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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . August 14th, 2005

Non-Subscriber - Summaries Only

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

Anthrax - Complement depletion renders mice sensitive to Bacillus anthracis

HIV/AIDS Vaccine - Impact of HIV genetic diversity on vaccine development reviewed

Lyssaviruses - Rabies biologics are effective against some lyssaviruses from Eurasia

Measles Virus - Amino acid variations affecting measles virus replication identified

Outbreaks - Seed source identified for E. coli outbreaks linked to sprouts

 Hemophilus ducreyi -  H. ducreyi dsrA mutant killed by normal human serum initiated by IgM binding

Adverse Drug Reactions - Importance of reporting suspected adverse drug reactions emphasized

Adverse Drug Reactions - Study reveals consumers willing to take medication with risks similar to Vioxx

Allergy & Immunology - Company announces rapid, expanded enrollment in ragweed allergy pediatric trial

Allergy Medicine - Labeling food allergens can be a struggle

Allergy Medicine - Sesame allergy is significant, serious and growing globally

Anthrax Vaccine - Oral spore vaccine based on Bacillus anthracis antigen developed

Antimicrobial Resistance - Susceptibility testing method to determine bacterial MICs standardized

Antimycobacterial Drug Development - Oxadiazolone derivatives have antimycobacterial activity

Aspergillosis Therapy - Voriconazole less expensive than amphotericin B for aspergillosis

Atrial Flutter - Company submits PMA for atrial flutter treatment

Avian Influenza - International health entity stresses threat from Avian influenza has not ebbed

Benign Prostatic Hyperplasia - FDA approves Cooled ThermoCath 4.5+ treatment catheter

Biotechnology - Health professionals hold positive attitudes toward biotechnology

Biotechnology - Jeff Myers named vice president of government affairs

Bioterrorism - Groups work to develop vaccine to reduce effects of ricin toxin

Bladder Cancer - Bladder cancer test receives marketing approval in Japan

Business & Finance - Biopharma company announced financial results

Business & Finance - Biosensor, microproccessor developer completes reverse acquisition transaction

Business & Finance - Single-use medical devices company listed on new Russell Microcap Index

Business Update - Cell-based regenerative therapies developer changes name to Cytori Therapeutics

Business Update - Centene Corp. subsidiary expected to expand operations in Texas

Business Update - Company gets clearance for its Dimension Vista 1500 integrated system

Business Update - Company to seek VA contracts for pharmacy robotic technology

Business Update - Radiofrequency ablation systems company appoints audit firm

CNS Lymphoma - Necrotizing vasculopathy diagnosed in primary CNS lymphoma

Cardiology - U.S. FDA grants full approval to conduct a pivotal trial of the Jarvik 2000

Cardioprotection - Cardiac GCA prevents cardiac remodeling by inhibiting calcineurin-NFAT pathway

Cardiovascular Research - Dedicated investment in CV outcomes research could improve care in the US

Chickenpox Vaccine - Oka/GSK attenuated varicella vaccine prevents chickenpox in clinical practice

Clinical Trials - Ghrelin agonist shows selectivity profile in treating gastrointestinal disorders

Clinical Trials - SPA process completed for paclitaxel formulation clinical trial in breast cancer

Coccidioidomycosis - Precipitation influences incidence of coccidioidomycosis outbreaks

Compliance - Ophthalmic products developer reports on latest communications with U.S. FDA

Dengue Fever - Cemetery is source of dengue vector

Diabetes Education - Predictors of compliance with diabetes education in Turkey reported

Diabetes Prevention - Six healthy habits program helps prevent diabetes

Diabetes Therapy - Diabetes patient-oriented evidence that matters on Internet studied

Diabetes Therapy - Metformin versus conventional approach for type 2 diabetes compared

Diagnostics - U.S. FDA grants 510(k) clearance for infectious mononucleosis rapid tests

Disease Associations - HIV/HCV co-infection associated with diabetes

Disease Management - Telephone communications credited with improving health

Drug Abuse - Wife influences husband's marijuana use during first year of marriage

