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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . September 17th, 2006

Non-Subscriber - Summaries Only

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

Diarrhea Epidemiology - Bacterial diarrhea and antimicrobial resistance in western Kenya were examined

Drug Safety - U.S. FDA warns three pharmacies to stop mass-producing unapproved inhalation drugs

Environmental Health -  Mycobacterium enzymes degrade polycyclic aromatic hydrocarbons

Food Safety -  Salmonella contamination of eggs is national epidemic in U.S.

Accreditation - Humana Military Healthcare Services receives URAC accreditation

Addiction Medicine - Effectiveness of detoxification programs at detention centers in Taiwan is in question

Addiction Medicine - Substance abuse treatment facilities adopting buprenorphine are described

Alzheimer Disease - Galantamine and memantine combination shows promise for Alzheimer disease treatment

Anesthesia - Advanced regional anesthesia is used for modern combat casualty care

Antibiotic Resistance - Tigecycline is presented in a critical analysis

Apoptosis - Tumor necrosis factor-related apoptosis-inducing ligand sensitizes tumors

Atopic Dermatitis - Ceragenix Pharmaceuticals initiates multi-center EpiCeram clinical trial for pediatric eczema

Attention Deficit Hyperactivity Disorder - Role of prefrontal cortex in pathophysiology of ADHD is examined

Bladder Cancer - Targeted bladder cancer screening using tumor markers may be cost effective

Breast Cancer - Breast cancer outcome associated with status of p53 and MDM2 SNP309

Business & Finance - Chembio reports net product sales increase 93% compared to second quarter of 2005

Business & Finance - Corcept Therapeutics reports second quarter net loss of $7.9 million

Business & Finance - DOR BioPharma, Inc. reports second quarter financial results and reviews achievements

Business & Finance - Rockwell reports second quarter financial information

Business Update - Akorn announces first ANDA submission for FDC

Business Update - Arthrosurface launches new product to treat knee pain

Business Update - Chembio features new procedure for Rapid HIV Test at International AIDS Conference

Business Update - MayaTech awarded U.S. CDC contract for legal review of HIV partner and referral services

Business Update - Medtronic announces market introduction of its three automatic pacemakers

Business Update - Mortara Instrument releases upgrade of electrocardiographic data warehousing software system

Business Update - Mylan receives U.S. FDA tentative approval for generic drug for depressive disorder

Business Update - Nuvo announces second-quarter financial results

Business Update - U.S. FDA clears BioSphere Medical's next generation EmboCath Plus Infusion Microcatheter

Business Update - U.S. FDA grants clearance to market Milestone's single tooth anesthesia device

Campylobacter Epidemiology -  Campylobacter jejuni infection characteristics in Finland are reported

Cancer Gene Therapy - Breast cancer-associated gene absence increases expression of axis members

Cancer Therapy - Antitumor activity of JS-K shown potent in both in vivo activities and rat liver model

Cancer Therapy - Consensus recommendations for imaging and oncologic drug development are needed

Candidiasis Therapy - Fluorescein assay has been modified for screening of agents against candidiasis

Clinical Trials - Neurochem receives approvable letter for eprodisate for treatment of amyloidosis

Clinical Trials - Northwest Biotherapeutics signs Synteract to manage DCVax-Brain Cancer trial

Complementary & Alternative Medicine -  Rhus verniciflua glycoprotein protects against carbon tetrachloride liver injury

Dengue Vaccine - Live attenuated tetravalent dengue vaccine was safe, effective in Thai children

Depression - Depression treatment in coronary heart disease patients is outlined

Depression - Fluoxetine reduces somatic symptoms in depressed patients

Dermatology - Method to analyze antioxidants and preservatives in cosmetics has been developed

Diabetes Complications - Early-onset type 2 diabetes mellitus is related to end-stage renal disease risk and mortality

Drug Delivery - Rotech Healthcare responds to U.S. Food and Drug Administration warning letter

Drug Safety - Dissemination of drug prescribing information needs improvement

Dysthymia - Pharmacotherapy of dysthymia is affected by routine use of operational diagnostic criteria

Embryonic Stem Cell Research - Embryonal stem cell-specific gene 1 is a putative RNA-binding protein with broad RNA targets

