Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . April 24th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Diet & Nutrition - Level of evidence needed for qualified health claim outlined
Food Allergy - ELISA-based assays for detection of peanuts in food validated
Pharmaceutical and Drug Development - pH dependence of binding of drugs to plasma proteins in man reviewed
Sexually Transmitted Diseases - Adverse health burden related to sexual behavior in U.S. reported
Vaccine Efficacy - Difficulty in ranking states' immunization coverage outlined
Acute Lymphocytic Leukemia - Clofarabine's interim results in leukemia reported at symposium
Allergic Rhinitis - Data announced on ragweed allergy immunotherapy clinical trial information
Allergy Medicine - Air particles increase cellular response to allergen in lymph nodes
Allergy Medicine - Documentation of allergy therapy through standardized forms promoted
Alzheimer Disease - Fish oil holds promise in Alzheimer fight
Anthrax - Anthrax spores cleared from lungs between 8-14% per day
HIV/AIDS Vaccines - Studies advance knowledge in HIV/AIDS vaccines research
Anthrax - Scientists seek answers on what activates deadly spores
Anthrax Vaccines - Reports advance knowledge in anthrax vaccines research
Anticholinergic Drugs - Levo isomers of atropine and hyoscyamine in products identified
Atherosclerosis - Recent findings in atherosclerosis described
Avian Viral Vaccines - RT-PCR used to detect reovirus contamination in avian viral vaccines
Bacteriology - Streptococcus transcriptome dynamics reveals survival strategies
Malaria Vaccines - Researchers detail new studies and findings in the area of malaria vaccines
Bacteriology - PSORTdb is protein subcellular localization database for bacteria
Biotechnology - Effects of elevated pCO2 and osmolality on CHO cell growth reported
Bioterrorism - Burkholderia species should be considered as possible agents of biowarfare
Bioterrorism - Data sources must be collected in timely manner for rapid bioterrism detection
Blood Safety - Blood supply remains unsafe in Latin America
Blood Substitute - Hemoglobin blood substitute used in critically anemic Jehovah Witness
Breast Cancer - New drugs contribute to neoadjuvant treatment of early breast cancer
Business Update - Company receives European approval for epicardial steroid lead
Business Update - FDA accepts Xyrem sNDA for review
Business Update - HHS awards BioShield contract for liquid potassium iodide
Business Update - Humanized monoclonal antibodies completes acquisition, reports on Nuvion
Business Update - Immunology-focused biotechnology company updates clinical development plans
Business Update - SinusPharma changes name to reflect focus on chronic rhinosinusisitis treatments
Business Update - Tissue engineering company provides update on premarket approval process
Business Update - U.S. FDA approves sterilization site for microsurgical dilation device
Cancer Therapy - Approvable letter issued by U.S. FDA for Combidex
Cancer Therapy - BAY 43-9006 delays disease progression in kidney cancer patients
Chagas Disease - Natural killer T cell functions examined during Trypanosoma infection
Clinical Trials - Medical diagnostics company signs dengue testing agreement with U.S. Navy
Cloning - Muslims distinguish between reproductive and therapeutic cloning
Collaborations - Patent, IP rights to colonic drug delivery system acquired
Colon Cancer - Primary care office strategies may increase colon cancer screening
Colon Cancer Prevention - Green vegetables may decrease colon cancer risk
Complementary & Alternative Medicine - Kavalactone levels in supplements containing kava determined by LC
Congestive Heart Failure - Heart assist device company files for CE Mark approval to market LVAS in Europe
Cord Blood Research - Legislation introduced to create inventory of cord blood stem cell units
Coronavirus Vaccine - Lactobacillus expressing coronavirus protein induces antibodies
Cosmetic Surgery - Use of polymethyl methaprylate microspheres in collagen reviewed
