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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . October 17th, 2004

Non-Subscriber - Summaries Only

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

Avian Influenza Vaccine - Vaccine development for potential avian influenza pandemic reviewed

Diagnostics - Proteomic pattern diagnostics has potential for diagnostics development

Diet and Nutrition - Dietary supplement use by U.S. adults reported

Hemorrhagic Fever - Ngari virus associated with outbreaks of hemorrhagic fever in Africa

Obesity Survival and Mortality - Methods of calculating deaths attributable to obesity compared

AIDS/HIV Therapy - Effort underway to improve the quality of HIV care in U.S.

AIDS/HIV Vaccine - Breakthrough infections occur during HIV-1 vaccine trials

AIDS/HIV Vaccine - Development of AIDS vaccine from South African perspective presented

AIDS/HIV Vaccine - Program changes needed to introduce vaccines targeted at adolescents

Anthrax - DNA-based anthrax vaccine generates antibodies in rabbits in challenge study

Anthrax Vaccine - Murine model of pulmonary anthrax described

Antibiotics - Pharma company recieves tentative FDA approval for Levoflozacin tablets

Anticoagulants - FDA committee wants more data to support approval of Exanta

Arthritis - VIOXX maker withdraws drug from market

Asthma Therapy - Monitoring response to treatment in asthma management reviewed

Autoimmune Disease - Distribution of pulmonary surfactant protein A in tissues is regular

Avian Influenza - U.S. may buy experimental bird flu vaccine

Bioterrorism - Bacterial genomics company secures defense research grant

Breast Cancer - Cigarette smoke condensate induces transformation of normal breast cells

Breast Cancer Risk Factor - Polychlorinated biphenyls and breast cancer risk ambiguous

Breast Cancer Risk Factor - Role of organochlorines in breast cancer carcinogenesis uncertain

Breast Implants - Settlement awards $11.3 million to U.S. government for Medicaid expenses

Cancer Therapy - AMD3100 to advance to phase III for stem cell transplant in cancer patients

Cancer Therapy - Novel antimetabolite exhibits antitumor activity in FU-resistant cancer

Cancer Therapy - Studies suggest alternatives to surgery needed in treatment of head, neck cancer

Cancer Vaccine - Proteasomal cleavage does not determine gp100 peptide immunogenicity

Cholera Vaccine - TcpA subunit induces IgA immune responses in patients with cholera

Clinical Trials - Drug company awarded phase 1 study worth $1.5 million in cardiac services

Clinical Trials - Enrollment begun in phase 3 clinical trial of Glufosfamide for pancreatic cancer

Clinical Trials - Oncology group participating in clinical trial of women with breast-brain cancer

Collaborations - Oral interferon rights licensed to Nobel to treat Behcet disease

Colon Cancer - Beta-catenin expression related to pit pattern in colorectal cancer

Colorectal Cancer - Newsletters, videos might cut cancer in churchgoing blacks

Complementary and Alternative Medicine - Exercise-induced syncope associated with ephedra-free xenadrine

Complementary and Alternative Medicine - Fatal hepatic failure possibly induced by nitrosofenfluramine reported

Creutzfeldt-Jakob Disease - vCJD epidemic estimated at 150-500 deaths if 11-15 year incubation period

Defibrillator - FDA clears HeartStart home defibrillator for over-the-counter sale

Depression - Treatment IDE submitted for VNS therapy

Depression - Two experts evaluate suicide risk with antidepressants

Diagnostics - FDA approves Second Look Digital CAD software for use with Hologic's FFDM

Diagnostics - Fluorescent probes can be used to examine intracellular organelle function

Disease Prevention - Senate committee approves funding for new U.S. CDC lab in Colorado

Distribution Agreement - Dynatronics named master distributor for IontoPlus electrodes

Domestic Violence - Emergency department-based screening project begins in Atlanta

Drug Delivery - Biopharma company announces license termination agreement with Pfizer

Drug Development - Biotech company updates progress of split flu vaccine production in China

Drug Development - Dopamine depletor for chorea receives FDA 'fast track' designation

Drug Development - Drug company in-licenses Alzheimer drug from Georgetown for further development

Drug Development - Pharma company preparing application for phase III study of muscle relaxant

Drug Development - Pharmaceuticals company reports on filing, approval of ANDAs with the FDA

Encephalitis Vaccine - Immunity after tick-borne encephalitis vaccination is persistent

Endometrial Cancer - Letrozole has limited activity in advanced endometrial cancer

Environmental Health - Washington representative says EPA is short on details of dredging plans

Epidemiology - Studies point to a pathophysiological basis for atherogenic potential of arsenic

Feline Virus Infection - Viral infection outbreaks seen in cats in Wroclaw city area in Poland

Filariasis Vaccine - Subtractive screening identifies Brugia malayi vaccine candidates

Filtration - CCAT awards EFP grant to begin nano-enhanced filter media test for U.S. military

Finance - CDC funding to develop TB vaccine trial sites in India

Finance - Company raises $7M from sale of common stock

Food Additive - FDA accepts adenosine monophosphate safety status

Fungal Infection - Company changes name of serum test

Gene Profiling - Antiangiogenic agents stimulate gene expression changes early on

