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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . October 1st, 2006

Non-Subscriber - Summaries Only

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

Antimicrobial Resistance - Carbapenem resistance in Klebsiella is not detected by susceptibility testing

Food Safety - Infections associated with cantaloupe are growing public health concern

Meningitis Risk Factors - Invasive Enterobacter sakazakii disease in infants was examined

Meningitis Vaccine - Hib conjugate vaccine was effective in children in Kenya

Occupational Exposure - Workplace conditions frequently exacerbate asthma

Addiction Medicine - Drug treatment programs reduce criminal behavior

Advocacy - March of Dimes: Drug to prevent preterm birth needs prompt U.S. Food & Drug Administration approval

Alcohol Use - Social model alcohol recovery programs were examined as therapeutic landscapes

Anesthesia - Higher doses of ketamine are linked to increased intraocular pressure in anesthetized children

Antimicrobial Resistance - Daptomycin is active against all Gram-positive bacteria in Europe

Antimicrobial Resistance - Macrolide resistance in adults with pneumococcal pneumonia was examined for risk factors

Attention Deficit Hyperactivity Disorder - Shire announces new drug application for guanfacine extended-release for attention disorders

Bariatrics - High bariatric surgery complications rates suggest that improvements are needed

Biomedical Engineering - NeuroMetrix announces latest U.S. FDA 510(k) clearance for NC-stat system

Bipolar Disorder - Attention deficits in manic and euthymic patients with bipolar disorder were examined

Blood Safety - Stanford Blood Center testing all donated blood for West Nile virus

Blood Transfusion - Efficacy of shipped HLA-matched platelets is reported

Business Update - Akorn-Strides announces tenth new abbreviated drug application submission

Business Update - Atrium Medical receives U.S. FDA approval for the iVENA Vascular Patch

Business Update - Card Guard receives U.S. FDA 510(k) approval for ambulatory cardiac telemetry solution

Business Update - Cardinal Health suspends production of infusion pump following U.S. FDA actions

Business Update - Colazal pediatric exclusivity granted for bowel disease

Business Update - EPIX receives response from U.S. FDA regarding appeal of Vasovist Approvable Letters

Business Update - Mitek and StayinFront, Inc. partner to develop software for reducing drug diversion

Business Update - U.S. FDA Advisory Panel recommends approval of RADIESSE for two facial aesthetic applications

Business Update - U.S. FDA approves wavefront-guided excimer laser system to correct eye conditions

Business Update - U.S. FDA conditionally approves modification of IDE endpoint for U.S. migraine implant study

Cancer Therapy - Proteasome inhibition is new therapy for non-Hodgkin lymphoma

Chronic Fatigue Syndrome - Cognitive dysfunction is linked to mental fatigue in chronic fatigue syndrome patients

Chronic Lymphocytic Leukemia - Genta briefing documents posted for U.S. FDA panel review of Genasense application

Clinical Trials - Starpharma initiates U.S. NIH-funded trial of microbicide for sexually transmitted diseases

Depression - Antidepressant-drug interactions are rarely clinically significant

Dermatology - Connetics reports positive results from second Phase III clinical trial of Extina Foam, 2%

Drug Abuse - Deaths from fentanyl-laced heroin overdoses highlight need for opioid addiction treatment

Drug Abuse - U.S. FDA grants clearance for OTC home use drug tests for marijuana, cocaine, others

Drug Development - OrthoLogic announces results of preliminary analysis of Phase IIb trial of Chrysalin

Drug Development - Photocleavage of o-nitrobenzyl ether derivatives allows rapid biomedical release

Drug Development - Reversed amide derivatives of arachidonoyl ethanolamide have been synthesized

Drug Development - U.S. FDA proposes new rule to automate drug registration and listing

Drug Resistance - Calcium channel blockers are substrates of multidrug resistance-linked ABC drug transporter

Encephalomyelitis -  Streptococcus pneumoniae infection aggravates autoimmune encephalomyelitis

Environmental Health - Bottled water is safe under U.S. FDA's comprehensive regulatory system

Epilepsy - Anti-epileptic drug rufinamide improves cognitive function

Epilepsy - Sleep disturbances exacerbate partial-onset epilepsy

Finance - Nastech receives small business grant to develop RNAi therapeutics for influenza