Cryptosporidiosis - Cryptosporidiosis declines after membrane filtration of public water supply
Diagnostics - Automated hepatitis C test launched for AxSYM immunoassay system
Diagnostics - Comparing aberration detection methods with simulated data
Diagnostics - Trial initiated on Androflo in preparation for FDA application
Diagnostics - U.S. FDA clears 510(k) for HemosIL D-Dimer assay
Diagnostics - U.S. FDA clears Hycor Biomedical autoimmune test for diagnosing celiac disease
Diagnostics - U.S. FDA grants approval to market cardiology device
Disease Management - New HIV patients more likely to seek medical care if they get case management
Disease Risk Factors - Method to estimate disease risk developed
Drug Development - Alvesco provides relief of asthma symptoms comparable to budesonide, fluticasone
Drug Development - Facts and myths about the pharmaceutical industry in Poland reported
Drug Development - Humanized immunoenzyme targets B-cell lymphoma
Drug Safety - Illegal hair products sold in Denmark
Ebola Outbreak - Wild animal mortality monitoring predicts human Ebola outbreaks
Ectopic Pregnancy - Outcomes of cervical pregnancy with/without methotrexate reported
Endocrinology - Supplemental DHEA may influence prostate health
Esophageal Candidiasis - Antifungal product for prophylaxis of Candida receives FDA approval
Female Sexual Dysfunction - Outcome measurement in female sexual dysfunction trials reviewed
Finance - Company reports on "most productive year to date"
Finance - Gastro-focused pharmaceutical company reports Q4, full year 2004 results
Finance - Minimally invasive ophthalmic products provider announces financial results
Finance - Pharma companys financial results reflect sale of probiotics business
Flavivirus - New flaviviruses in the Kokobera virus complex identified
Food Allergy - New approaches for treatment of peanut allergy reviewed
Gastroenterology - Enrollment completed in post-approval trial for GERD procedure
Genetics & Genomics - Company comments on FDA guidance on pharmacogenomics
Gonorrhea - New findings in the area of gonorrhea described
HIV/AIDS Coinfection - Interactions between HIV and herpes viruses occur within the oral mucosa
HIV/AIDS Drug Adherence - Medication adherence training instrument assists persons living with HIV/AIDS
HIV/AIDS Drug Resistance - HIV-1 mutations associated with reduced susceptibility identified in Brazil
HIV/AIDS Education - Community-based HIV education/prevention workers respond to changing environment
HIV/AIDS Epidemiology - HLA-A11 associated with CTL response against HIV-1 Nef in exposed persons
HIV/AIDS Epidemiology - Heterogeneous nature of HIV-1 recombinants spreading in Spain reported
HIV/AIDS Healthcare - Case management/shared-care schemes provide integrated care for HIV/AIDS
HIV/AIDS Prevention - Findings in HIV/AIDS prevention provide new insights
HIV/AIDS Research - Strong genetic signature exists for HIV-1 replication in male genital tract
HIV/AIDS Transmission - Understanding social risk factors essential to curb high-risk behavior
HIV/AIDS Vaccine - BCG Env V3 elicits protection against SHIV with homologous V3 motif
HIV/AIDS Vaccine - Correlates of HIV vaccine trial participation in India reviewed
HIV/AIDS Vaccine - Epidemiological contribution to HIV vaccine field trials reported
HIV/AIDS Vaccine - HIV-1 vectors produced from stable packaging cells
HIV/AIDS Vaccine - Polyethylenimine-plasmid complex induces gp120-specific immune response
HIV/AIDS Vaccine - SIV inactivated by N-ethylmaleimide with preservation of functional Env
HIV/AIDS Vaccine - Tat-neutralizing versus Tat-protecting antibodies investigated
HIV/AIDS Vaccines - Pharma company announced additional filings of antiretroviral agents with WHO
HIV/AIDS Vaccines - Studies add new findings to HIV/AIDS vaccines body of knowledge
HIV/AIDS-Tuberculosis Coinfection - Peripheral lymph node needle-core biopsies diagnose TB in HIV-infected adults
Heart Disease - Twin-to-twin transfusion syndrome presents an increased risk of adult disease
