Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . April 10th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Antimicrobial Resistance - Tn1546 elements in vancomycin-resistant Staphylococcus compared
Listeria Therapy - CpG oligodeoxynucleotides enhance neonatal resistance to Listeria
Prion Disease - Protocols for instrument decontamination after TSE exposure presented
Smallpox Vaccine - Severe headaches common after smallpox vaccination
Tobacco Use - Amounts of polycyclic aromatic hydrocarbons in cigarette smoke measured
Acinetobacter Infection - Risk factors identified for multidrug-resistant A. baumannii infection
Age-Related Macular Degeneration - Eye care company reports clinical study data on macular degeneration
Air Monitoring - PCR method quantifies A. fumigatus conidia from environmental air samples
Allergy Medicine - New findings in the area of allergy medicine detailed
Allergy and Immunology - FDA approves CLARINEX-D 24 hour
Anthrax Vaccines - Reports advance knowledge in anthrax vaccines research
Malaria Vaccines - Researchers describe findings in malaria vaccines studies
Antimicrobial Resistance - Carbapenem resistance is emerging in strains worldwide
Antimicrobial Resistance - Vancomycin resistance increases mortality in patients with neutropenia
Antipsychotic Drug - Disposition of quetiapine in determined specimens from postmortem cases
Asthma - Interleukin-5 controls UGRP-1 during allergic airway inflammation
Atherosclerosis - Researchers' work adds to atherosclerosis body of knowledge
Avian Influenza - Cross-impact analysis predicts mutation trends in influenza A
Tuberculosis Vaccines - Recent findings in tuberculosis vaccines described
Avian Influenza - Investigational pandemic influenza vaccine for NIAID clinical trials delivered
Bioterrorism - Governor to unveil biocontainment unit, welcomes CDC director
Bioterrorism - U.S. Homeland Security Subcommittee briefed on nuclear, bio attack prevention
Botulinum Toxin - Fatal case of Botox-related anaphylaxis reported
Breast Cancer - Research in breast cancer provides new insights
Business & Finance - Anti-infectives-focused drug company reports fourth quarter 2004 results
Business & Finance - Pharma company reports year-end operating results, product candidates progress
Business & Finance - Woman's health company updates quarter and year; revenues dip
Business Update - Company announces disruption of supply for Paxil CR and Avandamet
Business Update - Drug development firm participates in FDA task force
Business Update - Enzon announces termination of agreements
Business Update - Pharma company appoints CRO to manage phenoxodiol trial
Cancer Therapy - Phase III trials of Bema fentanyl to be initiated
Cancer Therapy - Primary endpoint met in CoFactor phase II metastatic colorectal cancer trial
Candidiasis - Discovery may lead to better antifungal drug
Cell Biology - Cooperation between POT1 and TRF2 maintains telomeric integrity
Chagas Disease Vaccine - Oral immunization with Phytomonas serpens protects against Trypanosoma
Chlamydia Vaccine - Immunology of Chlamydia infection aids Chlamydia vaccine design
Cholera Monitoring - Monitoring environment and cholera presence predicts diarrhea epidemics
Clinical Trials - Clinical trials for injected multiple myeloma retreatment initiated
Community-Acquired Pneumonia - Pharma company completes enrollment in phase III FACTIVE trial for pneumonia
Compliance - FCG upgrades FirstDoc Enterprise Content Management Suite
Corynebacterium - Iron transport in Corynebacterium diphtheriae investigated
Crimean-Congo Hemorrhagic Fever - ELISA method used to diagnose Crimean-Congo hemorrhagic fever
Cystic Fibrosis - Persistent environmental reservoirs of P. aeruginosa not found in CF center
Cytomegalovirus Vaccine - Cytomegalovirus DNA vaccine protects against murine cytomegalovirus challenge
DNA Research - Safety of Strattera for treating ADHD clarified by DNA testing
Dengue Hemorrhagic Fever - Dengue hemorrhagic fever increasing among children in northern Brazil
Diabetes Surgery - Researchers' data advance diabetes surgery research
Diabetes Type 1 - Diabetes type 1 outbreak earlier in immigrants' children born in Italy
Diagnostics - FDA clears use of NT-proBNP assay on Stratus CS Acute Care Diagnostics System
Diarrheal Illness - Hygiene interventions identified to reduce diarrhea in less developed countries
Diet & Nutrition - Acrylamide in baked and fried food doesn't increase women's breast cancer risk
Diet & Nutrition - Scientists confirm that healthier food costs more
Disease Associations - Case of congenital tuberculosis reported in Florida
Drug Development - Compound for MS, Crohn disease included in U.S. FDA clinical hold
Drug Development - Dermatologists comment on FDA decision regarding eczema medications
Drug Safety - Pain reliever remains safe, effective when taken as directed
Drug Safety - Pharmaceutical company issues clarification on Paxil CR for depression, anxiety
Electronic Medical Records - New study shows limited use of electronic medical records
Emergency Medicine - New hand-held information system for emergency responders
Endometrial Cancer - African American women have more aggressive disease than Caucasian women
Environmental Health - Propiconazole generates cytochrome P450 gene variations in animal livers
