Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . October 29th, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Food Safety - Method determines sulfonamide residues in aquacultured fish
Genetics & Genomics - Genomes have been determined for 13 Crimean-Congo hemorrhagic fever virus strains
HIV/AIDS Screening - Test showed high sensitivity, specificity for HIV antibody in blood and oral fluid
Morphogenesis - Decapentaplegic head capsule mutations disrupt Drosophila ventral head morphogenesis
Pertussis - Mixture model analyzes diagnostic cut-off for pertussis antibody levels
Acute Myelogenous Leukemia - Juvaris wins innovation research grant for acute myelogenous leukemia vaccine development
Addiction Medicine - Central excitatory effects of intravenous cocaine are related to Na+ channels
Amyotrophic Lateral Sclerosis - CytRx's Arimoclomol meets primary safety and tolerability endpoints in Phase IIa ALS clinical trial
Antituberculosis Drug Development - Front-line antitubercular drugs synergistic with ethylene diamine SQ109
Bacteriology - Verax Biomedical initiates two external clinical trials to test for bacteria in platelets
Bioterrorism - Hollis-Eden grants U.S. government extension of offer for acute radiation syndrome candidate
Business & Finance - CoAxia reports progress in stroke trial and terms reached for $11 million Series C financing
Business Update - Co-inventor of X STOP presents on novel technology at North American Spine Society Annual Meeting
Business Update - Crucell announces WHO prequalification for Quinvaxem vaccine
Business Update - Dade Behring launches CardioPhase hsCRP test for use on its Stratus CS Acute Care Diagnostic System
Business Update - Edwards Lifesciences launches LifeStent FlexStar and LifeStent FlexStar XL stent delivery systems
Business Update - Indevus announces clinical and regulatory plans for pagoclone
Business Update - MayaTech awarded U.S. CDC contract to evaluate grantee research on traumatic brain injury
Business Update - SunGard Availability Services introduces pandemic response planning services
Cardiology - U.S. FDA Advisory Committee strongly endorses use of Trasylol in CABG surgery patients
Cardiomyocytes - Circadian clock within cardiomyocyte is essential for heart responsiveness to fatty acids
Cervical Cancer - Advaxis meets with U.S. FDA regarding phase II of Lovaxin C
Clinical Trials - Restoration of sinus rhythm in atrial fibrillation patients is linked to improved quality of life
Degenerative Disc Disease - U.S. FDA approves clinical trial for Medtronic's DIAM Spinal Stabilization System
Dialysis - Rockwell Medical Technologies proprietary iron-delivery drug granted patent in Poland
Drug Development - Elusys presents positive data on anthrax therapeutic
Drug Development - Lexicon gets U.S. Defense Department funding to identify drug targets to combat sleep deprivation
Finance - NuVasive buys out remaining financial obligations relating to NeoDisc
Fitness & Wellness - Physical activity is linked to income, education, ethnic background, and commute requirements
Generalized Anxiety Disorder - EPIX announces top-line results from Phase 3 trial of PRX-00023 in generalized anxiety disorder
Graft-versus-Host Disease - DOR BioPharma files NDA with U.S. FDA to market orBec for GI graft vs. host disease
HIV/AIDS Diagnostics - OraSure Technologies begins initial studies for approval of home-use rapid HIV test
HIV/AIDS Screening - Rapid testing methods increase patient's knowledge of HIV status
Huntington Disease - Medivation receives permission from U.S. FDA to begin Dimebon Huntington disease trial
Hypothermia - Life Recovery Systems receives U.S. Food & Drug Administration clearance for its ThermoSuit System
Influenza Outbreaks - Influenza B outbreaks in Arizona and Nepal similar to proposed upcoming vaccine strain
Legal Issues - Savient Pharmaceuticals files patent infringement suit against Barr Laboratories
Medical Devices - Ascent Healthcare receives 510(k) clearance on Medtronic TORQR CS series catheters
Medical Devices - Medtronic receives U.S. FDA 510(k) clearance of next-generation vascular aspiration catheter
Medical Devices - Medtronic submits peripheral vascular iliac and renal stents to U.S. FDA and CE Mark
Medical Devices - U.S. FDA grants marketing approval for medical devices to treat clogged neck arteries
Mergers & Acquisitions - Safe Life, Triosyn merge to speed products to protect against pandemic flu and bioterrorism
Multiple Sclerosis - Avonex, frequently prescribed multiple sclerosis treatment, shows superior adherence
Multiple Sclerosis - Oral Cladribine for treatment of multiple sclerosis award fast track status
Nausea - A.P. Pharma expects data from APF530 pivotal trial in second half of 2007
