Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . July 3rd, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Arthritis - Trends in total knee replacements implicate osteoarthritis and obesity
Breast Pumps - Adverse events linked to breast pumps
HIV Vaccine - Sexual risk behavior is high among vaccine efficacy trial subjects
Hodgkin Lymphoma - Interleukin-4 cytotoxin may be a unique agent against Hodgkin lymphoma
Lead Poisoning - CDC issues recommendations for newly arrived refugee children
Acute Radiation Syndrome - New drug being developed for the treatment of acute radiation syndrome
Addiction Medicine - Priority review granted for Vivitrex
Adenovirus Outbreak - Neonatal ICU adenovirus type 30 outbreak spread via ophthalmologic procedures
Adiposity - Cause, possible treatment for abdominal fat in postmenopausal women found
Adverse Drug Reaction - Anti-HERG activity is associated with risk of ventricular arrhythmias
Allergy Medicine - Childhood immunization protects against atopic disease development
Angiology - Company initiates COSTAR II pivotal drug-eluting stent clinical trial in U.S.
Attention-Deficit Hyperactivity Disorder - FDA grants approval to market FOCALIN XR for the treatment of ADHD
Avian Influenza - Global threat of bird flu is being ignored, experts warn
Bipolar Disorder - Company receives KEMA EU approval for next-generation VNS Therapy Generators
Brain Cancer - Brain cancer treatment to undergo broader testing
Brain Cancer - Phase 2 clinical study of chlorotoxin compound to treat brain cancer initiated
Breast Cancer - Digital mammography doesn't improve detection rates, study finds
Breast Cancer - Women tend to overestimate breast cancer risk
Burkholderia Cepacia Outbreak - B. cepacia outbreak caused by Albuterol nebulization solution contamination
Business & Finance - Discoverer of transrenal-DNA announces 2005-2006 strategic initiatives, goals
Business Update - Agreement signed to sell fibrin sealant for orthopedic surgery in Netherlands
Business Update - Company files with U.S. FDA to expand ALERT product line
Cardiology - Pre-market notification submitted to U.S. FDA to expand technology labeling
Chickenpox Vaccine - Varicella vaccine rate linked to daycare and school vaccine requirement
Clinical Trials - Second study of small molecule organic arsenic in solid tumors underway
Crimean-Congo Hemorrhagic Fever Outbreak - Simple barrier methods may prevent Crimean-Congo hemorrhagic transmission
DNA Research - Treponemal DNA not preserved in bone
Dengue Fever - Multi-epitope protein developed as dengue diagnostic reagent
Dengue Fever - T helper 1 reaction altered in patients with dengue hemorrhagic fever
Dengue Virus Epidemic - Virus evolution pattern detected during a severe dengue epidemic in Cuba
Diabetes - Pregnant women with GDM associated with maternal medical complications
Diabetes Treatment - Foot care education gives patients power to prevent surgery
Diagnostics - ComfortScan PMA clinical trial progressing
Diagnostics - Data on bladder cancer detection test reported at urological association meeting
Diagnostics - FDA clearance received for PreAnalytiX PAXgene Blood RNA System
Diagnostics - Notification of registration for rapid cardiac marker assays in China received
Diet and Nutrition - Creatine monohydrate supplementation can trigger atrial fibrillation
Diet and Nutrition - Fluid milk produced in US has low prevalence of Listeria monocytogenes
Drug Abuse - Prescription of heroin is less costly for society
Drug Development - Orphan drug designation granted for visceral leishmaniasis drug
Drug Development - Synthetic Heparin market potential boosted by U.S. FDA approval for Arixtra
Drug Development - U.S. FDA grants IND to conduct phase I/II Trial with prostate cancer drug
Drug Development - U.S. FDA grants approval for Naglazyme for mucopolysaccharidosis VI
Drug Development - Written response from U.S. FDA issued on oral tazarotene
Dry Eye - Inspire submits amendment to new drug application for Diquafosol
ESBL-Producing Escherichia Coli - MSLT more discriminatory than PFGE in identifying ESBL-producing E. coli
Environmental Health - Health professionals should quit being passive about smoking
Environmental Pathogen - More bacterial pathogens identified in therapy pools compared with potable water
Escherichia Coli O157:H7 Outbreak - Escherichia coli O157:H7 outbreak associated with ground beef contamination
Gastroenteritis - Sanitation factors into diarrhea outbreaks on Denali climb
Gastroesophageal Reflux Disease - Nizatidine for the treatment of pediatric GERD is safe and effective
Generic Drugs - Pharma company receives tentative U.S. FDA approval to market Lamivudine
Growth Hormone Insensitivity Syndrome - Insmed reports results from clinical trial of SomatoKine replacement therapy
HIV/AIDS - Application submitted to U.S. FDA for new formulation of Kaletra
HIV/AIDS Diagnostics - Duplex real-time PCR assay detects HIV DNA in dried blood spots
HIV/AIDS Emotional Support - Older adults with HIV/few comorbid illnesses report inadequate emotional support
HIV/AIDS Epidemiology - "Surplus" men in China may become significant new HIV risk group
HIV/AIDS Healthcare - Evolving health delivery system designed to meet needs of changing HIV epidemic
HIV/AIDS Infection - Apoptosis may prevent HIV-1 infection in an exposed but uninfected population
