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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . September 26th, 2004

Non-Subscriber - Summaries Only

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

Alcohol Use - Drinking alcohol increases risk for fighting and injuries in adolescents

Coxiella - Biomarkers of whole Coxiella burnetii phase I identified

Cryptosporidiosis - Risk factors for cryptosporidiosis among immunocompetent persons reported

Fungal Infection -  Zygoascus hellenicus fungemia found in stem cell transplant recipient

Tick-Borne Disease - PCR method to detect Anaplasma and Borrelia developed

AIDS/HIV Vaccine - HLA-A and -B expression high in subtype C HIV-infected Ethiopians

Acute Bipolar Mania - FDA approves atypical antipsychotic Geodon for acute bipolar mania

Allergies - Pharma company receives approval to manufacture and market Loratadine

Allergies - U.S. FDA approves scent-free prescription nasal inhaled steriod

Anal Fissures - NDA for Cellegesic is accepted for review by U.S. FDA

Anti-Infectives - Quality control guidelines for investigational cephalosporin presented

Avian Influenza - Cats can catch, spread bird flu to other cats; human risk being investigated human

Avian Influenza - Concern at spread of H5N1 to Malaysia expressed by WHO

Bacteriology - First documented case of Paracoccus yeei infection in humans reported

Bioterrorism - Bioterrorism preparedness dependent on action of health care systems

Bioterrorism - Corvallis business will be studying bioterrorism threat

Breast Cancer - BCIRG 001 study is the basis for U.S. FDA approval of docetaxel

Breast Cancer - Probability of death from breast cancer or other causes estimated in patients

Brucellosis Vaccine - Vaccination of sheep and goats lowers human brucellosis prevalence

Bubonic Plague - Plague kills one, infects another in western China

Chlamydia - Assays to detect Chlamydia and Neisseria gonorrhoeae compared

Cholera - Chironomid egg masses natural reservoir of V. cholerae non-O1 and non-O139

Clinical Trials - Drug company initiates clinical testing of West Nile virus assay in Canada

Clinical Trials - Gastro-focused pharmaceutical company begins clinical trials for antacid capsules

Clinical Trials - Genetics-focused company gets orphan drug designation for multiple myeloma drug

Clinical Trials - Phase 2a trials reopened as U.S. FDA, pharmaceutical company reach agreement

Colitis - FDA clears ImmunoCard Toxins A&B rapid test for severe colitis

Collaborations - CuraGen inks collaboration with the NCI for clinical development of PXD101

Collaborations - Dengue virus collaboration signed with CDC

Collaborations - Nanomaterials company, NIST, enter instrumentation R&D agreement

Colon Cancer - Pharma company submits application to market Xeloda colon cancer treatment

Compression Fractures - FDA approves new clinical trial design for the study of CORTOSS

Developmental Biology - Mutant mice provide evidence for function of lamin B1 in mammalian development

Developmental Delays - FDA clears new lab test to help screen newborn infants for congenital disease

Diabetes - Diabetes reduces quality of life in older adults

Diabetes Risk Factor - Cigarette smoking increases risk of type 2 diabetes

Diagnostics - Cancer-focused company submits PMA for HPV test of cervical samples to U.S. FDA

Diagnostics - Digene announces FDA submission for SurePath Test Pack

Drug Delivery - Pharmaceutical company exercises option to license intranasal common cold drug

Drug Development - U.S. FDA approves tablets for relief of vasomotor symptoms of menopause

Endocarditis - Prosthetic mitral valve endocarditis due to Ochrobactrum anthropi reported

Endocrinology - Positive and negative adrenomedullin modulators identified

Enterocytozoon - Method to purify Enterocytozoon bieneusi spores from stool developed

Environmental Health - Developmental toxicity of perfluoroalkyl acids and derivatives reviewed

Environmental Health - Exposure models for military herbicides used in Vietnam developed

Environmental Health - Traffic air pollution and mortality rate advancement periods reported

Epidemiology - Cluster of male breast cancer linked to electromagnetic field exposure

Epidemiology - Infectious disease early-warning monitoring program free to Internet users

Finance - Pharma company issues financial update

Follicular Lymphoma - Bcl-2-independent prosurvival signals identified

Food & Nutrition - Processing of wild cereal grains revealed by starch grain analysis

Generic Drugs - Company receives approval to market generic potassium chloride

Genomics - Company launches Affymetrix microarray-based genotyping services

Global Health - Acceleration of health-systems knowledge required in developing countries

HIV Vaccines - Greater participation of women, adolescents needed in HIV vaccine trials

HIV/AIDS - Long-term data provides guidance on use of Sustiva in HIV treatment

HIV/AIDS - South Africa: Traditionalists call for virginity testing in HIV/AIDS campaign

HIV/AIDS Comorbidities - Duke medical center gets $4 million to study infectious diseases in Tanzania

HIV/AIDS Research - Progenitor cells may be a reservoir for HIV-1 in the brains of infected patients

HIV/AIDS Therapy - GSK grants third voluntary license to South African company

Hantavirus Vaccine - Cross-reactivity among hantaviruses investigated

Healthcare Equity - Minorities worry health system won't respond fairly in a bioterrorist event

