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Medical Letter on the CDC & FDA

Susan Hasty, Publisher
Table of Contents . . . October 23rd, 2005
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Breast Cancer Prognosis - Obesity increases mortality risk in women with breast cancer

HIV/AIDS Diagnosis - Rapid HIV antibody assays for detecting recent seroconversion modified

Rotavirus Vaccine Development - Candidate rotavirus vaccines derived from neonatal strains developed

Smallpox Vaccine - Outcome of smallpox vaccination in healthcare workers described

West Nile Virus - Immunoassay to detect anti-West Nile virus IgM antibodies developed

Allergy Medicine - Bifidobacterium bifidum G9-1 suppresses IgE production

Amyotrophic Lateral Sclerosis - CytRx initiates phase II clinical trial with arimoclomol for treating ALS

Anti-Inflammatory Drugs - Celecoxib and valdecoxib safety discussed

Ascaris Vaccine Development - Ascaris suum antigen protects against Ascaris lung infection

Bovine Spongiform Encephalopathy - RT-PCR assay identifies BSE risk material in meat and meat products

Breast Cancer - Arimidex gains U.S. FDA approval for breast cancer in postmenopausal women

Business & Finance - Tostrex maker to transfer listing of securities to Nasdaq SmallCap

Business Update - Drug discovery IT firm excels in Taratec audit for U.S. FDA compliance

Business Update - DuraSeal Sealant gets CE Mark for thoracic applications

Cancer Therapy - U.S. FDA expands Neulasta label

Cardiology - European approval granted for drug-eluting stent system

Cardiology - MCP-1 is involved in pathogenesis of atherosclerosis and MI

Cataracts - U.S. FDA approves AcrySof Toric intraocular lens

Chandipura Virus - Cytokine levels increased in Chandipura virus associated encephalopathy

Chromatography - Measurement of resiniferatoxin in serum samples was performed by HPLC

Clinical Trials - ComfortScan PMA clinical trial progresses

Community-Acquired Pneumonia - Data released from phase III trial comparing 5-, 7-day Factive treatment of CAP

Cryptosporidium Epidemiology - Cryptosporidium genotypes in storm water in New York examined

Cytomegalovirus Retinitis Prognosis - Detectable plasma CMV load at CMV retinitis diagnosis associated with mortality

Dengue Fever Outbreaks - Dengue outbreak characterized by prominent gastrointestinal symptoms

Dermatology - Agreements for expanded collaboration on psoriasis products in U.S. announced

Diabetes Epidemiology - Ethnic disparities exist in diabetes features in U.S. adults

Diabetes Risk Factors - Characteristics of type 2 diabetes in Vietnam reported

Diabetes Therapy - Adherence with therapy poor for working adults with type 2 diabetes

Diagnostics - AtherOx launched to identify risk for atherosclerotic cardiovascular disease

Diagnostics - CAD technology agreement with 3D imaging partner TeraRecon broadened

Diagnostics - Cancer-detection company comments on study citing efficacy of toluidine blue

Diagnostics - GC-MS detects prenatal exposure to environmental toxicants and their metabolites

Domestic Violence - Domestic violence against women seeking abortion in China reported

Drug Delivery - Four million dollar milestone payment made for nasal calcitonin osteoporosis therapy

Drug Development - Arranon cancer drug receives advisory committee support

Drug Development - Clinical study contracts for U.S. trials of two drugs awarded to CRO

Drug Development - Expanded indications for bioblanket soft tissue repair patch

Drug Development - Inhaled drug maker encouraged by U.S. FDA panel's decision on Exubera

Drug Development - Lipophilic antifolate trimetrexate inhibits Trypanosoma cruzi

Drug Development - Monoclonal antibody combination neutralizes natural rabies virus variants

Drug Development - New drug application for sorafenib accepted for U.S. FDA review

Drug Development - Positive opinion issued for Naglazyme from European regulatory authority

Drug Development - RSV infection program accelerated

Drug Development - U.S. FDA grants approval for Leflunomide for rheumatoid arthritis

Drug Resistance - Ciprofloxacin failure against TB due to rapid emergence of resistance

Drug Safety - Liposomal amphotericin B safe/effective for pediatric visceral leishmaniasis

Emergency Medicine - Infectious diseases treated in U.S. emergency departments reported

Environmental Health - Association of pollutants with inflammatory markers investigated

Environmental Health - Distribution patterns of dioxins in chlorinated chemicals reported

