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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . November 20th, 2005

Non-Subscriber - Summaries Only

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

Ebola Virus - Complete genome of Ebola virus causing outbreak in Uganda released

Escherichia Coli - Non-O157 Shiga toxin-producing E. coli infections in U.S. reviewed

Hepatitis A Virus - Molecular methods for hepatitis A surveillance improves outbreak detection

Malaria Vaccine Development - Model system for testing malaria vaccines developed

Tuberculosis Therapy - Rifampin-pyrazinamide not recommended for treatment of latent TB

Addiction Medicine - Many substance abuse treatment counselors unaware of buprenorphine

Adenovirus Outbreaks - B2 adenovirus was the cause of a respiratory disease outbreak in a military camp

Advocacy - Trade group: BioShield II bill needed, but without patent extensions

Anthrax Vaccine Development - Monoclonal antibody protects against anthrax toxin

Antibacterial Agents - Availability of preoperative antibacterial skin preparation announced

Antimicrobial Resistance - Campaign to Prevent Antimicrobial Resistance in Healthcare Settings assessed

Bacteriology -  Yersinia rohdei isolated from goats in New Zealand

Behavioral Medicine - Transtheoretical model promotes integrated pregnancy and STD prevention in family planning setting

Blood Safety - Amotosalen photochemical system inactivates SARS coronavirus

Blood Safety - Enhanced detection system screens platelet concentrates for bacteria

Botulinum Neurotoxin - Antibody response to receptor binding domain of botulinum serotypes examined

Bovine Tuberculosis -  Mycobacterium avium paratuberculosis seroprevalence is 9.6% for cattle

Breast Cancer Therapy - New aromatase inhibitors for treatment of metastatic breast cancer examined

Business & Finance - Drug-delivery company returns to profitability in the third quarter

Business & Finance - Pharmaceutical company updates program for lupus renal disease drug candidate

Cancer Therapy - New therapeutic targets for multiple myeloma identified

Cancer Therapy - Preliminary results reported from randomized phase II trial of Avastin and Tarceva in kidney cancer

Cardiac Surgery - Malleable surgical ablation probe receives U.S. FDA 501(k) clearance

Childhood Obesity - New findings in the area of childhood obesity detailed

Clinical Trials - Enrollment complete in phase 3 study of Evamist for treating menopausal symptoms

DNA Research - A467T mutation causes lower polymerase activity and loss of accessory subunit interaction

Depression Therapy - Interaction of fluoxetine with phosphatidylcholine liposomes examined

Diabetes Therapy - Pilots with type 1 diabetes can fly safely

Diagnostics - Auramine orange stain rapidly detects mycobacterial cervical adenitis

Diagnostics - Findings describe new data in diagnostics research

Diagnostics - Micronucleus frequency is higher in lymphocytes from neonates of high-risk pregnancies

Diagnostics - Multiplex PCR assay simplifies Listeria monocytogenes serotyping and sequence typing

Diagnostics - Nucleic acid test developer updates regulatory status of investigational PROCLEIX ULTRIO assay

Diagnostics - RT-PCR simultaneously detects multiple genes from SARS-coronavirus

Diagnostics - Real-time telomerase activity measurements may be useful cancer detection method

Diet & Nutrition - Data advance knowledge in diet & nutrition research

Disease Control - Public opinion supports condom education in Indiana public schools

Drug Development - Application filed with U.S. FDA for combined therapy for cancer treatment

Drug Development - First patients enrolled, treated in IRX-2 phase II head and neck cancer study

Drug Development - Meeting requested with U.S. FDA to seek guidance on neurodegenerative diseases drug

Drug Development - Progress is reported toward acetate supplementation therapy for Canavan disease

Drug Development - Response submitted to U.S. FDA regarding approvable letter for iPlex

Drug Development - U.S. FDA accepts Orapred ODT NDA filing

Drug Development - U.S. FDA issues approvable letter for Pargluva, an oral treatment for type 2 diabetes

Drug Development - U.S. FDA maintains clinical hold on IND application for RESUS phase II/III trial of Hemopure

Drug Development - U.S. FDA submission for Zimycan deemed a complete response

Drug Development - United States' exclusivity for Tramadol ER confirmed by U.S. FDA

Drug Development - Workshop proceedings discuss managing risks of therapeutic products

Drug Resistance - Bis-glycosylated diamino alcohol active against multidrug-resistant MTB

Drug Resistance - Prevalence of multiresistance to antituberculous drugs increases after treatment