Food Safety - Survival of Listeria monocytogenes in uncooked Italian salami was investigated

Foot-and-Mouth Disease - Method to detect antibodies to proteins of foot-and-mouth disease virus has been developed

Generic Drugs - Mylan receives tentative approval for generic Fluoxetine capsules for premenstrual disorder

HIV/AIDS Research - U.S FDA grants SPA for second phase 3 trial of HIV-associated lipodystrophy drug

HIV/AIDS Therapy - People with HIV/AIDS may migrate to obtain support and medical care

HIV/AIDS Transmission - Some HIV-1 genotypes increase risk of HIV transmission by breast-feeding

Headache & Migraine - Sick leave is related to migraine and non-migrainous headache frequency

Health Insurance - Individuals enrolled in HMOs have more doctor and emergency department visits per year

Healthcare Access - Case-mix payment increases access to care for higher acuity Medicaid residents

Imaging - Quest International announces clearance for ME551i2 5MP monochrome digital mammography display

Imaging - Risk of contrast-induced nephropathy is highest for iohexol

Immunology - T cell response to pulmonary Cryptococcus neoformans infection is diverse

Influenza Vaccine - Protein Sciences licenses FluBlOk to UMN Pharma for Japan market

Legal Issues - U.S. marshals seize defective Alaris infusion pumps made by Cardinal Health Care 303, Inc.

Malaria - Financial and clinical implications of malaria diagnosis using microscopy in Kenya were examined

Malaria - Malaria treatment error predictors for children in Malawi are determined

Malaria - Mitochondrial peroxiredoxin from Plasmodium has been characterized

Malignant Mesothelioma - Alfacell updates progress on development of Onconase in cancer

Market Analysis - All eyes are on Plan B's over-the-counter switch

Measles Vaccine - Time to intervene with vaccination campaign may be longer than thought during measles epidemic

Medical Devices - Advisories on defibrillators and accessories occur frequently

Medical Devices - Stryker receives U.S. FDA clearance for anatomic femoral heads with X3 polyethylene liners

Mental Health - Intervention efforts among serial bullies can eliminate origin of a school's forms of violence

Mental Health - Obsessive-compulsive disorder adversely impacts quality of life

Mental Health - Task concentration training helps social phobia patients

Mental Health - Wyeth receives extension of review for desvenlafaxine succinate

Mergers & Acquisitions - China Health Holding executes definitive acquisition agreement for 60% of Henan Furen Huaiqingtang

Mergers & Acquisitions - Mylan Laboratories to buy up to 71.5% of Matrix Laboratories shares for $736 million total

Mergers & Acquisitions - Paramount Acquisition to acquire majority interest in Valeritas

Mosquito-Borne Disease -  Aedes aegypti peritrophic matrix protein is identified as heme-binding protein

Multiple Sclerosis - Genentech and Biogen Idec announce positive results from trial of Rituxan in relapsing-remitting MS

Neonatology - Neonatal-onset multisystem inflammatory disease is responsive to anakinra

Neuroprotection - Sigma 1 receptor agonists are neuroprotective by inhibiting nitric oxide synthase

Obesity Complications - Aortic valvular regurgitation prevalence is higher than reported in obese adults

Obsessive Compulsive Disorder - Symptom patterns in children with obsessive compulsive disorder are presented

Obstetrics - Crying is seen as symptom of perceived insufficient milk among Mexican mothers

Ophthalmology - Cone photoreceptor development is activated by retinoid-related orphan receptor

Osteoporosis - Direct and indirect costs of osteoporosis management are significant

Pain Management - Alpha-1 and alpha-2 adrenoceptors contribute toward nociception

Pain Management - Low back pain management was surveyed by specialty group and practice experience

Parkinson Disease - Parkinson disease drug treatment and sleep complaints appear to be not associated

Pediatrics - Children's responses to disaster are examined

Personnel - Synovics Pharmaceuticals names Steven Getraer as CEO of subsidiary Kirk Pharmaceuticals

Pertussis Vaccine - Pertussis transmission and vaccination in Rio de Janeiro have been modeled

Physical Therapy - Care extenders cannot replace physical therapists

Pneumonia Therapy - WHO criteria for nonsevere pneumonia therapy failure in children too sensitive

