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Medical Letter on the CDC & FDA

Susan Hasty, Publisher
Table of Contents . . . December 12th, 2004
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Anthrax Vaccine - Mass value for IgG in standard anthrax reference serum assigned

Cancer Vaccine - IL-13 antagonist and Pseudomonas toxin fusion protein is anticancer

Ebola Virus - Disulfide bonds of Ebola-virus-secreted glycoprotein SGP assigned

Enzyme Immunoassays - Enzyme immunoassay tests to detect Mycoplasma antibodies assessed

Salmonella Vaccine - Live Salmonella vaccine protects against Salmonella enteritidis

AIDS/HIV Pathogenesis - CD4+ T cell depletion in HIV occurs predominantly in gastrointestinal tract

AIDS/HIV Pathogenesis - HIV linked to depletion of CD4+ T cells from effector sites in GI tract

AIDS/HIV Vaccine - Novel and promiscuous CTL epitopes in conserved regions of Gag identified

AIDS/HIV Vaccine - Therapeutic HIV vaccines reviewed

AIDS/HIV Vaccine - Vaccine provides T-cell-mediated protection in monkeys after SIV challenge

Addiction Medicine - Company licenses oral drug to treat impulse control disorder

Adverse Drug Effects - Dinitrophenol-related fatality reported

Adverse Drug Effects - Long-term use of depo-provera contraceptive injection may cause osteoporosis

Alcohol Abuse - Changes in cannabinoid brain receptor play role in alcoholism relapse

Amino Acid Supplementation - Branched-chain amino acid supplementation does not alter performance in the heat

Amyotrophic Lateral Sclerosis - ALS drug candidate Myogane gets U.S. FDA Fast Track designation

Anesthesia - Consider the effect of anesthesia when measuring circulating blood elements

Angiology - Hypoxia and erythropoietin cause endothelial cells to generate nitric oxide

Anthrax - Company completes first phase of ThraxVax design

Asthma - Neighborhoods near heavily traveled border crossings have high asthma incidence

Bacteremia - Enrollment complete for Cubicin's phase III endocarditis/bacteremia trial

Bladder Cancer - Promising data presented on phase 2 trial drug for superficial bladder cancer

Business & Finance - Company reports Q3 results, provides MS-325 regulatory update

Business & Finance - Company reports third quarter results, Chrysalin product activities

Business & Finance - Developer of surgical and diagnostic products announces financial results

Business & Finance - Prochieve maker provides Q3 report, updates PROTERM study

Business Update - ComfortScan agreements inked in Canada, Italy, and Russia

Business Update - Molecular diagnostics company announces expansion of diagnostic pipeline

Cancer Therapy - VELCADE gets fast track status for relapsed and refractory mantle cell lymphoma

Cardiac Arrhythmias - Freezor MAX obtains FDA approval in the U.S.

Cardiology - Pharmaceutical company comments on results of coronary artery disease study

Cardiology - Study shows differences in cardiovascular risk among cox-2 inhibitors

Cholera Vaccine - Vibrio cholerae amino acid sequence induces protective antibodies

Chronic Obstructive Pulmonary Disease - COPD afflicts three times the number of adults than previously estimated

Colon Cancer - ELOXATIN approved for colon cancer treatment following surgery

Dengue Virus - Dengue viral infections reviewed

Disease Prevention - African leaders, health activists push for money to fight disease

Disease Prevention - Global health alert network now scans for disease reports in seven languages

Disease Prevention - Lack of reliable death tolls worldwide makes curing the sick even tougher

Drug Development - Autoradioluminography useful to find tritium-labeled drug candidates

Drug Development - Bristol-Myers expects to file two additional new drug applications by year end

Drug Development - Elderly cancer patients significantly underrepresented in cancer trials

Drug Development - Immunosuppressant to enter clinical trials

Drug Development - WHO develops priorities for drug research, including expected flu vaccines

Environmental Health - Updated government study finds mercury levels in women, children 'not a concern'

Environmental Toxins - Government group to develop new RNAi library to help fight disease

Finance - GR-system developer reports Q3 net loss of $6.7 million

Finance - Genetic analysis company reports 190% increase in product sales in Q3

Finance - Medical research company reports 14% increase in net sales during first quarter

Finance - Pharmaceutical company reports 3Q results, highlighted by launch of lead product

Finance - Transdermal drug delivery pharmaceutical reports third quarter EPS of $0.11

Finances - Bridge financing for phase 2 trial on blood substitute set, phase 3 funds sought