Generic Drugs - FDA accepts NDA filing for megestrol acetate oral suspension NCD

Glanders - Scientists decipher genetic code of biothreat pathogen

Global Health - Combining TB treatment, HIV testing and treatment could save many African lives

Global Health - Fractures mean broken lives in developing world

HIV/AIDS Epidemiology - AIDS epidemic poses serious threat to Europe

HIV/AIDS Prevention - AIDS prevention programs can be transferred to developing countries

HIV/AIDS Research - Decreased T-cell proliferation is central in CD4 cell expansions induced by IL-2

HIV/AIDS Therapy - Access to HAART increasing in Thailand

Heart Disease - Rinspiration System receives FDA clearance for coronary, peripheral use

Heart Disease Risk - Abused, neglected children more likely to have heart disease as adults

Hepatitis B Vaccine - Hepatitis B prevalent despite vaccination programs in Pacific Islands

Hepatitis C Virus - Ovine atadenovirus induces strong T cell response against hepatitis C

Imaging - FDA gives Xplorer 1600 clearance

Immunology - Seventeen-color flow cytometry provide insights into immune system

Immunology - Type 1 and type 2 immunity in healthy Japanese adults assessed

Infection - Pharmaceutical company receives FDA approval to market ciprofloxacin tablets

Infectious Disease - In natural disasters, cadavers pose no threat of disease

Influenza - Recent advances in development of anti-influenza drugs reviewed

Information Technology - Company announces safety-critical platform for embedded medical devices

Legal Issues - Molecular diagnostics company files patent infringement suit against Stratagene

Leishmaniasis Vaccine - Intranasal vaccine protects against cutaneous leishmaniasis

Malaria - Genomics of innate immunity in malaria vector reviewed

Malaria Vaccine - Analogue of epitope from malaria vaccine protein characterized

Malaria Vaccine - Conserved region of P. falciparum targeted by antibodies identified

Malaria Vaccine - Effect of natural selection in malaria parasites discussed

Malaria Vaccine - Long-term T-cell responses induced by Plasmodium peptides

Malaria Vaccine - PfEMP1-DBL1 alpha antibodies protect Plasmodium falciparum

Melanoma Therapy - Curcumin plus tumor-related proteins inhibited growth of melanoma cells

Menopause - FDA issues approvable letter for ANGELIQ

Multiple Sclerosis - New immunosuppressants to treat multiple sclerosis developed

Myopia - FDA approves Artisan / Verisyse phakic intraocular lens

Nanotechnology - Grant award to fund NanoReader device to target detection of whole viruses

Narcolepsy - CNS pharma company announces clinical results for narcolepsy treatment

Nearsightedness - FDA approves Verisyse implantable lens

Neural Tube Defects - Fortifying food with folic acid benefits babies

Neurogenesis - Alproate promotes ERK pathway-dependent cortical neuronal growth/neurogenesis

Nicotine Vaccine - Ethics of nicotine conjugate vaccine discussed

Pain Medicine - Company provides update on status of oxymorphone program

Panencephalitis - Prevalence of sclerosing panencephalitis in Chinese children reported

Pediatric Practice - More medical devices needed for babies

Pneumococcal Disease - CDC recommends return to full four-dose series of Prevnar

Pneumonia - Oral amoxicillin could be future treatment for children in developing countries

Preparedness - Guide helps communities prepare for vaccine and drug dispensing

Psychotropic Drugs - Licensing agreement for triple uptake inhibitors for depression clears hurdle

Rectal Cancer - Radio-resistance-related proteins in rectal cancer reviewed

Regulatory Issues - Company responds to FDA recommendations on antidepressants in children, teens

Reovirus Vaccine - Dendritic cells process viral antigen from apoptotic epithelial cells

Respiratory Syncytial Virus - Recombinant respiratory syncytial virus with deletion characterized

Rosacea - Col-101 for rosacea to be dubbed "Oracea"'

Rotavirus - Group C rotavirus outbreak affected infants and children in Maizuru city

SARS - Aurintricarboxylic acid inhibits SARS coronavirus replication

SARS Vaccine - Advancements in the battle against severe acute respiratory syndrome

SARS Vaccine - Neutralizing monoclonal antibodies to SARS-coronavirus characterized

Sepsis - Cytokine is potential therapeutic target for septic patients

Sexually Transmitted Disease - Sexually transmitted diseases and managed care reviewed

Sleep Apnea - FDA clears implantable medical device as treatment for sleep apnea

Spinal Cord Injury - Spinal cord injury therapy granted FDA orphan drug designation

Streptococcus Vaccine - Maternal streptococcus antibody correlates with neonate protection

Supplements - Chromium picolinate safety data presented at CDC conference

Tula Virus - Tula virus strains from Poland closely related to TULV from elsewhere in Europe

Urban Health - Chinese study finds most city dwellers in poor health, educated most at risk

Vaccine Development - Current status and future directions of cell processing reviewed

Vaccinia Virus - A13 phosphoprotein required for assembly of mature vaccinia virions

Vascular Disease - Vascular repair and regeneration is regulated by bone-marrow derived cells

Water-Borne Illness - WHO issues revised drinking water guidelines

West Nile Fever - Factors related to West Nile control in British Columbia discussed

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