Environmental Health - HPLC-MS/MS method to measure environmental phenols in urine developed

Epidemiology - Amyloid A amyloidosis associated with familial Mediterranean fever

Epidemiology - Early clinical features of West Nile virus infection are nonspecific

Epidemiology - Osteomyelitis/septic arthritis outbreak in children caused by K. kingae

Finance - Cardiovascular medical device company reports sales of $16.3 million

Finance - Diabetes-, Alzheimer-focused company reports fiscal 2005 year end financial results

Food & Nutrition - U.S. DoD to pay company $2.9 million to develop longer lasting tomatoes, lettuce

Food Allergies - Growth of food allergies and intolerance fuels growth of the "free-from" market

Food Allergies - Proteolytic processing of the peanut allergen Ara h 3

Food Safety - High-pressure treatment increases inactivation of bacterial toxins

Foot-and-Mouth Disease Outbreaks - Foot-and-mouth disease virus variant responsible for recent outbreaks in India

Fosinoprilat - LC method to measure fosinoprilat in plasma developed

Generic Drugs - Citizens' petition filed with U.S. FDA on generic oral oxandrolone products

Generic Drugs - First tentative approval for generic, MetroGel, received

Generic Drugs - U.S. FDA gives approval for generic Arava

Genetics & Genomics - Comparative genomics assess significance of emerging Escherichia coli

HIV/AIDS & Pulmonary Tuberculosis - HIV patients with nonhealing oral lesions should be screened for pulmonary TB

HIV/AIDS Diagnostics - Dried blood spots used for molecular diagnosis and monitoring HIV-1 infection

HIV/AIDS Diagnostics - Genotypic assay detects all HIV-1 protease and reverse transcriptase subtypes

HIV/AIDS Diagnostics - Microchip CD4 counting method monitors HIV in resource-poor settings

HIV/AIDS Drug Adherence - Integrated home-based care increases adherence to antiretroviral therapy

HIV/AIDS Drug Adherence - Low HAART adherence in adolescents associated with younger age and depression

HIV/AIDS Epidemiology - HIV-1 group M isolates are 100-fold-more fit than group 0 or HIV-2 strains

HIV/AIDS Pathogenesis - Equal recombination events occur when infecting macrophages and T cells

HIV/AIDS Pathogenesis - Heterologous L-domain sequences have various abilities to promote HIV-1 budding

HIV/AIDS Pathogenesis - Mucosal barrier greatly limits SIV infection of cervicovaginal tissues

HIV/AIDS Prevention - HAART suppresses HIV-1 RNA/not DNA in breast milk during pregnancy/postpartum

HIV/AIDS Prognosis - Low CD4 counts before HIV-1 seroconversion do not affect disease progression

HIV/AIDS Prognosis - Monte Carlo approach simulates within-host dynamics of HIV-1 infection

HIV/AIDS Prognostic Indicator - Cutaneous HIV manifestations predict underlying immune status

HIV/AIDS Screening - HIV-positive women seeking abortions may form cohort for future studies

HIV/AIDS Superinfection - HIV-1 superinfection is not a common event

HIV/AIDS Therapy - CCR5 N-terminal region plays critical role in HIV-1 inhibition

HIV/AIDS Therapy - Diversity of thymidine analogue resistance genotypes in HIV reported

HIV/AIDS-Coinfection - C. gattii serotype C from AIDS patients belongs to rare VGIV genotype

Healthcare Coverage - Cash Technologies sub to process U.S. Air Force healthcare claims

Heart Disease Risk Factors - Moderate alcohol intake decreases risk of coronary artery disease

Heart Failure - U.S. FDA approves wireless home patient management system

Hurricane Katrina - U.S. DoD extends pharmacy copay waiver for military hurricane victims

Imaging - Serial chest radiographs necessary to rule out SARS in screening clinic

Implantable Cardiac Devices - Agency releases results of study on defibrillator and pacemaker malfunctions

Influenza Vaccine - Biologics license application submitted to U.S. FDA for CAIV-T

Influenza Vaccine - New influenza vaccines are needed for older adults

Influenza Vaccines - New findings in the area of influenza vaccines described

Legal Issues - Civil settlement reached on Zofran and Kytril

Legal Issues - Legal opinion reinforces patent for anti-allergy medication

Leishmaniasis - DNA fragment increasing stability of Leishmania DNA identified

Leukemia - Data from phase III trial of Genasense confirm extended durability of remission