Environmental Health - Radiation doses received by cleanup workers of Chornobyl accident estimated

Environmental Health - Serum immunoglobulins are elevated in people living near Superfund sites

Food Safety - Food-processing enzymes from recombinant microorganisms are focus of review

Gastroenterology - VSL#3 provides effective relief in the dietary management of serious gastrointestinal disorders

Genital Herpes - Famciclovir shortens outbreaks of genital herpes

HIV/AIDS Pathogenesis - Role of protein disulfide isomerase in HIV-1 protein-mediated fusion was examined

HIV/AIDS Therapy - Analysis provides additional data for Prezista as part of HIV combination therapy

HIV/AIDS Therapy - Ranbaxy receives approval to market triple antiretroviral combination for children in India

HIV/AIDS Vaccine - Saturation of TRIM5 alpha-mediated HIV restriction depends on stability of viral capsid

Heart Failure - Left ventricular assist devices are decreasing in cost

Hemorrhoid Risk Factors - Red hot chili peppers do not worsen symptoms of hemorrhoids

Herpes Simplex Virus - Bacterial artificial chromosomes containing HSV-1 strains 17 and KOS have been constructed

Human Papillomavirus Vaccine - Mothers have positive attitudes toward human papillomavirus vaccination

Idiopathic Pulmonary Fibrosis - Amarillo Biosciences IND application passes U.S. FDA review

Imaging - Noninvasive molecular imaging detects transgene expression of lentiviral vector

Immunotherapy - Omrix Biopharmaceuticals announces U.S. Phase III clinical trial for intravenous immunoglobulin

Influenza Vaccine - Determinants of influenza vaccination in hard-to-reach urban populations were examined

Influenza Vaccine - Late influenza vaccination is associated with reduced effectiveness

Influenza Vaccine - MedImmune replies to U.S. FDA letter requesting added data on new formulation of FluMist

Legal Issues - Penwest initiates dispute resolution procedures with Endo for Opana extended release

Leishmaniasis Vaccine - Distinct roles found for IL-1 receptor signaling in early versus late Leishmania infections

Leishmaniasis Vaccine - Liposomes show promise as an adjuvant for leishmaniasis vaccines

Lower Back Pain - U.S. FDA approves Synthes' ProDisc-L for treatment of lower back pain

Lymphoma - Complement-induced cell death by rituximab depends on CD20 expression

Malaria Therapy -  Plasmodium falciparum choline kinase has been characterized

Malaria Therapy - Small number of Plasmodium falciparum mutations are involved in drug resistance

Malaria Vaccine - Malaria vaccine RTS,S/AS02A is safe and immunogenic in Kenyan adults

Malaria Vaccine - Rhop-3 protein shows promise for an asexual stage malaria vaccine

Medical Devices - Company gets patent on noninvasive means to stimulate beneficial mediators from blood vessels

Medical Devices - Mechanical heart valve prosthesis made from polymeric materials has been developed

Medical Devices - U.S. FDA seeking comments on use of identifier system for medical devices

Medicare - INSPIRIS to serve Humana's frail elderly population in Phoenix

Mental Health - Approach and avoidance goals in treating sex offenders are discussed

Mergers & Acquisitions - EPIX and Predix Pharmaceuticals complete merger

Mycobacterium Tuberculosis Diagnostics - Agar-gel-immunodiffusion and ELISA specific but not sensitive for MAP detection in sheep

Nanotechnology - U.S. FDA forms internal Nanotechnology Task Force

Neuroscience - Neuronal cell death rescued by restoration of receptor physiological levels

Nosocomial Infections - Results of Cubist study of Staphylococcus aureus blood stream infections published in NEJM

Obesity Complications - Obesity and weight gain increase cancer risk in men

Onchocerciasis Epidemiology - Ivermectin was differentially effective against Onchocerca volvulus microfilariae

Osteoporosis - Male osteoporosis treatment approved in Europe and U.S.