Food Safety - Lateral flow strip for the detection of mycotoxins in grain introduced

Genetics & Genomics - United Nations approves first international standard for human genetic test

HIV Treatment - Monoclonal antibody among HIV therapies discussed at human virology meeting

HIV/AIDS Care - Family home AIDS care in rural sub-Saharan Africa is a minimal burden

HIV/AIDS Care - Level of HIV/AIDS patient care better if health facility funded by CARE Act

HIV/AIDS Cost - Household costs attributable to AIDS in Chad are devastating

HIV/AIDS Economics - Expenditure more sensitive indicator of economic impact of HIV/AIDS than income

HIV/AIDS Epidemiology - Reduction in new HIV infections in Southeast Spain

HIV/AIDS Healthcare - HIV/AIDS patients in Malawi seek hospital healthcare as a last resort

HIV/AIDS Prevention - Gay sex workers play important role as sex educators on the Internet

HIV/AIDS Prevention - Russian government lacks will to combat spread of HIV/AIDS, experts say

HIV/AIDS Prevention - STD/HIV prevention website navigation tools not helpful enough for teenagers

HIV/AIDS Psychology - Internet is a viable recruitment tool for reaching HIV at-risk individuals

HIV/AIDS Risk - High-risk sexual behavior prevalent among drug users in Pakistan

HIV/AIDS Risk - Online choice for sex-seeking among gay males varies with education level

HIV/AIDS Testing - Many people in the U.K. do not need to access HIV test results in person

HIV/AIDS Vaccine - Role of gastrointestinal T cells in HIV pathogenesis reviewed

Healthcare & Politics - New institute looks at healthcare in the second Bush administration

Healthcare Coverage - Gaps in pharmaceutical research and innovation can be closed, says WHO report

Healthcare Coverage - U.S. veterans give VA top healthcare rating for 5 years in a row

Healthcare Financing - Diabetes among older adults imposed an estimated $133.5 billion cost in 1990s

Healthcare Management - Over-the-counter medications can provide financial benefits

Heart Disease - U.S. FDA allows qualified health claim regarding risk of coronary heart disease

Hemorrhagic Fever - Signal peptide of arenavirus glycoprotein forms mature G1-G2 complex subunit

Herpesvirus - Early expression of HSV-1 ICP27 transcript not critical for replication

Hypertension Epidemiology - Adult hypertension in United States on the increase

Influenza - NIAID launches influenza genome sequencing project

Influenza - WHO says flu vaccine coming within year

Influenza Vaccine - HHS head Thompson announces contract to support egg supply for flu vaccines

Injury Prevention - Hands-free cell phones dangerously distract drivers' attention

Ischemia - An NO-dependent mechanism mediates sex difference in [Na⁺]_i regulation

Laboratory Methods - Study investigated methods of euthanasia for mouse fetuses and neonates

Leishmaniasis Vaccine - Leishmania major exogenous antigens protects against infection

Leishmaniasis Vaccine - Central memory T cells mediate long-term immunity to Leishmania major

Leishmaniasis Vaccine - T cells mediate immunity to Leishmania major in absence of parasites

Lipid Disorders - FDA grants approval for new formulation of TriCor

Liver Cancer Risk - Arsenic exposure increases the risk for liver cancer in females

Lumbar Spinal Stenosis - Spinal disorders-focused company receives U.S. FDA notice on for LSS device

Lyme Disease - Borrelia burgdorferi changes antigens based on host immune response

Lyme Disease - Receptor identified in tick guts

Malaria - Cytokine levels in Malian children with severe malaria determined

Malaria - Fine specificity of merozoite antibodies linked to malaria resistance

Malaria Vaccine - Plasmodium yoelii proteins enhance protection against malaria

Malaria Vaccine - Anatomy of Plasmodium falciparum MSP-1 epitope mapped

Malaria Vaccine - Antigenic drift in Plasmodium vivax protein confers antibody resistance

Malaria Vaccine - Immunogenicities of Plasmodium vivax protein fragments compared

Malaria Vaccine - Merozoite protein protects against lethal malaria parasite challenge

Measles Vaccine - Measles vaccination rate in developed world

Melanoma Vaccine - Quiescent phenotype of tumor-specific CD8+ T cells following immunization

Meningitis Epidemiology - Haemophilus influenzae incidence in South Korean children reported

Nephropathy - U.S FDA grants orphan drug designation for CR002 in IgA nephropathy indication

