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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 30th, 2005

Non-Subscriber - Summaries Only

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

Diabetes Type 2 Complications - Obesity and metabolic syndrome powerful predictors of diabetes type 2

Drug Resistance - CDC issues public reminder about proper antibiotic use

HIV/AIDS Prevention - One in five HIV-positive men knowingly put sexual partners at risk

Hepatitis C Virus - Testing for hepatitis C should be routine for persons at increased risk

Malaria - Travelers to Dominican Republic should take prophylaxis

AIDS/HIV Vaccines - New findings in the area of AIDS/HIV vaccines described

Adverse Drug Events - Consumer Group: Drug industry volunteer reporting plan falls short

Adverse Drug Events - U.S. FDA gives scientist permission to publish Vioxx safety data

Adverse Drug Reaction - Collaborative to study unanticipated serious adverse drug events using enTRUST

Air Pollution - Several hazardous air pollutants exceed cancer risk level in Portland

Anal Fissures - U.S. FDA issues not approvable letter for Cellegesic

Ankylosing Spondylitis - U.S. FDA approves REMICADE for patients with ankylosing spondylitis

Antimicrobials - Antimicrobial and antioxidant activities of medicinal plants reviewed

Argemone Oil - Argemone oil is genotoxic

Aspergillus - Intake of rice with Aspergillus and polybrominated diphenylethers studied

Atherosclerosis - Hepatic lipase can have a variable effect on atherosclerosis

Atrial Fibrillation - CE Mark clearance granted for the surgical ablation system

Bacteriology - Effect of oxalic acid on bacterial regrowth in drinking water studied

Bacteriology - Polychlorinated biphenyls degraded by newly isolated aerobic bacterium

Benzene - Xenobiotic metabolism and mechanism of benzene toxicity reviewed

Birth Defects - January 24-30, 2005 is Folic Acid Awareness Week

Bladder Cancer - No association between inorganic arsenic concentration and bladder cancer risk

Bovine Spongiform Encephalopathy - Canada, U.S. safeguards provide protection against BSE, USDA official says

Breast Cancer - New findings in breast cancer described

Breast Cancer - U.S. FDA clears use of automated scanning system for PathVysion DNA

Burkholderia - Patterns of genomic variation in Burkholderia species identified

Business Update - Generic pharmaceutical company announces filing of ANDA with U.S. FDA

Cadmium Exposure - Increased cadmium exposure may influence occurrence of disease

Cancer Survival - Reduced health care access and ability to pay decrease cancer survival

Cancer Therapy - Additional information provided to U.S. FTC for melanoma treatment

Cancer Therapy - Clolar wins FDA approval for common pediatric leukemia

Cancer Therapy - IND filed with U.S. FDA for AP5346

Candidemia - Antifungal medicine VFEND receives U.S. FDA approval for blood infection

Candidiasis - CaMIT1 inactivation reduces Candida albicans virulence

Cardiology - New findings in the area of cardiology described

Clinical Trials - Company provides update on cancer and HIV clinical-development programs

Clinical Trials - Results of autoimmune therapy in healthy volunteers study released

Cryptosporidium - Cyclospora oocysts are not ingested by the nematode Caenorhabditis elegans

Cystic Fibrosis - Biopharma company announces phase 1 study for PTC124

Depression - U.S. FDA grants ANDA for generic citalopram hydrobromide tablets for depression

Diabetes Therapy - Phloridzin improves hyperglycemia but not hepatic insulin resistance

Diagnostics - Company chosen to launch thyroid disease detection device

Diagnostics - Methods to analyze irradiated spicy vegetables described

Diagnostics - Microarray system cleared by U.S. FDA

Diagnostics - Neural networks used as statistical tools in epidemiological studies

Diagnostics - U.S. FDA clears standalone APTIMA test to detect chlamydia trachomatis

Diet & Nutritoin - Weight loss strategies work in people with prediabetes

Diphtheria - Proteins required for biosynthesis of diphthamide identified

Drug Development - FDA grants approval for Enjuvia for vasomotor symptoms

Drug Development - Genetically engineered animals in drug development reviewed

Drug Development - Investigational new drug application submitted for cancer candidate

Drug Development - Meeting with U.S. FDA completed for amoxicillin Pulsys phase III trial

Drug Development - NDA for Retaane submitted to U.S., European regulatory authorities

Drug Development - Pharmaceuticals company presents data on potency of antifungal, antibiotic drugs

Drug Resistance - ABC transporters have multiple functions in drug resistance

Emergency Contraception - Study: Readily available EC doesn't increase unprotected intercourse, STI risk

Emergency Contraception - U.S. ob/gyn group: Study findings put spotlight on controversial FDA OTC ruling

Environmental Health - Secondhand smoke linked to cognitive declines in children

Escherichia Coli - Ozone treatment alternative to pasteurization

Escherichia coli - High incidence of ESBLs among outpatient clinical E. coli isolates

Esophageal Variceal Bleeding - FDA issues approvable letter for Sanvar for esophageal variceal bleeding

Ethics - NIH whistleblower says government bungled AIDS study in Uganda

Finance - DNA-focused company announces third quarter 2004 financial results

Finance - Oncology-focused medical device company announces third quarter 2004 results

Food Contamination - F-specific coliphages detected by PCR in fresh market-ready produce

Food Safety - Emerging trends of foodborne illness surveillance and prevention analyzed

