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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . March 27th, 2005

Non-Subscriber - Summaries Only

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

Gonorrhea - Genetic typing of porin protein of Neisseria gonorrhoeae reported

Influenza Vaccine - Medical practice expenses from influenza vaccinations estimated

Polio Vaccine - Spread of vaccine-derived poliovirus from a paralytic case reported

SARS Infection - SARS coronavirus replication in monocytes and macrophages described

Tobacco Use - Covariates of cigarette smoking in Hungarian children reported

Addiction Medicine - U.S. patent rights licensed for use of drug to treat nicotine dependence

Adenovirus - Sequence polymorphism in subspecies B1 human adenoviruses reported

Adverse Drug Reaction - U.S. FDA approves i.v. immune globulin for adverse reactions to smallpox vaccine

Aging - Life expectancy hits record high; gender gap narrows

Alcohol Use - College binge drinking associated with state drinking rates

Alcohol Use - Researchers identify networks of genes responding to alcohol in the brain

Malaria Vaccines - Studies advance knowledge in malaria vaccines research

Antiviral Therapy - Efficient synthesis of 5'-homoaristeromycin reported

Aspergillosis - EIA/qPCR used to diagnose invasive aspergillosis in high-risk patients

Asthma Risk Factors - Country of birth is risk factor for asthma among Mexican Americans

Avian Influenza - U.S. prepares to test bird flu vaccines

Bacterial Evolution - VNTRs appropriate evolutionary marker for studying bacterial transmission events

Benign Epidermal Pigmented Lesions - FDA approves pulsed dye lasers for benign epidermal pigmented lesions

Bioterrorism - Interpol lays out measures to combat bioterrorism

Breast Cancer - Positron emission mammography device detects small lesions

Breast Cancer - U.S. FDA clears MammoReport(Plus) for extended use

Breast Cancer - Urinary estrogen metabolite ratio may signal higher risk in Asian Americans

Breast Cancer Risk Factors - Risk factors differ by age, race among African American and white women

Buruli Ulcer - Dry-reagent PCR used to confirm Mycobacterium ulcerans in tropics

Business & Finance - Pharma company announces financial results

Business Update - Company announces implant of cryopreserved osteoarticular allograft

Cancer Diagnostics - Diagnostic products company files IND for biopsy product

Cancer Therapy - Study shows patients get more benefit than thought from early cancer treatment

Cancer Vaccines - TP-3 immunotoxins improve antitumor activity in mice with osteosarcoma

Clinical Trials - Eyetech uses InForm EDC for Macugen trials; Macugen launched in January

Congenital Heart Disease - ENU-induced mutations may yield insights into genetic basis of CHD

Congestive Heart Failure - U.S. FDA approval to begin trial for left ventricular assist system granted

Coronavirus - Recurrent feline coronavirus infection and role of cellular immunity reported

Cryptococcus Diagnostics - RT-PCR assay detects and quantitates Cryptococcus neoformans

Deerpox Virus - Genome of deerpox virus reported

Dermatology - Safety of ingredients used in cosmetics reviewed

Diagnostics - Two HIV rapid tests submitted to the U.S.FDA for PMA

Diet & Nutrition - School programs help reduce childhood obesity

Disease Management - Panel slams Japanese government for forced isolation of leprosy

Disease Prevention - An apple a day can help keep breast cancer away, suggests rat study

Disease Transmission - Risk of HSV-1 infection rises with oral sex

Drug Development - Pharmaceutical company files ANDA with U.S. FDA for opthalmic product

Drug Safety - Drug safety issues expected to slow companies' FDA product approval

Drug Safety - FDA wants power to write warning labels on drugs

Drug Safety - Warning issued on use of cholesterol drug Crestor by Asians

Electronic Medical Records - Poll: HIPAA notices have improved public's confidence

Emerging Disease -  Plesiomonas shigelloides is emerging pathogen with unusual features

Enterotoxigenic Escherichia Coli - Phenotypes determined for ETEC associated with early childhood diarrhea

Environmental Health - IQ loss linked to mercury costs $8.7 billion

Environmental Health - Passive smoking kills 30 people a day in the U.K.

Escherichia Coli 0157 Diagnostics - IS1203 PCR rapidly genotypes Shiga toxin-producing Escherichia coli O157

Ethics - Publishers of second-hand smoke research had links to tobacco industry

Finance - COLD-EEZE manufacturer reports financial results

Finance - Cardio-focused medical devices company reports Q4, year ended December 31, 2004

Finance - Company attributes much of Q2's income drop to decline in ABELCET sales

Finance - Company focused on metabolic disorders reports Q4 and 2004 financial results

Finance - Company focused on protein deficiency treatments reports strong 2004 financials

Finance - MS drug's withdrawal triggers scrutiny of stock sales

Finance - Pharma company announces record financial results

Finance - Pharmaceutical company receives $750,000 equity investment

Finance - Science-based healthcare company reports Q4, full year 2004 financial results

Fitness - Urban green space linked to walking, cycling levels

Food-Borne Illness - Method of detecting Enterobacter sakazakii in infant formula developed

Fungal Therapy - Profile of an ideal antifungal presented

Gastroenterology - Treatment for upper GI bleeding, benign gastric ulcers released in U.S.