Drug Development - Agreement reached with U.S. FDA for renzapride phase III trial

Drug Development - IGIV selected by company as first therapeutic protein product for development

Drug Development - Phase II trial of Hematide for anemia begins

Drug Development - Positive opinion granted for Humira in Europe for rheumatoid arthritis

Drug Development - Product promotes healing in venous stasis ulcers

Drug Development - Sotradecol injection for varicose veins launched in U.S. market

Drug Development - U.S. FDA grants approval for Allegra capsules

Drug Importation - Professional society warns against discount injectables bought offshore

Endocarditis - AHA publishes statement on infective endocarditis

Environmental Health - Highest concentration of ground water contamination found in northeast U.S.

Epidemic Surveillance - Method rapidly identifies/types respiratory pathogens for epidemic surveillance

Epidemiology - Abortions/neonatal mortality associated with T. evansi infection in camels

Epidemiology - In utero factors may affect cancer risk differently among ethnic groups

Epilepsy - Seizure-focused foundation lauds U.S. FDA approval of monotherapy for epilepsy

Finance - Biotech company reports Q2 GAAP EPS of $0.46, non-GAAP EPS of $0.57

Finance - Diabetes-focused biotechnology company returns to independent status

Finance - Pharmaceutical company added to 2005 Russell Indices

Food-Borne Illness - Sources of variability of acrylamide levels in cracker model identified

Food-Borne Illness - What we don't know about handling food can hurt

Gastrointestinal Tuberculosis - Gastrointestinal TB not an uncommon diagnosis in northeastern Parisian area

Generic Drugs - Pharma company gains approval to market Metformin XL Tablets

Gentamicin - Method to measure gentamicin in bovine fluids and tissues developed

Grants - Michigan U health system receives $10 million NIA grant for Alzheimer research

Gynecology - Microsatellite profiles categorize endometrial cancers

HIV/AIDS & Dengue Fever - Dendritic cell precursors are permissive to dengue virus and HIV infection

HIV/AIDS Diagnosis - Efoora is rapid test for detection of HIV-specific antibodies

HIV/AIDS Epidemiology - Decrease in drug resistance levels of HIV epidemic can be bad news

HIV/AIDS Epidemiology - Laboratory method aids estimation of HIV-1 incidence

HIV/AIDS HAART - Risk of triple-class antiretroviral drug failure declining in Denmark

HIV/AIDS Infection - HIV infection in children of paid plasma donating community reported

HIV/AIDS Pathogenesis - Resting naive CD4+ cells massively infected/eliminated by X4-tropic SHIV

HIV/AIDS Prevention - Study shows barriers to HIV vaccine acceptance

HIV/AIDS Prevention - Why were the HIV prevention trials in commercial sex workers abandoned?

HIV/AIDS Risk Behavior - No difference in risk behavior when partner is aware of HIV serostatus

HIV/AIDS Risk Factors - Adolescent groups identified as at most risk for acquiring HIV infection

HIV/AIDS Stigma - Nine-item scale measures AIDS-related stigma in South Africa

HIV/AIDS Transmission -  Trichomonas vaginalis promotes sexual transmission of HIV-1

HIV/AIDS Vaccine - AIDS vaccine development reviewed

HIV/AIDS Vaccine - Adenoviral gene delivery for HIV-1 vaccination reviewed

HIV/AIDS Vaccine - Cross-reactivity of anti-HIV immune responses of major HIV-1 clades reported

HIV/AIDS Vaccine - Lentiviral vector encoding Gp41-derived fusion inhibitor suppressed HIV

HIV/AIDS Vaccine - Method to measure HIV vaccine efficacy ethically presented

HIV/AIDS-Associated Infection - Some HIV protease inhibitors can inhibit Encephalitozoon intestinalis growth

HIV/AIDS-Tuberculosis Coinfection - TB incidence remains high despite isoniazid prophylaxis in HIV-infected persons

Healthcare Coverage - DoD-sponsored health plan reports high enrollee satisfaction

