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Medical Letter on the CDC & FDA

Susan Hasty, Publisher
Table of Contents . . . July 24th, 2005
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Environmental Health - National exposure measurements to protect public health released

HIV/AIDS Therapy - Natural resistance of HIV type 2 to zidovudine described

Human Papillomavirus - Gene expression profile of cervical cells harboring HPV-16 reported

Listeriosis - Outbreak of listeriosis in U.S. traced to contaminated hot dogs

Pap Test - Physician recommendation improves likelihood of Pap testing

Acinetobacter Baumannii - Imipenem-resistant A. baumannii outbreak produced OXA-23 beta-lactamase

Allergy & Immunology - Formoterol fumarate inhalation powder for asthma and COPD approved in Germany

Allergy Medicine - Minority children not less likely to be diagnosed with asthma

Allergy Risk Factors - Routine immunizations do not reduce hay fever risk

Amyotrophic Lateral Sclerosis - Phase II trial for ALS expected to begin after second quarter

Anopheles - Deforestation facilitates survival of immature stage of Anopheles gambiae

Obstetrics - Researchers provide details of new studies and findings in the area of obstetrics

Antimicrobial Drug Adherence - Pharmionics measures patient adherence to prescribed antimicrobial drug regimens

Asbestos - Computed tomography useful in detecting asbestos-related abnormalities

Aspergillosis - Scoring system developed to help predict risk of invasive aspergillosis

Atrial Fibrillation - Dr. Andrea Natale files IDE for use of the linear ablation technology

Avian Influenza - Researchers describe findings in avian influenza studies

Bacterial Vaginosis - TNF-alpha secretion/TLR4 mRNA expression stimulated in bacterial vaginosis

Biomedical Engineering - U.S. NIH selects Vanderbilt University for new molecular screening center

Blood Safety - Pathogen inactivation proactively protects the blood supply

Brain Cancer - No significant increase in glioma risk seen in women exposed to farm pesticides

Brain Injury - Characteristics of traumatic brain injury in elderly people described

Breast Cancer - Researchers seek quicker, less invasive cancer detection

Breast Cancer - U.S. FDA: Second Look Digital can be packaged with MAMMOMAT NovationDR

Breast Cancer Screening - Women want to participate in decision on first mammogram

Burkholderia Pseudomallei - Schema developed for laboratory identification of Burkholderia pseudomallei

Business & Finance - Cancer-, hepatitis-focused company affirms clinical progress, notes milestones

Business Update - Company gets orphan drug designation for Prestara

Business Update - DARPA to sponsor evaluation of CX717 in a new study in shift work

Business Update - FDA approves Immedia PT System

Business Update - Radiofrequency ablation company completes manufacturing transfer

Business Update - U.S. FDA clears ICG device with 12-lead ECG

Cancer Prevention - Selenium levels relate inversely to liver cancer occurrence

Cancer Research - Pharma company presents broad antiviral potential of Tarvacin at conference

Cancer Therapy - Influence of type 2 diabetes on cancer treatment and outcome reported

Cancer Therapy - U.S. FDA grants fast track status for Fodosine in refractory T-cell leukemia

Cardiology - Transmyocardial revascularization and gene therapy fight myocardial dysfunction

Cardiovascular Disease - Rimonabant accepted for filing by the FDA

Cervical Dystonia - Trial shows Myobloc clinically equivalent to Botox in cervical dystonia

Chemotherapy - Tentative FDA approval received for Ondanestron Hydrochloride

Chickenpox Vaccine - Oka/GSK attenuated varicella vaccine prevents chickenpox

Childhood Cancer - Public health partnerships of childhood cancer studies examined

Chlamydia Trachomatis - Higher vaginal pH associated with Chlamydia trachomatis infection in women

Chlamydiosis - Azithromycin should be effective against IFN-gamma-induced persistent infection

Clinical Trials - Bioscience company expands development program for EGFR inhibitor nimotuzumab

Coccidioidomycosis Vaccine - Immune response of vaccinated mice to Coccidioides investigated

Colorectal Cancer - Gene methylation may play an important role in adenoma recurrence

Cosmetics - OTC progesterone cream results in significant drug exposure

Cystic Fibrosis - Progress in phase 2 clinical trial of cystic fibrosis drug candidate reported