Epidemiology - Diabetes is major health problem in Bedouins of Southern Israel

Epidemiology - Indigenous Western Australians have greater HIV transmission risk than nonindigenous people

Epidemiology - Pontiac fever outbreak associated with exposure to hotel pool/spa area

Epidemiology - Socioeconomic deprivation increased the incidence of tuberculosis in Naples

Finance - Gene-identification company reports 27% increase in revenues in the fourth quarter

Finance - Oncology-focused biopharm company reports Q3 2005 revenues of $67.9 million

Food Safety -  Mycobacterium avium subsp paratuberculosis detected in powdered infant milk

Food Safety - Animal food supplement may be contaminated with Mycobacteria

Food-Borne Illness - Method for rapid phenotypic characterization of Vibrio isolates developed

Genetics & Genomics -  Mycobacterium avium subspecies paratuberculosis genome fully sequenced

Genetics & Genomics - Multiple persistent lineages and reassortment exists among recent human influenza A H3N2 viruses

Giardiasis - Metronidazole-treated patients with giardiasis became 100% parasite-free

Glaucoma - Approval granted for studies of DeepLight gold micro-shunt implant for glaucoma

Graft versus Host Disease - U.S. FDA approves trial of stem cell drug for acute graft vs. host disease

HIV/AIDS Antiretroviral - UC-781 inhibits HIV-1 infection of cervical tissue and dissemination by migratory cells

HIV/AIDS Diagnosis - Reports advance knowledge in HIV/AIDS diagnosis research

HIV/AIDS Diagnostics - Ultrasensitive p24 antigen ELISA diagnoses subtype C HIV-1 infection in infants

HIV/AIDS Drug Resistance - Molecular footprint of drug-selective pressure identified in HIV transmission chain

HIV/AIDS Epidemiology - HIV prevalence associated with increased intravenous drug use increasing in Mexico

HIV/AIDS Epidemiology - Monte Carlo model estimates the natural variation in HIV infection

HIV/AIDS Pathogenesis - HIV-1 variants from single plasma samples have various neutralization sensitivities

HIV/AIDS Topical Microbicide - Topically applied amphibian-derived antimicrobial peptides inhibit HIV infection

HIV/AIDS Vaccine Development - CD8+ lymphocytes do not protect against acute SIV superinfection

HIV/AIDS Vaccine Development - HIV trials feasible with fewer animals if subjects repeatedly challenged with low doses

HIV/AIDS-Related Infection - Incidence of esophageal candidiasis in AIDS patients in Europe is declining

HIV/AIDS-Related Infection - Nocardiosis to be considered in HIV patients with low CD4 counts

HIV/AIDS-Related Infection - Oral lesions are indicators of infection in HIV/AIDS

Healthcare Access - Peters-Belson method advised for study of health care disparities from complex survey data

Helicobacter Pylori - Probiotic supplementation improves tolerance to H. pylori eradication therapy

Hematology - Method developed to automate glycerolization of red blood cells

Hepatitis B Vaccine - Alaska Natives immunized at birth are protected against hepatitis B

Hepatitis B Virus - Vaccination reduces hepatitis B prevalence in U.S. children

Herpes Simplex Virus Type 2 Risk Factors - Fatal herpes simplex virus type 2 infection occurred in Darier disease

Hookworm Vaccine Development - Hookworm heme-binding glutathione transferase has vaccine potential

Imaging - U.S. FDA clearance of high-frequency intravascular imaging catheter announced

Infectious Diseases - Disease susceptibility to tuberculosis is dependent on host genetic predisposition

Influenza - Antivirals and vaccines maker offers pandemic flu plans

Influenza Vaccines - Dutch company updates progress in scale-up of cell-culture-based influenza vaccine programs

Information Technology - ECG monitoring services provider achieves Mortara Certified Partner status

Ischemia - Therapy potential of mitochondrial biogenesis regulatory program in ischemia discussed

Kidney Disease - U.S. NIH study shows kidney failure rates stabilized, racial disparities persist

Legal Issues - U.S. marshals seize infusion pumps made by Baxter after warnings ignored

Leukemia - U.S. Food and Drug Administration grants fast track designation for Troxatyl

Malaria - HRP2 antigen levels remain elevated for at least 7 days after malaria treatment

Malaria Drugs - HIV-1 protease inhibitors have antimalarial activity

Malaria Therapy - Nitric oxide bioavailability restoration may be an effective antimalaria therapy

