Susan Hasty, Publisher
Table of Contents . . . January 8th, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Lyme Disease - Report compares multiplex assays for detecting Borrelia in Ixodes nymphs
Medical Devices - U.S. FDA uses judgment in applying standards for medical devices
Tick-Borne Disease - Robotic method for high-throughput molecular testing of ticks has been developed
Anti-Infectives - U.S. FDA clears the ON-Q SilverSoaker antimicrobial catheter
Antibiotic Resistance - Report reviews evolution of antibiotic resistance in S. pneumoniae in Brittany
Apoptosis - Retinol induces cytochrome c release from rat liver mitochondria
Asthma Therapy - Montelukast is beneficial in treating asthma in preschool children
Attention Deficit Hyperactivity Disorder - Psychopharmacologic drugs advisory committee supports safety and efficacy of Daytrana
Avian Influenza - U.S. FDA issues investigational new animal drug number for study of avian flu on pigs
Bacillus Anthracis - Anthrax toxin enhances VCAM-1 expression in endothelial cells
Behavioral Medicine - Adolescent alcohol use disorders predict adult borderline personality
Bioterrorism - Expert panel evaluates implementation of Project BioShield and procurement of biodefense vaccines
Cancer Therapy - Analysis of phase III kidney cancer trial to be completed in March 2006
Cardiology - Fish oil may prevent potentially deadly decline in heart rate variability
Cerivastatin - Mitochondria are involved in exercise-induced cerivastatin muscle toxicity
Cervical Cancer - Pharma company submits biologics license application for papillomavirus vaccine to U.S. FDA
Clinical Trials - Racial minorities are willing to participate in health research when there is an opportunity
Community Acquired Pneumonia - U.S. FDA provides guidance on a pivotal phase III clinical protocol evaluating Cethromycin in CAP
Complementary & Alternative Medicine - Study shows Ierobina is an antidyspeptic agent
Consumer Alert - Consumers warned about bacterially contaminated Miracle II Neutralizer and Gel
Crohn Disease - U.S. FDA grants clearance to begin phase II clinical trial of Crohn disease treatment
Diabetes - U.S. FDA activates diabetes drug investigation
Diabetes Pathogenesis - Deficiency in Ikk beta gene enhances arsenic-induced gadd45 alpha expression
Diabetes Pathogenesis - Lower catecholamine-induced lipolysis and HSL expression are linked to obesity
Diet & Nutrition - High carotenoid-rich vegetables and fruit intake reduced plasma C-reactive protein in men
Drug Delivery - Rutin and quercetin gastro-resistant microparticles have been obtained by spray-drying
Drug Delivery - U.S. FDA approves Hylenex
Drug Development - Biologics license application filed with U.S. FDA for Hunter syndrome treatment
Drug Development - Favorable regulatory developments reported for Veronate may help smallest neonates
Drug Development - Phase I/II trial to evaluate bone formation in spine with tissue repair cell product
Drug Development - Positive meeting with U.S. FDA reported for development of lung cancer drug
Drug Development - Positive results reported from first of two phase III trials of ophthalmic anti-infective solution
Drug Development - Protein engineering company establishes proof of concept with TNF-alpha antagonist
Drug Development - Regulatory status of U.S. Navy's proposed RESUS trauma trial updated
Drug Development - Tentative U.S. FDA approval issued for sertraline hydrochloride tablets
Drug Development - U.S. FDA grants approval for Kogenate FS with Bio-Set for patients with hemophilia A
Electrocardiography - U.S. FDA Electrocardiogram Warehouse provides clinical utility
Electronic Medical Records - Community Health Network of West Virginia selects Medsphere OpenVista
Endocrinology - E.U. marketing authorization application for primary IGFD treatment submitted
Environmental Health - Exposure to farming environments as a child does not increase type 1 diabetes risk
Food-Borne Illness - Biomarkers of marine neurotoxicant domoic acid have been identified
Food-Borne Illness - Method is developed to measure putrescine and cadaverine in seafood
Gastric Cancer - U.S. FDA grants priority review to Taxotere for advanced gastric cancer
Gastric Cancer Risk Factors - Report describes cell proliferation and inflammation before and after H. pylori eradication
Gynecological Cancer Risk Factors - Report asserts no proof of carcinogenic properties for combined therapy
HIV/AIDS Epidemiology - AIDS triples the mortality of adults aged 25-44 years in Pointe-Noire
