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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 14th, 2003

Non-Subscriber - Summaries Only

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

Breast Cancer - Mechanisms of Taxol resistance related to microtubules reviewed

Cancer Therapy - IL-4-Pseudomonas exotoxin protein used for malignant glioma therapy

Dengue Fever - Dengue 2 PDK-53 virus used as chimeric carrier for dengue vaccine

Tuberculosis - CD4+ T cells mediate IFN-gamma-independent control of M. tuberculosis

AIDS Epidemiology - Fewer AIDS babies born in U.S. but worldwide transmissions remain epidemic

AIDS Testing - VScan maker receives IRB approval for live testing

Aging - Testosterone research strategies outlined by IOM

Amyotrophic Lateral Sclerosis - Company receives orphan drug designation for ALS drug candidate

Anthrax - Pathology is critical in investigation of cutaneous anthrax

Bradycardia - Company receives U.S. approval of INSIGNIA Ultra pacemaker

Breast Cancer - Incidence of unusually large tumors increased in 1990s

Cancer Epidemiology - Report shows prostate leading cancer among men, breast cancer leads for women

Cancer Screening - Elderly women overscreened for cancers with little measurable benefit

Candidiasis - Method to distinguish among Candida species developed

Chemogenomics - Company provides model drug submission to FDA

Diabetes Epidemiology - Incidence of diabetes in developing nations may double

Drug Development - Improved testing of linearity for analytical methods developed

Drug Review - FDA's fast track initiative cut development time by 3 years

Ebola - Human trials start on Ebola vaccine

Environmental Toxins - Feds worried about playground-cancer link

Finance - Company reports revenue of $23.6 million in Q3, provides updates on Erbitux

Gastroenterolgy - Norwalk virus mRNA 3' end regulates VP1 expression via VP2

Gene Mutations - Muse lymphoma thymidine kinase gene mutation assay evaluated

HIV/AIDS Diagnosis - Newly approved rapid HIV-1 test is really rapid

HIV/AIDS Therapy - Early SHIV control in monkeys causes long-lasting asymptomatic outcomes

Heart Pumps - Site selection nears completion for trial of DeBakey VAD for destination therapy

Hematology - Diamond Blackfan anemia stem cells fail to repopulate erythropoiesis

Hepatitis A Virus - Consumers advised that recent outbreaks have been associated with green onions

Imaging - Company obtains FDA approvable letter for mammography CAD

Immunology - CpG oligodeoxynucleotides need second receptor or cofactor to signal

Immunology - G protein coupled receptors allow manipulation of inflammation in vivo

Infectious Disease -  Cryptococcus recombination event may underlie Vancouver Island outbreak

Infectious Disease Diagnostics - Real-time PCR improves respiratory syncytial virus infection diagnosis

Influenza - Early evidence suggests current flu season could be severe

Injury Prevention - Culture affects links drawn between alcohol and injury

Insomnia - FDA extends PDUFA action date for Estorra NDA

Leishmaniasis - Histone H1 antigen protects against cutaneous leishmaniasis in monkeys

Leukemia Therapy - Gemtuzumab ozogamicin treatment of acute myeloid leukemia promising

Malignant Glioma - IL-13 cytotoxin used for malignant glioma therapy

Minority Health - Haircuts and healthcare offered at black men's clinic

Mitral Regurgitation - Myocor presents valve repair abstract, begins Coapsys trial

Mumps Virus - Changes in mumps virus gene sequence linked to phenotype variability

Nicotine Addiction - Study: High school students smoking less

Obesity Epidemiology - Tracking in epidemiologic studies exemplified by obesity study

Obesity Epidemiology - Weight loss programs needed for obese adolescents in Latin America

Occupational Health - DNA adducts from lung tissue of asphalt fume-exposed mice characterized

Osteoporosis - Fracture risk reduction after osteoporosis treatment outlined

Papillomavirus - Peak HPV seropositivity occurs after DNA positivity; duals have high cancer risk

Patents - Patent office allows additional patent claims to STR for cancer therapy

Patents - Patents issued for carbohydrate drug targeting and delivery platforms

Prescription Drug Importation - U.S. wants Canada to better regulate Internet pharmacies

Prostate Cancer - Study finds racial differences in survival rates after treatment

Public Health - CDC launches SMART project on local-level health risk data

Pulmonary Embolism - Gunther Tulip Vena Cava Filter receives FDA clearance for retrievability

Regulatory Issues - NCI, FDA announce two new initiatives as part of strategic partnership

Rheumatoid Arthritis - Phase IIb clinical trials of Pralnacasan discontinued due to toxicity

SARS - High pollution may increase death rate

SARS - Respiratory disease could come back, CDC head says

Smallpox - Studies describe heart disease following vaccination

Smallpox Vaccine - Eosinophilic-lymphocytic myocarditis proven after smallpox vaccination

Smallpox Vaccine - Safer smallpox vaccination regimen modeled for HIV-1-infected patients

Streptococcus - Streptococcal protein GB1 mutation causes large molecular conformation changes

Tachyarrhythmia - ENDOTAK RELIANCE G leads get FDA nod

Toxicology - Glucuronidation patterns of monoester phthalate metabolites reported

Vertebral Compression Fractures - FDA grants investigational device exemption for bone void filler clinical study

West Nile Virus - Company gets $4.3 from NHLBI to pursue licensure of WNV nucleic acid test

West Nile Virus - West Nile/dengue virus vaccine protect monkeys from West Nile virus

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