Gender Medicine - Thailand Ministry to campaign for breast-enlargement exercise

HIV/AIDS Coinfection -  Schistosoma mansoni/HIV-1 coinfection leads to CD4 cell reduction

HIV/AIDS Diagnosis - Dual testing better for monitoring new cases of HIV

HIV/AIDS Epidemiology - HIV infection rate among blacks doubles

HIV/AIDS Epidemiology - New HIV strain has very deadly aspects

HIV/AIDS Infection - Influence of host genetic variation on susceptibility to HIV type 1 infection

HIV/AIDS Mental Health - Factors associated with victimization of African American female DUs identified

HIV/AIDS Prevention - Fear of test result and stigmatization are barriers to HIV testing in Bali

HIV/AIDS Prevention - HIV/AIDS risk perception predicted among low-income/urban/older adults

HIV/AIDS Prevention - High mobility among rural-urban migrants associated with increased sexual risk

HIV/AIDS Prevention - Rural Malawians publicly discuss strategies for HIV prevention

HIV/AIDS Prevention - Sexual compulsivity scores associated with risky sexual behavior frequency

HIV/AIDS Prevention - Youth with HIV take more risks after new meds introduced

HIV/AIDS Transmission - Older macaque infants are more susceptible than neonates to SHIV 89.6P

HIV/AIDS Vaccine - Antibody response elicited by trimeric HIV glycoproteins analyzed

HIV/AIDS Vaccine - HIV-1 virus-like particles are potent immune stimulators

HIV/AIDS Vaccine - Inactivated HIV antigen plus CpG ODN protects against infection

HIV/AIDS Vaccine - Modified HIV envelope proteins exhibit enhanced binding to antibodies

Haemophilus Vaccines - Studies describe new findings in haemophilus vaccines research

Health Promotion - Expert cautions against FDA approval of "race-based" pharmaceutical

Healthcare Disparity - Although disparities remain, improvements made in healthcare quality

Heart Failure - U.S. FDA approves candesartan cilexetil for the treatment of heart failure

Human Papillomavirus - Prevalence of human papillomavirus genotypes in women reported

Imaging - Technology company receives approval to expand use of ImageChecker D product

Infant Mortality - Call to action issued to address neonatal health issues

Infant Mortality - Individual solutions needed for poor countries to reduce neonatal death rates

Influenza - Vaccination programs for children in U.S., Canada based on little evidence

Influenza Vaccine - Norway to be supplied with special vaccines in event of influenza pandemic

Information Technology - GE Healthcare to supply U.S. government with pharmacy information system

Information Technology - Technology company releases donor management system for review

Information Technology - U.S. Department of Defense health system contracts for compliance software

Leishmaniasis - Promising visceral leishmaniasis treatments must translate into actual therapy

Leptospirosis - Percutaneous exposure results in laboratory-acquired leptospirosis

Licensing - Pharmaceutical firm acquires license to endothelinB agonists for chemo delivery

Listeriosis - Growth conditions affect thermal inactivation of Listeria

Lymphangioleiomyomatosis - High rate of abnormal BMD found in women with pulmonary disease

Malaria - Malaria morbidity in children increases as transmission intensity decreases

Malaria - Malaria still reduced in areas after withdrawal of deltamethrin spray

Malaria Diagnostics - Four plasmodium species detected in blood by real-time PCR

Malaria Therapy - Researchers provide details of new studies and findings in the area of malaria therapy

Malaria Vaccine - Baculovirus-based malaria vaccine shows promise in Senegalese village

Malaria Vaccine - Epitope mapping of malaria parasite inhibitory antibodies reported

Malaria Vaccine - Modified HRP-I peptide analogue protects against malaria

Malaria Vaccines - Reports add new data to malaria vaccines research

Marek's Disease Virus - Marek's disease virus genome copy number in chicken feathers quantified

Measles Vaccine - Measles genotype in Spain after measles elimination plan reported

Mergers & Acquisitions - Letter of intent signed to acquire parts of pHarlo Citrus Technology, 2 labs

Microbial Identification - Multispacer typing useful for strain genotyping during outbreaks/bioterrorism

Microbial Resistance - Beta-lactam susceptibilities evaluated against Enterobacteriaceae isolates

Microbial Resistance - In France, ESBL-producing S. enterica strains emerging in chickens & humans

Mosquito-Borne Disease - Aircraft is the main vessel for mosquito entry into New Zealand

Mycobacterial Infection - New mycobacaterial species found in sputum of patient with hemoptoic pneumonia

Mycobacterium Abscessus - Inability to type M. abscessus by PFGE assoc. with single clone of organism

Mycobacterium Xenopi Infection -  Mycobacterium xenopi infection developed following heart transplantation

Myocardial Infarction - African Americans receive less aggressive heart attack treatment

