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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 18th, 2004

Non-Subscriber - Summaries Only

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

Bacteriology - Methods for counting water-borne bacteria compared

Annuloplasty - Company reports human implant of its Northrup Universal Annuloplasty System

Sudden Infant Death - U.S. NIH alerts parents to winter SIDS risk

Syphilis - Health departments should adopt new notification policies for gay men

Syphilis - Outbreak in Vancouver said to be world's worst

Thrombophilia - Genetic disorder tests receive FDA clearance and CE Mark

Tuberculosis Therapy - Half a million TB patients to get free drugs under new U.N. health agency accord

Typhus - Increase in rodent-transmitted disease seen in Hawaii

Varicella-Zoster Virus - Baseline values of herpes zoster among children and adolescents determined

Anthrax - First FDA-cleared laboratory test for Bacillus anthracis

Anthrax Vaccine - Safety profile of anthrax vaccine for U.S. soldiers in Korea determined

Anxiety Disorder - Lexapro receives FDA approval for generalized anxiety disorder

Arthritis - FDA grants approval for Indomethacin capsules

Babesiosis - Immunohistochemical assay for babesiosis in tissue samples developed

Behavior - NHGRI launches social and behavioral research branch

Bile Duct Tumors - Investigational new drug application filed for XL119

Cancer Detection - Large Scale Biology announces breakthrough diagnostic technology

Herpesvirus - Herpesvirus 8 and Epstein-Barr virus seropositivity among children compared

Carcinogens - Drug carcinogenicity determined using structural similarity and E-state index

Chagas Disease - Free fatty acids induce cell differentiation in Trypanosoma cruzi

Chemical Exposure - Low incidence of non-Hodgkin lymphoma in Sweden may result from carcinogen bans

Childhood Immunization - Invalid vaccine doses would cost millions to fix

Childhood Immunization - Vaccine shortages affect child immunization programs

Clinical Trials - Company achieves phase III patient enrollment goal for Xibrom

Computer-aided Diagnostics - Company reports FDA approvals, provides progress report

Contraception - FDA panel votes to allow sale of emergency contraceptive

Cosmetic Procedures - FDA approves dermal filler Restylane

Dermatology - FDA approves Polaris WR wrinkle treatment system

Adenovirus - Intestinal intussusception associated with adenovirus in Mexican children

Diabetes Therapy - Second approvable letter issued for Symlin

Diabetic Nephropathy - 12-Lipoxygenase plays role in experimental diabetic nephropathy

Diagnostics - Liquid chromatography method for impurities in methoxsalen developed

Diagnostics - Rapid identification method for E. coli O157:H7 using real-time PCR developed

Drug Delivery - Company announces newly patented lorazepam nasal delivery system

Drug Development - Anti-HIV alkaloids isolated from Monanchora sponge

Environmental Testing - Immunomagnetic-based method detects Cryptosporidium, Giardia oocysts

Environmental Toxins - Low-mercury choices for fish a challenge

Environmental Toxins - Scientists begin measuring pollution in human bodies

Ephedra - FDA plans to prohibit sales of diet supplements containing ephedra

Influenza Vaccine - Cold-adapted influenza A H9N2 reassortant is influenza vaccine candidate

Ethics - U.S. officials say interviews for HIV study were fabricated

Finance - Company's FY2003 highlighted by preparation for launch of trospium in 2004

Finance - Testing products company announces 2004 financial guidance

Food-borne Illness - Agency says U.S. outbreaks and deaths from salmonella strain on the decline

Food-borne Illness - Researchers find low levels of perchlorate in evaporated milk samples

Fungal Infections - Abbreviated new drug application filed with FDA for Fluconazole

Guillain-Barre Syndrome - galE gene in campylobacters linked to Guillain-Barre syndrome

HIV Testing - Additional data submitted to FDA for OraQuick HIV-2 claim

HIV Therapy - 48-Week data submitted to FDA for full approval of HIV fusion inhibitor

HIV/AIDS Cancer - Skin capillary endothelium SDF-1 plays key role in Kaposi sarcoma pathogenesis

Meningococcal Vaccine - Antigen-coating concentration affects presentation of Neisseria epitopes

