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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . April 3rd, 2005

Non-Subscriber - Summaries Only

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

Antibiotics - Intent-to-treat and per-protocol results in antibiotic trials compared

Biowarfare - Chlorine inactivation of bacterial bioterrorism agents reported

HIV/AIDS Vaccine - Experiences of men who have sex with men with risk counseling reported

Hepatitis C Virus - Obtaining maximum information about hepatitis C quasispecies discussed

Neisseria Epidemiology - Risk of N. meningitidis high in travelers to Hajj in Saudi Arabia

AIDS Funding - U.S. HHS awards almost $1.7 billion for HIV/AIDS care

AIDS Mortality - U.N.: AIDS may kill 80 million Africans by 2025

Aesthetic Medicine - U.S. FDA clears Ellipse I2PL system for skin rejuvenation

Age-Related Macular Degeneration - FDA completes review of age-related macular degeneration trial protocols

Age-Related Macular Degeneration - New treatment for wet age-related macular degeneration

Alcohol Use - Police alcohol checks put sales to teens on ice

Androstenedione - No hepatotoxicity of androstenedione found in pregnant rats

Anthrax Vaccine - HEPA/vaccine plan for indoor anthrax remediation outlined

Anthrax Vaccine - Mucosal administration of rPA protects against inhalational anthrax

Arsenic Exposure - Eliminating arsenic in drinking water decreased lung cancer mortality in Taiwan

Assisted Reproduction - Suboptimal endometrial lining may thwart ART success in some women

Bacteriology - U.S. FDA grants priority review for antibiotic treatment for skin infections

Black Tea - Black tea intake does not modulate mutagen excretion from ingested beef

Blood Banking - Quality control programs ensures quantity/quality of preserved cord blood

Bovine Arbovirus -  Culicoides oxystoma potential vector for bovine arbovirus in southern Japan

Breast Cancer - Neulasta trial results published in The Journal of Clinical Oncology

Breast Cancer - XPD polymorphism increases breast cancer risk from PAH-DNA adducts/cigarettes

Business & Finance - ATryn maker reports "significant progress" in 2004

Business & Finance - Anti-infectives-focused biotech company reports Q4, year end 2004 results

Business & Finance - Medical device firm reports record 4Q, 2004 neuro sales increased 36%

Business Update - FDA issues warning letter to insulin pump maker

Cancer Diagnostics - FDA does not recommend approval of the proposed indication for Combidex

Cancer Research - Pharmaceutical company reports transfer of orphan drug status for oncology drugs

Cancer Risk - Opium smoking associated with elevated carcinoembryonic antigen levels

Cancer Therapy - Alliance established for trial of non-small cell lung cancer vaccine

Cancer Vaccines - New findings in cancer vaccines described

Carcinogens - Carcinogenicity of dioxin-like compound mixture is dose additive

Childhood Immunization - Many children are undervaccinated in their first 2 years of life

Childhood Immunization - Openness is key to winning the war over MMR

Childhood Obesity - Study of obesity and type 2 diabetes in adolescents reported

Clinical Trials - Company to meet with FDA before unblinding of phase III E2F Decoy trial

Clostridium Infection - Patients with C. difficile-related diarrhea have higher mortality

Complementary & Alternative Medicine - Kava ingestion results in altered mental status and ataxia

Cryptosporidium -  Cryptosporidium outbreak in Milwaukee, Wisconsin, analyzed

Cryptosporidium Outbreaks -  Cryptosporidium outbreaks occur from microbiology standard-compliant water

DPT Vaccine - Diphtheria/pertussis vaccine components should be inactivated toxins

Dementia - Midlife CV risk factors increase risk for late-life dementia

Dengue Virus - Selection for virulent dengue viruses occurs in humans and mosquitoes

Diagnostics - ELISA developed for detection of bromoxynil in water

Diagnostics - FDA grants clearance to market drug screens with acetaminophen

Diet & Nutrition - Food costs, convenience predict obese women's fat intake

Diet & Nutrition - Nutrient content of parental and genetically modified rice compared

Drug Abuse - Study examines consequences of Thailand's "war on drugs"

