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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . August 20th, 2006

Non-Subscriber - Summaries Only

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

Outbreaks - Marburg virus was linked to large hemorrhagic fever outbreak in Angola

Rotavirus Epidemiology - Rotavirus results in significant number of hospitalizations in U.S.

Streptococcus Genetics & Genomics - Streptococci from children in Nepal share genetic relatedness with isolates from other countries

Virology - Real-time quantitative PCR assays to detect virus-specific DNA have been developed

Addiction Medicine - Severity of Dependence Scale indicates cannabis dependence in adolescents

Alcohol Use - Gabapentin does not alter effects of alcohol

Alcohol Use - Single question about drunkenness can detect college students at risk for injury

Allergy & Immunology - Effect of gastric digestion on food allergy is focus of review

Antimicrobial Resistance - Accuracy of antibacterial and antifungal susceptibility tests is reported

Avian Influenza Vaccine - Reverse-genetics-produced H5N1 bird flu vaccine protects ferrets

Bioterrorism - Method to retrospectively identify ricin in animal tissues has been developed

Breast Cancer - Albumin-bound paclitaxel is the focus of review

Burn Therapy - Burn-cooling blanket reduces evaporative water loss without causing hypothermia

Business Update - Corgenix submits U.S. FDA Premarket Notification of AspirinWorks Test Kit

Business Update - CytoCore engages Beaufort Advisors as U.S. FDA consultants for trials and product manufacturing

Business Update - Lupin announces approval of Meloxicam Tablets

Cancer Diagnosis - Workshop was conducted on biomarker validation for cancer diagnosis

Cancer Gene Therapy - Pseudovirion gene delivery of a toxin treats human adenocarcinomas

Cancer Prevention - Effect of long-term raloxifene on estradiol may enhance its use as cancer-preventive agent

Cancer Therapy - Cancer, quackery and meanings of hope in 1950s America are examined

Cardiac Medical Devices - Spectranetics enrolls first patient in trial of laser ablation device in arterial blockage

Cardiac Medical Devices - SynCardia receives CE mark to market artificial heart with 20-pound portable drive unit

Cardiac Medical Devices - U.S. FDA approves St. Jude Medical's devices for treating heart arrhythmias, heart failure

Chickenpox Vaccine - Live varicella vaccine benefits HIV-infected children with depressed CD4+ T cell counts

Child Abuse - Anxiety Disorder Interview Schedule IV is inadequate for detecting childhood maltreatment

Clinical Trials - U.S. FDA cancels meeting on proposed clinical trial for blood substitute product

Collaborations - Whatman to screen for parasites in produce, water supply under collaboration with U.S. FDA

Colon Cancer - Intracel gets SPA from U.S. FDA for pivotal Phase III study of OncoVAX colon cancer vaccine

Complementary & Alternative Medicine -  Panax notoginseng attenuates LPS-induced pro-inflammatory mediators

Contraception - U.S. FDA approves Implanon 68 mg, first and only single-rod implantable contraceptive

DNA Vaccine - Toll-like receptor adaptor molecules enhance immune responses against influenza and tumors

Diabetes Medical Devices - U.S. FDA approves Medtronic's continuous glucose monitoring system for diabetes management

Diabetes Pathogenesis - M3 muscarinic acetylcholine receptors play key role in regulating insulin and glucose

Diarrhea Surveillance - Enterotoxigenic Escherichia coli most frequently isolated pathogen in U.S. military in Egypt

Diet & Nutrition - Community-based program to manage malnutrition was effective in Ethiopia

Diet & Nutrition - U.S. FDA warns consumers about danger of "dietary supplements" promoted for sexual enhancement

Down Syndrome - Down syndrome survival data among infants in Metropolitan Atlanta is presented

Drug Delivery - BioDelivery Sciences International submits two Emezine study designs to U.S. FDA

Drug Delivery - U.S. FDA grants premarket approval to Milestone to sell computer controlled infusion pump

Drug Development - Cortex issues CX717 Clinical Hold update

Drug Development - Crucell announces suspension of Aerugen clinical development

Drug Development - Recombinant human alpha-1 proteinase inhibitors are reviewed

Drug Development - Somaxon Pharmaceuticals updates development program for doxepin Hc1 treatment for insomnia

Drug Safety - Sindbis virus is tool for quality control of viral inactivation of plasma-derived products

Ebola Virus - Reverse genetic generation of Ebola viruses attenuates virus growth

Environmental Health - Method to identify contaminant sources in water distribution systems has been developed

Epidermolysis Bullosa - Cambrex and Ortec submit to U.S. FDA Humanitarian Device Exemption application for OrCel

