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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 8th, 2006

Non-Subscriber - Summaries Only

Related 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

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