Drug Development - Aczone demonstrates reduction in number, severity of acne lesions

Drug Development - Enrollment of new patients in trials of alagebrium temporarily suspended

Drug Development - European approval granted for Omnex surgical sealant

Drug Development - FDA grants Fast Track designation for aerosolized Amikacin

Drug Development - FDA grants approvable letter for extended-release Glumetza for diabetes

Drug Development - FDA grants approval for protocol amendment to ARISE phase III trial

Drug Development - Tentative FDA approval for conepezil hydrochloride to Ranbaxy Lab announced

Drug Importation - International drug sales rose 7% last year but pace of growth slowed

Drug Safety - Companies voluntarily suspend Tysabri for multiple sclerosis

Drug Safety - FDA advisory panel discussion points to Aleve

Ebola Virus - Ebola glycoprotein toxicity mediated by dynamin-dependent pathway

Endocrinology - NDA for human insulin-like hormone to treat IGF-1-caused short stature submitted

Environmental Pollution - Carcinogens in house dust can pose potential health risks

Epidemics - Outbreak frequency selection explains frequent infection via pathogen evolution

Epidemics Dynamics - Actual reproduction number adds to understanding of epidemic dynamics

Epidermolysis Bullosa - Next stage of clinical trial for treatment of epidermolysis bullosa underway

Epilepsy - Company launches VNS Therapy system in Korea and Brazil

Epstein-Barr Virus - Real-time Q-PCR distinguishes disease-associated EBV from incidental virus

Euthanasia - Newborn euthanasia often goes unreported in Netherlands

Finance - Drug-delivery company reports full-year 2004 sales growth of 50%

Finance - Pharmaceutical company announces filing of ninth ANDA with U.S.FDA

Finance - Pharmaceutical company completes $25M financing

Finance - Pharmaceutical company reports 2004 4th quarter and year end financial results

Finance - Pharmaceutical company reports fourth quarter results

Food Safety - Antimicrobial solution effective against 'Campylobacter jejuni,' company says

Food-Borne Illness - Norovirus and food-borne disease in the United States reviewed

Food-Borne Pathogen - Active hand washing training increases retention in food preparers

Food-Borne Pathogen - Street vended food poses risk of Salmonella and E. coli infection

Fungi Toxin - Molecular aspects determined for fungi toxin

Gastropathy - Current approaches to prevent NSAID-induced gastropathy outlined

Generic Drugs - FDA gives tentative approval to market donepezil hydrochloride tablets

Genetic Disorders - Company receives nonapprovable letter for panic disorder indication for Lexapro

Genotoxicity - Genotoxicity of ambient outdoor air due to hundreds of identified compounds

Green Tea Extract - Catechin extracts from green tea promotes tumor cell survival pathways

HIV Prevention - Company announces 50% enrollment in phase III HIV prevention trial in Ghana

HIV/AIDS Epidemiology - Steady rise in HIV among heterosexuals seen in the U.K.

HIV/AIDS Prevention - Community-based health-education strategy increases STD awareness in rural India

HIV/AIDS Prevention - Few needle sharers perceive susceptibility of contracting HIV

HIV/AIDS Prevention - HIV/AIDS knowledge increases the likelihood of HIV testing in Uganda

HIV/AIDS Prevention - Studies of the social context of microbicide use to prevent STDs inadequate

HIV/AIDS Risk Behavior - Alcohol use associated with HIV risk behavior among rural adolescents

HIV/AIDS Therapy - Study examines lessons learned at Africa's first public antiretroviral clinic

HIV/AIDS Vaccine - DermaVir is a new topical vaccine for HIV/AIDS

HIV/AIDS Vaccine - HIV genomic RNA sequences in female genital tract and blood reported

HIV/AIDS Vaccine - Innate immunity in experimental SIV infection and vaccination explored

HIV/AIDS Vaccines - Researchers' data advance HIV/AIDS vaccines research

HIV/AIDS-Associated Disorder - Acquired rectal fistula may be sign of HIV infection in children

Hantavirus - Trafficking of Andes and Sin Nombre hantavirus glycoproteins outlined

