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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . May 10th, 2006

Non-Subscriber - Summaries Only

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

Depression Therapy - Suicidality is slightly increased in children taking antidepressant drugs

Drug Resistance - T cell cytokine responses are dependent on multidrug resistance protein-1

Nosocomial Infection -  Clostridium infection is increasing in elderly patients discharged from hospitals

Outbreaks - Norovirus causes about one-quarter of gastroenteritis outbreaks in U.S.

Stroke - Folic acid fortification reduces stroke mortality in Canada and U.S.

Anthrax - Recent studies from the United States add new data to anthrax research

Attention Deficit Hyperactivity Disorder - U.S. FDA approves methylphenidate patch to treat ADHD in children

Avian Influenza - Measures to eradicate highly pathogenic avian influenza in Europe are examined

Avian Influenza - Pennsylvania Governor Rendell says Pennsylvania is ready in the event of avian influenza

Awards - IncisionTech wins Medical Design Excellence Award for work on device for Patton Surgical

Bacteriology - Gene products required for polysialic acid synthesis in Escherichia coli K1 are reported

Baculovirus - Method to estimate baculovirus titer based on viable cell size has been developed

Blood Transfusion - Immucor announces Capture-S (Syphilis) and CMV assays have been cleared for use on the Galileo

Botulinum Toxin Vaccine - DOR BioPharma announces advances in mucosal vaccines for botulinum toxin

Breast Cancer - Neoprobe completes regulatory submission for Lymphoseek for breast and skin cancer biopsies

Business Update - Celera Genomics announces sale of therapeutic programs to Pharmacyclics

Business Update - Demand for Medical Services' Dengue Fever rapid test kit heats up

Business Update - Genelabs announces receipt of notice from Nasdaq, drug development restructuring

Campylobacter - Signal transduction in epithelial cell invasion by Campylobacter is examined

Cancer Research - Reata announces RTA 402 entering clinical development as promising oral anticancer drug

Cancer Therapy - U.S. FDA grants 510(k) clearance for implantable radiation sensor for treating cancer

Cervical Cancer - Cervical cancer linked to expression of FasL

Chickenpox Vaccine - Routine varicella vaccination should be implemented in Saudi Arabia

Clinical Trials - Chiron announces initiation of Phase 1 trial for CHIR-265 in melanoma

Clinical Trials - Corautus announces termination of patient enrollment in GENASIS severe angina clinical trial

Clinical Trials - Cortex updates progress on clinical hold of AMPAKINE CX717

Clinical Trials - Emisphere completes enrollment for Phase II oral insulin clinical trial

Clinical Trials - Labopharm reports positive results for phase 3 study of once-daily pain medication tramadol

Collaborations - Forest and Almirall announce a collaboration agreement on new therapy for COPD

Colon Cancer - MoviPrep receives U.S. FDA approval letter

DPT Vaccine - Costs of scaling up vaccination in poor countries are examined

Dengue Fever - Recent studies from France, Brazil and the United States add new data to dengue fever research

Diabetes Type 2 - Depomed data published on Glumetza, an FDA-approved treatment for type 2 diabetes

Diabetic Peripheral Neuropathy - Quigley to commence human testing of QR-333 topical diabetic peripheral neuropathy new drug

Drug Delivery - Non-oral methylphenidate transdermal patch system for ADHD approved by U.S. FDA

Drug Development - Aldagen IND for stem cell trial to treat critical limb ischemia is cleared by U.S. FDA

Drug Development - American Pharmaceutical Partners receives U.S. FDA approval for Mitoxantrone

Drug Development - Cellegy's licensee for Tostrex in Europe has reported successful conclusion of E.U. MRP process

Drug Development - MGI Pharma submits NDA to U.S. FDA on oral glutamine for treating oral mucositis

Drug Resistance - Multidrug resistance in cancer targeted with newly developed drugs

Ebola Virus Vaccine - cAdVax-based bivalent Ebola vaccine induces immunity against Sudan and Zaire Ebola species

Ebola Virus Vaccine - Chimpanzee adenovirus vaccine protects against Zaire Ebola virus

Environmental Health - Method to measure urinary monohydroxy metabolites of polycyclic aromatic hydrocarbons is developed

Epidemiology - Canine visceral leishmaniasis in United States and Canada is focus of review

Epidemiology - Improved measles surveillance in Cameroon reveals two dynamic patterns of incidence

