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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . May 17th, 2006

Non-Subscriber - Summaries Only

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

Allergy & Immunology - Competition ELISA is sensitive for detection of small allergen quantities

Epidemiology - Analysis of deaths with unknown cause in mortality analyses is discussed

Food-Borne Illness - Analyzing Campylobacter species on turkey farms benefits from multiple typing methods

Stroke - Preeclampsia increases risk of ischemic stroke among young women

Tuberculosis - Public-private collaborations can improve tuberculosis control in India

Adverse Drug Reaction - Adverse events after hepatitis A/B combination vaccine reported

Angiology - Lymphangiogenesis occurs with hemangiogenesis via vascular splitting

Anthrax Vaccine - Recombinant Bacillus anthracis protective antigen protects against inhalational challenge

Asthma - First patient in U.S. is treated with Asthmatx' investigational outpatient procedure

Autoimmune Diseases - Theiler virus infection induces astrocyte recognition by autoreactive T cells

Avian Influenza - Aquatic birds, not cats, play role in spread of H5N1 Asian strain of avian flu, WHO says

Avian Influenza - GEN ID Lab Services, Inc. to identify molecules for treating human infections of avian flu

Blood Safety - Gen-Probe applies to use PROCLEIX TIGRIS System to screen donated blood for West Nile virus

Blood Safety - West Nile virus targets monocytes-macrophages after blood transfusion

Bovine Tuberculosis Vaccine - Mycobacterial vaccine is more potent than BCG against bovine tuberculosis

Breast Cancer - North American Scientific announces U.S. FDA clearance of low-dose breast brachytherapy product

Breast Cancer - RANKL regulates cancer cell migration and bone metastasis

Business & Finance - Endo Pharmaceuticals reports net sales of $205 million in first quarter

Business & Finance - Enpath Medical reports 42% increase in first quarter sales

Business Update - Amitiza launches in U.S. to treat chronic idiopathic constipation

Business Update - Speedel, Phase I and II developer of hypertension drug, announces Novartis NDA accepted

Cancer Gene Therapy - Cervical cancer HPV16 oncogene silencing is affected by RNA interference

Cancer Research - Lilly comments on results of tamoxifen and raloxifene cancer study reported by NSABP

Cancer Therapy - Intravenously administered vitamin C proposed as cancer therapy

Cancer Treatment - New findings from the United States, People's Republic of China and France in the area of cancer treatment detailed

Cardiovascular Disease - Two approaches to coronary risk assessment are discussed

Cardiovascular Research - Looming chronic disease plus infectious disease epidemics creates a double burden in Africa

Childhood Obesity - Predictors of overweight at the age of 4.5 years have been determined

Cholera Vaccine - Cholera vaccine candidate IEM108 resists CTX Phi infection

Clinical Trials - GenoMed to offer free clinical trial for mumps

Clinical Trials - U.S. FDA approves further changes to CORTOSS IDE pivotal study protocol

Complementary & Alternative Medicine - Immunogenicity is enhanced by Chinese herbal medicinal ingredients

Diagnostics - DOBI Medical's ComfortScan system granted approval in the Russian Federation

Diagnostics - Evidence is deficient for efficacy of bleach microscopy for TB case detection

Diet & Nutrition - Mossbauer spectroscopy was applied to determine iron state in ferrous-iron-containing supplements

Drug Development - Alkermes, Cephalon receive U.S. FDA approval for Vivitrol to treat alcohol dependence

Drug Development - Antares announces U.S. FDA acceptance of NDA for transdermal estradiol gel

Drug Development - Baxter announces new Aviva line of intravenous solutions

Drug Development - FermaVir announces U.S. FDA supports proceeding with clinical study of antiviral for shingles

Drug Safety - Shire receives interim response from U.S. FDA on Adderall XR citizen petition

Epidemiology - Live shigellosis clusters identified by prospective space-time scan statistics

Epidemiology - Malawian children are 5 times more likely to die of bacterial meningitis than English children

Epidemiology - Parents with atopic family history may adopt 'prudent' lifestyle for their infant

Facilities - Novavax successfully completes renovation and validation for cGMP compliance for Maryland facility

Food-Borne Illness - Staphylococcal enterotoxin B quantification in food matrixes by LC-MS method is developed

Genetics - New findings from the United States, Taiwan and Japan in the area of genetics detailed

Genetics - Researchers from the United States, France and Canada describe findings in genetics studies

Genetics & Genomics - Press coverage of genomics in Quebec are focus of review

Genetics & Genomics - Tm Bioscience signs Turkey distributor for RVP to detect avian flu virus, many others

HIV Genetics - HIV envelopes induce distinct gene expression profiles in blood mononuclear cells

HIV/AIDS - Reports from Switzerland, the United States and France add new data to HIV/AIDS research

HIV/AIDS - Reports from the United States and Italy describe recent advances in HIV/AIDS research

HIV/AIDS - Researchers from the United States and India provide details of new studies and findings in the area of HIV/AIDS

HIV/AIDS Therapy - Amino acid insertions of HIV-1 protease interfere with virus replication

HIV/AIDS Therapy - U.S. FDA grants fast track status to tramadol ER to treat HIV-associated neuropathy

HIV/AIDS Vaccine - HIV clade C immunization by DNA prime/protein boost was safe and immunogenic in mice

HIV/AIDS Vaccine - HIV-1 control is affected by escape mutations in p24 Gag

HIV/AIDS Vaccine - HIV-1 subtype C vaccine candidate for India has been developed

HIV/AIDS Vaccine - HIV-1 Tat protein plus lipopeptide adjuvant elicited systemic and mucosal immune responses

Hepatitis C Virus - Hepatitis C virus NS5A protein is involved in apoptosis and infectivity