Hantavirus Vaccine - Viremia delayed in immunized macaques challenged with hantavirus

Healthcare Disparities - Differences in care based on class, not just race

Hemophilia B - Major genes share the control of factor IX antibody expression

Hepatitis C Therapy - FDA approves drug combination as first hepatitis C treatment for HIV patients

Hepatitis C Virus - U.S. FDA approves Pegasys and Copegus as hepatitis C treatment for HIV patients

Home Healthcare - Oregon center seeks participants for federally funded family caregiver program

Human Herpesvirus-8 Infection - Sociological risk factors determined for HHV8 infection in cancer patients

Human Papillomavirus - Subsequent HPV risk in HIV+ women not lowered by natural infection

Hypertension - Blood pressure treatment could cut risk of strokes and heart attacks

Hypertension - U.S. FDA extends PDUFA action date for Nebivolol tablets

Imaging - Measuring cardiac rest periods improves understanding of imaging constraints

Influenza - Healthcare employee vaccination rates could be better

Influenza - Hotline method works to educate public

Influenza - World poorly prepared for next influenza pandemic, scientists warn

Influenza Vaccine - Economic analysis of annual influenza vaccination of children reported

Influenza Vaccine - Epitope analysis for influenza vaccine design reported

Information Technology - IT company, Kyberpass release legally enforceable digital signatures system

Injury Prevention - Severe injuries on the rise among children and adolescents riding motorbikes

Insulin - Long-acting insulin analog developed using albumin fusion technology

Lead Poisoning - Lead isotopic measurements in feces match levels in household dust

Leishmaniasis Vaccine -  Leishmania membrane proteins are prophylactic against leishmaniasis

Leishmaniasis Vaccine - Drug-sensitive Leishmania vaccine developed

Leptospirosis Outbreaks - Morbidity/mortality decreased among children pre-exposed to leptospires

Listeria Monocytogenes - Low prevalence of Listeria monocytogenes in humans

Liver Cancer - Researchers detail new studies and findings in the area of liver cancer

Lung Cancer - Physical activity may reduce lung cancer risk among those with high exposure

Lymphoma - Company initiates pivotal trial with FK228 in cutaneous t-cell lymphoma

MMR Vaccine - Policies on MMR vaccinations must balance freedoms and responsibilities

MMR Vaccine - Respiratory delivery of MMR vaccine more immunogenic than injection

Malaria Diagnosis - Nucleic acid sequence amplification better than PCR to quantify malaria

Malaria Infection -  Plasmodium protein proteolytically processed during cell invasion

Malaria Vaccine -  Plasmodium merozoite surface protein protects against malaria

Malaria Vaccine - Allele specificity of antibody responses against P. falciparum outlined

Malaria Vaccine - Parasite growth rates measured in volunteers challenged with malaria

Malaria Vaccine - Vaccines with DNA and viral vectors possess differential immunogenicity

Malaria Vaccines - Researchers report details of new studies and findings in the area of malaria vaccines

Malignant Gliomas - FDA clears phase I/II recurrent malignant gliomas clinical trial

Measles - WHO: Global measles deaths drop 39%

Measles Epidemiology - Measles virus isolated in Croatia during outbreak characterized

Medical Devices - Company receives U.S. FDA clearance for spinal device

Medical Devices - New easy to use defibrillator introduced

Mental Health - Minnesota researchers find promising results for VNS therapy in bulimia patients

Mergers & Acquisitions - Companies discuss proposed acquisition of IMPAC

Mergers & Acquisitions - DaVita receives second FTC request regarding Gambro acquisition

Metabolic Syndrome - Metabolic syndrome examined in Chinese, Malays, and Asian Indians

Metabolic Syndrome - Short-term very-low-carbohydrate diets improve metabolic abnormalities

Mother-to-Child HIV Transmission - Program evaluation in Bangkok finds factors that hinder women's use of services

Neisseria meningitides - Repetitive-PCR distinguishes N. meningitidis outbreak-related strains

Neonatology - How many lives of newborn babies can we save?