Dengue Epidemic - Anticipating emergence/preventing spread reduces effects of dengue epidemics

Dengue Fever - Ultrasound assists in diagnosis of dengue fever

Dengue Virus Vaccine - DNA vaccine induces protective antibodies against dengue virus

Depression - Study found profound morning elevations of plasma IL-6 in depressed patients

Diabetes Complications - Scale measuring fear of complications in type 1 diabetes developed

Diabetes Control - Pager-sized monitor for diabetes control receives FDA clearance

Diabetes Epidemiology - Diabetes management in San Diego's Chamorro community examined

Diabetes Therapy - Barriers to diabetes education in urban patients presented

Diabetes Therapy - U.S. FDA approves Levemir

Diagnostics - U.S. FDA grants 510(k) clearance for blood screening controls

Diagnostics - U.S. FDA grants clearance for immunoassay for diagnosing venous thrombembolism

Diet & Nutrition - FDA review period extended for chromium picolinate diabetes-related petition

Drug Delivery - Licorice root treatment in medicated disc for canker sores introduced

Drug Development - Allon files IND to begin clinical trials for second product AL-208

Drug Development - Botox to be studied as potential headache treatment

Drug Development - Phase III trial of Neurodex initiated for diabetic neuropathic pain

Drug Development - U.S. label changed for Iressa (gefitinib)

Drug Safety - U.S. FDA reports on first meeting of Drug Safety Oversight Board

Ebola Vaccine - Ebola virus L-domains characterized using VSV recombinants

Endometrial Cancer - Phase II clinical trial of cell-signaling protein inhibitor seeks patients

Environmental Health - Human health research and policy development near Great Lakes described

Epidemiology - Global trends in breast cancer incidence and mortality reported for 1973-1997

Epilepsy - U.S. FDA approves Lyrica as epilepsy add-on treatment for partial onset seizures

Epilepsy - U.S. FDA approves new indication for Topamax

Etiology - Genetic analysis of common diseases in postmenopausal women is funded

Food Safety - Texas companies join to make beef genetic information available through web

Fungal Infection - Phototoxicity results from prolonged voriconazole therapy

HIV/AIDS Coinfection - HIV-specific cytolysis/increased IL-10 associated w/ S. mansoni coinfection

HIV/AIDS Diagnosis - Efoora test rapidly detects HIV-specific antibodies

HIV/AIDS Drug Resistance - Mutations not associated with primary antiretroviral resistance in Chili

HIV/AIDS Epidemiology - Mathematical models make qualitative predictions about spread of HIV over time

HIV/AIDS Epidemiology - Mutagenetic trees describe accumulation of HAART-induced HIV mutations

HIV/AIDS Pathogenesis - Reports advance knowledge in HIV/AIDS pathogenesis research

HIV/AIDS Research - Report issued on phase 1/2 clinical trials for HIV/AIDS antiretroviral drug

HIV/AIDS Therapy - FDA approves new therapy for HIV patients with advanced disease

HIV/AIDS Treatment - U.S. FDA announces tentative approval of Lamivudine tablets

HIV/AIDS Vaccine - Enrollment in protease inhibitor program for HIV/AIDS patients to begin in fall

HIV/AIDS Vaccine - Multiclade envelope HIV vaccine expands extent of virus neutralization

HIV/AIDS Vaccine - U.S. NIH center places HIV vaccine production order for phase 2 trials

HIV/AIDS Vaccines - Researchers publish new studies and findings in the area of HIV/AIDS vaccines

HIV/AIDS-Related Infection - Invasive S. pneumoniae infections declining in HAART era

Haemophilus Outbreak - Outbreak of invasive Haemophilus influenzae serotype A reported

Haemophilus Vaccine - Epitope of nontypeable H. influenzae protein plays role in immunity

Health Policy - Women's health suffers under welfare reform, study says

Health Screening - Nurses perform as well as doctors in routine screening in STD clinic

Healthcare Coverage - Chicago health leaders meet on state of the region's healthcare market

Heart Failure - FDA advisory committee recommends approval for BiDil for black patients

Heart Failure - FDA approves BiDil heart failure drug for black patients

Helicobacter Pylori - Probiotics improves tolerance to Helicobacter pylori eradication therapy

