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Medical Letter on the CDC & FDA

Susan Hasty, Publisher
Table of Contents . . . February 20th, 2005
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Antimicrobials - Findings advance knowledge in antimicrobials research

Bioterrorism Vaccine - Efficacy and safety of vaccines against bioterrorism evaluated

HIV/AIDS Pathogenesis - Mechanisms for macrophage-mediated HIV-1 induction investigated

Infection Control - Portable particulate air filtration for patient isolation evaluated

Lyme Disease - Immature ticks controlled on rodent reservoirs of B. burgdorferi

Mycobacteria - Mycobacterium cosmeticum isolated from cosmetic infections

Acute Coronary Syndrome - Antiplatelet therapy has an essential role in treating acute coronary syndromes

Acute Myeloid Leukemia - Pharma company says additional trial necessary for Ceplene plus Interleukin-2

Adverse Drug Reaction - Group opposes over-the-counter status for Mevacor

Anthrax Vaccine - Protein fusion enhances immunogenicity of anthrax protective antigen

Antimicrobial Resistance - Antimicrobial use in equine hospitals lead to multidrug-resistant Salmonella

Aortic Aneurysms - Panel recommends conditional approval of the TAG Thoracic Endoprosthesis

Atherosclerosis - Noninvasive fingertip test to detect early coronary disease is study topic

Avian Influenza - Bird flu battle could be a long one, top Vietnamese health official

Avian Influenza - Italy's health officials call meeting to discuss bird flu

Avian Influenza - Man tests positive for bird flu, human-to-human transmission investigated

Avian Influenza - Thai Cabinet allocates emergency funds to fight bird flu

Bariatric Surgery - Bariatric program collaborates with Michigan Medical to offer new band procedure

Bioterrorism - Bioterrorist attack easier to control at onset rather than waiting for spread

Bioterrorism - Multipathogen oligonucleotide microarray developed

Bioterrorism - National preparedness for bioterrorist attack is still weak

Bladder Cancer - Notice of U.S. patent allowance for superficial bladder cancer drug received

Breast Cancer - FDA approves Abraxane, first in new class of protein-bound particle drug

Business Update - Company provides update on Myopore Rx steroid lead status with FDA

Business Update - Diagnostic technology company's HIV test remains choice of U.S hospitals

Business Update - Vaccine maker anticipates more inspections for remediation of Liverpool facility

Business Update - William Sietsema authors book on trategic clinical development planning

Cancer Treatment - Zalypsis for solid tumors enters clinical development

Cardiovascular Disease - Peripheral arterial disease is underdiagnosed and undertreated

Cardiovascular Research - Results suggest molecular link between cellular injury and inflammatory response

Cervical Cancer - Report card on cervical cancer prevention underscores importance of HPV testing

Cholera - Findings advance knowledge in cholera research

Cholesterol - Prototype for low cost monitor introduced, concept presented at U.S. FDA hearing

Clostridium Perfringens - Clostridium perfringens can adapt to low temperatures

Coccidiosis Vaccine - In ovo subunit vaccine and cytokine genes protected against coccidiosis

Complementary and Alternative Medicine - Food and drink products containing kava analyzed

Complementary and Alternative Medicine - Phosphodiesterase-5 inhibitors in dietary supplements analyzed

DTP Vaccine - Potency of pertussis component in DTP vaccine in Poland evaluated

Dengue Virus - Sustained dengue outbreak due to repeated introductions of different strains

Diagnostics - Approvable letter issued for new contrast agent MS-325

Diagnostics - Company gets receipt of approvable letter from FDA for MS-325

Diagnostics - FDA clears genetic probe test for bone marrow transplant patients

Diagnostics - Results from mycology laboratories for onychomycosis diagnosis compared

Diagnostics - Sensitivity/concordance validated lab testing Salmonella-spiked baby food

Diet and Nutrition - Negative Mg balance affects Ca, K, cholesterol metabolism in older women

Disease Control - Changing pattern of HIV infection described in New Delhi, India, hospital

Disease Control - Mortality increase in Russia attributed to preventable noncommunicable diseases

Disease Threat - U.N. says warnings helped avert major disease outbreak in tsunami

Disease Threat - WHO warns of increased risk of malaria, dengue fever in tsunami-hit areas

Drug Development - ANDA filings buy time for branded drugs

Drug Development - Regulatory submissions made for Humira for rheumatoid arthritis

Drug Development - Regulatory summit panel addresses U.S. FDA process with combination products

Ebola Virus - Rescue of Ebola virus from cDNA using heterologous support proteins studied

Ehrlichiosis - Ehrlichia chaffeensis detected in ticks from Long Island, New York

Environmental Health - Optical method to measure temporal changes in brown tides developed

Environmental Health - Potentially harmful fluoride levels found in some instant teas

Epidemiology - Branching model estimates spread of infectious diseases in varying environments