Heart Disease Risk - Joint effects of cardiac risk factors mean more then just double trouble

Hepatitis B Vaccine - Postvaccination hepatitis B surface antigenemia explored

Hepatitis C Vaccine - Hepatitis C virus mutation affects proteasomal epitope processing

Immunizations - Travel immunizations reviewed

Immunology - Peripheral CD4+CD8+ T cells participate in adaptive immunity

Incontinence - Drug approved across E.U. for treating stress urinary incontinence in women

Infection Control - Hard surface killer proven to kill E. coli in 2 minutes

Infectious Disease - Returning travelers could highlight emerging infections worldwide

Legal Issues - Pharmaceuticals company, chief executive officer settle with the SEC

Leukemia - European marketing approval sought for Clofarabine

Leukemia - New patient data generated in support of the clofarabine new drug application

Leukemia - Orphan drug status granted for BCX-1777 in two additional cancer indications

Lung Cancer - Pharma company and Roche announce filing Tarceva with European Authorities

Lung Cancer - Pharma company files marketing application for Tarceva with European authorities

Lymphoma - HuMax-CD4 receives U.S. orphan drug designation

Magnetic Resonance Imaging - Heating of human head due to magnetic resonance imaging evaluated

Malaria Vaccine - DNA vaccine protected against malaria in African black-footed penguins

Mammography - FDA approves PMA for MAMMOMAT NovationDR

Medical Devices - Medical device company receives two U.S. patents for stylets delivery system

Medical Devices - Veterinary diagnostics testing kit for feline leukemia virus approved by USDA

Medicare - Oncology-focused company progresses with Medicare coverage of device in U.S.

Meningitis Vaccine - Prevalence of bacterial meningitis among children in Romania reported

Nervous System - Semaphorin-plexin signals guide the direction of vascular development

Neuroscience -  Clock mutation doesn't increase effects of age on circadian rhythms

Nicotine Addiction - Study: Heart scares may not stop smokers

Nutrition - Smoking, obesity, poor eating highest among young people

Obesity - NIH releases research strategy to fight obesity epidemic

Obstetrics - Hepatitis E outbreak could cause maternal deaths to skyrocket in Sudan

Oncogenesis - Nivalenol induces benign and malignant tumors in mice

Overactive Bladder - Data on SANCTURA for OAB: Patients don't experience daytime sleepiness

Overactive Bladder - Data on SANCTURA presented at continence conference

Pain Therapy - Risk of heart attack related to COX-2 inhibitors studied

Pancreatic Islets - Three paths to islet bursting described

Panic Disorders - Company submits response to U.S. FDA regarding Lexapro for panic disorder

Patents - Federal judge dismisses case against Roche

Pharmacology - Protein calorie malnutrition alters ketamine pharmacokinetics

Proteomics - Novel spectroscopic assay devised for ligand-protein conjugates

Public Health - Architect advocates more and better women's restrooms in public facilities

Public Health - Formerly incarcerated men have a hard time finding jobs, healthcare

Regenerative Medicine - 510(k) application submitted to FDA for Adipose Tissue Extraction System

Reproductive Health - Stress-activated hormone inhibits female reproductive system

Reproductive Medicine - Nucleotide phosphodiesterase 3A-deficient mice can model female infertility

SARS - Infectious disease consultants in U.S. question hospital preparedness for SARS

Salmonella - PCR primer pair based on 16S rDNA detects Salmonella serovars in food samples

Salmonella - Preschool-aged children at high risk of catching disease from reptiles

Schistosomiasis - ED50 values for praziquantel in Schistosoma mansoni determined

Schistosomiasis - Schistosome transcriptome analysis at cutting edge reviewed

Schistosomiasis - Schistosome transcriptome reviewed

Sexual Violence - Commitment renewed to fund sexual violence resource center

Sexual Violence - U.N. agency seeks funds to treat Darfur rape victims, make camps safer

Smallpox - Progress reported in smallpox vaccine development

Smallpox - SIGA announces receipt of $12 million in NIH funding for biodefense

Smallpox Vaccine - 'Non-take' responses in adults vaccinated with smallpox reported

Solid Tumors - Pharma company files FDA IND for Provectus, treatment of solid tumors

Stem Cell Research - Company granted U.S. patent for human neural stem cell compositions

Stem Cell Research - Serum-free media improve generation of embryonic stem cells

Stress - Mental distress raises heart disease risk in patients with diabetes

Syphilis - Increased syphilis testing coincided with public health interventions

Technology - Radio frequency ID technology use predicted to increase during next 18 months

Tuberculosis - Financial difficulties influence TB care-seeking behavior in rural China

Tuberculosis Therapy - Multidrug-resistant tuberculosis treated successfully after liver transplant

Tuberculosis Vaccine - Prevalence and diversity of M. tuberculosis arabinomannan reported

Vaccine Adjuvant - Cholera toxin prevents autoimmune disease by inducing immune deviation

Virology - Belo Horizonte virus isolated from infected mice

West Nile Virus - California passes Arizona as worst in nation for West Nile cases

West Nile Virus - Scientists find year-round West Nile activity on Gulf Coast

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