Nosocomial Infections - U.S.FDA grants priorty status to drug for serious skin, soft tissue infections

Obstetric Fistula - Over 300 Nigerian women's obstetric injuries treated in first week of campaign

Obstetrics - Gestational night blindness seen in 18% of women attending Brazilian hospital

Obstetrics - U.S. FDA clear new fetal-health device

Orthopedics - Company gets FDA clearance for pivotal trial of Z-Lig device

Osteoporosis - Intervention results in significantly greater calcium intake among women

Pancreatic Cancer - U.S. FDA clears randomized portion of phase II TNFerade in pancreatic cancer

Parkinson Disease - European approval to market rasagiline 1 mg for Parkinson disease granted

Patents - Patent challenge of injection to treat migraine attacks in adults initiated

Patents - RNA-focused company granted 2 RNAi technology patents by U.K. Patent Office

Patents - Therapeutics company granted U.S. patent for developing allergy antibodies

Personnel - Richard C. Levin named CEO and president of natural personal products company

Philanthropy - U.N. health body welcomes Canadian gift

Pneumococcal Vaccine - Rapid multiplex assay for serotyping pneumococci developed

Pregnancy - Obese and tall women have increased incidence of fraternal twins

Probiotics - Use of probiotics reviewed

Prostate Cancer - Provenge/Avastin combo increases PSADT

Prostate Cancer - U.S. FDA approves new device for diagnosing and treating prostate cancer

Pseudomonas Aeruginosa -  Pseudomonas aeruginosa is non-clonal but has an epidemic population

Rabies Vaccine - New rabies vaccine manufactured in India is safe and immunogenic

Regulatory Issues - FDA seeks drug-warning-label authority

SARS Coronavirus - Chronological evolution of Ab levels determined after SARS coronavirus infection

SARS Coronavirus - RT-PCR distinguishes SARS coronavirus from other respiratory tract infections

SARS Vaccine - Binding system restores interaction between SARS protein and receptor

SARS Vaccine - Intranasal immunization with inactivated SARS-CoV induces antibodies

SARS Vaccines - Recent findings illuminate research in SARS vaccines

Salmonella Vaccine - Type 1 fimbriae protects laying hens against Salmonella

Sexual Behavior - Contraception use not keeping up with conception rates in Latin America

Sexually Transmitted Diseases - Funding affects incidence of sexually transmitted diseases

Shigellosis Vaccine -  Shigella flexneri vaccine strains characterized

Skin Cancer - Recent studies add new data to skin cancer research

Smallpox Vaccine - Smallpox vaccine does not protect macaques with AIDS from monkeypox

Smoking Cessation - "Truth" campaign driving youth smoking rates down

Smoking Cessation - Global tobacco treaty enters into force with 57 countries already committed

Smoking Cessation - Parents who quit smoking may influence their offspring to quit as young adults

Social Policy - Branding practices in rural India should be banned

Sociology - Child sex-trafficking study in Bosnia reveals misperceptions

Space Travel - Nanobacterial infections important during space travel

Spinal Cord Injury - U.S. FDA grants 510(k) clearance to market 2 fusion spine products in the U.S.

Spinal Cord Injury - U.S.FDA grants clearance of device to detect possible vertebral pedicle breach

Stem Cell Research - PTH/PTHrP signaling is major regulator of bone marrow ontogeny

Streptococcal Equi Diagnostics - Multiplex PCR differentiates closely related streptococcal species

Stroke - U.S. FDA accepts application for tool to aid in stroke assessment, diagnosis

Surgical Technology - Positive reaction to femoral puncture closure device, developer reports

Tick-Borne Virus - Tick-borne viruses in Europe are potential agents of bioterrorism

Tobacco Use - Treatment of tobacco dependence reviewed

Toxoplasmosis Vaccine -  Toxoplasma gondii proteins protect against oral infection

Tuberculosis -  M. tuberculosis lineage with low IS6110 copy numbers clonally expanded

Tuberculosis - Genotypic/phenotypic heterogeneity among M. tuberculosis isolates determined

Tuberculosis - Molecular genetic methods for mycobacterial research reviewed

Tuberculosis Vaccines - Cutaneous tuberculosis evoked by BGG vaccination in healthy baby

Tuberculosis Vaccines - Findings in tuberculosis vaccines provide new insights

Type 2 Diabetes - Diabetes prevention efforts worth every penny

Urea Cycle Disorder - Pharmaceutical company obtains FDA approval of treatment for urea cycle disorder

Vaccine Development - Biopharma initiates new Botulinum toxin therapeutic program

Vaccine Development - Sugar epitopes are potential disease transmission blocking targets

Vancomycin-Resistant Enterococcus - Esp/vancomycin resistance may contribute to clonal enterococcal dissemination

Vibrio Cholerae - Possible source of V. cholerae outbreak is effluent from ships or poachers

Virology - Studies add new findings to virology body of knowledge

Water-Borne Illness - Unsafe water, poor sanitation causes 4000 children to die each day

West Nile Virus - West Nile virus is an emerging arbovirus

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