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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . October 2nd, 2005

Non-Subscriber - Summaries Only

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

Addiction Medicine - Prevalence of crack-cocaine injection in U.S. drug users reported

Antimicrobial Resistance - Susceptibility testing method for aquatic bacteria standardized

Gastroschisis - Epidemiology of gastroschisis in metropolitan Atlanta reported

Myelodysplastic Syndrome - Azacitidine for treatment of myelodysplastic syndrome summarized

Polymerase Chain Reaction - PCR assay for dual detection of bacteria and parasites developed

Adverse Drug Reaction - Prolonged linezolid for TB associated with anemia and peripheral neuropathy

Alcohol Use - Alcohol abuse related to risky sex among HIV-positive men who have sex with men

Allergy & Immunology - FDA approves grape flavored version of Children's Claritin

Alzheimer Disease - Company submits sNDA to FDA for Aricept for treatment of severe AD

Anxiety - IND filed with U.S. FDA for anxiety drug YKP3089

HIV/AIDS Vaccines - Researchers describe findings in HIV/AIDS vaccines studies

Asthma - GRC 3886 molecule to be named Oglemilast; receives approval for further trials

Avian Influenza - United Nations organization warns wild birds may spread bird flu virus further

Awards - U.S.D.A. scientist receives award for scientific contribution

Bacteriology - Erythromycin affects microbial populations in aquaculture sediment

Bacteriology - Intracellular persistent mycobacteria amenable to antibiotic treatment

Behavioral Medicine - Company places ocinaplon phase III clinical trial on hold

Behavioral Medicine - Quality of parent-child relationship related to rate of risk behaviors

Bovine Spongiform Encephalopathy - U.S. APHIS, U.S. FDA report investigation results of BSE+ cow

Breast Cancer - Letrozole effects in women with early-stage breast cancer reported

Breast Cancer Therapy - Femara granted FDA priority review for new indication: early breast cancer

Business Update - Company gets U.S. NIH grant for quantitating protein phosphorylation

Business Update - Company to develop a process for emergency pharmaceutical manufacturing

Business Update - DoD recognizes company for saving $100M on TRICARE pharmacy expenditures

Business Update - FDA clears heparin-coated auto transfusion and cardiotomy products

Business Update - Vascular Relief Centers Corp. retains securities law firm

Cancer Therapy - Supplemental Biologics License Application filed for head, neck cancer treatment

Cancer Vaccine Development - Gene profiling of immune responses against tumors reveals complexity

Cancer Vaccine Development - Multimodal therapy required to eliminate established tumors

Cancer Vaccines - Researchers provide details of new studies and findings in the area of cancer vaccines

Deep Vein Thrombosis - Abbreviated new drug application filed for M-Enoxaparin with FDA

Dengue Fever Outbreaks - Dengue fever cases in Trinidad increase during rainy season

Diabetes Therapy - Results of diabetes care trial in newly developed country reported

Diagnostics -  M. avium subsp. paratuberculosis found in majority of Crohn disease patients

Diagnostics - CLIA waiver granted for Triage BNP Test

Diagnostics - FDA approves CardioSight Service

Diagnostics - Gastric juice PCR assay enables efficient H. pylori identification

Diagnostics - Maryland facility approved for the manufacture of HIV-1 Urine EIA test

Diagnostics - PCR diagnoses peritoneal tuberculosis mimicking ovarian cancer

Diagnostics - Rapid HIV test modified to detect recent seroconversion

Diet & Nutrition - Government perspective on food labeling presented

Disease Control - CTX marginally effective in HIV-infected adults with new smear-positive TB

Disease Control - Epidemic modeling quantifies MRSA transmission rates in intensive care unit

Drug Development - Clinical trial enrollment initiated for arthroplasty system

Drug Development - Humira approved in Europe for psoriatic arthritis, rheumatoid arthritis

Drug Development - IND filed for drug to treat patients with non-small-cell lung cancer

Drug Development - Pharma company gets SBIR award to support Huntington research

Drug Development - Phase III trial of CPI-226 initiated for catheter-related infections

Drug Development - Positive Bronchitol cystic fibrosis trial results reported

Drug Development - Rv3806c-encoded enzyme is a target for the development of new tuberculosis drugs

Drug Development - Spectrum Pharmaceuticals announces filing of twelfth ANDA with the U.S. FDA