Enzymology - Findings in enzymology provide new insights
Enzymology - Sex differences in cytochrome P4501B1 found in monkey telencephalon
Exercise and Nutrition - Exercise and diet have roles in prevention of chronic disease
Female Genital Mutilation - National telephone hotline effort in Burkina Faso aims to stop outlawed cutting
Finance - Pharma company reports improved 2004 financial results
Finance - Stem cell-focused biotech company announces Q4, year end 2004 financial results
Fluconazole - Bioequivalence of fluconazole capsules evaluated
Food Contamination - Continuous education assures good food hygiene on merchant ships
Food Safety - FDA assesses new report on acrylamide
Food-Borne Illness - Drug-resistant bacteria on poultry products differ by brand
Food-Borne Illness - FDA issues health advisory about certain soft cheese made from raw milk
Gender - Studies expand understanding of X chromosome
Growth Hormone Insensitivity Syndrome - FDA accepts for review SomatoKine NDA for GHIS
HIV/AIDS Diagnosis - Uncertainties of incidence estimates of HIV/AIDS diagnoses adjusted
HIV/AIDS Education - Cognitive intervention method reduces HIV/AIDS discriminatory attitudes
HIV/AIDS Healthcare - Unmet dental needs perceived to be associated with socioeconomics in HIV/AIDS
HIV/AIDS Prevention - Appropriate HIV education maximizes acceptance of antenatal HIV antibody test
HIV/AIDS Prevention - Predictors of condom use determined among HIV-positive patients in South Africa
HIV/AIDS Prognosis - Survival prognostic factors differ by CD4 count among IVDU pre/post HAART era
HIV/AIDS Research - MLV RNase H primer grip is an important determinant of fidelity of DNA synthesis
HIV/AIDS Screening - Urgent care center-based routine HIV screening programs are effective
HIV/AIDS Therapy - Expansion of AIDS centers needed to prevent spread of HIV in Russia
HIV/AIDS Therapy - Fixed conformation nucleoside analogs inhibit excision-proficient HIV-1 RT
HIV/AIDS Vaccine - C-terminal tail of HIV transmembrane glycoprotein involved in cell fusion
HIV/AIDS Vaccine - HIV preclinical interventions in nonhuman primates investigated
HIV/AIDS Vaccine - HIV preventive vaccine trials in developing countries examined
HIV/AIDS Vaccine - Poxvirus SIV vaccine partially protects juvenile macaques against SIV
HIV/AIDS Vaccine - Predictive value of primate models for AIDS therapies reviewed
HIV/AIDS Vaccine - Rhabdoviral prime-boost induces strong anti-HIV immune responses
HIV/AIDS Vaccine - Role of IL-7 in pathogenesis and treatment of HIV infection reviewed
HIV/AIDS Vaccine - Targeting CD4i epitope in HIV vaccine design explored
HIV/AIDS Vaccines - Researchers' findings advance HIV/AIDS vaccines research
Heart Transplantation - Ventricular repolarization heterogeneity may identify risk after OHT
Hereditary Angioedema - Protein therapeutic company recombinant human C1 inhibitor trial approved
Human Papillomavirus - HPV-13 polymorphisms determined for HIV+ and women at risk for HIV infection
Imaging - FDA clears smaller ultrasound catheter for visualization of entire heart
Imaging - FDA committee does not recommend approval of molecular imaging agent
Infection Control - Emerging Infections Program reduces response time to foodborne disease
Influenza - Flu pandemic: Are we ready?
Influenza Vaccine - Acidic polymerase epitope of influenza elicits potent antiviral response
Influenza Vaccine - Approaches to influenza prevention and treatment in travelers reviewed
Influenza Vaccine - Growth of attenuated influenza vaccine strains in cell lines achieved
Influenza Vaccine - Safety and immunogenicity of adenovirus-vectored influenza vaccines reviewed
Insulin Resistance - Routine clinical measurements to diagnose insulin resistance presented
Kaposi Sarcoma-Associated Herpesvirus - New findings in the area of kaposi sarcoma-associated herpesvirus described
Legal Issues - SAppeals court rules healthcare company did not violate patent antitrust laws
Leishmaniasis - Desert plant may help treat insidious tropical diseases
Macular Degeneration - Pharma company begins phase III clinical trial in macular degeneration therapy
Malaria Epidemiology - Researchers offer new estimates on extent of malaria
Malaria Vaccine - CD28 in T and B cell responses required for protection against malaria
Malaria Vaccine - Genetic approach to identify immunity targets in malaria parasites developed
Malaria Vaccine - Polymerized d-peptides used for immunizing animals against malaria
Malaria Vaccines - Recent findings illuminate research in malaria vaccines
Marketing - Company launching direct-to-consumer advertisements for HPV test
Measles Vaccine - Impact of population decline on dynamics of measles in Italy explored
Medical Devices - FDA clears polyethylene for hip replacement implants
Medical Devices - Medical device company announces FDA approval of OsseoSpeed
Medical Devices - Technology company receives U.S. NIH grant to develop dental implant coatings
Medical Errors - Hospital executives have concerns about error reporting systems
Mental Health - Abilify (aripiprazole) granted approval for new indication
Multiple Myeloma - External analyses of multiple myeloma trial announced
Neonatology - What will it take in reality for poor countries to reduce neonatal deaths?