High Blood Pressure - U.S. FDA to review new drug application for Rasilez to treat high blood pressure

Human Herpesvirus-8 Infection - HHV-8 infection control influenced by common variants in key host immune genes

Infection Control - Ultrasonic nebulizers should be disinfected at least once daily

Influenza - Researchers' data from the United States and Canada advance influenza research

Influenza - Researchers' work from the United States and Norway adds to influenza body of knowledge

Influenza Vaccine - Age-related changes were found in immune response to influenza vaccine in elderly adults

Influenza Vaccine - Anti-influenza responses produced by DNA chimeric molecule are long-lasting

Influenza Vaccine - Impact of corticosteroids on immune response to influenza vaccine is examined

Influenza Vaccine - Influenza hemagglutinin is purified and expressed

Information Technology - BrainLAB iPlan Flow software opens new avenues for delivering drugs to the brain

Labor Monitoring - U.S. FDA provides LMS Medical Systems clearance for standalone offering of CALM Curve

Leishmaniasis Vaccine - DNA vaccine effective against visceral leishmaniasis in dogs

Leishmaniasis Vaccine - Leishmaniasis immunity is conferred by IL-12 DNA with rORFF antigen

Leishmaniasis Vaccine - Leishmaniasis vaccine candidates were screened

Liver Function - Telithromycin can cause severe hepatotoxicity

Malaria - Researchers from the United States and Colombia describe findings in malaria studies

Malaria Vaccine -  Plasmodium falciparum merozoite surface protein-142 shows promise as vaccine candidate

Malaria Vaccine -  Plasmodium yoelii selectable markers have been developed

Malaria Vaccine - Clinical immunity to malaria is focus of review

Malaria Vaccine - Immune response to pre-erythrocytic stages of malaria parasites is focus of review

Medical Devices - Ascent Healthcare receives 510(k) clearance for DePuy ACE external fixation devices

Medical Devices - Studies show increased rate of suicide in women with silicone breast implants

Medical Devices - U.S. FDA approves programmer for implantable cardioverter defibrillators, pacemakers

Medical Devices - U.S. FDA grants 510(k) clearance for image analysis system used with Ki-67 stained tissues

Meningitis Vaccine -  Neisseria meningitidis vaccine's weak immunogenicity is overcome by prime-boost strategy

Meningococcal Vaccine -  Neisseria meningitidis outer membrane vesicles prevent bacteremia

Meningococcal Vaccine - Antibody responses to meningococcal vaccines were focus of randomized trial

Mumps Vaccine - Leningrad-3 live mumps vaccine virus can be transmitted horizontally

Mumps Vaccine - Monotypic immune responses to different mumps virus strains found

Ophthalmology - Doctors of optometry support Bausch & Lomb's solution recall, urge users to stop using

Osteoporosis - Methods to improve compliance with bisphosphonate therapy for osteoporosis outlined

Pediatric Vaccine - Vaccination information leaflets are useful for parents

Pertussis Vaccine - Single dose of acellular pertussis vaccine was effective in nonvaccinated adolescents

Pharmacology - Bioavailability of two losartan formulations is equivalent

Pharmacology - Pharmacokinetics of liquid versus tablet buprenorphine reported

Phenylketonuria - Phenylketonuria was corrected by vector-mediated gene transfer in mouse model

Plague - Findings from the United States advance knowledge in plague research

Plague Transmission - Pneumonic plague transmitted by respiratory droplets not aerosols

Polio Vaccine - Poliovirus replicative fitness is modulated by deoptimization of synonymous codon usage in capsid

Prison Health - MRSA outbreak among prison inmates associated with low personal hygiene

Product Licensing - Purdue researchers report progress on compounds that may prevent neural cell death

Public Health -  Haemophilus type b plus DPT vaccine (DTP-Hib) is cost-effective in Indonesian infants

Quality Assurance - Best Practices offers toolkit for improving quality assurance in pharma industry

Rabies - Researchers from the United States and India describe findings in rabies studies

Rabies Diagnosis - Rabies antibody is quantified by chicken-embryo-related cell line

Renal Anemia - Roche submits application to U.S. FDA to market C.E.R.A. for renal anemia

Sexual & Reproductive Health - Unprotected sex with multiple partners more likely after drinking alcohol

Shigellosis Vaccine -  Shigella flexneri 2a and S. sonnei bivalent invasin complex vaccine is developed

Tuberculosis - Findings from Switzerland, the United States and France advance knowledge in tuberculosis research

Tuberculosis - Research from the United States and People's Republic of China add new data to tuberculosis body of knowledge

Tuberculosis Screening - Symptom-based screening identifies 91% of children with intrathoracic tuberculosis

Tuberculosis Vaccine -  Mycobacterium tuberculosis mce-2 and mce-3 mutants increase immunogenicity of live vaccines

Tuberculosis Vaccine - TB epitope immunity is elicited by dendritic cell vaccine

Type 1 Diabetes - Type 1 diabetics on inhaled insulin show positive results in phase 2 clinical trial

U.S. Food & Drug Administration - Study assesses relationship between conflicts of interest and voting patterns at U.S. FDA meetings

Vaccine Development - Microencapsulated foot-and-mouth disease DNA vaccine enhances immunogenicity

Vaccine Safety - Anaphylaxis after vaccination due to gelatin hypersensitivity has been reported

Vaccines - Data from the United States, China and France advance knowledge in vaccines research

Vaccines - Studies from Taiwan and the United States advance knowledge in vaccines research

Vascular Disease - Schering-Plough gets Fast Track designation for thrombin receptor antagonist SCH 530348

Virology - Researchers from the United States, Germany and Japan publish new studies and findings in the area of virology

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