HIV/AIDS Pathogenesis - HIV-1 envelope V2 region influence HIV entry and spread in macrophages
HIV/AIDS Pathogenesis - Mannose receptor is potential intracellular target of HIV-1 Nef
HIV/AIDS Prevention - Latin America/Caribbean nongovernmental organizations help prevent HIV infection
HIV/AIDS Research - Pharma company makes three antiretroviral formulation filings to WHO
HIV/AIDS Risk - Recent incarceration independently associated with syringe sharing
HIV/AIDS Vaccine - Constraints on HIV antibody epitope increase antigenicity
HIV/AIDS Vaccine - HIV minimal gag protein inhibits reverse transcription
HIV/AIDS Vaccine - Majority of HIV-1B fails to prime CTL response against HLA-A2-restricted epitope
HIV/AIDS Vaccines - Recent findings in HIV/AIDS vaccines provide new insights
Haemophilus Influenzae - H. influenzae most common bacterium isolated from sputum in AECOPD patients
Healthcare Coverage - Children in foster care may be underaccounted for in Medicaid
Healthcare Disparity - Minorities receive less diabetes-related prevention care
Hemorrhagic Fever - Researchers look at Crimean-Congo hemorrhagic fever virus glycoproteins
Hepatic Tuberculosis - Hypercalcemia in hepatic tuberculosis resolved with antituberculosis medication
Hepatitis C - Pharmaceutical company receives IND clearance for antiviral clinical trial
Hepatitis C Virus - Researchers propose antiviral pathway via ADAR1
Human Papilloma Virus - PreservCyt fixative allows for HPV presence detection for up to 3 months
Hypertension - Capsule and tablet forms of combination amlodipine-benazepril are bioequivalent
Hypertension - Company initiates phase II trial for Ventavis in expanded indication
Hypertension - FDA approvable letter received for Nebivolol
Immunization - Parents must be armed with basic information about vaccine use and safety
Infectious Disease - Rotavirus probable cause of large outbreak in Indonesia
Influenza Vaccine - Beliefs of Ontario midwives about influenza immunization reported
Information Technology - Tracking system helps emergency departments manage volume of patients
Injury Prevention - Men, women disagree on number of guns at home
Kidney Transplantation - Recent findings in kidney transplantation provide new insights
Legal Issues - Biopharmaceutical company files preliminary injunction against Insmed, Celtrix
Legal Issues - Diagnostics company announces settlements with the SEC and DOJ
Liver Cancer - Exposure to carcinogenic crop toxin lowered by simple intervention
Lupus Erythematosus - Pharmaceutical company provides update finances, trials on lupus renal drug
Malaria - Factors influencing the pattern of imported malaria determined
Malaria Vaccine - Exposure to malaria parasites boosts gamma interferon responses
Malaria Vaccine - Results of phase 1 malaria vaccine trial reported
Medicare - Bariatric surgeons seek expanded medicare coverage for weight loss surgery
Medicare - Survey reports physicians' attitudes and impact of Medicare Part B
Metabolic Syndrome - New data illuminates research in metabolic syndrome
Milk Pasteurization - Pasteurization inactivates M. avium subsp paratuberculosis in milk
Mycobacerium Bovis - Mycobacerium bovis persists in farm environment outside of host
Mycobacterium Diagnostics - PCR assay identifies Mycobacterium species in contaminated cultures
Mycobacterium Tuberculosis - Blood agar rapidly tests susceptibility of MTB to isoniazid and rifampin
Mycobacterium Tuberculosis - Cyclic AMP-regulated genes identified in Tuberculosis complex mycobacteria
Mycobacterium Tuberculosis - MTB families identified that are specific to Spain-related settings
Mycobacterium Tuberculosis - Macrolide derivatives active against Mycobacterium tuberculosis
Mycobacterium Tuberculosis - Modified immunohistological staining detects Ziehl-Neelsen-negative MTB
Mycobacterium Tuberculosis - Two low-cost colorimetric methods rapidly detect ofloxacin resistance in MTB
Mycobacterium Tuberculosis Diagnostics - Real-time PCR rapidly detects Mycobacterium tuberculosis in clinical samples
Neisseria Meningitidis - Variable-no. tandem repeats used to examine N. meningitidis gene diversity
Non-Hodgkin Lymphoma - Patients being enrolled in Rituxan trial for follicular NHL
Non-Small Cell Lung Cancer - Celecoxib can be safely used concurrently with thoracic radiotherapy
Norovirus - One-step RT-PCR rapidly detects noroviruses in fecal and shellfish samples
Obstetrics - Almost 2 million babies die either during labor or of childbirth complications
Ophthalmology - Medical industries company receives approval for ultrasound biomicroscope
Oral Cancer - Visual screening could prevent 37,000 deaths from mouth cancer worldwide
Orthopedics - Orthofix's Physio-Stim now eligible for reimbursement in France
Outcomes - American Indians, Alaska Natives have higher mortality rate after surgery
Pancreatic Cancer - Phase III clinical data from Tarceva trial presented
Patents - Danish oncology company receives broad U.S., E.U. patents for HDAC inhibitors
Patents - Patent issued for mutated interleukin 13 technology to treat malignant glioma
Patents - Pharmaceutical company announces issuance of patent for cancer treatment
Patents - Transdermal-DNA developer files provisional U.S. patent for Down syndrome test
Patents - U.S. patent granted for modified pectin drugs to treat angiogenesis diseases
Pediatric Obesity - 100% childhood obesity by 2044?