Hemoglobin - O-raffinose crosslinked hemoglobin lacks site-specificity in cavity

Hepatitis Vaccine - First sales of hepatitis A&B vaccine to Hunan Province, China CDC announced

Herpes Zoster - Varicella vaccine does not increase incidence of herpes zoster

Herpesvirus Epidemiology - Human herpesviruses-6 and -7 cause significant neurological morbidity

Human Herpesviruses - Valacyclovir decreases EBV prevalence in saliva but not HHV-6 and HHV-7

Human Papillomavirus - Screening important to detect persistent infections seen in older women

Human Papillomavirus Vaccine - HPV-16 vaccine elicits broad cytokine response in whole blood

Infant Abuse - Early experience, not genetics, key factor in intergenerational infant abuse

Infection Control - Guidance on public reporting of healthcare-related infections released

Infectious Disease - Serum IgG mediates mucosal immunity against rotavirus infection

Influenza - Production range for Fluvirin vaccine revised

Influenza Vaccine - Factors influencing influenza vaccination in elderly reported

Influenza Vaccine - Influenza vaccination recommended for HIV-1-infected patients

Influenza Vaccine - Standing orders in ambulatory setting increases influenza vaccine usage

Information Technology - Company helps U.S. FDA identify online pharmacy misrepresentation

Information Technology - Device maker initiates worldwide physician communications on safety information

Information Technology - U.S. FDA-compliant content management software for pharma, biotech use launched

Isotretinoin - Accutane SMART Program may not reduce pregnancy during isotretinoin use

Kidney Disease - FDA clearance received for Allient Sorbent Hemodialysis System

Lead Poisoning - Improved strategies to prevent childhood lead poisoning reported

Legionella Pneumophila - Sequence-based L. pneumophila typing concordant and discriminatory

Leishmaniasis Vaccine - DNA vaccine protects against Leishmania donovani

Leukapheresis - Magnesium supplementation does not reduce side effects of leukapheresis

Listeria Monocytogenes - Cell-to-cell spread facilitates L. monocytogenes mom-to-fetal transmission

Liver Cancer - Data advance knowledge in liver cancer research

Liver Failure - U.S. NIH SIBR grant awarded for study of stem cell therapeutics in liver disease

MMR Vaccine - Eliminating MMR immunizations does not decrease autism incidence

Malaria - Babies born from malaria-infected mothers susceptible to malaria early in life

Malaria - Further studies needed to determine accuracy of rapid malaria diagnostic tests

Malaria Vaccine - P. falciparum surface protein P. vivax homologue characterized

Medical Devices - Defibrillator software upgrade notification for physician customers announced

Medical Devices - International regulatory approvals granted for 2 resuscitation products

Medical Devices - Medical device company prepares to launch oxygen alert system

Medical Devices - Medical device company receives FDA approval for its high flux filter

Medical Devices - Panel to recommend physician and patient communication guidelines for devices

Medical Devices - SmartStep launched for improved gait rehabilitation

Medical Informatics - Record linkage protocol for diabetes registry at health center reported

Mercury Poisoning - Loss of IQ due to mercury poisoning is economic productivity loss to U.S.

Mergers & Acquisitions - Agreement makes RFID products available through healthcare supply services

Mergers & Acquisitions - Pharma company to acquire Vicuron Pharmaceuticals

Metabolic Syndrome - New findings in metabolic syndrome described

Mycobacterium Avium - M. avium enters state of metabolic dormancy in response to starvation

Mycobacterium Bovis - Tuberculosis in animals and humans reviewed

Mycobacterium Tuberculosis - M. avium subsp. paratuberculosis rapidly detected/typed from broth cultures

Mycobacterium Tuberculosis - Development of antitubercular drugs against persistent bacilli is needed

Mycobacterium Tuberculosis - HemZ is essential for heme biosynthesis in Mycobacterium tuberculosis

Mycobacterium Tuberculosis - Immunity to infection with Mycobacterium tuberculosis is influenced by age

Mycobacterium Tuberculosis - Transmembrane TNF provides acute control of M. tuberculosis infection

Mycobacterium Tuberculosis - W-Beijing MTB strains identified with targeted IS6110 fingerprints hybridization

Myelodysplastic Syndromes - U.S. FDA grants priority review for REVLIMID

Necatoriasis Vaccine - Hookworm calreticulin is potential vaccine candidate for necatoriasis