Hemodialysis - Surveillance of hemodialysis-associated infections in Israel reported

Hepatic Veno-Occlusive Disease - Company gets go-ahead for phase III clinical trials with Defibrotide

Hypertension - Review discusses in vivo hypotensive, cardiodepressant effects of cannabinoids

Imaging - Company reports progress in ComfortScan clinical trial

Immunology - Tyrosine 775 plays role in immune receptor signaling

Influenza - Mouse studies of oseltamivir show promise against H5N1 influenza virus

Influenza Vaccine - B cell responses to influenza vaccine compromised in HIV-infected individuals

Influenza Vaccine - Influenza immunization coverage poor in children in central Israel

Information Technology - Healthcare IT event highlights PACS

Information Technology - IT companies partner to provide mobile computing systems to regulated industries

Information Technology - U.S. FDA grants approval of software for remote patient monitoring

Injury Prevention - Injuries higher among obese people

Insomnia Therapy - Diagnosis and treatment of chronic insomnia reviewed

Lead Exposure - Moderate lead exposure elicits neurotrophic effects in cerebral cortical NSCs

Leishmaniasis -  Leishmania donovani trypanothione reductase characterized

Leptospirosis & Dengue Outbreak - Concurrent outbreak of leptospirosis and dengue occurred in Mumbai city slums

Listeriosis - Details of 1998 outbreak of listeriosis in United States reported

Low Birth Weight - Children born in the 1990s have long-term health needs

Malaria - Deltamethrin exposure affects host resistance to Plasmodium infection

Malaria - Fetuses acquire Plasmodium falciparum inhibitory antibodies transplacentally

Malaria - Prostaglandin E2 production impaired in children with cerebral malaria

Malaria Vaccine -  Plasmodium surface protein 8 localizes to parasitophorous vacuole

Malaria Vaccine - Immune evasion by malaria parasites reviewed

Marketing - Independent testing to support safety marks for nanoarray system complete

Medical Devices - 510(k) submitted to U.S. FDA for resorbable cement restrictor product in US

Medical Devices - Drug-eluting stents tested in two patients with peripheral arterial disease

Medical Devices - Investigative device exemption application submitted for arterial closure device

Medical Devices - Study conducted to show potential benefits of cardioscan system

Medical Devices - U.S. FDA grants clearance for osteoinductive bone matrix putty

Medicare - Coventry Health Care of Iowa to offer Medicare Advantage products

Medicare - Seniors get more cholesterol screenings with new Medicare reimbursement levels

Metabolic Syndrome - Cardiovascular fitness and metabolic syndrome in youths examined

Microbicidal Contraceptives - Antimicrobial peptides have potential as microbicidal contraceptives

Monoclonal Antibodies - Plant biopharming of monoclonal antibodies reviewed

Mycobacteria Exposure - Workplace exposure to mycobacteria cause of hypersensitivity pneumonitis

Mycobacterium Tuberculosis - Fluoroquinolone resistance protein from M. tuberculosis mimics DNA

Mycobacterium Tuberculosis - GM-CSF production disruption in lungs affects ability to control MTB infection

Mycobacterium Tuberculosis - Laboratory cross-contamination with MTB identified using NVTR typing

Mycobacterium Tuberculosis - Nitroimidazopyran PA-824 active against multidrug-resistant MTB

Mycobacterium Tuberculosis - Nitroimidazopyran PA-824 bactericidal against Mycobacterium Tuberculosis

Neisseria Meningitides - Outer membrane vesicle vaccine against serogroup A N. meningitides developed

Non-Small Cell Lung Cancer - Journal publishes report on Tarceva trial

Non-Small Cell Lung Cancer - Pivotal phase III Tarceva study published in journal

Obesity Risk Factors - Test results on obesity-risk affect patient behavior

Obstetrics - Multiple abortions may be predictive of vaginal bleeding during pregnancy

Obstetrics - Perinatal factors affecting breast density are investigated

Osteogenic Sarcoma - Cancer drug granted orphan-drug designation for osteogenic sarcoma treatment

