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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . July 23rd, 2006

Non-Subscriber - Summaries Only

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

Anthrax Vaccine - Immunochromatographic device to measure anti-anthrax protective antigen IgG is developed

Drug Development - Global perspective on advisory process for anticancer drug regulation are outlined

Epilepsy - Attitudes about epilepsy components of U.S. Centers for Disease Control and Prevention epilepsy instrument have been validated

Respiratory Syncytial Virus - Alpha and lambda interferon suppress CD4 T cells induced by respiratory syncytial virus

Allergy Medicine - House dust extracts have both Th2 adjuvant and tolerogenic activities

Avian Influenza - Sinovac reports positive phase 1 preliminary trial results on bird flu vaccine

Biliary Tract Cancer - Biliary tract cancer risk reduced by tea drinking

Bipolar Disorder - Functional outcome after first episode of psychotic mania is poor

Bipolar Disorder - Structural brain correlates of IQ changes in bipolar disorder are examined

Blood Clotting - Future of pharmacogenetics in oral anticoagulation therapy is reviewed

Business Update - Enginuity software selected by Procter & Gamble for global product development

Business Update - Neoprobe elects directors and gives business update

Business Update - U.S. government to purchase Human Genome Sciences' ABthrax for Strategic National Stockpile

Cancer Therapy - Access Pharmaceuticals reports positive clinical results of MuGard

Cardiac Medical Devices - SyntheMed reports positive results from European clinical study of REPEL-CV adhesion barrier

Cervical Cancer - U.S. Food and Drug Administration approves first drug treatment for late-stage cervical cancer

Chronic Kidney Disease - Advanced Magnetics reports panel identifies no safety issues for ferumoxytol phase III trial

Clinical Trials - New data on renin inhibitor SPP100 (Rasilez) demonstrates potential use in diabetic patients

Collaborations - Ceragenix R & D agreement targets prevention of influenza and eradication of MRSA colonization

Colorectal Cancer - Avastin approved in combination with chemotherapy for second-line metastatic colorectal cancer

Cushing Syndrome - Corticotropin-producing pulmonary gangliocytic paraganglioma linked to Cushing syndrome

Diabetes Complications - Fatless diabetes models do not support a link between obesity and cancer risk

Diabetes Monitoring - U.S. Food and Drug Administration clears MD Scientific's tight glucose control software

Drug Delivery - Avonex may now be given with smaller needle

Drug Development - Anti-cancer therapeutic from Adnexus to start clinical trials

Drug Development - Athenagen advances angiogenesis drug to clinical testing

Drug Development - Neurocrine completes review of indiplon action letters

Drug Development - OccuLogix reports on meeting with FDA

Drug Development - U.S. Food and Drug Administration informs AVANIR of revised Neurodex NDA action date

Drug Safety - U.S. Food and Drug Administration warns consumers not to use Triaminic Vapor Patch

Enzymology - Glutamate, tryptophan, and arginine are involved in xylanase activity from Bacillus species

Epidemiology - Diagnosis of malaria imported to Jakarta, Indonesia may be overlooked, delayed

Esophagitis - Basal cell hyperplasia severity differs in reflux versus eosinophilic esophagitis

Food Safety - Independent lab finds low mercury levels in 142 fish samples tested in Washington, DC area

Food Safety - U.S. Food and Drug Administration cutbacks may mean elimination of some food safety programs

HIV/AIDS Diagnostics - Bayer receives U.S. Food and Drug Administration approval for HIV antibody test

HIV/AIDS Pathogenesis - HIV-1 induces IFN-alpha and the TRAIL/DR5 apoptotic pathway in lymphoid tonsillar tissue

Hairy Cell Leukemia - Clone-specific PCR assesses minimal residual disease in hairy cell leukemia

Healthcare Coverage - Private health insurance may improve health of older, working age adults

Heart Failure - Study data suggest Aranesp (darbepoetin alfa) may decrease anemia risk related to heart failure

Human Papillomavirus Vaccine - Combined prophylactic and therapeutic cervical cancer vaccine is developed

Human T Cell Lymphotropic Virus Infection - Reduced Foxp3 expression associated with inflammatory disease during HTLV-1 infection

Immunology - Sensitivity of alveolar macrophages to substrate properties is described

Leukemia Therapy - Approach to managing leukemia in the developing world is presented

Liver Cancer - Nexavar receives Fast Track designation from FDA for metastatic liver cancer

Market Analysis - Report looks at off-label use reimbursement challenges

Marketing - Tm Bioscience signs agreement with Sanbio to market respiratory viral panel in Netherlands

Medical Devices - Aksys receives U.S. Food and Drug Administration warning letter

Medical Devices - Devon Medical receives U.S. Food and Drug Administration clearance for SharpShield safety syringe

Melanoma - Medarex gets U.S. FDA SPA to initiate registration trial of ipilimumab in melanoma patients

Mental Health - Evolution of outpatient commitment in U.S. is focus of review

Mental Health - Sexual offending treatment effectiveness can be aided by examining theories