Finance - Sinovac Biotech reports fiscal year 2005 sales increase of 33.4% to $8,608,000 over 2004

Food-Borne Illness - Front-face fluorescence spectroscopy method to monitor egg freshness has been developed

Gastroenterology - Wyeth, Progenics report methylnaltrexone for postop ileus gets U.S. FDA fast track status

Generic Drugs - Teva announces final U.S. FDA approval of AB-rated generic equivalent arthritis drug

Generic Drugs - U.S. FDA grants tentative approval for generic Didanosine chewable tablets for AIDS

HIV/AIDS Diagnostics - CD4 count, CD4%, and HIV viral load are correlated with HIV symptoms

HIV/AIDS Therapy - U.S. FDA approves first once-a-day three-drug combination tablet for treating HIV-1

HIV/AIDS Vaccine - HIV-1SF162-derived envelope gp140 proteins do not protect against SHIV

HIV/AIDS Vaccine - Vaccination preserves CD4 memory T cells during acute SIV challenge

Head & Neck Cancer - Head and neck cancer chemotherapy options reviewed

Healthcare Access - Effects of state parity laws on mental health care are examined

Healthcare Access - State Medicaid policies present obstacles for obtaining chemical dependency treatment

Hematology - Abbott receives U.S. FDA clearance for Cell-Dyn Ruby hematology instrument

Hepatitis B Virus - Abbott receives U.S. FDA approval for automated blood screening tests for hepatitis B

Hepatitis B Virus - Neutralization epitope is responsible for hepatitis B virus protection

Imaging - Fetal structures in multiple perspectives in real time were examined by direct 4-D imaging

Immunology - Interferon-beta contributes to immune activation induced by double-stranded DNA

Influenza Vaccine - Immunoglobulin mucin-1 antibodies and inactivated influenza enhances cross-strain reactivity

Influenza Vaccine - Multifaceted roles for CD4+ T cells in protective immunity to influenza are reviewed

Influenza Virus - Features of fatal influenza in U.S. children during 2003-2004 are presented

Influenza Virus - U.S. FDA issues complete response letter to MedImmune's new formulation of FluMist

Lung Cancer - Overdiagnosis in lung cancer screening persists

Malaria Vaccine - TNF-alpha was associated with fetal death in malaria during pregnancy

Medical Devices - Alphatec Holdings announces U.S. FDA clearance of adjustable bridge product

Medical Devices - Biolase gets U.S. FDA clearance for Oculase MD Laser System for ophthalmology

Medical Devices - Cyberonics receives FDA Real-Time Review approval for new VNS Therapy Perennia Lead

Medical Devices - U.S. FDA grants market approval for ingestible GI monitoring, data transmitting device

Medical Devices - U.S. FDA grants market clearance for 400 hertz Wavefront optimized excimer laser system

Meningitis Risk Factors - No risk factors were identified for Haemophilus influenzae type b carriage in Alaska

Meningitis Vaccine -  Haemophilus influenzae type b vaccine is needed in Japan to prevent severe Hib infections

Meningitis Vaccine - Meningococcal vaccination primes for immunologic memory in vaccine-naive adults

Mental Health - Cyberonics gets U.S. FDA approval for harmonized/modularized VNS Therapy System

Mycobacteria Vaccine - Mycobacteria impair function of dendritic cells through IL-1 beta

Occupational Health - Lead exposure may reduce spine bone mineral density

Orthopedics - U.S. FDA grants approval for Smith & Nephew's pulsed ultrasound bone healing system

Osteoarthritis - Nuvo's resubmits Pennsaid new drug application to the U.S. Food and Drug Administration

Ovarian Cancer - U.S. FDA approves Lilly's Gemzar for ovarian cancer treatment

Pain Management - Clinical trials using oral triptans for early migraine management are reviewed

Pain Management - Rizatriptan + trimebutine combination is more effective than rizatriptan alone for migraine

Pharmaceutical Research - Three-quarters of people receive prescription antidepressants for unapproved use

Pneumococcal Vaccine - Adhering to current recommendations would prevent invasive pneumococcal disease

Pneumococcal Vaccine - Cost-effectiveness of pneumococcal conjugate vaccine is increased due to herd effects

Polio Vaccine - First decade of studies and trials with polio vaccine are reviewed

Polio Vaccine - GlaxoSmithKline view of inactivated polio vaccine is presented

Polio Vaccine - Inactivated poliovirus vaccine derived from Sabin strains has been developed

Polio Vaccine - Long-term excretors of vaccine-derived poliovirus are reported

Polio Vaccine - Methods for interrupting poliovirus transmission are presented

Polio Vaccine - Persistent poliovirus excretion is unusual in HIV-infected patients

