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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 26th, 2004

Non-Subscriber - Summaries Only

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

AIDS/HIV Transmission - Topical microbicides to prevent HIV-1 transmission compared

Mycobacteria - Taxonomy of Mycobacterium fortuitum determined

Neurology - FDA-approved neurologic devices for use in children reviewed

Regulations - Navigating the waters of U.S. Food and Drug Administration presented

Vagococcus -  Vagococcus carniphilus isolated from ground beef

AIDS/HIV Pathogenesis - Leukocyte antigen alleles linked to viral load in HIV seroconverters

AIDS/HIV Vaccine - Disease-modifying HIV vaccines could increase epidemic severity

AIDS/HIV Vaccine - HIV immunization strategies involve adenovirus and poxvirus vaccine vectors

AIDS/HIV Vaccine - Increased HIV mucosal replication linked to mucosal cytokine activation

AIDS/HIV Vaccine - Method to predict impact of nonsterilizing vaccine against HIV developed

Acne - FDA announces enhancement to isotretinoin risk management program

Alzheimer Disease - Neurosciences center patents two potential Alzheimer treatments

Alzheimer Disease - U.S. FDA accepts sNDA to expand Namenda's indication

Angiology - Study investigated mechanisms of vitamin E suppression of aortic lesions

Anthrax Vaccine - Human immune response to U.K. anthrax vaccine characterized

Anti-Infectives - Yeast killer toxin-like antibodies possess therapeutic potential

Antibiotics - Antibiotic use database used for benchmarking and resistance research

Asthma - Investigational New Drug application for Aridol filed with the U.S. FDA

Asthma - Young volunteers sought for study to test if infant rash cream prevents asthma

Avian Influenza - H5N1 avian influenza A virus genome sequenced from Thailand poultry outbreak

Botulinum Toxin - Dosing and dilution of botulinum toxin reviewed

Brain Cancer - Daily topotecan blocks glioblastoma growth in animal models

Business & Finance - Medical technology company releases financial results

Business & Finance - Pharma company releases third quarter 2004 results

Cancer Epidemiology - Prostate leading newly diagnosed cancer among men; breast cancer leads for women

Cancer Research - Pharma company announces results from two clinical trials

Cancer Therapy - U.S. FDA approves new drug for the most common type of lung cancer

Chronic Fatigue Syndrome - Ampligen mentioned prominently at government meeting

Clinical Trials - Company suspends enrollment in phase 3 study of pathogen inactivation system

Collaborations - Genasense development agreements with Genta terminated

Colon Cancer Screening - More than 41 million Americans need colorectal cancer screening

Complementary and Alternative Medicine - Fenugreek extract found non-genotoxic

Contraception - U.S. FDA approves levonorgestrel, ethinyl estradiol for pregnancy prevention

Coronary Total Occlusions - Use of Safe-cross radiofrequency total occlusion crossing reported

Counterfeit Drugs - Drug tracking effort launched to support FDA battle against counterfeit drugs

Dengue Virus - Peridomestic mosquito adaptation mediates dengue emergence from progenitor DENV

Dermatitis - Company receives U.S. FDA nonapprovable letter for Extina

Diabetes Diagnosis - Method to determine acetone in human breath developed

Diabetic Neuropathy - Rural model to increase annual diabetic foot examinations presented

Diagnostics - Infectech engages Lake Erie Research Institute for FDA submissions

Diagnostics - PCR test differentiates between Staphylococcus aureus and S. intermedius

Diagnostics - U.S. FDA clears IQQA-Chest software for digital x-ray

Diet and Nutrition - Poor nutrition leads to stunting and wasting in Kenyan children

Drug Abuse - FDA clearance granted for new amphetamine test

Environmental Health - Toxic effects of trans-cinnamaldehyde characterized

Escherichia Coli -  E. coli O157 cluster evaluation does not support epidemiologic association

Finance - Medical device company closes $4.3 million financing

Finance - Ohio organizations get federal funds for nonembryonic stem-cell research

Finance - Opthalmic medical devices company reports third quarter 2004 financial results

Finance - Pharmaceutical development company announces financial results

Finance - Research to reduce chemo's side effects receives state-federal dollars

Formaldehyde Exposure - No links found between formaldehyde exposure and leukemia

Gender & Health - Women and girls need access to AIDS therapies and protection from violence

Generic Drugs - Generic drugs developer gets U.S. FDA tentative approval for anticonvulsant drug

Geriatric Wellness - Report on aging and health in American finds unhealthy diets, lack of exercise

Global Health - Developing nations share stories of success

Global Health - Four million more health workers required to improve global health

Global Health - Important priorities for prevention and treatment of HIV/AIDS

Glycemic Control - Exendin-4 pharmacodynamics conducted

HIV Therapy - Interim results reported from second phase III study of tipranavir

HIV/AIDS Diagnosis - CDC updates status of HIV testing in U.S.