Food Safety - Food safety company's germicidal product passes U.S. EPA Protocal testing

Food Safety - Listeria food poisoning cases rose in '03

Generic Drugs - Company launches Halobetasol Cream 0.05% (Rx), and Ointment 0.05% (Rx)

Generic Drugs - Research: Generics provide consumers more savings than price controls

Geriatrics - Data: Florida nursing home residents receive higher quality of care than in 2002

Global Health - Science should be at center of decision making for developing nations

HIV/AIDS Epidemiology - Surveillance needed to track epidemiology of HIV among Mexican migrants in US

HIV/AIDS Healthcare - Education positively associated with awareness of HIV/AIDS-related services

HIV/AIDS Healthcare - Point-of-care rapid HIV testing may improve entry into healthcare

HIV/AIDS Prevention - Acceptability of HIV prevention strategies in central Tanzania explored

HIV/AIDS Prevention - Comprehensive response to HIV could prevent 10 million AIDS deaths in Africa

HIV/AIDS Prevention - Indian media to boost government efforts in combating AIDS

HIV/AIDS Prevention - Misconceptions about medical advances may lead to risky sex practice

HIV/AIDS Prevention - Multifaceted intervention strategy associated with lower HIV rates

HIV/AIDS Prevention - Policy policies analyzed that affect HIV prevention in Mexican migrants

HIV/AIDS Prevention - U.S. NIH overlooked problems in Uganda AIDS study, whistleblower says

Health Education - U.S. young people's views of sexual terms undergo big changes

Healthcare Coverage - U.S. HHS issues final regulation on access to group health coverage

Healthcare Coverage - World leaders vow to work together to help tsunami victims

Infections - Growth of Escherichia coli O157:H7 inhibited in vitro by colicin

Injury Prevention - Children at risk from unexploded military material

Injury Prevention - Injury toll in U.S. homes tops 12 million yearly

Injury Prevention - Most alcohol-related plane crashes occur at night, in bad weather

Injury Prevention - Parents more likely to follow advice if they trust their children's doctors

Injury Prevention - Snowy roads lead to more crashes

Lead Poisoning - Low levels of lead affect proliferation and differentiation of embryonic NSCs

Legal Issues - Augsburg flu shot case referred to federal prosecutors

Legal Issues - U.S. court upholds patent infringement suit against generic antibiotic maker

Legionella pneumophila -  Legionella pneumophila genomes have high plasticity

Leishmania Diagnostics - Real-time RT-PCR and PCR-ELISA quantifies L. infantum from tissue biopsies

Leishmaniasis - Drug company receives regulatory approval in Germany for leishmaniasis therapy

Leishmaniasis - New findings in the area of leishmaniasis described

Listeria - Epidemic L. monocytogenes dairy farm strain causes sporadic human illness

Liver Disease - NIH action plan charts future challenges for research

Lysteria monocytogenes -  L. monocytogenes attachment to alfalfa sprouts leads to irrigation changes

Macular Degeneration - Study shows drug effectively treats neovascular age-related macular degeneration

Medical Devices - Medical device company gets IDE for embolic protection filters in clinical trial

Mental Health - Effects of oral hormone receptor antagonist studied in a primate stress paradigm

Migraine Therapy - Cost of prophylactic migraine treatments outlined

Nanoparticles - Biomolecular interaction between biotin and streptavidin detected

Non-Hodgkin Lymphoma - Pesticide exposure may be associated with increased risk of NHL among women

Obstetrics - Birth simulator helps identify least forceful way to manage problem deliveries

Occupational Health - Welding fumes suppress lung defense responses after bacterial infection

Oncology - Studies advance knowledge in oncology research

Patents - Patent granted for detecting environmentally toxic dioxin-like chemicals

Patents - Patent infringement lawsuit filed against Insmed for growth hormone treatment

Patents - Remote ICU monitoring technology company challenges Visicu's patent rights

Patient Safety - Forum for chief nursing officers emphasizes role of nurses in patient safety

Personnel - Biotechnology company appoints director of regulatory affairs

Plague - Virulence factor expression in Yersinia pestis characterized

Psoriatic Arthritis - U.S., European submissions made for Humira

Public Health - Gangrene, pneumonia, and risk of malaria in some tsunami refugee camps

Pulmonary Hypertension - U.S. FDA approves Ventavis for pulmonary arterial hypertension

Rabies - First rabies survivor without vaccination leaves hospital

SARS - Assay for studying mutations of SARS virus protease developed

SARS - Geographic information system offered real-time tracking of SARS spread

SARS Coronavirus - Reports describe recent advances in SARS coronavirus research

SARS Prevention - Knowledge level regarding SARS transmission associated with formal education

Smallpox Vaccines - Recent findings in smallpox vaccines provide new insights

Substance Abuse - CDC grant enables research on alcohol-exposed pregnancies to continue

Toxicology - Method for in vivo bioluminescent monitoring of toxicity developed

Toxicology - Tool to study oxidative stress and inhalation toxicokinetics developed

Trypanosoma - Plant arginine decarboxylase gene expressed in Trypanosoma cruzi

Tuberculosis Diagnosis - Simple sputum test useful to confirm childhood tuberculosis

Type 2 Diabetes - 7-Hydroxystaurosporine inhibits Akt Thr308) not Ser473 phosphorylation

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