Obesity - Therapeutic targets for obesity-associated diabetes based on inflammation link

Pediatric Vaccines - Cost of child immunization services in urban Bangladesh reported

Personnel - Former U.S. FDA chief counsel Peter Barton Hutt nominated to company board

Pneumococcal Vaccine - Self-reported pneumococcal vaccination validated through local agencies

Pneumococcal Vaccines - Research add new data to pneumococcal vaccines body of knowledge

Polio Vaccine - Dendritic cells and macrophages are productively infected by poliovirus

Polio Vaccine - Immunization schedules affect excretion of polio vaccine strains

Polio Vaccine - Seroprevalence of poliovirus antibody in northern Greece reported

Porcine Epidemic Diarrhea Virus - Competitive blocking ELISA detects porcine epidemic diarrhea virus in feces

Prison Health - Expansion to 1,918-bed Lawton Correctional Facility in Oklahoma announced

Probiotics - Guidelines are important in developing and using probiotics

Product Labeling - Labeling revision for cholesterol-reducing statin approved by U.S. FDA

Prostate Cancer - HPV DNA found in prostate tissue suggests role in prostate cancer

Prostate Cancer - Phase 3 data on satraplatin as chemotherapy for prostate cancer published

Pseudomonas Aeruginosa - Multilocus sequence typing used for genetic analysis of P. aeruginosa

Receptor Studies - Study examined the role of estrogen receptors in hypertrophy

Rotavirus Epidemiology - Epidemiology of rotavirus G-types circulating in Hong Kong is changing

Rotavirus Vaccine - Distribution of rotavirus serotypes has implications for vaccines

SARS - Multiple factors increase risk of developing SARS in health care workers

SARS - Researchers publish new studies and findings in the area of SARS

SARS Coronavirus - SARS coronavirus detected in lungs by RT-PCR following death from SARS

SARS Coronavirus - SARS coronavirus more stable than human coronavirus HcoV-229E in lab conditions

Salmonellosis Outbreak - Salmonellosis outbreak associated with rare phage type of S. enteritidis

Severe Combined Immunodeficiency - Panel recommends some gene therapy limits

Sexual & Reproductive Health - English-speaking Hispanic youth more likely to have sex early

Sexually Transmitted Infection - Exploring sexual networks yields insights into sexually transmitted infections

Smallpox - WHO seeks increase in smallpox vaccines

Smallpox Vaccine - Neutralizing anti-vaccinia antibodies titration method standardized

Smallpox Vaccine - Poxvirus CD8+ T cell determinants aid smallpox vaccine design

Stroke - Premarket notification submitted to U.S. FDA for stroke risk assessment test

Stroke - Research add new data to stroke body of knowledge

Sudden Infant Death Syndrome - Tobacco industry pays scientists to challenge secondhand smoke's health risk

Syphilis - Syphilis rates increasing around the world

Syphilis Epidemic - Syphilis epidemics in U.S. have unforced oscillations every 8-11 years

Toxicology - CDC announces first ever agency-wide research agenda

Transplant Medicine - Japan has first death of heart transplant recipient

Tuberculosis Vaccine - BCG vaccine protects neonatal calves against M. bovis challenge

Tuberculosis Vaccine - Early BCG vaccination elicits adult-like immune response in calves

Tuberculosis Vaccines - New research in the area of tuberculosis vaccines detailed

Umbilical Cord Blood - Cord blood banking regulated in the EU to assure safety/efficacy

Vaccine Development - Ethics of mandatory childhood immunizations discussed

Vaccine Development - Oral vaccination with biodegradable particulates reviewed

Vaccine Development - Tiered pricing of vaccines is not subsidy

Vaccine Efficacy - Shifts in global immunization goals from 1984 to 2004 reviewed

Vaccines Development - Researchers provide details of new studies and findings in the area of vaccines development

Varicella-Zoster Virus - Polymorphisms to distinguish varicella-zoster virus strains evaluated

West Nile Encephalitis Vaccine - Live measles vaccine expressing protects against West Nile encephalitis

Zoonosis - Hepatitis E virus chimeras portray replication in cultured cells

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