HIV/AIDS Disease Progression - Selenium status associated with increased HIV disease progression in pregnancy

HIV/AIDS Epidemiology - Rates of U.S. HIV/AIDS diagnoses are steady; racial disparities persist

HIV/AIDS Epidemiology - Ten U.N. agencies urge new focus on women and HIV in Latin America

HIV/AIDS Funding - $1.6 million grant will fund children's clinic in Tanzania

HIV/AIDS Funding - HHS awards $10.4 million to fight AIDS on 3 continents

HIV/AIDS Prevention - Counseling plus case management reduces HIV risk behaviors in IVDUs

HIV/AIDS Prevention - Inconsistent condom use related to abuse history and HIV serostatus

HIV/AIDS Prevention - Thousands rally to mark World AIDS Day in Bangladesh

HIV/AIDS Research - NIAID seeks applicants to lead revamped HIV/AIDS clinical trials networks

HIV/AIDS Risk - Asia marks World AIDS Day amid new warnings that women most at risk

HIV/AIDS Therapy - Two AIDS medicines back on WHO prequalification list

HIV/AIDS Transmission - Preventing infection among HIV+ men who have sex with men reviewed

HIV/AIDS Treatment - U.N. health agency reinstates two Indian AIDS drugs to approved list

HIV/AIDS Treatment - United Nations urges better help for women, girls infected with HIV

HIV/AIDS Trends - Government falls short of pledge to 'break the back' of AIDS

HIV/AIDS-Related Pneumocystis -  Pneumocystis pneumonia infection is a continuing public health issue

Head Lice - State of head lice management and control reviewed

Healthcare & Politics - Washington State citizens' groups warn against Governor Locke's Rx Washington

Healthcare Benefits - HHS approves Maryland plan: Individuals with disabilities may direct own care

Healthcare Coverage - Disability income insurer announces settlement of multistate market conduct exam

Hemorrhagic Fever Virus - Evidence of segment reassortment in Crimean-Congo hemorrhagic fever virus

Hepatorenal Syndrome - U.S. FDA grants orphan drug status to I.V. Terlipressin

Immunology - Gen-Probe acquires rights to develop point-of-use platform for NAT instrument

Influenza - Americans flock to Canada for influenza vaccine

Influenza - Kriging analysis spots geographic/temporal trends in influenza epidemics

Influenza Vaccine - Efficacy of DNA influenza vaccine increased by Schiff base-forming drug

Information Technology - CliniComp to upgrade server platform for U.S. DoD military treatment facilities

Injury Prevention - Driving motorcycles safer but still far more dangerous than driving cars

Insomnia - New Drug Application submitted for insomnia treatment

Legal Issues - Company comments on patent infringement suit that seeks judicial declaration

Leishmaniasis Vaccine -  Leishmania antigen and ODN protect against L. donovani infection

Lipid Studies - Current approaches to increasing HDL involve infusions of apoA-I

Listeria Monocytogenes - Pasteurization destroys Listeria monocytogenes in peanut and chocolate products

Liver Transplantation - Hepatopulmonary syndrome and portopulmonary hypertension reviewed

Lung Cancer - Biotech pharmaceutical firm gets U.S. FDA approval for lung cancer medicine

Lung Cancer - Tarceva approved for non-small cell lung cancer after failure of chemotherapy

Malaria - Susceptibility of Anopheles farauti to Plasmodium tested

Medical Device - Diagnostic devices company announced Model 100 completed safety testing

Medical Device - Healthcare services supports FDA policy on radio frequency identification

Medical Devices - EpiLift system for corrective vision surgery introduced

Medical Devices - FDA approves Xcelerant Delivery System with AneuRx AAA Stent Graft System

Medical Imaging - Kodak gets U.S. FDA approval for mammography system

Meningococcal C - Phase III program for Menjugate meningococcal C vaccine concluded

Mergers & Acquisitions - OEM medical device announces sale of AngioLink

Mosquito-Borne Disease - Commercial mosquito trap and gravid trap oviposition media evaluated

Multiple Sclerosis - Clinical trial of multiple sclerosis drug gets OK to proceed

