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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . June 26th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Anthrax Therapy - Management of anthrax meningitis reviewed

Heart Disease Risk Factors - Moderate drinking may not reduce cardiovascular disease risk

Human Papillomavirus - Factors linked to cervical cancer in HPV-16-positive women reported

Obesity Therapy - Diet and physical activity surveyed among Americans trying to lose weight

Obstetrics - Pregnancy-related mortality in United States assessed

Addiction Medicine - Over 4% of pregnant women used illicit drugs in past month

Adverse Drug Reaction - The Research on Adverse Drug Events and Reports (RADAR) project

Air Pollution - Air pollutants associated with early mortality

Alcohol Use - Students who get drunk weekly have higher risk of injuries

Amyotrophic Lateral Sclerosis - Company files IND application for arimoclomol to treat ALS

Anthrax Vaccines - Reports advance knowledge in anthrax vaccines research

Pneumococcal Vaccines - New findings in the area of pneumococcal vaccines described

Anti-infectives - Tribendimidine is promising, broad-spectrum anti-helmintic agent

Arthritis Therapy - Flurbiprofen preparation improves bioavailability

Asthma - Navy women have higher incidence of first hospitalization for asthma than men

Baculovirus Vaccine - SARS coronavirus protein possesses interesting structure

Bone Marrow Transplant - High autopsy rates maintained in Canadian blood and marrow transplant program

Breast Cancer - Diagnostics company updates NMP66 protein program for breast cancer detection

Breast Cancer - Home-based intervention increases survivors' physical activity

Breast Implants - Fungal contamination of saline-filled breast implants is rare, preventable

Business & Finance - Buccal drug-delivery company gets more time to comply with NASDAQ requirement

Business Update - FDA accepts Hylenex NDA

Business Update - FDA approves 12-month shelf life for Taxus stent system

Business Update - Imaging company's registration statement declared effective

Business Update - U.S. FDA requests additional information on VelaSmooth 510(k) submission

Campylobacter Diagnosis -  Campylobacter coli and C. jejuni identified by PCR

Campylobacter Jejuni - Long-term clonal lineages within C. jejuni O:2 strains from different areas

Cancer Epidemiology - Cancer is major cause of childhood death in developing countries

Cancer Vaccines - Human anti-globulin antibody responses to antibodies reviewed

Carcinogenesis - Carcinogen-DNA adducts formed in mammary cells treated with benzopyrene

Carcinogenesis - Transcriptional signatures of benzo[a]pyrene in mammary cells reported

Cardiology - Medical device company launches 3 cardiology products at EuroPCR 2005 meeting

Chagas Disease - Studies add new findings to Chagas disease body of knowledge

Chemotherapy-Induced Anemia - Data: Aranesp dosed every 2 weeks is comparable to Epoetin alfa dosed weekly

Childhood Obesity - Prevalence of obesity in children in Istanbul reported

Chronic Lymphocytic Leukemia - FDA clears CLL trials for inhibitor drug GRN163L

Chronic Tuberculosis - Chronic TB pulmonary Th1 cell maintenance requires persistent IL-12 production

Clinical Trials - Trial in older cancer patients suggests benefits of drug plus chemotherapy

Collaborations - Commercial supply agreement signed for active drug in AzaSite

Collaborations - Company is first to perform HBV screening using U.S. FDA-licensed protocol

Congestive Heart Failure - Telemonitoring or telephone calls prevent heart failure deaths

Coronavirus Outbreaks - Human coronavirus OC43 caused influenza-like illness in aged-care facilities

Dengue Fever - Dengue virus vaccine induces broad protective antibody response

Dengue Fever - Early T-cell responses to dengue virus epitopes described

Depression - Little change in suicidal thoughts, plans or attempts in U.S.