Preterm Birth - Columbia Labs comments on U.S. FDA Reproductive Drugs Advisory Committee recommendation on 17-OHPC

Preterm Birth - U.S. FDA Advisory Committee recommends approval of Adeza's NDA for Gestiva to prevent preterm birth

Psychology - Low self-efficacy predicts greater response to intervention in caregivers of adults with dementia

Radiation Damage -  Salmonella carrying platelet factor 4 cDNAs protects against radiation

Radiation Exposure - ImmuneRegen continues Radilex study at Oak Ridge National Laboratory

Respiratory Medicine - Respiratory virus infections in hospital admissions were monitored using rapid methods

Schizophrenia - Perospirone improves schizophrenia symptoms through cognitive change indexed by P300

Schizophrenia - Questionnaire improves patient subjective response to neuroleptics

Schizophrenia - Risperidone after unsuccessful olanzapine treatment was useful for first-episode schizophrenia

Schizophrenia - Social disadvantage and schizophrenia were examined

Stem Cell Research - Lipoaspirates and dermis are alternatives to bone-marrow-derived cell therapy

Stem Cell Research - Polyclonal long-term MFGS-gp91phox marking in rhesus macaques is evaluated

Surgical Technology - RSB Spine announces approval to market InterPlate Vertebral Body Replacement Implant System

Tuberculosis Epidemiology - Three countries account for 62% of estimated global multidrug-resistant tuberculosis burden

Tuberculosis Vaccine - Early clinical trials are testing new tuberculosis vaccine

Vaccine Development - Biology of IL-2 and IL-15 is focus of review

Antibiotics - New findings from Spain, Sweden and the United States in the area of antibiotics detailed

Antibiotics - Recent findings from the United States illuminate research in antibiotics

Antibiotics - Researchers from the United Kingdom and United States report recent findings in antibiotics

Antibiotics - Researchers from the United States and Netherlands publish new studies and findings in the area of antibiotics

Antifungals - Reports from the United States and Thailand add new data to antifungals research

Aspergillosis - Researchers from the United States and Germany publish new studies and findings in the area of aspergillosis

Endocrinology - Recent findings in endocrinology described by researchers from Denmark, the United States and Italy

HIV/AIDS - Findings from the United States advance knowledge in HIV/AIDS research

HIV/AIDS - New findings in HIV/AIDS described from the United States and Belgium

HIV/AIDS - New research from the United States and France in the area of HIV/AIDS detailed

HIV/AIDS - Reports from the United Kingdom and United States advance knowledge in HIV/AIDS research

HIV/AIDS - Researchers' data from the United States and Japan advance HIV/AIDS research

Hepatitis B Virus - Findings from the United States, Taiwan and India describe new data in hepatitis B virus research

Influenza - Data from the United States and United Kingdom advance knowledge in influenza research

Lymphoma - Researchers from the United States report details of new studies and findings in the area of lymphoma

Malaria - Reports from Kenya, Uganda and the United Kingdom describe recent advances in malaria research

Malaria - Researchers' data from the United Kingdom and United States advance malaria research

Measles - New findings in measles described from the United States and Mexico

Papillomavirus - Researchers from the United States and United Kingdom provide details of new studies and findings in the area of papillomavirus

Pneumococcal - New findings from the United States in the area of pneumococcal described

Pneumococcal - Research from The Gambia, South Africa and United States add new data to pneumococcal body of knowledge

Pneumococcal - Researchers' work from the United States and France adds to pneumococcal body of knowledge

Polio - New research from the United States and New Zealand in the area of polio detailed

Polio - Researchers from the United States, Nigeria and South Africa report recent findings in polio

Rotavirus - New research from India, Venezuela and the South Korea in the area of rotavirus detailed

Rotavirus - Recent findings in rotavirus described by researchers from the United States and Colombia

Schistosomiasis - New data from the United Kingdom and Brazil lluminates research in schistosomiasis

Urology - Recent findings in urology described by researchers from the United Kingdom, South Korea and United States

Vaccines - Findings from the United Kingdom, United States and Portugal advance knowledge in vaccines research

Vaccines - New findings in vaccines described from the United States and United Kingdom

Vaccines - Reports from Germany and the United Kingdom advance knowledge in vaccines research

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