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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . November 17th, 2006

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Food and Drug Law Weekly | Other Publications

Acute Care - Satisfied patients are also vulnerable patients

Addiction Medicine - Beck Depression Inventory predicts drug use severity during opiate agonist maintenance therapy

Advanced Squamous Cell Carcinoma - Taxotere receives U.S. FDA approval for treatment for patients with head and neck cancer

Aesthetic Medicine - Isolagen and U.S. FDA reach agreement on phase III protocol design for wrinkle therapy

Alcohol Use - Naltrexone and disulfiram offer no advantage for treating alcohol abuse and psychotic disorder

Allergy & Immunology - U.S. FDA approves Allegra Oral Suspension for seasonal pediatric allergies, idiopathic urticaria

Alzheimer Disease - Lysosome-associated membrane protein 1 is involved in pathogenesis of Alzheimer disease

Alzheimer Disease - Memory Pharmaceuticals reports U.S. FDA status of trial on MEM 3454 in Alzheimer disease

Alzheimer Disease - Regression-stage senile plaques in natural course of Alzheimer disease are described

Alzheimer Disease - U.S. FDA approves Eisai's Aricept to treat severe Alzheimer disease

Anthrax - Medarex, PharmAthene report positive phase 1 results in anthrax therapeutic Valortim trial

Anthrax Immunology - Research on anthrax immunology published by scientists at Technion, Bruce Rappaport Faculty of Medicine

Antibiotics - Data presented on Factive Tablets short-course antibiotic therapy in patients with co-morbidities

Antimicrobial Resistance - Beta-lactam exposure increases risk of metallo-beta-lactamase-producing Pseudomonas infection

Antimicrobial Resistance - Mutations in topoisomerase targets produce fluoroquinolone resistance in Salmonella typhi

Antimicrobial Resistance - Role of hospital stay and antibiotics on Pseudomonas in hospitalized patients is examined

Asthma - U.S. FDA accepts for review Critical Therapeutics' NDA for controlled-release zileuton

Bacillus Genetic & Genomics -  Bacillus cereus isolates linked to fatal pneumonias harbor B. anthracis virulence genes

Bioterrorism - Studies from University of Chicago add new findings in the area of bioterrorism

Blood Glucose - HbA1c provides glycemia information, but does not reflect short-term fluctuations

Blood Safety - Human herpesvirus 8 can be transmitted by blood transfusion

Blood Safety - U.S. National Institutes of Health awards grant for clinical trial of bacterial test

Business & Finance - Endo Pharmaceuticals reports third quarter 2006 financial results

Business Update - Abaxis announces U.S. FDA action on status

Business Update - Arizona hospital treats first U.S. patient with Disc Dynamic's disc arthroplasty system

Business Update - Bayer appoints independent investigator to review Trasylol study issues

Business Update - Breakthrough reported for Sangui oxygen carriers

Business Update - CogState launches world's first real-time cognitive data monitoring system

Business Update - CryoCor PMA amendment delayed

Business Update - DuPont introduces Biosecurity Kits for businesses seeking assistance with disease preparedness

Business Update - Endo Pharmaceuticals comments on Lidoderm

Business Update - Merck and Lundbeck update submission plans for U.S. FDA approval of insomnia drug gaboxadol

Business Update - Roche's nine-month sales hit record high

Cancer Therapy - Effect of protein loss on spontaneous gynecological tumor development clarified

Cancer Therapy - Study anticipates rapid growth in kinase drug development space

Chronic Kidney Disease - Amgen receives complete response letter for extended dosing of Aranesp

Chronic Obstructive Pulmonary Disease - Prevalence of chronic obstructive lung disease in Sweden is reported

Cognitive Science - Blood pressure reduction appears to have heterogeneous effect on cognitive function

Cognitive Science - Donepezil improves cognition of patients undergoing electroconvulsive therapy

Complementary & Alternative Medicine - Major components of Si-Ni-San that prevent contact sensitivity are identified

Cystic Fibrosis - Newborn screening for cystic fibrosis may improve child survival

Dengue Vaccine - Antibody responses to combinations of dengue virus vaccines are described

Dengue Vaccine - Dengue DNA vaccine elicits neutralizing antibody to four virus serotypes

Dental Research - American Dental Association applauds health claim for fluoridated bottled water

Depression Therapy - Escitalopram was better than citalopram for treatment of depression

Depression Therapy - No sustained effect of bright light after discontinuation was found for depression