Dermatology - FDA approves MERREM I.V. for complicated skin and skin structure infections

Diabetes - U.S. FDA grants clearance for expanded indication of wound treatment device

Diabetes Pathogenesis - Data advance knowledge in diabetes pathogenesis research

Diagnostics - FDA advisory panel meeting for AlzheimAlert kit PMA application expected in July

Diagnostics - Method to measure perfluorooctanoic acid by LC-MS/MS developed

Diet & Nutrition - Adolescent girls skip breakfast more often as they grow older

Diet and Nutrition - Dietary vitamin K1 intake may be unrelated to premature coronary calcification

Diet and Nutrition - Stress, anxiety, fatigue influence women's food choices during pregnancy

Diet and Nutrition - Vitamin C modulates T cells only during T cell activation

Disease Outbreaks - Europe still lacks epidemiological field forces to quickly diagnose outbreaks

Drug Abuse - U.S. FDA warns against abuse of dextromethorphan

Drug Delivery - Company expands line with new technologies for biocompatible device coatings

Drug Delivery - Preclinical results with transdermal drug technology announced

Drug Development - Generic Demulen oral contraceptive tablets approved by U.S. FDA

Drug Development - Not approvable letter issued from U.S. FDA for Zimycan

Drug Development - Researchers' data advance drug development research

Drug Development - U.S. FDA grants approvable letter for Retaane suspension

Drug Development - U.S. FDA grants approval on 600 and 800 mg gabapentin tablets

Drug Development - U.S. FDA grants orphan drug designation for cardiogenic shock drug

Drug Resistance - Nevirapine resistance may be higher than previously thought

Drug Safety - Crestor safe, effective when used according to prescribing information

Encephalitis Vaccine - Cytokine-encoding plasmid delivery improves immune response

Environmental Health - Dioxins alter weight by decreasing insulin-like growth factor signaling

Environmental Health - Fungal biotransformation of benzo-quinolines reported

Environmental Health - Healthcare use, work productivity linked to health levels

Environmental Health - Workers exposed to vermiculite have high rate of chest wall abnormalities

Ethics - International medical journal editors call for drug trial registration

Ethics - Medical whistleblowers speak out

Finance - Company is awarded NIEHS grant in toxicogenomics

Food Safety - Hygromycin B phosphotransferase expressed in E. coli

Food-Borne Illness - Information on risks of eating saltwater fish needs broader audience

Food-Borne Outbreak Epidemiology - Questionnaire investigates food-borne disease outbreak in early 20th century

HIV/AIDS Diagnosis - Gay men with late HIV diagnosis have increased short-term mortality

HIV/AIDS Epidemiology - Complex structure of HIV-1 transmission within risk groups revealed

HIV/AIDS Epidemiology - Heterosexual route most common means of HIV transmission in Central India

HIV/AIDS HAART - Nursing guidelines detailed for enfuvirtide management in HIV-infected patients

HIV/AIDS Mental Health - HIV status disclosure yields greater self-esteem and lower depression

HIV/AIDS Pathogenesis - Memory CD4+ T cells decline in multiple tissues during SIV infection

HIV/AIDS Prevention - Alcohol use and victimization predicts high risk sex in cohabiting adults

HIV/AIDS Prevention - Culturally based model designed to reduce Latino adolescent HIV sexual risk

HIV/AIDS Prevention - Differences in risk behavior and perception between U.S. and Russian IVDUs

HIV/AIDS Prevention - Education used to prevent the spread of HIV infection

HIV/AIDS Prevention - Vaginal microbicides can reduce the risk of acquiring HIV in female sex workers

HIV/AIDS Risk Behavior - Crystal methamphetamine use leads to high-risk sex in gay men

HIV/AIDS Testing - HIV voluntary counseling and testing center efficiency lacking in Andhra Pradesh

HIV/AIDS Therapy - FDA committee recommends accelerated approval for Tipranavir

HIV/AIDS Therapy - U.S. FDA approval granted for once-daily Kaletra (lopinavir/ritonavir)

HIV/AIDS Vaccine - Company obtains HIV vaccine license from NIH

HIV/AIDS Vaccine - Detection of HIV gag- and pol-CD8/A2 help monitor vaccine efficacy

HIV/AIDS Vaccine - HIV-mediated cell fusion differentially inhibited by C34 peptides

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

HIV/AIDS-Associated Kaposi Sarcoma - Generic HAART reduces viral load to undetectable in AIDS-associated KS patients

HIV/AIDS-Associated Pneumococcal Infection - Elevated procalcitonin/CRP predictive of pneumococcal infection in HIV patients

HIV/AIDS-Associated Pneumonia - IVDU fueling recurrent bacterial pneumonia in people with AIDS in Europe

