovirus - Detergent followed by bleach/detergent reduces Norovirus contamination

Nutrition - Older Americans not eating well

Obesity - Cardiovascular treatment drug used for smoking cessation also keeps weight off

Obesity Therapy - Recent advances in cannabinoids reviewed

Oncology - Biotech company announces commercial supply agreement for cancer treatment

Oncology - Biotech company announces initiation of Phase II trial for cancer treatment

Oncology - U.S. FDA accepts Onco-LIFE PMA supplement for filing

Overactive Bladder - U.S. FDA approves new medication

Pain Therapy - FDA issues approvable letter for Ralivia ER

Pharmaceutical Marketing - Pfizer halts Celebrex sales in Turkey in dispute over warning

Pneumocystis Carinii Pneumonia - Suspected pediatric PCP in resource-poor settings should be treated as emergency

Polio Epidemiology - Areas at increased risk for poliovirus circulation in Ecuador assessed

Premenstrual Dysphoric Disorder - Approvable letter granted for oral contraceptive containing drospirenone

Prescription Drugs - Doctors say statin drug should have been pulled sooner

Primary Care - Statewide emergency mental health preparedness plans compared

Prostate Cancer - Provenge data: Vaccine therapy for prostate cancer is shown to extend survival

Proteomics - Results change the paradigm for vitamin K-dependent protein carboxylation

Psoriasis - Clinical development of BCX-4208 for psoriasis initiated

Pulmonary Hypertension - Exacerbation of underlying pulmonary disease in pregnancy investigated

Pulmonary Hypertension - Exercise desaturation and pulmonary hemodynamics link unclear

Quality Assurance - Company's sera, media division registers as class I medical device manufacturer

Regulatory Issues - FDA called "defenseless" against bad drugs

Regulatory Issues - FDA tried to discredit whistleblower over drug safety claims

Respiratory Syncytial Virus - Palivizumab used to control RSV outbreak in neonatal intensive care unit

Rhabdomyolysis - Risk of muscle-damaging disorder low for most commonly prescribed statin drugs

Rheumatoid Arthritis Therapy - Compliance is viral for the success of TNF antagonist therapy

Rubella Vaccine - Immunization law revisions affect incidence of congenital rubella in Japan

SARS - Methods to inactivate SARS virus described

Sexual Health - Article: Controversial testosterone patch for women puts FDA on the hot seat

Sexual Violence - Grants awarded to end violence against women in conflict-affected areas

Sexual Violence - UNICEF: Impunity for rape and sexual violence in war must end immediately

Smallpox - Computer modeling helps identify new smallpox drug candidate

Smallpox Diagnosis - Rapid detection method for vaccinia virus developed

Thrombosis - First international standard for common genetic test approved by WHO

Toxoplasmosis Vaccine - Vaccination protects B cell-deficient mice against Toxoplasma gondii

Tuberculosis - Mathematical model predicts emergence of multidrug-resistant TB 'hot zones'

Tuberculosis - Small populations of fit MDRTB strains can out-compete low fitness strains

Urinary Tract Infection - Incidence of Salmonella-caused UTI has increased in elderly U.S. women

Vaccinia Virus Vaccine - Neutralizing antibody activities to vaccinia virus proteins are synergistic

Vancomycin Resistance - Two vancomycin-resistant E. faecium outbreaks in NICU caused by different clones

West Nile Virus - Economic impact of West Nile virus in Louisiana estimated

Wound Management - FDA clears V1 Wound Vacuum System for marketing, Medicare confirms coding

X-ray Imaging - Theory of X-ray imaging based on Wigner distributions developed

Yellow Fever Vaccine - Risk of fatal adverse events linked to 17DD yellow fever vaccine determined

Yersinia Pestis - Study shows evolution of virulent Yersinia pestis epidemic clone

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