Epidemiology - Influenza pandemic planning is reviewed

Finance - DOR BioPharma announces private equity financing of $3.65 million

Finance - Fred Hutchinson Cancer Research Center receives boost from Susan G. Komen Foundation

Food Safety - Antibiotic-resistant Salmonella isolated from imported foods is characterized

Food Safety - PCR methods to measure Salmonella in homemade ice cream compared

Food Safety - Tissue-fluid correlations were used to estimate gentamicin in steer kidneys

Food-Borne Illness - Multidrug-resistant Salmonella outbreak linked to ground beef at school potluck

Forensic Science - GHB free-acid solution formation studies and characterization reported

Forensic Science - Isolation and spectroscopy characterization of gamma-hydroxybutyric acid is reported

HIV/AIDS - Data from Germany, the United States and Belgium advance knowledge in HIV/AIDS research

HIV/AIDS - Recent findings in HIV/AIDS described by researchers from the United Kingdom, Mexico and Spain

HIV/AIDS - Recent studies from the United States and Spain add new data to HIV/AIDS research

HIV/AIDS - Researchers from Switzerland, Australia and the United States provide details of new studies and findings in the area of HIV/AIDS

HIV/AIDS - Researchers' work from the United States and South Africa adds to HIV/AIDS body of knowledge

HIV/AIDS Diagnosis - HIV-infected adolescents unlikely to initiate HIV testing

HIV/AIDS Diagnosis - Increased HIV testing among young men who have sex with men is needed

HIV/AIDS Education - Conference to address significant impact of HIV/AIDS on Native Americans

HIV/AIDS Pathogenesis - CD4+ T cell depletion correlates with peak viral load in SHIV infection

HIV/AIDS Risk Factors - Methamphetamine use and associated risk of HIV/STD infection were focus of national consultation

HIV/AIDS Vaccine - Robust HIV-specific immune responses were induced by DNA vaccine plus vaccinia virus boost

HIV/Tuberculosis Epidemiology - HIV infection is driving tuberculosis epidemic in periurban South African community

Healthcare Coverage - Centers for Medicare and Medicaid Services (CMS) advises Niaspan is now Part D-eligible

Hepatitis B Virus - Studies from the United States and Canada describe new findings in hepatitis B virus research

High Cholesterol - National Lipid Association statin study shows liver monitoring is unnecessary

Imaging - U.S. FDA grants clearance to new PACS functions for diagnosing scanned cardiac images

Infectious Diseases - U.S. FDA alerts professionals of eye infections related to soft contact lens, solutions use

Influenza Vaccine - DelSite Biotechnologies presents data on innovative influenza vaccine

Influenza Vaccine - GEN ID Lab Services Inc. to clone entire H5N1 influenza virus genome to develop new vaccines

Influenza Vaccine - Influenza vaccine shortage did not affect pattern of vaccine-seeking behavior

Kawasaki Syndrome - Link between Kawasaki syndrome and coronary artery abnormalities was investigated

Lung Cancer Therapy - Genentech moves on Avastin with chemotherapy for nonsquamous, non-small-cell lung cancer

Malaria Therapy - Mefloquine induces dose-related neurological effects in rat model

Malaria Vaccine - Cellular reactivity to Plasmodium falciparum protein trap in Kenyans was examined

Marketing - U.S. FDA awards contract to assess postmarketing study commitment decision-making process

Measles Virus - Quantitative real-time RT-PCR assays to detect measles virus have been developed

Medical Devices - AerovectRx receives U.S. FDA 510(k) clearance for nebulizer drug delivery system

Medical Devices - Ellex receives FDA 510(k) clearance for industry's first solid-state red/green photocoagulator

Medical Devices - Medtronic receives FDA approval for insulin pump with real-time continuous glucose monitoring

Medical Devices - Medwave deploys 3D interactivity enabling online demonstration of blood pressure measuring device

Medical Devices - NxStage Medical receives FDA clearance of novel device to prepare high purity dialysate at home

Medical Statistics - One-shot estimate of multiple readers and multiple cases variance has been developed

Meningitis - Meningococcal disease mortality in U.S. for 1990-2002 is reported

Mental Health - HIV/AIDS stigma adversely affects mental health of HIV-positive men

Mergers & Acquisitions - Cellegy reports sale of Cellegy Australia to Epsilon Pharmaceuticals