Malaria Therapy - Trimethoprim-sulfamethoxazole is efficacious for uncomplicated malaria

Malaria Vaccine - Binding hot spot for invasion inhibitory molecules on P. falciparum antigen identified

Malaria Vaccine - Polymorphisms in malaria T cell epitopes not selected by immune pressure

Malaria Vaccine - Protective human immunity is a vaccine discovery tool for falciparum malaria

Malaria Vaccine Development - Changes in host cell tropism limits efficacy of malaria vaccine

Medicaid - U.S. HHS approves Medicaid reform demonstration in Florida

Medical Devices - Company files application with U.S. FDA for polymer coated surgical mesh product

Medical Devices - SELDI-TOF mass spectrometry proposed for biomarker discovery and serum proteomic study

Medical Devices - U.S. FDA grants 510(k) clearance for urine preservative transport

Melanoma - Ultraviolet A exposure increases melanoma-endothelial adhesion in mouse model

Meningitis Risk Factors - Meningococcal disease rate higher in microbiologists than general U.S. population

Meningitis Vaccine Development - Anti-idiotypic antibody is candidate for meningitis vaccine

Meningitis Vaccine Development - Meningococci from invasive meningococcal disease cases in Canada characterized

Mosquito-Borne Disease - Reports describe recent advances in mosquito-borne disease research

Mosquito-Borne Disease - Wash resistance predicts longevity of long-lasting insecticidal nets

Mumps Vaccine - Plaque reduction neutralization is sensitive, specific for wild-type mumps virus

Non-Small Cell Lung Cancer - Enrollment opens in Phase III study of treatment for non-small cell lung cancer

Norovirus Outbreaks - Majority of Norovirus outbreaks transmitted by human contact

Nosocomial Infections - Global nosocomial safety campaign with guidelines on hand hygiene launched

Nosocomial Infections - Two nosocomial Mycoplasma pneumoniae epidemics in Korea separated by 3 years

Obesity Genomics and Genetics - Mature adipocytes play active role in obesity-related inflammation

Packaging - U.S. FDA approves Flexbumin, an albumin solution, in a flexible container

Patents - U.S. patent awarded for UCOE gene expression technology

Pediatric Vaccine - Electronic registries may allow children to receive late routine vaccinations

Personnel - Genomics research organization names MaryAnn Guerra chief operating officer

Pertussis Vaccines - New research in the area of pertussis vaccines detailed

Pharmaceutical Research - RiVax maker provides business and clinical update; RiVax phase I trial complete

Physical Activity - Exercise can decrease health care utilization and costs in Medicare retirees

Professional Education - Knowledge solutions company rolls out Medicare Part D nine-course curriculum

Proteomics - Protein measurement company receives $500,000 SBIR grant from U.S. National Science Foundation

Radiology - Regulatory exemptions for humans in radiology research outlined

Respiratory Medicine - Genetically related RSV circulate the same years within neighboring countries

Respiratory Medicine - Long-term outcome good for simple aspergilloma and satisfactory for complex aspergilloma

Respiratory Medicine - Pneumonia and pulmonary TB most common respiratory tract infections in hospitalized travelers

SARS - Reports advance knowledge in SARS research

Scabies - HTLV-1 infection is an important co-factor related to Norwegian scabies in Peru

Sepsis Therapy - Drotrecogin alfa not beneficial for severe sepsis with low risk of death

Smallpox Vaccines - Reports describe recent advances in smallpox vaccines research

Sociology Research - Many health workers in Nigeria discriminate against patients with HIV/AIDS

Stem Cell Research - Government contractor, AntiCancer Inc. collaborate to develop neural diseases therapy

Streptococcal Vaccine Development - Prospects for group A streptococcal vaccine reviewed

Surgical Techniques - Trends in ablative techniques for Barrett esophagus are investigated

Trypanosoma Cruzi - DHEA enhances reduces level of Trypanosoma cruzi parasites

Tuberculosis - Recurrent tuberculosis in HIV-infected children is common in a high-burden TB setting

Tuberculosis Risk Factors - Risk of tuberculosis infection in children related to number and duration of exposure

Urology - U.S. FDA grants marketing clearance for urological neurostimulation device

Vaccine Safety - Data mining methods on the Vaccine Adverse Event Reporting System database compared

Vaccinia Virus - PCR is most sensitive for vaccinia virus detection in patient specimens

X-Ray Exposure - Germ cell-transmitted alteration may be initiated by preconceptual maternal X-ray exposure

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