Newcastle Disease Vaccine - Existing vaccines protect chickens against Newcastle disease outbreak

Nocardiosis - Underlying diseases common in patients with nocardiosis

Obesity Genomics and Genetics - Peptide YY and Y2 receptor genes linked to obesity in Pima Indian men

Obstetrics - Pomegranate juice for moms may help babies resist brain injury

Obstetrics - Recent findings illuminate research in obstetrics

Patents - Biopharm company associated with U of Texas awarded additional Advexin patent

Pediatric Vaccine - Immunogenicity of vaccines in Asian infants born in U.K. reported

Personnel - Mechanical heart device company names John J. Vajda VP of manufacturing

Pneumococcal Vaccine - Multiple pneumococcal vaccinations do not increase adverse reactions

Poisoning - Guidelines aid centers in managing patients who have ingested beta-blockers

Poliovirus - Cloning system mass produces virus-binding protein specific for poliovirus-1

Post-Traumatic Stress Disorder - Mental health of Kosovar Albanian humanitarian aid workers examined

Product Recall - Guidant recalls certain defibrillators

Prostate Cancer - Phase III enrollment complete in Provenge trial for early-stage prostate cancer

Pseudomonas Aeruginosa - Mab against P. aeruginosa protective against fatal pseudomonas sepsis

Pseudomonas Aeruginosa - Substance P regulates NK cell IFN-gamma production/resist to P. aeruginosa

Public Health - Perspectives on using scientific knowledge for public health presented

Public Health - Surveillance of hazardous substance emergency events described

Respiratory Syncytial Virus - Group A RSV isolates from Argentina have more genetic variability than group B

Rotavirus Gastroenteritis - G9 is predominant genotype in pediatric rotavirus gastroenteritis in Belgium

SARS Coronavirus - Rolling circle amplification test rapid/sensitive for SARS coronavirus detection

SARS Outbreaks - Recent findings illuminate research in SARS ouTBreaks

SARS Vaccine - RNA interference inhibits SARS-CoV antigen

Saccharomyces Cerevisiae - Saccharomyces cerevisiae fungemia is an emerging infectious disease

Sepsis Therapy - Dendritic cells encoding IL-10 used to treat sepsis

Sexual and Reproductive Health - Pharma company received action letter from U.S. FDA for contraceptive implant

Smoking - Association of tooth loss with disease risk was not confounded by smoking

Staphylococcus Aureus - S. aureus Panton-Valentine leucocidin+ isolates from diverse backgrounds

Stem Cell Research - WNT1 and WNT3a promote expansion of melanocytes through distinct modes of action

Stem Cell Transplantation - Clinical sequelae following microbially-contaminated SC infusions are rare

Streptococcus Infection - Wound care team transmits group A streptococcal nosocomial transmission

Streptococcus Vaccine - COPD azithromycin therapy after Streptococcus vaccine reported

Stress Urinary Incontinence - Phase 2 clinical study of oral drug for stress urinary incontinence approved

Transfusion Medicine - U.S. FDA grants priority review for Exjade for chronic iron overload

Tuberculosis - Children require higher INH dose to achieve concentrations comparable to adults

Tuberculosis - Gestational multidrug-resistant tuberculosis therapy not toxic among children

Tuberculosis - High-resolution CT detects activity of suspected smear negative pulmonary TB

Tuberculosis Risk Factors - Risk of TB for children in contact with infected adults reported

Tuberculosis Vaccine - M. tuberculosis 19-kDa lipoprotein eliminates BCG protection

Tuberculosis Vaccine - Mucosal delivery of ESAT-6 induces cell-mediated responses in lung

Umbilical Cord Blood Banking - Semiautomated RBC depletion system saves time/improves cell recovery

Varicella Vaccine - Disparities exist in varicella vaccine coverage in Canada

Varicella Zoster Virus - VZV reactivates following discontinuation of aciclovir prophylaxis for HSCT

Virology - Parvovirus B19 transmission caused by factor VIII concentrate

Virology - Protein from the open reading frame 3 gene generates hepatitis E infection

Water-Borne Illness - Genetic diversity of noroviruses in sewage water examined

Water-Borne Illness - Systems approach to water-borne disease outbreak study described

Yellow Fever - Fragment of yellow fever virus may hold key to safer vaccine

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