Polio Vaccine - Poliovirus facilities pose risk to surrounding communities

Polio Vaccine - Rapid manufacture of oral polio vaccines was accomplished for supply to endemic countries

Polio Vaccine - Strategy for technology transfer of Sabin vaccine to developing countries is outlined

Polio Vaccine - Worldwide oral polio vaccine cessation strategy is presented

Preterm Birth - U.S. FDA advisory committee to review Gestiva to prevent preterm births

Prison Health - Marijuana Ladder predicts motivation to stop marijuana use in incarcerated adolescents

Schizophrenia - AstraZeneca submits NDA for Seroquel for schizophrenia

Sexual & Reproductive Health - Organon's Implanon contraceptive implant receives approval in U.S.

Sexual & Reproductive Health - Starpharma's IND for VivaGel for genital herpes prevention clears U.S. Food and Drug Administration

Skin Cancer - Nexavar receives fast track designation for melanoma from the U.S. Food and Drug Administration

Smallpox Vaccine - Antibody prevents poxvirus from forming pock lesions that promote virus transmission

Smallpox Vaccine - Human leukocyte antigen-A2-restricted CD8+ CTL responses to vaccinia virus epitope are examined

Smallpox Vaccine - Immunity against secondary poxvirus infection depends on antibody, not on CD4 or CD8 function

Smallpox Vaccine - Immunity and immunological memory following smallpox vaccination are reviewed

Spinal Implants - Innovasis announces U.S. Food and Drug Administration clearance for Opteryx Cervical Plate System

Streptococcal Vaccine -  Streptococcus pneumoniae serotype distribution in Switzerland is reported

Surgical Technology - AtriCure receives U.S. FDA 510(k) clearance for multifunctional isolator transpolar pen system

Systemic Lupus Erythematosus - Criteria to evaluate response to therapy in juvenile systemic lupus erythematosus are presented

Transplant Medicine - Y's Therapeutics compound for graft dysfunction granted orphan status in U.S. and Europe

Trypanosomiasis Vaccine -  Trypanosoma Tc13 Tul antigen decreases parasitemia but does not increase survival

Trypanosomiasis Vaccine - Complete cap 4 formation is not required for Trypanosoma brucei viability

Tuberculosis Diagnosis - RD1-based ELISPOT IFN-gamma assay for diagnosis of latent M. tuberculosis has been developed

Turner Syndrome - Cangene's human growth hormone drug submission is accepted for review by FDA

Anthrax - Reports from the United States and People's Republic of China describe recent advances in anthrax research

Breast Cancer - Researchers from the United States and Germany provide details of new studies and findings in the area of breast cancer

DNA - Researchers' data from the United States advance DNA research

Dengue Fever - Findings from the United States, France and Brazil in dengue fever provide new insights

Depression - Researchers from Australia, the United States and France publish new studies and findings in the area of depression

Environmental - Researchers' findings from the United States advance environmental research

Epidemiology - Findings from the United States, People's Republic of China and New Zealand in epidemiology provide new insights

Epidemiology - Researchers from Canada, the United States and Spain publish new studies and findings in the area of epidemiology

Epidemiology - Researchers from the United States report recent findings in epidemiology

HIV/AIDS - Studies from the United States and France add new findings to HIV/AIDS body of knowledge

Leukemia - Findings from the United States advance knowledge in leukemia research

Leukemia - Studies from the United States add new findings to leukemia body of knowledge

Malaria - Reports from the United Kingdom and Japan describe recent advances in malaria research

Malaria - Research from Laos, Switzerland and the United Kingdom add new data to malaria body of knowledge

Measles - New findings from Denmark, Germany and the United States in the area of measles described

Melanoma - Recent findings from the United States and the Netherlands illuminate research in melanoma

Multiple Sclerosis - Researchers from Germany, the United States and the North Ireland report recent findings in multiple sclerosis

Mycobacteria - Researchers from the United Kingdom, Israel and Mexico publish new studies and findings in the area of mycobacteria

Neurology - Data from the United States and Japan advance knowledge in neurology research

Parasites - Researchers' data from the United States and Gabon advance parasites research

Pneumococcal - Researchers from the United States, Spain and Finland provide details of new studies and findings in the area of pneumococcal

Respiratory System - Reports from the United Kingdom, Netherlands and People's Republic of China advance knowledge in respiratory system research

SARS - Researchers from South Korea, China and People's Republic of China report recent findings in SARS

Tuberculosis - Research from Brazil and the United States add new data to tuberculosis body of knowledge

Vaccines - New findings from the United States, Canada and Brazil in the area of vaccines detailed

West Nile Virus - Research from the United States add new data to west nile virus body of knowledge

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