Infant Mortality - Second-born very low birth weight twins risk increased respiratory morbidity
Influenza A Virus - Avian influenza A subtype H7-infected pigeons multiply and excrete H7 viruses
Influenza Vaccine - Antibody levels against denatured influenza virus reported
Influenza Vaccine - Population-wide benefits of influenza vaccination in children outlined
Injury Prevention - Trauma impacts minority children more than white children
Interferon - Control of culture conditions enhances production of interferon-beta
Leishmaniasis - 71 strains from cutaneous leishmaniasis in Tunisia characterized
Leishmaniasis - Bioluminescent Leishmania developed for rapid drug screening
Lung Cancer - New lung cancer medicine receives Swiss approval
Lung Cancer Therapy - Potent CDC25 inhibitors synthesized
MMR Vaccine - intervention improves MMR vaccination coverage in immigrant children
Malaria Transmission - Standard membrane feeding assay for malaria transmission evaluated
Malaria Vaccines - Reports add new data to malaria vaccines research
Measles - Rubella no longer major public health threat in the United States
Medical Devices - U.S. FDA grants clearance for treatment table with 550-pound load capacity
Medical Statistics - Model for assessing aberration detection methods developed
Medicare - Concentra teams with PRG-Schultz for pilot program
Medicare - HealthPartners reports $1.5M savings with Medicare drug discount card
Melanoma - Chromosome locus identified as possible bearer of genes key to tumorigenesis
Metabolic Syndrome - Researchers' work adds to metabolic syndrome body of knowledge
Mycobacterium Detection - Staining parameters determined to increase sensitivity of mycobacterial smears
Mycobacterium Diagnosis - PCR identifies nontuberculous mycobacteria from paraffin-embedded tissues
Mycobacterium tuberculosis - DC-SIGN differentiates between pathogenic and nonpathogenic mycobacteria
Myeloma - U.S. DOD awards $1.6 million contract to develop bone-targeting nanocapsules
Neuroscience - Effect of hypoosmolality on SON magnocellular neuron gene expression clarified
Neuroscience - GluR6-deficient mice change behavior in response to noxious stimuli
Neuroscience - U.S. FDA IDE approval granted for tremor therapy device
Nocardia brasiliensis - Patients with N. brasiliensis actinomycetoma have type Th2 immune response
Non-Small Cell Lung Cancer - Phase III study of XYOTAX results reported
Obstetrics - Prenatal care access a problem for many U.S. immigrants
Ocular Inflammation - U.S. FDA approves Xibrom NDA for ocular inflammation following cataract surgery
Oncology - Environmental factors modify genetic susceptibility to primary liver cancer
Ophthalmology - New corrective eye surgery system to be distributed in Asia
Opportunistic Infections - Guidelines for treating infections in HIV-exposed children released
Ovarian Cancer - BRCA1 mutation acts through indirect, biochemical route
Pain Management - Report: FDA's COX-2 recommendations will benefit Bextra and Celebrex
Pediatric Vaccines - Parental decisions about MMR vaccinations influenced by emotion
Personnel - Keith Yamamoto, PhD, appointed to chair of scientific advisory board
Personnel - Pharma company announces resignation of president, provides business update
Personnel - Pharmaceutical company expands sales force, names new member of board
Philanthropy - Grants support public awareness initiatives for global disease prevention
Philanthropy - Imaging company donates airway intubation system to Army Hospital in Iraq
Plague - Yersinia pestis outbreak strains susceptible to antimicrobials
Pneumococcus - Childcare may affect entire community's risks of infection
Pneumocystis Infection - Pneumocystis outbreak transmitted within pediatric transplant unit
Pneumocystis Infection - General population may be a reservoir of Pneumocystis jirovecii
Polio Vaccine - Antibody against poliovirus blocks poliovirus-induced cytopathic effect
Primary Care - Primary care access decreases death risk even for poorest communities