Neuroendocrine Tumors - Molecular Insight Pharmaceuticals initiates trial for neuroendocrine cancer treatment

Ovarian Cancer - Morphotek granted orphan drug status for monoclonal antibody for ovarian cancer treatment

Pain Management - Substance Abuse and Mental Health Services Administration finds 2.4M started using pain relievers

Pediatric Vaccine - Individual risk factors do not predict infant under-immunization in a disadvantaged urban area

Polio Vaccine - Oral polio vaccine has potential to cause polio epidemic

Restless Legs Syndrome - New studies support efficacy of pramipexole in treating restless legs syndrome

Salivary Gland Carcinoma - Salivary gland carcinoma pathogenesis linked to ras oncogene

Schistosomiasis Vaccine - Tegumental protein Sm29 is potential vaccine candidate against schistosomiasis

Seasonal Affective Disorder - Circadian basis of winter depression was examined

Systemic Lupus Erythematosus - Cytotoxic treatment is risk factor for osteonecrosis in lupus patients

Systemic Sclerosis - Hypothesis-driven treatment strategies for systemic sclerosis are outlined

Tick-Borne Disease - Follistatin-related protein from ticks has been identified

Tobacco Use - Parents are supportive of a school role in tobacco use prevention for youth

Tropical Diseases - Authors cite vaccines' potential to break poverty cycle

Urology - Uroplasty's device to treat overactive bladder receives CE Mark approval

Vaccinia Virus - Groove interactions of vaccinia Topo I provide specificity by phosphotyrosine linkage positioning

Vector Development - Gangliosides are essential for bovine adeno-associated virus entry

Virology - Mayaro virus nucleotide sequence has been determined

Virology - Mixed retrovirus infections have profound effects on disease processes

Angiology - Reports from the United States and Canada advance knowledge in angiology research

Breast Cancer - Research from the United States and Spain add new data to breast cancer body of knowledge

Depression - Reports from the United States and United Kingdom describe recent advances in depression research

Diet & Nutrition - Data from the United States and Italy advance knowledge in diet & nutrition research

Eating Disorders - Reports from Japan, Germany and the United States describe recent advances in eating disorders research

Genetics - Studies from the United States and Japan describe new findings in genetics research

HIV/AIDS - New findings from the United States and United Kingdom in the area of HIV/AIDS described

HIV/AIDS - Researchers from the United States and United Kingdom detail new studies and findings in the area of HIV/AIDS

HIV/AIDS - Researchers from the United States report recent findings in HIV/AIDS

HIV/AIDS - Researchers from the United States, Japan and Australia describe findings in HIV/AIDS studies

HIV/AIDS - Researchers' data from the United States, Canada and France advance HIV/AIDS research

Hepatitis C Virus - Studies from the United States, People's Republic of China and Chile add new findings to hepatitis C virus body of knowledge

Herpes - New data from the United States lluminates research in herpes

Influenza - New findings from the United States and Cuba in the area of influenza described

Influenza - Researchers' data from Israel, the United States and Norway advance influenza research

Leishmania - Recent studies from Iran and the United States add new data to leishmania research

Leishmania - Reports from the Netherlands, Brazil and Italy advance knowledge in leishmania research

Malaria - Recent findings from Germany, Switzerland and Colombia illuminate research in malaria

Malaria - Reports from Canada, Australia and the United States add new data to malaria research

Meningitis - Data from the United Kingdom and Italy advance knowledge in meningitis research

Meningitis - Findings from Netherlands, Brazil and United Kingdom advance knowledge in meningitis research

Meningitis - Studies from the United States and United Kingdom add new findings to meningitis body of knowledge

Ovarian Cancer - New findings from the People's Republic of China and United States in the area of ovarian cancer described

Pneumococcal - New findings in pneumococcal described from the United States and United Kingdom

Pneumococcal - Researchers' data from the United Kingdom and United States advance pneumococcal research

Pneumococcal - Researchers' findings from the United States and Spain advance pneumococcal research

Rabies - New findings from Brazil, Netherlands and the United Kingdom in the area of rabies detailed

SARS - New findings from the United States, Taiwan and People's Republic of China in the area of SARS described

SARS - Studies from South Korea and People's Republic of China describe new findings in SARS research

Toxoplasmosis - New findings from France and Malaysia in the area of toxoplasmosis described

Tuberculosis - Findings from the United Kingdom, Wales and United States in tuberculosis provide new insights

Tuberculosis - Researchers from France, the United States and India report recent findings in tuberculosis

Vaccines - New research from South Korea, United Kingdom and United States in the area of vaccines detailed

Vaccines - Recent findings in vaccines described by researchers from Germany, Taiwan and the United States

Vaccines - Research from the People's Republic of China and Canada add new data to vaccines body of knowledge

Vaccines - Researchers' work from the United States and Italy adds to vaccines body of knowledge

Vaccines - Researchers' work from the United States, Canada and Brazil adds to vaccines body of knowledge

Virology - Researchers from the United States, Belgium and Australia publish new studies and findings in the area of virology

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