HIV/AIDS Prevention - U.S. labor secretary launches HIV/AIDS initiative in Ghana

HIV/AIDS Therapy - Novel HIV viremia model may aid evaluation of drug efficacy

HIV/AIDS Vaccine - Multiple gene and clade HIV-1 DNA vaccines broaden immune response

Healthcare Access - WHO: Battle against AIDS will founder without boost to basic healthcare

Helicobacter Pylori - Company announces new rapid test for stomach ulcers

Hernia Repair - FDA issues alert on counterfeit polypropylene mesh used in surgery

Hypertension - Standardized blood pressure measurement could improve hypertension care

Immunoglobulin Production - Common variable immunodeficiency may be treatable with B lymphocyte stimulator

Immunology - Company submits new drug application for Riquent

Infection Control - CDC releases new guidelines for hygiene in dental care settings

Virology - Bat lyssaviruses from Central Asia categorized

Influenza - CDC: Flu activity widespread in 45 states

Influenza - Catholic archdiocese asks parishioners with cold or flu to forgo communion

Influenza - Experts: Antiquated flu vaccine system needs updating

Influenza - FDA investigating reports of unlicensed influenza vaccine

Influenza - Flu seems to be hitting kids very hard

Influenza - Plan expands coverage to nasal flu vaccine

Injury Prevention - Data show little change in DUI rates

Injury Prevention - Urban TV surveillance does not prevent street violence, but reduces severity of injuries

Insulin Resistance - FDA grants orphan drug designation for rhIGF-I/rhIGFBP-3, SomatoKine

Insulin-Like Growth Factor - IIp45 antagonizes IGFBP-2 stimulation of glioma cell invasion

AIDS Monitoring - FDA 510(k) clearance granted for the CellTracks Analyzer for HIV/AIDS

Joint Replacement - FDA clears Palacos G antibiotic-loaded bone cement

Kala-Azar - Thousands threatened by epidemic in southern Africa

Legg-Perthes Disease - Beta fibrinogen G-455-A polymorphism is risk factor for Legg-Perthes disease

Leishmaniasis - Control measures of Lutzomyia longipalpis s.l. in Venezuela outlined

Lower Extremity Injuries - Treatment of lower extremity injuries due to land mines examined

Lyme Disease - Diagnostic kit gets FDA approval

Macular Degeneration - Company launches expansion of its R&D program in ophthalmology

Malaria Vaccine -  Plasmodium berghei circumsporozoite protein protect against malaria

Malignant Pleural Effusion - FDA grants approval of Sterile Talc Powder

Meningitis - CDC: Vaccine shortage likely

AIDS Testing - Company files additional data with FDA on new Reveal Rapid HIV-1 Antibody Test

Meningococcal Vaccine - Vaccine reduces meningococcal risk in patients with immune deficiency

Multiple Myeloma - Committee recommends early end to confirmatory phase III Velcade trial

Obesity Management - FDA approves labeling for use of Xenical in adolescent patients

Parkinson Disease - DJ-1 gene polymorphism not linked to Parkinson disease

Pharmacokinetics - Time profile of L-dopa metabolites in nonhuman primates determined

Polio - U.N.: Spread of polio in West Africa threatens global eradication drive

Poliovirus - Strand-specific RNA synthesis defects found in mutated poliovirus

Premenstrual Dysphoric Disorder - New drug application submitted to FDA for lower-dose Yasmin

Prostate Cancer - Valera submits NDA for Vantas, an LHRH implant for treating prostate cancer

Public Health Practice - Filariasis prevention programs are adequate for excluding pregnant women

Acne Vulgaris - FDA grants clearance for light unit assembly acne vulgaris treatment

Regulatory Issues - Study: Reduced FDA resources cause of decline in drug approval times

Regulatory Issues - U.S. officials say it's too costly to legalize drug imports

Respiratory Syncytial Virus - Epidemiology of severe respiratory syncytial virus infection reviewed

Rotavirus - Cytokines act as mediators for or effectors against rotavirus disease

Rubella - Use of vaccine is growing worldwide, but more work remains

SARS - Hong Kong scientists work on vaccine

Salmonella - Small children at risk from reptile exposure

Smallpox Vaccine - Long-term B cell memory found in humans after smallpox vaccination

Streptococcus - Opsonophagocytosis assay effective for Streptococcus pneumoniae antibodies

Substance Abuse - Teen drug abuse declines across wide front

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