Protease - Entamoeba histolytica cysteine protease involved in virulence
Refractory Angina - FDA approves protocol amendments to GENASIS phase IIb clinical trial
Respiratory Medicine - Asthma therapy developer gets U.S. FDA investigational new drug number
Restenosis - Company gets conditional IDE to begin COSTAR II pivotal clinical trial
Rotavirus Vaccine - Non-human primate model of rotavirus infection developed
SARS - Quarantine for SARS indirectly reduces infections
SARS Coronavirus - Researchers' findings advance SARS coronavirus research
SARS Outbreak - SARS needs to be distinguished from other febrile respiratory illnesses
SARS Prevention - Findings describe new data in SARS prevention research
SARS Vaccine - Antibodies binding to SARS spike and nucleocapsid proteins identified
SARS Vaccine - Fragment 450-650 of SARS coronavirus spike protein purified
SARS Vaccines - New findings in the area of SARS vaccines detailed
SARS Virus - Evasion of antibody neutralization in SARS coronaviruses investigated
Schistosomiasis Vaccine - Immune response to schistosomiasis DNA vaccine in baboon described
Sexual & Reproductive Health - Data reported from trial of co-administration of erectile dysfunction drugs
Sexual & Reproductive Health - HIV testing should be routine part of primary healthcare for sexually active
Sexually Transmitted Diseases - Intervention to promote female condom to STD clinic patients described
Sleep Disorders - Health organizations say insomnia is a public health issue
Smallpox - Surveillance and control measures during smallpox outbreaks reviewed
Smallpox Vaccines - Researchers provide details of new studies and findings in the area of smallpox vaccines
Surgical Technology - Elekta Neuromag receives regulatory approval in Canada
Systemic Lupus Erythematosus - Antibody-induced IL-2 deficiency could cause autoantibody production in lupus
Tick-Borne Disease - Serine protease inhibitor shows promise as anti-tick vaccine
Transplant Medicine - Bioequivalence of Cicloral is different from Neoral
Transplant Medicine - Positive results reported from first islet cell transplant
Trypanosomiasis - Casein kinase activities identified in Trypanosoma evansi
Tuberculosis - DOTS show the way to tackle the toughest tuberculosis
Tuberculosis - Fixed dose combinations for TB helps prevent emergence of drug resistance
Tuberculosis - Gene expression diversity among M. tuberculosis isolates determined
Tuberculosis - Pathogen-induced microenvironments exist within host cell endosomal system
Tuberculosis - Proportion method for drug resistant-TB determination not supported by research
Tuberculosis - Pyrosequencing differentiates between M. tuberculosis complex species
Tuberculosis Control - Tuberculosis control programs in China may exclude poor people
Tuberculosis Diagnostics - Heat-fixed unstained sputum AFB smears stable up to 10 months
Tuberculosis Therapy - Diamine-based antituberculosis drug inhibits intracellular M. tuberculosis
Tuberculosis Therapy - Majority of MDR-TB isolates in Thailand susceptible to second-line drugs
Tuberculosis Treatment - Melatonin prevents free radical/MADD metabolic profiles induced by anti-TB drugs
Tuberculosis Vaccine - M. tuberculosis protein epitopes with vaccine potential identified
Tuberculosis Vaccine - BCG vaccine protects girls against lower respiratory tract infections
Tuberculosis Vaccine - Factors influencing immune response to BCG vaccine antigens outlined
Tuberculosis Vaccines - Research add new data to tuberculosis vaccines body of knowledge
Vaccine Development - Vaccine research and development is global science policy priority
Vaccine Safety - Simulation used to assess signal detection tool for surveillance data
Virology - Novel flavivirus or new lineage of West Nile Virus identified
West Nile Virus - Moroccan West Nile virus isolates related to equine outbreaks in Mediterranean
West Nile Virus - Weather forecasts may be predictors for prevalence of West Nile
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