Hantavirus - Hantavirus epidemics are cyclical

Hantavirus - Hantavirus infections increased in 2003 in France

Health Behaviors - Nondieters more successful at boosting health than dieters, study finds

Health Care Costs - Obesity increases use of health care services

Heart Failure - FDA approves updated labeling for Coreg

Heart Failure - FDA okays additional indication for Candesartan for treatment of heart failure

Heart Valve - CarboMedics prosthetic heart valve proves reliable and safe

Hepatectomy - Living donor hepatectomies safely performed in Jehovah Witnesses

Herpes Vaccine - Method to predict effects of imperfect herpes vaccines developed

Idiopathic Pulmonary Fibrosis - Data support trial design evaluating Actimmune in IPF patients

Infectious Disease Surveillance - Microbiology labs have role in infectious disease surveillance/alert/response

Influenza Vaccine - BLA submitted for Fluarix

Influenza Vaccine - Polycation-mediated delivery of siRNAs prevent influenza infection

Influenza Vaccine - Sequence comparison of influenza A viruses aids vaccine design

Influenza Vaccines - Studies add new findings to influenza vaccines body of knowledge

Injury Prevention - New playground equipment safer

Injury Prevention - Three children killed each week in preventable auto-related deaths

Insomnia - Biopharmaceutical company submits new drug application for insomnia treatment

Kawasaki Syndrome - Kawasaki syndrome diagnosis often delayed in children

Klebsiella Pneumonia Outbreaks - Isolates ESBL-producing K. pneumoniae hospital outbreaks molecularly typed

Legionellosis - Physicians need heightened awareness of hospital-acquired legionellosis

Leishmaniasis - Findings in leishmaniasis provide new insights

Listeria Monocytogenes Outbreak - Gastroenteritis outbreaks caused by Listeria monocytogenes

Liver Cancer - Progress reported in liver cancer trials of light infusion treatment with drug

Lupus Pathogenesis - Epstein-Barr virus associated with systemic lupus erythematosus

Lymphogranuloma Venereum - New detection of an STD not so new to the U.S. prompts fresh concerns

Malaria Therapy - WHO malaria project may establish adverse event monitoring in Africa

Malaria Vaccines - New findings in malaria vaccines described

Marketing - Fleishman-Hillard launches new healthcare public affairs business

Medicaid - Agency establishes commission to work on strengthening and sustaining Medicaid

Medicaid - Colorado Foundation for Medical Care selects Milliman Care Guidelines

Medical Devices - Orthopedic device maker completes first clinical implants

Medical Devices - Premarket notification filed with U.S. FDA for spectroscopy device

Melanoma - Drug developer announced initiation of phase II PI-88 anticancer product trial

Meningitis - Association supports meningococcal disease vaccination for youth

Meningitis Vaccine - Vaccine strategies for meningococcal disease in travelers outlined

Meningococcal Disease - Combined testing increases early detection of meningococcal disease outbreaks

Menopause - ACOG issues newly revised menopause magazine

Metabolic Syndrome - Sedentary behavior increases metabolic syndrome risk among U.S. adults

Mycobacterium Tuberculosis - Designer arrays detect genes essential for M. tuberculosis survival in lungs

Mycobacterium Tuberculosis - PCR + restriction enzyme analysis rapidly/reliably identifies mycobacteria

Mycobacterium Tuberculosis Complex - Direct detection method rapidly detects MTBC in pulmonary/extrapulmonary samples

Neurodegeneration - Studies advance knowledge in neurodegeneration research

Nicotine Addiction - Raising tobacco taxes could curb youth's cigar habits

Obesity - Reducing energy density of food while maintaining volume may help combat obesity

Obesity and Diabetes - Caloric restriction modulates insulin receptor signaling in liver

Pain Management - FDA approves IND for abuse-resistant oxycodone product

Patents - EP Office approves application for psychiatric and neurologic disorders

Patents - U.S. patent granted for betulinol derivatives being developed as cancer therapy

Patient Safety - Pharma firm suspends manufacturing operations, announces product recall

Personnel - Dhirajlal Kotadia named co-chair, managing director by biomedical tech company