Pertussis - Booster vaccine for adolescents and adults shows promise
Pertussis - Study supports whooping cough booster shot for adolescents
Pharmaceuticals - Gastrointestinal-focused pharmaceutical company submits NDA proton inhibitor
Phthalate Exposure - Researchers develop method to evaluate prevalence of phthalate exposure
Phytoestrogens - Infant formula ingredient may disrupt development of female reproductive system
Pneumococcal Vaccine - Adult reported pneumococcal vaccination status of children inaccurate
Prostate Cancer - Combining recombinant cancer vaccine with radiotherapy is a safe regimen
Prostate Cancer - U.S. FDA authorizes clinical trial in drug for hormone dependent prostate cancer
Psoriatic Arthritis - FDA expands Enbrel indication to include additional psoriatic arthritis symptoms
Red Blood Cell Substitute - Red blood cell substitute has no significant side effects
Respiratory Infection Therapy - Gemifloxacin is safe and efficacious against respiratory tract infections
Respiratory Syncytial Virus - Depletion of RSV glycoprotein antibodies in immunoglobulin investigated
Rotavirus Vaccines - Reports describe recent advances in rotavirus vaccines research
Salmonella Outbreak - Raw egg shells in meringue pie cause of Salmonella outbreak in cafeteria
Secondary Hyperparathyroidism - Cinacalcet shows promise as a treatment for secondary hyperparathyroidism
Sexual & Reproductive Health - Fertility organization comments on U.S. FDA donor eligibility guideline revision
Smallpox Vaccine - Policies related to bioterrorism and smallpox examined
Smallpox Vaccines - Recent findings in smallpox vaccines described
Stem Cell Research - Stem Cell Therapeutic and Research Act of 2005 passes House of Representatives
Surgical Technology - Autologous thrombin processing device receives CE Mark to allow sales in Europe
Syphilis Vaccine - Antibody partially protects against syphilis
Toxicology - Water in Navajo Nation could cause reproductive problems
Transplant Medicine - College students think favorably, but act timidly about organ donation
Transplant Medicine - Non-steroid therapy after liver transplant comparable to steroids, study shows
Trauma - Location, access to trauma centers often inadequate, inefficient
Tuberculosis - Clinical tuberculosis symptoms necessary to predict high PPD antibody titers
Tuberculosis - High prevalence of pulmonary TB in patients seen at DOTS clinics in Nigeria
Tuberculosis - Incidence of extrapulmonary tuberculosis lower than pulmonary TB in Estonia
Tuberculosis - Matrix metalloproteinase-9 is increased in tuberculous pleural effusions
Tuberculosis - Quality improvement in disease management increases tuberculosis drug compliance
Tuberculosis - Reports describe recent advances in tuberculosis research
Tuberculosis Diagnosis - Blood-based TB test matches up to old skin test in study among health workers
Tuberculosis Diagnosis - Chest x-rays not effective in determining when TB acquired
Tuberculosis Diagnostics - Pulmonary tuberculosis rapidly diagnosed via mass spectrometry method
Tuberculosis Epidemiology - Multidrug-resistant TB persists in California
Tuberculosis Prevention - Treatment helps in preventing TB among those at high risk
Tuberculosis Risk - Risk factors for tuberculosis and homelessness often overlap in U.S.
Tuberculosis Therapy - Goals for TB control reachable for most of world
Tuberculous Meningitis - Ligase chain reaction sensitive/specific for tuberculous meningitis diagnosis
Ulcerative Colitis - REMICADE supplemental biologics license application up for review
Vaccine Efficacy - CDC READII programs increase vaccination coverage
Vaccines Development - New findings in the area of vaccines development detailed
Vancomycin-Resistant Enterococci Outbreak - VRE outbreaks in Italy due to spread of a multidrug-resistant VREfm clone
Venous Thromboembolism - U.S. FDA approves new ARIXTRA indication: prevention of VTE in abdominal surgery
Ventilator-Associated Pneumonia - Ventilator-associated pneumonia more prevalent in antibiotic prevention studies
West Nile Virus - Multifaceted surveillance plan decreases West Nile virus infection risk
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