Finance - Cardiovascular-focused drug company reports financial results for Q2 2005

Finance - Gates Foundation, Norway contribute $1 billion to increase child immunization

Finance - Medical product company reports financial performance for 4Q and year 2004

Foot-and-Mouth Disease Vaccine - Method to validate BEI inactivation of foot-and-mouth disease virus

Generic Drugs - Pharmaceutical company receives U.S. FDA approval for generic antifungal agent

Generic Drugs - U.S. FDA grants approval for generic antifungal vaginal cream

Generic Drugs - U.S. FDA grants tentative approval for Oxybutynin Chloride Extended-release

Global Health - 700,000 AIDS patients in developing countries now receiving treatment

HIV/AIDS Epidemiology - Mortality rates from HIV/AIDS vary greatly among sub-Saharan African countries

HIV/AIDS Impact - Disproportionate HIV/AIDS impact on racial/ethnic minorities examined

HIV/AIDS Prevention - HIV prevention programs in prisons may be tailored to risk behavior type

HIV/AIDS Prevention - NIAID begins enrolling volunteers for novel HIV vaccine study

HIV/AIDS Research - HIV-1 populations in blood and breast milk are similar

HIV/AIDS Risk Factors - DC-SIGN promoter polymorphism increases risk of parenteral HIV-1 infection

HIV/AIDS Screening - EIA is acceptable for HIV surveillance in urine samples of high-risk populations

HIV/AIDS Treatment - Production on generic AIDS drug could begin in March

HIV/AIDS Vaccine - Cross-clade CD8 response to HIV-IIIB and Chinese B' and C/B' viruses reported

HIV/AIDS Vaccine - Glycoprotein-deficient rabies virus expressing SHIV envelope suppressed SHIV

HIV/AIDS Vaccine - Immunogenic consensus T helper epitopes for HIV vaccine engineered

HIV/AIDS Vaccine - Neutralization profiles of HIV-1 by monoclonal antibodies presented

HIV/Tuberculosis Coinfection - Survival time is decreased for HIV patients with drug-resistant tuberculosis

Hantavirus Vaccine - Protective effectiveness of hantavirus vaccine reported

Health Promotion - Pilot education program aims improve health of rural Afghan women

Healthcare Access - Nine of ten war casualties survive due to Army's Health Care Team, report says

Infant Mortality - More babies born at very low birth weight linked to rise in infant mortality

Influenza - National influenza vaccine summit stresses vaccination

Influenza - States lifting flu vaccine restrictions

Influenza Vaccine - Dutch biotech joins influenza IVS international task force

Influenza Vaccine - States lifting flu shot restrictions as vaccine remains plentiful

Influenza Virus - Role of matrix gene in attenuation of ca A/AA/6/60 influenza virus studied

Internet Medicine - Information not balanced on consumer prescription drug websites

Legal Issues - Aesthetic technologies company says Syneron countersuit is 'without merit'

Legal Issues - Girl born disabled gets $9,170 per month settlement

Leishmaniasis - Early cellular response to Leishmania major characterized

Leishmaniasis Vaccines - New findings in the area of leishmaniasis vaccines detailed

Low Birth Weight - Rise in infant mortality in 2002 linked to greater number of small babies

Lung Cancer Risk Factors - Lung cancer risk from hexavalent chromium exposure assessed

Malaria Vaccine - Progress in developing a malaria vaccine reviewed

Mammography - Lubberts effect in columnar phosphors examined

Measles Vaccine - Confirmed measles in settings of low measles transmission reviewed

Medical Devices - U.S. FDA gives market clearance for noninvasive tissue oxygen measuring device

Meningitis Vaccine - Immunogenicity of meningitis oligosaccharide-protein vaccine described

Meningococcal Infection - U.S. FDA licenses menactra vaccine against meningococcal infection

Meningococcal Vaccines - Reports advance knowledge in meningococcal vaccines research

Mental Healthcare - Acehnese may need mental care in Indonesia's tsunami-devastated province

Methicillin-resistance Staphylococcus Aureus - MRSA isolates become susceptible to antimicrobial of minor use

Mycobacteria - Phthalate degradation operon of Mycobacterium vanbaalenii reported

Mycobacterium Bovis - Outbreak of M. bovis outbreak occurred in conditioned macaque colony

Mycobacterium Vaccine - Effect of repeated TB skin testing of cattle on immune responses reported

Myocardial Infarction - International research finds mixed results for heart attack treatments

Necrotic Enteritis - Experimental disease model for necrotic enteritis developed

Neospora Caninum Vaccine - Antigenic proteins from Neospora caninum identified

Newcastle Disease Virus - Velogenic NDVs of different genotype/antigenic types co-circulating in Taiwan

Non-Hodgkin Lymphoma - FDA issues "not approvable" letter for Marqibo

Obstetrics - Progesterone treatment decreases preterm birth rate

Occupational Health - Farmers evaluate NIOSH rollover protective structures prototype

Overactive Bladder - Prescription medication for symptoms of overactive bladder launched in U.S.