Otitis Media Therapy - Pathogens and cure rates are changing for otitis media and tonsillopharyngitis

Pain Management - Opioid receptors play roles in antinociceptive effect of oxytocin in pain response

Pain Management - Side effects of sclerosing solutions for back pain are reported

Pancreatitis Therapy - Pancreatitis inflammation was decreased and survival improved by activated protein C

Parkinson Disease - Slow oscillatory activity is linked to levodopa-induced dyskinesias in Parkinson disease

Patents - Lorus sub GeneSense wins patent for antisense oligonucleotides

Pediatrics - Developmental and behavioral screening and surveillance in primary care are discussed

Pneumococcal Vaccine - Cost-effectiveness of 7-valent pneumococcal conjugate vaccine was evaluated

Pneumococcal Vaccine - Pneumococcal antibody titers in children with humoral immunity were evaluated

Pneumococcal Vaccine - Pneumococcal surface protein A effectively elicits T cell-mediated responses

Proteomics - Human nitric oxide synthase expression is regulated by signaling

Psoriatic Arthritis - U.S. FDA expands Remicade psoriatic arthritis indication

Public Health - Pharmacist team's response to Hurricane Katrina is presented

Rotavirus Vaccine - Current prospects and future challenges of rotavirus vaccines are reviewed

Rubella Epidemiology - Epidemiological data aids decision-making in response to rubella epidemics in Israel

Rubella Vaccine - Rubella vaccination program in Taiwan was evaluated

Schistosomiasis Vaccine -  Schistosoma mansoni tetraspanins protect against schistosomiasis

Staph Infection - New treatment is demonstrated for dangerous staph infections

Staphylococcus Epidemiology -  Staphylococcus aureus bacteremia incidence and risk factors were evaluated

Tetanus Vaccine - Two intramuscular vaccinations protected monkeys against tetanus

Thalassemia Therapy - Deferasirox has efficacy similar to deferoxamine for treatment of transfusional iron overload

Tissue Engineering - Adult stem cells are promising for use in cartilage regeneration and tissue engineering

Tuberculosis Diagnosis - Blood test avoids effect of BCG vaccine in detecting Mycobacterium tuberculosis infection

Tuberculosis Diagnosis - Combining tuberculin skin testing and new blood assay reduces public health costs

Tuberculosis Epidemiology - Tuberculosis skin testing conversion rates determined for U.S. Navy and Marine Corps

Tuberculosis Vaccine - Danish-SSI 1331 and Glaxo-Evans 1077 BCG vaccines possess similar immunogenicity

Tuberculosis Vaccine - Phosphorylation sites of Mycobacterium tuberculosis protein kinases have been characterized

Vaccine Efficacy - Study design permits investigation of immune function in a 4-week study in rats

Vaccine Safety - Study designs to evaluate vaccine safety were equally valid but had contrasting limitations

Allergies - Findings from the United States, United Kingdom and Japan in allergies provide new insights

Allergies - New research from Canada, Singapore and Italy in the area of allergies detailed

Antifungals - Studies from the United States, Thailand and Canada add new findings to antifungals body of knowledge

Bird Flu - Recent findings in bird flu described by researchers from France, the United States and Sweden

Depression - Researchers' work from the United States and Canada adds to depression body of knowledge

Diabetes - Recent findings in diabetes described by researchers from the United States and India

Diabetes - Researchers from Ireland, the United States and Italy report recent findings in diabetes

Environmental - New findings in environmental described from the United States

HIV/AIDS - Research from the United States and France add new data to HIV/AIDS body of knowledge

Healthcare - Recent studies from Italy and the United States add new data to healthcare research

Hypertension - New data from the United States and Australia lluminates research in hypertension

Lymphoma - Researchers' data from the United States and Germany advance lymphoma research

Measles - New data from Japan and the People's Republic of China lluminates research in measles

Meningitis - New findings from the United Kingdom, United Arab Emirates and Russian Federation in the area of meningitis described

Multiple Sclerosis - Researchers from Germany, the United States and the North Ireland report recent findings in multiple sclerosis

Papillomavirus - Findings from the United States and United Kingdom advance knowledge in papillomavirus research

Rabies - New findings from France and Netherlands in the area of rabies detailed

Rotavirus - Reports from the United States and United Kingdom advance knowledge in rotavirus research

Vaccines - Reports from Germany, the United States and Austria add new data to vaccines research

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