Osteoporosis - PREOS new drug application accepted for review by U.S. FDA

Patents - European patent granted for Thymosin beta 4 wound-healing technology

Patents - U.S. Patent issued for ultrasonics-assisted transdermal drug delivery technology

Patents - U.S. patent granted for hospital test kit assay to diagnose 'Candida' infection

Patents - U.S. patent granted for interferons for treating hepatitis C, viral diseases

Pediatric Vaccine - Longitudinal study of child immunization determinants in China reported

Personnel - Pharmaceutical development company announces resignation of CEO

Pertussis - Health burden of pediatric pertussis remains major public health concern

Pertussis - Health burden of pertussis in adolescents and adults determined

Pertussis - Overview of Global Pertussis Initiative process presented

Pertussis Epidemiology - Epidemiology of pertussis reviewed

Pertussis Transmission - Sources of infection and routes of transmission outlined for pertussis

Pertussis Vaccine - Economics of pertussis immunization of adolescents in U.S. outlined

Pertussis Vaccine - Strategies for pertussis immunization in Europe outlined

Pertussis Vaccine - Strategies for pertussis immunization in North America outlined

Pest Resistance - Transgenics provide sustainable pest resistance in genetically enhanced crops

Polio Vaccine - Prevalence of human serum antibodies to simian virus 40 vp1 virus-like particles

Product Licensing - Flourocarbon-based oxygen delivery technology sublicensed to ImaRx Therapeutics

Pulmonary Arterial Hypertension - Company announces PDUFA date for Thelin NDA

Q-Fever - Seroprevalence rates of Q-fever are high in febrile individuals in Mali

Rabies - Fluorometric cell-ELISA quantifies rabies infection and heparin inhibition

Rabies Vaccine - Indirect oral immunization of captive vampire bat against rabies reported

Rabies Vaccine - Oral vaccination of dogs with recombinant rabies virus vaccines reported

Rabies Vaccine - Status of oral rabies vaccination in wild carnivores in U.S. reported

Rabies Virus - Epizootiology of rabies linked to Mexican carnivores described

Rabies Virus - Pathogenicity and antigenicity of P gene-deficient rabies virus described

Rabies Virus - Review of rabies in the Americas presented

Retrovirus - HAART safe/effective in HIV-infected children with advanced disease

SARS Vaccine - Epitope mapping of antibodies produced by inactivated SARS isolate reported

Salmonella - StrSPF/GF mice similar for Salmonella Enterica serovar Typhimurium colitis study

Schistosomiasis - T cell epitope map of Schistosoma mansoni protein presented

Sexually Transmitted Disease - Asymptomatic rectal infections support routine STD screening

Sexually Transmitted Disease - Patterns in sex work, drug use, and STDS in Russia reported

Smoking Cessation - Assessing stop-smoking programs - does the 5A program work?

Smoking Cessation - Quitting smoking could save your teeth

Stem Cell Transplantation - CD34+ cell dose plays role in preventing late infections in pediatric SCT

Stroke - Use of chewing tobacco, snuff may increase mortality from heart disease, stroke

Tuberculosis - Isolated positive sputum cultures appear infrequently during TB treatment

Tuberculosis - Tuberculosis should not be part of the clinical case definition of AIDS in India

Tuberculosis Vaccine - Carboxy end of M. tuberculosis deformylase required for enzyme activity

Tuberculosis Vaccine - DNA vaccine protects against M. tuberculosis during chemotherapy

Tuberculosis Vaccine - Exchanging esat6 with tb10.4 in TB vaccine provides efficient protection

Tuberculosis Vaccine - Order of vaccination with BCG and DNA vaccine not critical for protection

Vaccine Safety - Vaccination promotes and prolongs activation of stress-activated kinases

Vector Development - HIV-1-derived lentivirus vector induces megakaryocyte gene expression

West Nile Virus - CDC and Fort Dodge Animal Health achieve first licensed DNA vaccine

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