Diagnostics - External RNA controls for assessment of microarray performance were evaluated

Diagnostics - MicroArray Quality Control project shows reproducibility of gene expression measurements

Diagnostics - New assay screens for inhibitors of hypoxia-inducible factor 2 activity

Diagnostics - Performance of one- and two-color platforms within MicroArray Quality Control project are similar

Diagnostics - Rat toxicogenomic study reveals analytical consistency across microarray platforms

Drug Development - Sequential genome-wide association test for analyzing adverse drug events is developed

Drug Safety - Newer COX-2 selective inhibitors do not increase risk of angioedema

Ebola Virus - Luciferase-based budding assay for Ebola virus is developed

Epidemiology - Research reports from National Institute for Public Health and the Environment provide new insights into epidemiology

Epidemiology - Researchers from University of Oklahoma, Health Science Center describe findings in epidemiology

Epidemiology - Studies conducted at University of Wisconsin, Department of Medicine on epidemiology recently published

Epilepsy - Seizure anticipation in epilepsy was investigated

Escherichia Coli - New findings from Korea University in the area of escherichia coli published

Finance - Lifeblood Medical to receive U.S. Department of Defense funding for organ donation research

Food-Borne Illness - Diets with monensin or tylosin did not affect E. coli O157:H7 shedding by cattle

Gastroenterology - Small bowel bacterial overgrowth is under-recognized malnutrition cause in older adults

Graft-versus-Host Disease - Osiris is granted European manufacturing certification for Prochymal

Graft-versus-Host Disease - Osiris Therapeutics receives approval to conduct Phase III clinical trial for lead stem cell drug

Hantavirus Therapy - Swedish Institute for Infectious Disease Control describes research in hantavirus therapy

Hepatitis B Therapy - U.S. Food and Drug Administration approves new treatment for chronic Hepatitis B in adults

Hepatitis B Virus - Hepatitis B virus genotypes detected and quantified

Hepatitis C Therapy - Roche advances oral polymerase inhibitor into Phase II study in patients with chronic hepatitis C

HIV/AIDS Diagnostics - U.S. FDA grants approval for MedMira's third-generation rapid HIV test

HIV/AIDS Vaccine - SIV multigene prime/protein boost vaccine regimen protects against rectal challenge

Human Papillomavirus Epidemiology - HPV infection is highly prevalent among sexually active men

Hypertension - CVRx receives approval for Rheos Baroreflex Hypertension Therapy System trial

Influenza - Los Alamos licenses avian flu modeling & simulation software to CIVA

Influenza - U.S. Secretary of Health and Human Services remarks on pandemic flu

Influenza Vaccine - Immunogenicity of influenza A/Duck/Singapore/3/97(H5) vaccines in ferrets was examined

Learning Disabilities - Strategies improve writing of middle school students with disabilities

Legionnaire Disease Cell Biology - Study findings from Seoul National University, Department of Biological Sciences broaden understanding of legionnaire disease cell biology

Legionnaire Disease Therapy - New legionnaire disease therapy findings from University of South Florida, Department of Medical Microbiology and Immunology described

Leishmaniasis Therapy - Miltefosine analog with leishmanicidal activity is synthesized

Lymphoblastic Leukemia Therapy - Approval summary of nelarabine for T cell lymphoblastic leukemia and lymphoma is released

Lymphoma - Mantle cell lymphoma pathogenesis and survival linked to constitutive activation of PI3K/Akt

Marburg Virus Vaccine - Live vaccine provides cross-protection against Marburg virus strains

Measles Epidemiology - Methods to elute serum from dried blood spot samples for measles serology were compared

Medical Devices - Bovie Medical reports U.S. FDA clearance to market new laparoscopic instruments

Medical Devices - Medtronic to initiate large clinical study evaluating drug eluting stent safety

Medical Devices - RITA Medical Systems announces 510(k) clearance of HABIB 4X laparoscopic device

Medical Devices - TyRx Pharma submits premarket application for Pivit CRM

Medical Devices - Ultrasound experts support decision to deny over-the-counter sale of handheld doppler fetoscopes

Medulloblastoma - Medulloblastoma treated by craniospinal radiation therapy followed by adjuvant chemotherapy

Menopause - Depomed obtains exclusive sublicense for Gabapentin use in hot flashes

Mental Health - Associations between cognition and costs among people with schizophrenia were examined