Pharmacokinetics - Clinical pharmacokinetics of TNF antagonists reviewed

Pneumococcal Vaccines - New findings in pneumococcal vaccines described

Premature Ejaculation - Men with PE show improvement with dapoxetine hydrochloride

Preparedness - Web-based tool helps communities plan for public health emergencies

Product Licensing - Radiofrequency ablation company signs license agreement with EMcision Limited

Prostate Cancer - MUSE urethral suppository erectile dysfuncation trial results presented

Prostate Cancer - Results announced in phase II study of Provenge in early-stage prostate cancer

Public Health - Homicide-suicide in elders a growing concern

Pulmonary Arterial Hypertension - Company submits new drug application for Thelin

Pulmonary Medicine - Bioaerosols cause subclinical 'toxic pneumonitis' at low exposure

Pulmonary Medicine - Influenza vaccination reduces severity of COPD

Pulmonary Tuberculosis - NRAMP1 gene variants associated with severe forms of pulmonary tuberculosis

Q Fever - Extreme infectivity of Coxiella burnetti makes it a potential bioweapon

Q Fever - Q fever prison outbreak caused by exposure to dust contaminated by passing sheep

Rectal Cancer - Company gets FDA okay to resume phase II trial in rectal cancer with TNFerade

Regulatory Issues - Crestor problems support urgent need for U.S. FDA safety reform

Rickets - Reemerging nutritional rickets recalls historical perspective

Rotavirus Infection - Method to detect memory T-cell response to rotavirus developed

SARS - SARS outbreak correlates with environmental temperature 7 days before onset

SARS - Viral aerosols generated by SARS patient

SARS Coping Strategy - Coping responses to SARS differ among healthcare providers

SARS Coronavirus - Phylogenetic method analyzes SARS-CoV sources and dissemination paths

SARS Outbreak - Temporal-spatial SARS spread in hospital consistent with airborne transmission

SARS Therapy - Protein-based SARS-CoV entry inhibitors developed

Schistosomiasis Vaccine - Epitopes of Schistosoma fatty acid-binding protein mapped

Schizophrenia - FazaClo granted monthly safety monitoring by U.S. FDA

Smallpox Vaccine - Interferon peptide mimetics possess antiviral properties

Smallpox Vaccines - Findings in smallpox vaccines provide new insights

Smoking Cessation - Intensive tobacco control measures can sharply reduce smoking rates

Smoking Cessation - Smokers with access to low-tax cigarettes less likely to quit

Spinal Cord Injury - Spinal device company reaches 350 human implantations of cervical, lumbar discs

Toxicology - Environmental phthalate levels adversely affect male reproductive development

Toxicology - Harmful chemicals may reprogram gene response to estrogen

Transplant Medicine - Therapeutic drug monitoring to personalize CellCept therapy is feasible

Traumatic Brain Injury - U.S. FDA grants Anatibant orphan drug status for severe traumatic brain injury

Travel Medicine - Vaccine-preventable diseases in long-term expatriates reviewed

Tuberculosis - Delay in seeking medical care for TB in Ethiopia is due to multiple factors

Tuberculosis - Drug-resistant tuberculosis stable in California from 1993 to 2002

Tuberculosis - Tuberculosis can occur within first 12 weeks of infliximab treatment

Tuberculosis Drug Development - Type II NADH:-menaquinone oxidoreductase inhibitors new class of anti TB drugs

Tuberculosis Epidemiology - High rates of tuberculosis found among HIV+ people in Tanzania

Tuberculosis Vaccine - Gamma/delta T-lymphocyte activity against M. bovis analyzed

Tuberculosis Vaccines - New findings in tuberculosis vaccines described

Urinary Tract Infection - FDA approves Proquin XR for uncomplicated urinary tract infections

Urogynecology - Modification prevents urinary retention in bladder replacement in women

Vaccine Safety - System to detect early signs of adverse vaccine events developed

Vaccinia Virus - Isatin-beta-thiosemicarbazones as anti-poxvirus agents optimized

Vaccinia Virus - Therapeutic value of vaccinia-immune IgG investigated

Viral Infection Diagnosis - Electron microscopy rapidly diagnoses viral infections

Viral Meningitis - Viral meningitis outbreak associated with public swimming pond

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