Multiple Myeloma - Revlimid marketing authorization application accepted by EMEA for review

Myocardial Infarction - Diabetes-related myocardial infarction is increasing in New York City

Obesity - Recent studies from the United States add new data to obesity research

Obesity Epidemiology - Public housing developments have limited access to physical activity or healthy food resources

Obstetrics - Obstetricians and radiologists express concerns about nonmedical fetal ultrasound

Ophthalmology - Federal agencies investigate soft contact lens use, solution as cause of serious eye fungus

Ophthalmology - Fusarium keratitis infection may put soft contact lens wearers at risk

Orthopedics - Adverse events related to autologous chondrocytes are summarized

Otitis Media - Specialists try to speed up cure for ear infections

Ovarian Cancer - Up-regulation of VEGF and induction of MMP-2 enhance ovarian cancer invasiveness

Pain Management - Neuroscience Therapy Corp. receives FDA approval to begin marketing P-Stim in U.S.

Patents - VISICU notified patent office to allow amended claims of eICU patent after re-examination

Patient Safety - U.S. FDA proposal seeks to prevent deaths and injuries from medical gas mix-ups, contamination

Pediatric Vaccines - $1.5 billion needed to ensure 12-month stockpile of pediatric vaccines

Pediatrics - Reports from the United States add new data to pediatrics research

Personnel - Devon Medical Supplies announces John Iona as new president

Personnel - Invitrogen names NIH stem cell scientist Mahendra Rao, MD, PhD, to lead new research area

Pertussis Prevention - Vaccinating health care workers against pertussis is cost effective

Pneumococcal - Research from the United States and United Kingdom add new data to pneumococcal body of knowledge

Proteins - Researchers from the United States, France and People's Republic of China detail new studies and findings in the area of proteins

Public Health - Violence prevention agenda is established at U.S. CDC

Rabies Virus - Incidence of rabies post-exposure prophylaxis in South Carolina is higher than estimated

Respiratory Syncytial Virus - Rule to predict hospitalization risk for respiratory syncytial virus infection is developed

SARS - Research from Austria, Taiwan and the People's Republic of China in SARS provides new insights

SARS Vaccine - SARS vaccine development is focus of review

Salmonellosis - Method enables effective supplementation for isolation of Salmonella enteritidis in egg white

Sexually Transmitted Disease - Self-esteem and emotional distress affect sexual behavior differently in adolescent females

Sinusitis - U.S. FDA grants Accentia Biopharmaceuticals Fast Track status for SinuNase

Smallpox Vaccine - Smallpox vaccines were efficacious after exposure to temperatures not recommended for shipping

Streptococcus Pneumoniae - Proteomic analysis of Streptococcus pneumoniae reveals new protein relationships

Suicide - Integrated approach helps prevent suicide and youth violence

Surgical Technology - Atrium Medical receives U.S. FDA approval for C-QUR coated mesh

Surgical Technology - U.S. FDA clears Medtronic Performer Cardiopulmonary Bypass System heart-lung machine

Tuberculosis - Improved programs are associated with decreasing TB incidence in U.S.

Tuberculosis - Researchers' data from Canada and the United States advance tuberculosis research

Tuberculosis - Researchers' work from the United States adds to tuberculosis body of knowledge

Tuberculosis - Risk of active TB among schoolchildren in Hong Kong is reported

Tuberculosis Vaccine -  Mycobacterium bovis BCG expressing SIV Gag protein induces immune responses

Vaccines - Reports from Netherlands and United States advance knowledge in vaccines research

Vaccines - Reports from the United States add new data to vaccines research

Vaccines - Research from the United States and United Kingdom add new data to vaccines body of knowledge

Vaccines - Researchers from the United States and Ireland describe findings in vaccines studies

Vaccines - Studies from the United States and United Kingdom describe new findings in vaccines research

Vaccinia Virus Vaccine - Vaccinia virus mutated in envelope proteins A33R and B5R are immunogenic

Virology - Chimeric SIN/VEE viruses clear Venezuelan equine encephalitis virus from brain

Virology - PKR activity is modulated in cells infected by bovine viral diarrhea virus

Virology - Some porcine endogenous retroviruses can infect human cells

West Nile Virus - Rapid assay to measure West Nile virus neutralization has been developed

West Nile Virus Vaccine - West Nile virus vaccination is currently not cost effective

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