Mycobacteria - Proteomic profiling of intact mycobacteria by MS conducted

Nicotine Addiction - Tobacco companies target U.S. immigrants

Nicotine Addiction - WHO tobacco treaty set to become law

Norovirus - Vaccine for food poisoning possible

Nosocomial Infections - Infection control measures rapidly controlled Norovirus hospital spread

Nutrition - Strict diet can help fight diseases like Alzheimer, E.U. scientists say

Obesity Epidemiology - CDC admits errors in obesity risk study

Obstetrics - Racial discrimination may contribute to premature births and low birthweight

Oral Contraceptive - Approvable letter for new oral contraceptive YAZ issued in United States

Outbreak Surveillance - Syndromic surveillance rapidly detects infectious disease outbreaks

Outbreak Surveillance - U.S. approach to outbreak detection uses five interacting health care systems

Overactive Bladder - U.S. FDA approves Vesicare for the treatment of overactive bladder

Overactive Bladder - U.S. FDA approves treatment for overactive bladder

Pain Medicine - Novartis withdraws application for E.U. approval of Prexige

Pain Medicine - Oxymorphone extended-release tablets approved by U.S. FDA

Pain Medicine - U.S. FDA approves protocol for oxymorphone extended-release tablets

Parasitology Vaccine - Veterinary parasitic vaccines reviewed

Patents - U.S. composition of matter patent for transported prodrug of gabapentin issued

Patents - U.S. patent issued for stabilized bioactive peptides

Pneumococcal Vaccine - Pneumococcal bacteremia in children in Barcelona reviewed

Pneumocystis Pneumonia Transmission - PCP transmitted from hospitalized HIV patients to renal transplant recipients

Prescription Drugs - Survey shows physicians have confidence in FDA approval process

Product Licensing - U.S. FDA approves depression drug citalopram hydrobromide

Prostate Cancer - New in vitro data on second-line chemotherapy for prostate cancer presented

Prostate Cancer - Phenoxodiol in patients with hormone-refractory prostate cancer results released

Prostate Cancer Therapy - Gonadotrophin-releasing hormone antagonist approved for prostate cancer

Pseudoporphyria - Pseudoporphyria resulting from voriconazole use reported

Quality Assurance - Health professionals group calls for probe into Iraqi healthcare system

Quality Assurance - Ontario leader says government on right track with doctors, healthcare

Rabies - Experimental rabies treatment sees success

Radioactive Poisoning - Agreement signed for Calcium-DTPA and Zinc-DTPA

Regulations - Agency finalizes new rules for "good tissue practice"

Regulatory Issues - FDA proposes draft guidance for new plant varieties intended for food use

Ricin Poisoning - UT Southwestern initiating trials in humans for ricin vaccine

SARS Prevention - Masks/handwashing effective but gowns/gloves not effective in SARS control

SARS Transmission - Main mode of SARS transmission through droplet spread and close/direct contacts

Salmonella Outbreak -  Salmonella enteritidis outbreak associated with school-lunch dessert

Salmonella Outbreaks -  S. enterica serotype typhimurium outbreak linked to raw milk consumption

Sepsis - Simple intervention nearly eliminates catheter-related bloodstream infections

Shellfish Poisoning - Paralytic shellfish poisoning outbreak caused by Gymnodinium catenatum

Smallpox Vaccine - Papular spongiotic dermatitis of smallpox vaccination reported

Smallpox Vaccine - Position statement on donor suitability after smallpox vaccination released

Smoking - Insulin-like growth factors decreased in men who smoke cigarettes

St. John's Wort - Stability of St. John's Wort in aqueous solutions determined

State Medicaid - HMS provides revenue collection for new Iowa Medicaid enterprise

Streptococcus -  Streptococcus detection method helps prevent perinatal disease

Tobacco Use - World Health Organization says anti-tobacco treaty set to come into effect

Transplant Medicine - Biopharmaceuticals reports on progress in HepeX-C program

Transplant Medicine - Grant to help with detecting genes that contribute to transplant rejection

Uterine Fibroids - Surgery Without Incisions: New Frontiers for Radiology

Vaccinia Virus -  Bacillus alcalophilus peptidoglycan inhibits vaccinia virus replication

West Nile Virus - CDC gravid trap attractants to West Nile virus vectors evaluated

West Nile Virus - High risk of meningoencephalitis in transplant recipients with WNV infection

Zoonoses - Discriminatory vaccination is modern strategy to control epizootic diseases

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