Lyme Disease - New antigens for serologic diagnosis of neuroborreliosis identified

Malaria Risk Factors - Non- and semi-immune pregnant women and their fetuses are at risk for malaria

Measles Vaccine - Contribution of measles antibodies to virus neutralization examined

Measles Vaccine - Measles vaccination effective after household exposure during outbreak

Measles-Mumps-Rubella-Varicella Vaccine - Dose response of children to measles, mumps, rubella and varicella vaccine tested

Medical Devices - U.S. FDA issues conditional IDE approval for orbital atherectomy system

Medical Devices - U.S. FDA issues recall for Colleague infusion pump

Medicare - United American company updates Medicare Prescription Drug Program information

Mental Health - UCLA sponsors trial of Prometa treatment protocol for methamphetamine dependence

Migraine - U.S. FDA approves enrollment in migraine clinical study

Mycobacterium Tuberculosis - MTB pknH gene deletion confers higher bacillary load during chronic infection

Nephrectomy - Oligonucleotide delivery method in partial nephrectomy model developed

Neurology Vaccine - Vaccine to protect neurons against toxicity of nerve agents developed

Non-Small Cell Lung Cancer - Tarveca approved by European Commission for non-small cell lung cancer

Obesity and Diabetes - British South Asians have higher fasting glucose levels than Europeans

Occupational Health - Microwave popcorn production workers face risk of airway inflammation

Oral Health - Nicotine inhibits myofibroblast differentiation in gingival fibroblasts

Osteoarthritis - Indication for Hyalgan to include shoulder pain from osteoarthritis

Osteoporosis - Once-monthly oral Bonviva approved for postmenopausal osteoporosis in Europe

Ovarian Cancer - U.S. NCI and 10 other institutions launch ovarian cancer clinical trial

Patents - U.S. patent granted for array of direct-load DNA polymerases in product line

Personnel - U.S. VA under secretary for health named to IT systems special commission

Pertussis Vaccines - Studies add new findings to pertussis vaccines body of knowledge

Prosthetic Joints - Characterization of prosthetic joint biofilms described

Public Health - MAPP community health improvement tool developed

Public Health - WHO guidelines for safe wastewater use explained

Respiratory Syncytial Virus Epidemiology - High infectiousness of RSV permits rapid geographic spread of novel variants

Rubella Vaccines - Researchers describe findings in rubella vaccines studies

SARS - Angiotensin converting enzyme 2 is a crucial SARS coronavirus receptor

SARS Coronavirus - Findings advance knowledge in SARS coronavirus research

SARS Epidemiology - Inapparent nosocomial SARS coronavirus infection in Vietnam evaluated

Sexually Transmitted Disease - Dating violence associated with STD/HIV in sexually active adolescents girls

Staphylococcus Aureus Infection - Favorable European opinion received for Altastaph

Stem Cell Transplantation - Selective depletion of alloreactive donor lymphocytes reduces GVHD severity

Stroke - U.S. FDA approval granted for device to treat carotid artery disease

Surgical Technology - Features of device for clearing arterial leg blockages extended to product line

Syphilis Genomics and Genetics - Molecular subtyping of Treponema pallidum from Carolinas reported

Tissue Engineering - Recent findings illuminate research in tissue engineering

Tuberculosis - VScan Tuberculosis (TB) rapid test kit achieves regulatory approval in India

Tuberculosis Diagnosis - TB case detection improved through public-private partnership

Tuberculosis Treatment - Poor patient compliance and duration of TB treatment predict recurrent disease

Tuberculosis Vaccines - Data advance knowledge in tuberculosis vaccines research

Typhoid Fever Vaccine - Typhoid and paratyphoid fever reviewed

Vaccine Development - IL-4 and IL-482 ratio may be marker for pulmonary tuberculosis disease activity

Vaccine Efficacy - Herbicides affect antibody response after Streptococcus vaccine

Vaccine Safety - Computerized database used to monitor vaccine safety in Vietnam

Vaccine Vector - Surface properties limit convective distribution of viruses in CNS

Vaccines Safety - Researchers' data advance vaccines safety research

Vaccinia Virus Vaccine - Protein encoded by all poxviruses required for cell entry and fusion

Venezuelan Equine Encephalitis - Envelope glycoprotein mutations mediate VEE amplification and virulence

Virology Vaccine - Influence of culture conditions on Vero cell propagation described

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