Pain Management - FDA clears 10-inch ON-Q Soaker Catheter for pain relief

Pain Management - Tramadol gets French regulatory approval for once-daily dose

Pediatric Asthma - U.S FDA grants clearance for children's asthma incentive spacer/chamber inhaler

Pediatric HIV/AIDS - Health officials talk of eliminating AIDS in infants

Personnel - Arkansas doctor to perform operations in West Bank, Jerusalem

Philanthropy - Foundation gives $750 million for immunization programs in developing countries

Pneumococcal Vaccine - PneumoADIP accelerates pneumococcal vaccination in developing countries

Pneumococcal Vaccines - Findings in pneumococcal vaccines provide new insights

Pneumonia Therapy - Management strategies for community-acquired pneumonia reviewed

Polio Vaccine - Poliovirus sampling accomplished using chromatography paper strips

Poliovirus Vaccine - Circulation of type 1 vaccine-derived poliovirus in the Philippines in 2001

Preventive Medicine - Investments in public health paying off, but more funds needed

Product Licensing - Hospital licenses nitric oxide technology

Pseudorabies Virus - IFN-gamma response of PBMC indicates productive pseudorabies virus infection

Respiratory Syncytial Virus - Guide for palivizumab to prevent RSV infections in children reported

Respiratory Syncytial Virus - Information presented at Respiratory Syncytial Virus 2003 symposium reviewed

Respiratory Syncytial Virus - Pharma company files IND with U.S. FDA for RSV vaccine

Ross River Virus - Temperature plays role in promoting or inhibiting Ross River virus outbreaks

SARS - SARS changed the emergency department paradigm in Singapore

SARS Vaccines - Findings describe new data in SARS vaccines research

Salmonella - Active efflux systems important in quinolone resistance of Salmonella

Salmonella Outbreak - Foodborne S. enterica spp enterica serovar Madelia outbreak affected 44

Sexual & Reproductive Health - Study finds conspiracy beliefs among African Americans deter condom use

Sexual & Reproductive Health - U.S. rate of disability from sexual behavior triple other wealthy nations

Sexual & Reproductive Health - Young men all too often excluded in bid to curb chlamydia infection

Skin Cancer - Preventing skin cancer by reducing exposure to UV radiation reviewed

Social Issues - Group opposes suggestion to gender-adjust U.S. Social Security

Streptococcus Infection - Perinatal infections due to group B streptococci reviewed

Stroke - Antiplatelet agents are important in therapy to prevent recurrent stroke

Surgical Technology - Breast implant product submissions review scheduled

Syphilis - Health leaders target at-risk groups as syphilis problem persists

TB Prevention - Basis for deciding cost-effectiveness of TB vaccine programs questioned

Tick-Borne Disease - Mus musculus mice do not develop resistance to Amblyomma ticks

Tobacco Use - Magnesium useful for treating nicotine pharmacodependence and smoking

Toxic Oil Syndrome - Nuclear factor deregulation may be involved in Toxic Oil Syndrome pathogenesis

Toxicology - Photodecomposition products of pigment used in tattoo inks identified

Toxoplasma Gondii - PCR detects Toxoplasma gondii in the CSF of HIV-infected patients

Tuberculosis Diagnosis - Interferon-gamma assays in immunodiagnosis of tuberculosis reviewed

Tuberculosis Vaccine - Immunization strategy improves protection against tuberculosis in mice

Tuberculosis Vaccines - New data illuminates research in tuberculosis vaccines

Tuberculosis Vaccines - Researchers report details of new studies and findings in the area of tuberculosis vaccines

Tularemia - Reactive nitrogen and oxygen play distinct roles in F. tularensis infection

Typhoid Fever Vaccine - Cost-benefit analysis of typhoid fever immunization programs performed

Typhoid Vaccine - Epidemiology plays role in introducing typhoid fever vaccines in Asia

Vaccine Development - FDA licenses Menactra for protection against meningococcal disease

Vaccine Development - Malaria vaccine program expanded under U.S. NMRC contract

Vaccine Development - Text mining supports knowledge discovery for vaccine development

Vaccine Development - Transcriptomic analysis of the phylum Nematoda

Vaccine Efficacy - Relevant cultural considerations essential for vaccine success

Vaccine Efficacy - Sociobehavioral research methods to introduce vaccines in Asia described

Vaccine Efficacy - Vaccine trials used to estimate burden of disease

Virology Vaccine - Inhibiting Arp2/3 complex limits infection of vaccinia virus and lentiviruses

Virology Vaccine - Yellow fever/St. Louis encephalitis chimeric virus constructed

Weight Loss - IND for obesity therapeutic accepted by U.S. FDA

Yersiniosis Vaccine - Isogenic sodA Yersinia enterocolitica mutant shows promise as vaccine strain

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