Neurology - Companies announce agreement for technology used in clinical trials of stroke treatment

Neuroscience - Novel syntaxin-1-binding protein identified

Nicotine Addiction - Grant to study why teens smoke

Nutrition - Dietary supplements manufacturer endorses dietary supplement act

Obstetrics - U.S. FDA adds new warnings to mifepristone labeling

Occupational Health - Occupational health and gorilla conservation in Rwanda

Oncogenesis - Nuclear factor-kappa B rules the malignant phenotype of squamous cell carcinoma

Oncology - Bevacizumab reduces tumor progression in patients with metastatic renal cancer

Oncology - Pharmaceutical company announces Phase I clinical trial for myeloma treatment

Oncology - Xcytrin data prsented at Chemotherapy Foundation Symposium XXII

Oral Health - The market for betel quid is increasing despite risk to oral health

Pain Medicine - Survey: Doctors cautiously supportive of COX-2 drugs in wake of Vioxx withdrawal

Parvovirus Therapy - Sequestration of receptor by NS2 mutations regulates parvovirus fitness

Patents - Anticancer drug receives Candian patent

Patents - Canada-based biotechnology company receives U.S. patent for vaccine production

Patents - Collagen Infusion Delivery System receives U.S. patent

Pediatric Cancer - U.S. NCI pediatric program established under contract to research hospital

Personnel - Clinical research company announces new regulatory affairs leader

Personnel - Martin Kaplan, U.N. scientist and former head of Pugwash, dies at 89

Plastic Surgery - Company announces clinical trial results for permanent injectable wrinkle filler

Pneumococcal Vaccine - Multiplex opsonophagocytosis assay useful to monitor pneumococcal vaccine

Pneumonia - IND submitted for aerosolized antibiotic

Policy - Poor communities should decide their own priorities for aid

Poliomyelitis - U.N. says African conflicts, funding gap threaten polio eradication

Primary Biliary Cirrhosis - URSO Forte launched in the U.S.

Product Licensing - Biotech company obtains patent for key target involved in chronic pain

Product Licensing - U.S. Patent issued for nucleic acid amplification device for biological research

Product Licensing - U.S. patent granted for technology to detect nucleic acid sequences

Quality of Life - New WHO study asks, "How happy are you with your lot in life?"

Regulatory Issues - Pharmacists share concerns about relaxation of drug importation laws

Renal Disease - Hepatitis C treatment receives new indication in Europe

Respiratory Syncytial Virus - Signaling via prostaglandin receptor protects against RSV

SARS Virus - Native form of recombinant SARS coronavirus spike glycoprotein characterized

Salmonella Vaccine - Attenuated Salmonella mutants cause fatal infections in mice

Schistosomiasis Vaccine - Vaccine protects against tetanus and schistosomiasis in mice

Skin Cancer - Learning to cover up reduces risk of skin cancer

Skin Cancer Marker - HLA A11 is marker for nonmelanomatous skin cancer risk after renal transplant

Smoking Cessation - HHS launches new initiatives to help Americans quit smoking

Sports Medicine - U.S. FDA clears technology designed to simplify common sports-related surgery

Substance Abuse - 2004 survey shows decline in teen drug use continues

Tardive Dyskinesia - Upswing in metoclopramide use linked with neurologic symptoms

Treatment - VNS maker reports Q2 results, makes sales targets

Tuberculosis - Cytokine responses and active TB disease in HIV-1-infected Ugandans studied

Tuberculosis - Pulmonary tuberculosis associated with diabetes

Tuberculosis - Tuberculosis and HIV co-infection is a symbiotic relationship

Tuberculosis Vaccine - BCG can subvert monocyte differentiation into dendritic cells

Tuberculosis Vaccine - CD8 T cell activation protects against pulmonary tuberculosis

Tuberculosis Vaccine - Guidelines for latent tuberculosis testing and treatment released

Tuberculosis Vaccine - Lipoarabinomannan antibody prolongs survival of mice with tuberculosis

Uterine Leiomyomas - U.S. FDA approves new device to treat uterine fibroids

Vaccine Development - U.S. HHS buys new anthrax vaccine for stockpile

Vaccinia Virus - Vaccinia virus mutants fail to initiate morphogenesis

Varicella-Zoster Virus - Epidemiology of severe varicella-zoster infection in Spain reported

Virology - Internal controls enhance the detection of waterborne enteric viruses

West Nile Virus - CDC expects mild season for mosquito-borne virus

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