Drug Development - Supplemental BLA submitted to U.S. FDA for Rituxan

Drug Development - U.S. FDA approves NDA for type 2 diabetes drug

Drug Development - U.S. FDA grants approval for Allegra tablets

Drug Development - U.S. FDA grants tentative approval for Zolpidem Tartrate

Drug Development - U.S. regulatory perspective on multicenter trials presented

Drug Development - Xechem UK formed to file orphan drug application in E.U. for sickle cell drug

Drug Resistance - Antibiotic resistance of Gram-negative bacilli increasing in children in Kilifi

Drug Safety - Drug safety, risk management discussed at U.S. FDA symposium at Harvard

Ebola Vaccine Development - Humoral and CD8+ responses needed to protect against Ebola infection

Enterococcus Faecium Outbreak - Vancomycin-resistant Enterococcus faecium outbreak identified in France

Environmental Health - Autoreactive responses to environmental factors examined

Environmental Health - Estrogen status modulates anthracene-induced mutation in rat liver

Environmental Health - Risks identified for occupationally acquired histoplasmosis outbreaks

Epidemiology -  S. pneumoniae meningitis serotype 1 outbreak identified in northern Ghana

Epidemiology - Genital HSV-1 and HSV-2 epidemiology varies between ethnic groups in U.K.

Epidemiology - HIV prevalence increasing among injecting drug users in England and Wales

Epidemiology - HIV/AIDS epidemiology in Caribbean Basin difficult due to lack of uniform data

Epidemiology - Model estimates number of orphans in high HIV prevalent areas

Fasciola Vaccine - Immune responses to Fasciola DNA vaccine investigated

Finance - Blood volume analyzer maker delays filing of second-quarter 10Q

Finance - Pharma company reports revenue of $13.3 million

Finance - Pharmaceutical company consummates convertible debentures, warrant financing

Follicular Lymphoma - Proteomics of apoptotic pathways reveals lymphoma prognostic factors

Gene Research - U.S. NIH grant awarded to identify genetic factors related to nicotine addiction

Generic Drugs - FDA approves NDA for cholestyramine for oral suspension

Generic Drugs - Pharma company announces tentative approval for Ondansetron Hydrochloride Tablet

Generic Drugs - Tentative FDA approval granted to market Glimepiride Tablets

HIV/AIDS - Leishmaniasis in HIV-infected patients investigated

HIV/AIDS Diagnosis - CD4 count among normal north Indians lower than in Western populations

HIV/AIDS Pathogenesis - Resting naive CD4+ T cells massively infected and eliminated

HIV/AIDS Risk Assessment - Written/electronic STD testing protocols promotes risk assessment questioning

HIV/AIDS Risk Factors - Polygamy and extramarital sex are risk factors for HIV transmission in Nigeria

HIV/AIDS Therapy - Nandrolone decanoate benefits HIV-infected men with weight loss

HIV/AIDS Vaccine Develoment - Determinants of HIV resistance to gp41-derived peptides examined

HIV/AIDS Vaccine Development - Different epidemic potentials of HIV-1B and C subtypes reported

HIV/AIDS Vaccine Development - Global enterprise uses scientific/financial resources to develop AIDS vaccine

HIV/AIDS Vaccine Development - Measles vaccine vector primes antibodies against HIV-1 epitopes

HIV/AIDS Vaccine Development - Soluble HIV-1 envelope glycoprotein trimers characterized

HIV/AIDS Vaccines - Findings advance knowledge in HIV/AIDS vaccines research

HIV/AIDS-Tuberculosis Coinfection - Elevated CCR5/CXCR4/cytokines persistently increase viral load in TB coinfection

Health Policy - Public policy change on firearms and youth in California reported

Healthcare Policy - Reproductive health group comments on Susan Wood's resignation from OWH post

Hookworm Vaccine Development - Antibodies against hookworm larvae protein reduce hookworm infection

Hypertension - FDA grants expanded label for Ventavis

IGF-1 Deficiency - FDA approves Increlex for short stature from severe primary IGF-1 deficiency

Imaging - Real-time MRI-guided stenting achieved in porcine model

Infectious Disease - New drugs may soon be available for some previously ignored worst diseases

Influenza - CDC's recommended influenza prioritization schedule includes FluMist

Influenza - GlaxoSmithKline announces U.S. FDA approval of FLUARIX

Influenza Vaccine - Company announces favorable results of FDA inspection of Fluvirin facility

Information Technology - One-hundredth eCTD submission completed by tech firm for pharma clients

