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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . August 29th, 2004

Non-Subscriber - Summaries Only

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

AIDS/HIV Diagnosis - IgG-capture BED-enzyme immunoassay detects recent HIV seroconversion

Outbreaks - Norovirus causing gastroenteritis on cruise ships identified

Rubella Vaccine - Rubella vaccination strategy for women of childbearing age developed

Toxicology - CDC makes advances in identifying and measuring chemical agents in humans

Ultrasound - Ultrasonography causes temperature rise at bone/soft-tissue interface

AIDS/HIV Diagnosis - Performance of the Celera Diagnostics ViroSeq HIV-1 Genotyping System reviewed

Adolescent Health - Street youth more likely to die of suicide and drug overdose

Alzheimer Disease - Mice overexpressing A-beta are incomplete model of Alzheimer disease

Amyotrophic Lateral Sclerosis - Orphan drug designation granted by FDA for drug candidate to treat ALS

Anthrax - Company awarded NIH grant to develop anthrax vaccine

Antidepressants - Agency approves new antidepressant for adults

Arthritis - New study will show how rheumatoid arthritis patients rate improvement change

Avian Influenza - World Bank approves US$5 million loan for Vietnam to fight bird flu

Behavior Disorders - Involvement in bullying linked with poor psychosocial adjustment

Bioterrorism - Study finds ample opportunities for life science suppliers in biodefense market

Breast Cancer - FDA clears mammography diagnostic workstation

Breastfeeding - New specific data will help states better target programs

Business & Finance - Biotech corporation announces results of annual shareholders meeting

Business & Finance - Drug company announces product development progress, second quarter financials

Business & Finance - GVAX maker reports net loss of $26.0 million for the quarter

Business & Finance - Medical device company announces financial results

Business Update - Living-tissue company pursuing medical device research grant

Business Update - Pharma company announces financial results, merger and approval of new product

Cancer Therapy - PEP005 shows highly selective activity against acute myelogenous leukemia

Cancer Vaccine - Irradiation of tumors promotes vaccine-mediated T-cell killing

Cancer Vaccine - Therapeutic idiotype vaccines in B lymphoproliferative diseases reviewed

Cardiovascular Disease - Cardiac manifestations in HIV-infected Thai children reported

Chagas Disease - Basis of non-virulence of Trypanosoma cruzi clone determined

Childhood Immunization - Child vaccines high, but more needed

Colon Cancer - Bile derivatives induce apoptosis in HT-29 human colon cancer cells

DNA Research - Cdk1 (Cdc2)/cyclin A prevents Orc1 binding to chromatin during mitosis

DNA Vaccine - Beta-actin promoter plus regulatory element enhances efficacy of DNA vaccines

Dental Health - Chinese FDA approves clinical trials of new dental product

Depression - Depression traced to overactive brain circuit

Dermatology - Approval gained for sun-induced, precancerous skin condition treatment

Dermatology - New techniques for combating aging skin explored at scientific session

Dermatology - XOMA Ltd. and partner announce results of chronic plaque psoriasis study

Diabetes Therapy - Guidelines for diabetes care in geriatric populations reported

Disease Control - CDC building new infectious disease lab in Colorado

Drug Development - Drug developer receives approval for drug bringing 2004 total approvals to 10

Drug Development - Manhattan Pharmaceuticals, Inc., to file for IND for lingual spray sedative

Drug Development - U.S. FDA approves Medroxyprogesterone Acetate Injectable Suspension

Drug Development - U.S. FDA approves URSO 500 mg tablets for treating primary biliary cirrhosis

Drug Development - U.S. FDA approves drug application for corticosteroid and antifungal lotion

Emerging Disease - Emerging and re-emerging infectious diseases reviewed

Encephalitozoon - Oral Encephalitozoon cuniculi induces rapid lymphocyte response

Endocarditis - Endocarditis due to Oerskovia turbata evaluated

Enterovirus - Complete genome sequences of all human enterovirus A species reported

Environmental Health - Study finds high levels of mercury are common in lake fish

Environmental Toxins - Study finds high mercury in lake fish

Finance - Gene-expression company sees revenues drop in second quarter

Fitness - Some exercise programs have lasting effects

Food-Borne Illness - Symptoms of food-borne botulism may help predict fatality

Funding - Hopkins wins $75M USAID grant to lower childbirth-related deaths in developing world

Gastroenterology - Pharmaceutical company launches Axid Oral Solution

Gastroenterology - Recombinant adenoviral vector encodes functional vasoactive intestinal peptide

HIV/AIDS Epidemiology - Global burden of HIV/AIDS best estimated using plausible ranges

HIV/AIDS Prevention - Free antiretroviral drugs cut Taiwan's HIV transmission rate in half

HIV/AIDS Prevention - Physicians need to keep counseling HIV-positive patients

HIV/AIDS Therapy - Application submitted to FDA for once-daily Kaletra

HIV/AIDS Therapy - WHO removes three Indian HIV drugs from approved list

HIV/AIDS Treatment - Agency approves drug to plump up faces left wasted by HIV

HIV/AIDS Treatment - FDA approves new combination AIDS drugs

HIV/AIDS Treatment - Washington decides not to intervene and force AIDS drug price down

Healthcare Costs - Drug costs tied to adherence, but prices still climbing, says Internet pharmacy