Norovirus - New data illuminates research in norovirus
Obesity - Perspective change needed in obesity prevention
Obesity Pathogenesis - Sensory experience of food and obesity examined by PET
Occupational Health - Gas chromatographic test to quantify bromopropane in urine developed
Oncology - VEGF receptor inhibition impairs mammary tumor growth in mice
Opioid-Induced Bowel Dysfunction - Companies report initial results from phase II studies of Entereg (alvimopan)
Oral Health - Finances, lack of dentist barriers to seniors receiving needed dental care
Pancreatic Cancer - Pancreatic cancer clinical trial begins using MedPulser tumor ablation system
Pathogenic Escherichia coli - E. coli O157:H7 survival on vegetables dependent on soil compost type
Pediatric Obesity - Weight status of children ages 8-15 predicts obesity, high blood pressure
Personnel - Cervical cancer-focused company elects new board member: Carmen Medina
Personnel - Dr. Randall Lutter to succeed William Hubbard as FDA associate commissioner
Personnel - Pharma company names vice president of government relations
Personnel - Synthetic blood-focused biopharm company convenes medical advisory board
Pertussis Genomics and Genetics - Differential gene promoter activation in B. pertussis demonstrated
Policy - Drug companies and governments must act on fake drug problem
Polio Vaccines - Researchers' work adds to polio vaccines body of knowledge
Pre-eclampsia Risk Factors - Smoking does not increase severity of pre-eclampsia
Respiratory Pathogen - Respiratory infection spread during air travel rarely occurs
Rotavirus Vaccine - Immunization with rotavirus virus-like particles elicits immune responses
Rotavirus Vaccines - Researchers detail new studies and findings in the area of rotavirus vaccines
SARS - Convalescent plasma therapy shortens hospitalization stays of SARS patients
SARS - Events reconstructed during SARS outbreak in February 2003 in Singapore
SARS - Nursing students more stressed than medical students during SARS outbreak
SARS - SARS seroprevalence rate is low in apparently healthy healthcare workers
SARS Coronavirus - Recombinant nucleocapsid protein-based assay detects anti-SARS-CoV IgG
SARS Prevention - Residents of Taiwan have increased "willingness to pay" to reduce SARS risk
SARS Vaccine - Two neutralizing regions on SARS spike glycoprotein identified
SARS Virus - Hamster is better model than mouse for therapy against SARS virus replication
SARS Virus - SARS clinical features in the United States described
Schistosomiasis - Impact of 10-year project on schistosomiasis control in China reported
Schistosomiasis Vaccine - Calpain found in penetration glands of Schistosoma japonicum cercariae
Sleep Disorders - FDA approves portable non-EEG device to monitor of REM stage sleep
Smoking Cessation - U.K. NHS stop-smoking services insufficient to deliver national smoking targets
Sporotrichosis - Sporotrichosis diagnosis may be confounded by Leishmania coinfection
Stem Cell Research - Cytokines reverse gamma-globin gene silencing in erythroid stem cells
Tuberculosis - M. tuberculosis SigD sigma factor required for full virulence
Tuberculosis - String test as sensitive as sputum induction for TB detection in HIV infection
Tuberculosis Therapy - Mortality high among HIV-infected tuberculosis patients
Tuberculosis Vaccine - Fragmented M. tuberculosis cells increase efficacy of therapy against TB
Tuberculosis Vaccine - Plasmid DNA encoding mycobacterial hsp65 is effective treatment for TB
Tuberculosis Vaccine - Secretory protein ESAT-6 of Mycobacterium tuberculosis cloned
Tuberculosis Vaccine - Vaccination of possums with BCG reduces Mycobacterium bovis replication
Tuberculosis Vaccines - New findings in the area of tuberculosis vaccines detailed
Tuberculosis and Candida Coinfection - Candida coinfection higher in tuberculosis patients with complications
Vaccine Development - Clinical holds for vaccine INDs reviewed
Variant Creutzfeldt-Jakob Disease - Model choices for variant Creutzfeldt-Jakob disease projections are problematic
Virology - Norovirus transmission documented on cruise ship
Waterborne Illness - Health experts begin first national initiative to promote healthy swimming
West Nile Virus - Interferon can cure cells of West Nile virus replicons
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