HIV/AIDS HAART - Replication-competent HIV persists in patients with uninterrupted HAART
HIV/AIDS Pathogenesis - Pathogenic simian immunodeficiency syndrome infection does not correlate with viral load
HIV/AIDS Research - Health Canada grants approval for first-in-man clinical trial of treatment of drug resistant HIV
HIV/AIDS Therapy - HIV fusion inhibitors have been developed to battle AIDS
HIV/AIDS Therapy - Non-nucleoside reverse transcriptase inhibitor has anti-HIV activity
Heart Failure - Review focuses on key issues in end point selection for heart failure trials
Hematopoiesis - Janus kinase 3 negatively regulates dendritic-cell cytokine production and survival
Hepatitis C Therapy - Pharma company receives U.S. FDA approval to market ribavirin tablets for hepatitis C
Hepatitis C Therapy - Update provided on clinical development program for valopicitabine for hepatitis C
Hepatitis C Virus - U.S. FDA grants approval of ribavirin tablets for treatment of chronic hepatitis C
Herpesvirus - Genital herpes infections predominantly transmitted via asymptomatic viral shedding
Imaging - Imaging company receives U.S. FDA clearance of new advanced software
Information Technology - U.S. CDC awards BearingPoint $9.8M contract to support center for Public Health Informatics
Japanese Encephalitis Vaccine - WHO report on endpoints to evaluate Japanese encephalitis vaccines is released
Kaposi Sarcoma-Associated Herpesvirus - KSHV K8 beta blocks K8 alpha-CDK2 interaction
Kidney Transplantation - Report reviews clinical trials with mycophenolate mofetil in renal transplantation
Legal Issues - Biopharma company files unfair business practices lawsuit against Insmed
Legionellosis - Pathogenic Legionella species and legionella-laden amoebae isolated in dental unit waterlines
Leukemia - sBLA filed for first-line use of Oncasparin ALL; U.S. FDA accepts application for review
Lung Cancer - U.S. FDA agrees that advancing combination lung cancer treatment into phase III study is warranted
Managed Care - Medicaid statement issued concerning management strategies for GERD
Manufacturing - Avid Bioservices to manufacture a recombinant human enzyme
Marketing - Company acquires U.S. rights to sell Norgine's liquid PEG bowel cleanser
Medical Devices - Medical devices company announces U.S. FDA (510)k clearance of two lumen catheter
Medical Devices - Small stature cervical plate system offers better fit for patients
Medical Devices - System for intraperitoneal hyperthermia treatment of cancer receives CE Mark approval
Medicare & Medicaid - FamilyCare selects PBM services provider for Medicare and Medicaid
Mergers & Acquisitions - Drugmaker acquires influenza vaccine manufacturer ID Biomedical Corp.
Narcolepsy - European Commission grants marketing approval of oral solution for treating cataplexy
Nausea - Study shows dissolving Emezine tablet is more concentrated and effective than oral tablet
Neuroscience - Brain chemical appears to boost trust and reduce fear
Nuclear Medicine - Role of imaging in ibritumomab tiuxetan regimen is examined
Oral Health - Discus Dental granted sole U.S. distribution rights to drug for aphthous ulcers
Pancreatic Cancer - Pancreatic cancer linked to high insulin levels in male smokers
Patents - Patent protection obtained for ECO-4601
Patents - U.S. FTC will not file objections to settlement of patent dispute over venlafaxine
Patents - U.S. patent allowance covering PBR protein technology announced
Patents - U.S. trademark office to confirm validity of patent of key ingredient in Lipitor
Personnel - Consultant to assist in completing Bio-E-Gel new drug application to the U.S. FDA
Prostate Cancer - Target enrollment achieved in satraplatin phase III trial for prostate cancer
Public Health - Federal government begins pandemic planning with states
Public Health - Hepatitis C summit engages HCV stakeholders to elevate the response to the HCV epidemic
Radiation Exposure - QR-336 shown to protect against lethal doses of ionizing radiation
SARS Pathogenesis - Assembly of SARS RNA packaging signal into virus-like particles is nucleocapsid-dependent
Surgical Technology - U.S. FDA grants 510(k) clearance for DBM and bone chip compound for orthopedic use
Surgical Technology - U.S. FDA grants clearance for DBM paste products as bone fillers
Vectors and Zoonosis - Rift valley fever is reported in small ruminants in Senegal
West Nile Virus - Temperature-dependent, spatial model of West Nile encephalomyelitis dynamics is developed
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.