Mental Health - Effect of self-esteem and self-acceptance on psychological health is examined

Molecular Biology - Lawrence Berkeley National Laboratory opens the National Center for X-ray Tomography

Mosquito-Borne Disease - Japanese encephalitis virus was found in mosquitoes collected in Korea

Mosquito-Borne Disease - West Nile virus from mosquitoes in ground and canopy habitats in Connecticut were examined

Myelodysplastic Syndrome - New agents for management of myelodysplastic syndromes are focus of review

Non-small Cell Lung Cancer - U.S. FDA approves new combination therapy for lung cancer

Pain Management - Laser therapy is effective for relieving chronic neck pain

Pain Management - Reliability of pain interference measures in multiple sclerosis was examined

Pandemic - Studies in the area of pandemic reported from Hospital Ramon y Cajal

Pelvic Inflammatory Disease - Low prevalence of tubo-ovarian abscess was found in adolescents with pelvic inflammatory disease

Personnel - PortBlue names Dr. Daniel Lucey senior advisor to CommandAware

Plague Epidemiology - Researchers from Centers for Disease Control and Prevention provide details of new studies and findings in the area of plague epidemiology

Pneumococcal Vaccine - Many at-risk older adults were not receiving pneumococcal vaccine in England

Portopulmonary Hypertension - Portopulmonary hypertension case was treated successfully with bosentan

Prion Disease - Styrylbenzoazole derivatives are useful for treatment of transmissible spongiform encephalopathies

Proteomics - Microarray platforms are useful for quantitative characterization of gene expression

Psoriasis Therapy - Pediatric psoriasis case was treated successfully with indigo naturalis composite ointment

Psychiatry - Problems of objectivity and critique in psychoanalysis are examined

Rabies Vaccine - German travel health advisors need more thorough training in rabies preventive measures

Reovirus - New mammalian reovirus characterized

Rheumatoid Arthritis Therapy - Cartilage oligomeric matrix protein level is used to monitor therapy in rheumatoid arthritis

SARS Genetics & Genomics - Large deletion in SARS coronavirus may provide evidence for quasispecies

Schistosomiasis Vaccine - Schistosomiasis and molecular biology of male-female interaction of S. mansoni are discussed.

Schizophrenia - Correlates of P50 sensory gating abnormalities in schizophrenia patients are reviewed

Serratia Marcescens Outbreaks -  Serratia marcescens meningitis outbreak caused by improper betamethasone compounding

Sexual & Reproductive Health - Exhaustive endurance exercise induces reversible fertility changes in men

Smallpox - SIGA announces smallpox treatment breakthrough

Stroke - Continuous positive airway pressure did not benefit stroke patients

Systemic Lupus Erythematosus - Allele in brain-derived neurotrophic factor gene prevents neurocognitive dysfunction in lupus

Toxicology - Dioxin and polychlorinated biphenyl human toxicity is reviewed

Toxoplasmosis Vaccine - Mic1-3 knockout Toxoplasma gondii is efficacious against toxoplasmosis

Toxoplasmosis Vaccine - P30 peptides protect against Toxoplasma gondii infection

Transplant Medicine - Cylex ImmuKnow assay assesses immune function in transplant recipients

Travel Medicine - Health information given by Swiss travel agencies was examined

Travel Medicine - Pharmacists need training in travel medicine in Portugal

Travel Medicine - Risk of SARS coronavirus transmission is low aboard commercial aircraft

Tuberculosis Epidemiology - Researchers from Wellcome Trust Research Laboratories, Faculty of Medicine Imperial College London publish new studies and findings in the area of tuberculosis epidemiology

Tuberculosis Vaccine - Helminths could influence TB vaccine effectiveness in tropics

Type 2 Diabetes - U.S. FDA approves Januvia, the first and only DPP-4 inhibitor available U.S. for type 2 diabetes

Ulcerative Colitis - U.S. FDA expands Remicade indication for ulcerative colitis

Vesicoureteral Reflux Therapy - Vesicoureteral reflux management in era of dextranomer/hyaluronic acid copolymer is reviewed

Zollinger-Ellison Syndrome - U.S. FDA approves Nexium for treatment of Zollinger-Ellison Syndrome

Depression - Studies from the United States and Greece in the area of depression detailed

Drug Development - Studies from Food and Drug Administration, U.S., further understanding of drug development

Healthcare - Investigators from University of British Columbia, Canada, release new healthcare data

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