Information Technology - Taratec audit performed for U.S. FDA regulatory compliance

Insulin Resistance - FDA approves qualified health claim for chromium picolinate and diabetes risk

Interarterial Block - Interpreters of ECGs should seek interatrial block in all 12 leads

Legal Issues - U.S. solicitor general recommends LabCorp's petition in patent case be denied

Legionellosis - Proactive approach can prevent nosocomial Legionnaires' disease

Lipid Therapy - Intervention program increased prescription rate of lipid modifying therapy

Lymphocytosis - Diagnostic criteria for monoclonal B-cell lymphocytosis outlined

Malaria Therapy - Future clinical research on malaria discussed

Malaria Vaccine - Reference standard for antibody to Plasmodium protein characterized

Measles Vaccine Development - Measles vaccine vector induces broadly neutralizing antibodies against HIV-1

Mechlorethamine - Analysis of nitrogen mustard in topical drugs reported

Medical Devices - First European spinal surgeries follow CE marking, ISO certification of devices

Medical Devices - U.S. FDA grants clearance to sell female incontinence sling in U.S. market

Medical Devices - U.S. NIH grant awarded to fund study of stroke recovery system

Mycobacterium Tuberculosis - Host control of MTB regulated by 5-lipoxygenase-dependent lipoxin production

Mycobacterium Tuberculosis - Inducible promoter generates a conditional auxotroph of M. tuberculosis

Mycobacterium Tuberculosis - MTB PknH gene deletion confers higher bacillary load during chronic infection

Mycobacterium Tuberculosis Diagnostics - Genotyping rapidly detects rifampin/isoniazid resistance in MTB complex isolates

Neonatal Sepsis - Neonatal sepsis associated with bacterial contamination of intravenous fluids

Nosocomial Infections - ESBL-producing K. pneumoniae outbreak related to onychomycosis discovered

Nosocomial Infections - Toxicogenomic effects of peracetic acid on P. aeruginosa characterized

Obstetrics - New findings in the area of obstetrics described

Pain Management - FDA grants orphan drug designation to CGX-1160 for chronic intractable pain

Parvovirus - Virulent variants of parvovirus minute virus investigated

Pertussis Vaccines - New research in the area of pertussis vaccines detailed

Philanthropy - Pharma company donates 3 million treatments of antiviral Tamiflu to WHO

Pneumococcal Vaccines - Research in pneumococcal vaccines provides new insights

Polio Vaccine Develoment - MRC-5 cells provide alternative for oral polio vaccine production

Pseudomonas Aeruginosa Outbreaks - Nosocomial outbreak caused by multidrug-resistant IMP-producing bacteria

Recalls - U.S. FDA announces recall of Medline brand of alcohol-free mouthwash

SARS - Assays assess neutralizing antibody activity against SARS-associated coronavirus

SARS - Recent findings in SARS described

SARS Vaccine Develoment - Expression of SARS nucleocapsid protein in E. coli achieved

SARS Vaccines - Researchers detail new studies and findings in the area of SARS vaccines

Sexual & Reproductive Health - FDA defers decision on Plan B over-the-counter application

Sexually Transmitted Diseases - Increasing rates of STDs in homosexual men in Europe and U.S. examined

Shigella Sonnei Outbreaks -  Shigella sonnei outbreak in Canary Islands produced by a single strain

Smallpox Vaccine Development - No oropharyngeal vaccinia virus detected after smallpox vaccination

Smallpox Vaccine Development - Vaccinia strain used for smallpox vaccine 1937 to 1970 characterized

Smallpox Vaccine Development - Vaccinia virus L5r gene encodes protein required for cell entry

Staphylococcus Vaccine Development - Vaccine protects against Staphylococcus aureus infection

Stem Cell Research - State of California grants manufacturing license for cell processing facility

Thalidomide - Dermatological indications and side effects of thalidomide reported

Tobacco Use - Looking to the future: Helping 33 million smokers quit

Tuberculosis - Predictors of recurrent pulmonary tuberculosis identified

Tuberculosis Pathogenesis -  M. tuberculosis plcD gene may be involved in tuberculosis pathogenesis

Tuberculosis Reinfection - Rate of reinfection TB after successful treatment higher than rate of new TB

Tuberculosis Vaccine - TB vaccines in developing countries need to block immunopathological responses

Vaccine Development - Recombinant proteins produced by vaccinia virus in perfusion bioreactor

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