Ophthalmology - Alcon's Travatan approved by U.S. FDA to treat glaucoma, ocular hypertensive patients
Pain Management - Cephalon receives U.S. FDA approval of Fentora for breakthrough pain in patients with cancer
Pancreatic Cancer - U.S. FDA grants orphan drug status to Threshold's glufosfamide for treating pancreatic cancer
Personnel - Justin P. Eggleton named director, spine regulatory affairs, by orthopedics consulting firm
Prenatal Testing - Ikonisys receives U.S. Food & Drug Administration clearance for prenatal testing application
Prostate Cancer - Spectrum announces positive results of phase 3 satraplatin trial in prostate cancer patients
Renal Dialysis - Pervasis Therapeutics' Vascugel initiates U.S. clinical trials
Stem Cell Research - Cytohesin binder and regulator not required for hematopoietic cell development or function
Stem Cell Research - ViroPharma initiates first of two studies of maribavir in stem cell transplant patients
Surgical Technology - Exactech gains U.S. FDA clearance for Optecure+CCC, new formulation allograft with bone chips
Surgical Technology - Impliant begins pivotal clinical trial for the TOPS System, alternative to spinal fusion
Tuberculosis Epidemiology - Strain-specific differences in Mycobacterium tuberculosis genotype clusters determined
Antibiotics - New findings from the United States in the area of antibiotics described
Antibiotics - New research from Japan and the United States in the area of antibiotics detailed
Antibiotics - Studies from the United States and Spain describe new findings in antibiotics research
Apoptosis - Data from , Canada and Netherlands advance knowledge in apoptosis research
Biomedical Engineering - Researchers from the United States detail new studies and findings in the area of biomedical engineering
Cancer Treatment - Researchers' findings from the United States advance cancer treatment research
Cardiology - Reports from the United States, Japan and Switzerland add new data to cardiology research
Depression - Studies from the United States and Japan advance knowledge in depression research
Genetics - Studies from the United States, Israel and Japan advance knowledge in genetics research
HIV/AIDS - Findings from the United States advance knowledge in HIV/AIDS research
HIV/AIDS - Reports from the United Kingdom, Italy and Switzerland advance knowledge in HIV/AIDS research
HIV/AIDS - Reports from the United States advance knowledge in HIV/AIDS research
HIV/AIDS - Research from the United States and Japan add new data to HIV/AIDS body of knowledge
HIV/AIDS - Researchers from the United Kingdom, France and United States describe findings in HIV/AIDS studies
Leishmania - Researchers' findings from Japan, Brazil and Iran advance leishmania research
Measles - Studies from Germany, Denmark and the Saudi Arabia advance knowledge in measles research
Neurology - Researchers' findings from Japan and France advance neurology research
Neurology - Researchers' findings from Spain, Australia and the United States advance neurology research
Obesity - New research from the United States and Japan in the area of obesity detailed
Parkinson Disease - Findings from Spain, the United States and Italy advance knowledge in Parkinson disease research
Pneumococcal - Findings from the United Kingdom and United States describe new data in pneumococcal research
Pneumococcal - New findings from The Gambia, Germany and South Africa in the area of pneumococcal described
Pneumococcal - New research from Spain and the United States in the area of pneumococcal detailed
Respiratory System - Findings from the United Kingdom advance knowledge in respiratory system research
Rotavirus - Researchers' findings from the United States, United Kingdom and Portugal advance rotavirus research
Stress - Reports from the United States advance knowledge in stress research
Toxoplasmosis - Researchers' findings from the United States, Brazil and Italy advance toxoplasmosis research
Transplants - Reports from Spain and France describe recent advances in transplants research
Transplants - Studies from the United States, Spain and Ireland describe new findings in transplants research
Tuberculosis - Findings from the United States and United Kingdom in tuberculosis provide new insights
Tuberculosis - Recent studies from France and the United States add new data to tuberculosis research
Vaccines - Researchers' data from the United States and Netherlands advance vaccines research
Vaccines - Researchers' findings from the United States and Taiwan advance vaccines research
Vaccines - Researchers' work from the United States adds to vaccines body of knowledge
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