Heart Failure - Expanded user labeling recommended for resynchronization therapy defibrillators

Heart Pump - FDA approves reliability label revision for Novacor LVAS

Hematology - Oxygen binding of hemoglobin conjugated to carboxylate dextran reported

Hepatitis C Vaccine - Antigen and CpG with liposomes enhance hepatitis C virus immune responses

Hepatitis Risk - Georgia inmates get hepatitis B in prison, but cash not available for vaccine

Hypercholesterolemia - FDA approves VYTORIN for LDL cholesterol reduction

Hyperparathyroidism - New Drug Application submitted to U.S. FDA for Zemplar (Paricalcitol)

Hypertension - FDA approval granted for Atenolol tablets

Imaging - Modern heart devices can be safely used during MRIs

Immunization - Infant immunization reaches record high in Hawaii

Immunology - FDA accepts NDA for Xibrom

Influenza Vaccine - Chemiluminescent neuraminidase assay monitors drug susceptibility

Influenza Vaccine - Influenza definition influences economic analyses of vaccine efficacy

Influenza Vaccine - Monovalent influenza whole virus vaccine developed for pandemic use

Keratoconus Eye Disease - Intacs corneal rings receive FDA approval for keratoconus eye disease

Legal Issues - CEO of sued company responds to Thermage patent infringement lawsuit

Lung Cancer - Positive endorsement granted by FDA panel for Alimta for lung cancer

Malaria - Real-time PCR assay quantifies Plasmodium infection in mosquitoes

Malaria Vaccine - Merozoite surface protein antibodies protect against malaria infection

Malaria Vaccine - Targeting Plasmodium proteins blocks malaria transmission

Medical Devices - Medical device maker announces IDE approval, first implant of heart-pacing lead

Medical Marijuana - Medical marijuana initiative sparks debate

Melanoma - Abstract presented on the use of peptide vaccine for melanoma

Mental Health Epidemiology - Substance use and mood and anxiety disorders common in the U.S.

Multiple Sclerosis - FDA accepts BLA for ANTEGREN

Nocardia - Sequence-based identification of aerobic actinomycetes reported

Norovirus - Kits to detect antigenically diverse noroviruses in stool evaluated

Ophthalmology - Supplemental NDA submitted for Vitrase for use as a spreading agent

Peptic Ulcer Disease - FDA issues 510(k) clearance for POCone infrared spectrophotometer

Peptides - Company announces the launch of Human Secretin for Injection

Peripheral Vascular Disease - Clinical trial initiated for a drug-eluting non-coronary stent

Personality Disorders - Survey reports on the prevalence of personality disorders in the United States

Pertussis Vaccine - Acellular pertussis vaccines safer than whole-cell pertussis vaccines

Post-Traumatic Stress Disorder - High rates of mental health symptoms reported in Afghanistan

Prescription Drugs - Group alleges delayed reports of Crestor side effects

Prion Disease - Prions found in skeletal muscle cells and papillae in the tongue

Product Licensing - Biotech company granted U.S. Patent for manufacture of multiferon

Pulmonary Hypertension - Diagnosis of pulmonary arterial hypertension discussed

Pulmonary Medicine - Adenovirus vectors cause severe pulmonary pathology in cirrhotic rats

Respiratory Syncytial Virus - FDA approves liquid formulation of Synagis

SARS Vaccine - Antigenic determinant in SARS coronavirus glycoprotein elicits antibodies

Scabies - Genetic epidemiology of Sarcoptes scabiei in Australia reported

Sexually Transmitted Diseases - Pilot study of a free home test kit for STDs under way

Smallpox Vaccine - Modified vaccinia ankara shows potential as alternative smallpox vaccine

Smallpox Vaccine - Vaccinia and variola viruses epitope protects against lethal vaccinia virus

Spinal Fusion Procedures - Hydrosorb Spine System receives FDA clearance for spinal fusion procedures

Stem Cell Research - Human embryonic stem cell lines bear unique gene sets

Syphilis - Pathophysiology and treatment of maternal syphilis reviewed

Syphilis - Prevention and management of congenital syphilis reviewed

Trichinella - Mucosal mast cell precursors exit bone marrow after infection

Tuberculosis - In vitro assays accurate for TB diagnosis in non-human primates

Tuberculosis - Markers of T cell activation after Mycobacterium stimulation identified

Tuberculosis Vaccine -  M. tuberculosis H37Rv:Delta RD1 more virulent than M. bovis BCG

Tuberculosis Vaccine - Epitopes that improve specificity of M. tuberculosis assay identified

Tuberculosis Vaccine - Vaccines prepared from macrophages infected with live bacteria

Tumorigenesis - Suppressed Bcl-X-L blocks the tumorigenic potential of oncogenic enzyme

Urinary Retention - Four FDA approvals granted for Bethanechol Chloride Tablets

Vaccine Development - Reassortment and evolution of current human influenza viruses reviewed

Vaccine Development - Use of CpG oligodeoxynucleotides as immunoprotective agents reviewed

Vaccinia Virus - Vaccinia virus protein essential for morphogenesis of virions

Violence Prevention - Gun safe storage laws may help reduce some teen suicide rates

Water-Borne Illness - CDC pushing for cleaner swimming pools

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