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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . May 30th, 2004

Non-Subscriber - Summaries Only

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

Anthrax - Anthrax lethal toxin neutralization assay validated

DNA Microarray - Correction for dye-bias in microarray gene expression studies reported

Hormone Replacement Therapy - Postmenopausal estrogen guidelines for treating hot flashes released

Lead Poisoning - Lead-contaminated moonshine constitutes significant health hazard

Mycobacterium -  M. tuberculosis strain with resistance to isoniazid identified

AIDS/HIV Therapy - Lymphocytes in transgenic mice are resistant to viral infection

AIDS/HIV Transmission - AZT causes pattern of mutations in Tk gene of mice treated as neonates

AIDS/HIV Vaccine - Immune efficiency correlates with specific targeting

Allergy Therapy - FDA approves chewable allergy medicine for children

Alzheimer Disease - Progress being made toward structural understanding of amyloid fibrils

Alzheimer Disease Therapy - Memantine (Namenda) approved for moderate to severe Alzheimer disease

Anthrax - Anthrax lethal factor-cleavage products of MAPK exhibit reduced binding

Anthrax Vaccine - Glycine prevents thermal inactivation of Bacillus anthracis antigen

Antibiotic Resistance - Pediatrician approach can influence parental agreement with treatment

Arrhythmia - FDA clears steerable cardiac catheters

Assisted Reproduction - Worldwide distribution agreements signed for Cumulase

Asthma - FDA approval granted for Theophylline

Attention Deficit Hyperactivity Disorder - FDA issues approvable letter for Concerta 72 mg

Benign Prostatic Hyperplasia - FDA approves Proscar combined with Doxazosin

Bioterrorism - Bioterrorism fear may cause mass sociogenic illness

Blood Banking - Galileo cleared by U.S. Food and Drug Administration for use in U.S.

Breast Cancer - FDA issues 510k clearance for single-channel device for HDR brachytherapy

Cancer Risk Factor - Nitrites consumed from animal products may increase pancreatic cancer risk

Cancer Vaccine - Immunoregulatory T cells in tumor immunity reviewed

Candidiasis - Company submits NDA for treatment of esophageal candidiasis

Cardiology - Diastolic Ca2+ release controls beat rate of rabbit sinoatrial node cells

Cardiology - Membrane depolarization not needed for diastolic RyR Ca2+ release

Cataract - FDA approves new labeling claims for lens implant

Childhood Immunization - Business strategy used to increase vaccination rates in children

Chronic Pain - FDA approves rechargeable implantable spinal cord stimulation system

Clinical Trials - Cancer therapeutics company names Jerry McMahon CEO; Jack Bowman to retire

Collaborations - Ortec to collaborate to facilitate stem-cell therapy development

Compliance - Report: Many healthcare organizations remain noncompliant with HIPAA

Critical Care Medicine - Discharge diagnoses not suitable for monitoring surgical infections

Cystic Fibrosis - Company announces positive results in cystic fibrosis study

Cystic Fibrosis Therapy - FDA mandates approval for all pancreatic enzyme replacement products

Cytotoxicity - Copper counteracts the toxic effects selenite has on human cancer cells

Dementia - Portraits of dignity in dementia presented

Drug Delivery - Positive results reported on CAP adjuvant study in CDC collaboration

Drug Delivery - Research: ZOMIG nasal spray single dose is rapidly absorbed intranasally

Drug Resistance - Extended-spectrum beta-lactamase-producing bacteria risks outlined

Emergency Contraception - FDA turns down OTC Plan B; outlines necessary information for approval

Emergency Contraception - Medical groups urge FDA not to delay OTC status to EC pill

Endoscopic Products - Flexible Cystoscope with Slide-On EndoSheath System receives FDA clearance

Enterococcus - Three new enterococcal species from human specimens characterized

Environmental Health - Mutations in Big Blue rats fed leucomalachite green analyzed

Environmental Toxins - New research outlines public health consequences of 911 rescue efforts

Epidemiology - Computers combat disease: new modeling grants target epidemics, bioterror

Epidemiology - Prevalence of HIV among childbearing women has declined in New York

Facial Wrinkles - FDA approves Hylaform gel for the correction of facial wrinkles

Finance - Albuferon maker reports increased net losses, mostly due to R&D

Finance - Genasense maker reports first quarter revenues of $1.7 million

Finance - Spinal device company reports 77% increase in net sales during first quarter

Food-Borne Illness - FDA announces modernization of food good manufacturing practices

Gastric Ulcers - FDA accepts NDA for Rapinex powder for oral suspension 40mg

Generic Drugs - Innovative acquires abbreviated new drug application for Cephalexin

Glucose Control - FDA approval granted for Fortamet; Altocor gets new name

HIV/AIDS - SBIR grant to fund company's HIV/AIDS program

HIV/AIDS Treatment - South Africa's government faulted for surging AIDS deaths

Hantavirus - Wounding is primary mode of Seoul virus transmission in male rats

Heart Failure Therapy - Valsartan offers benefits for treatment of heart failure

Hemorrhagic Fever - Bovine aortic endothelial cells susceptible to Hantaan virus infection

Hypertension - FDA grants orphan drug status to Hydralazine

Hypertension - Ranbaxy receives approval to market fosinopril sodium tablets

Immunology - Allergy and immunology organization wins $25 million contract from NIH

Immunology - T-cell sphingosine 1-phosphate receptor regulates thymic egress

Infant Mortality - Breastfeeding decreases risk of infant death in the U.S.

Influenza - Immunization practices group recommends flu vaccine for young children

Injury Prevention - Child safety restraint use increasing in auto trips

Leishmaniasis - Leishmanial amastigote antigen induces natural killer-cell reactivity

Leishmaniasis Vaccine - Vaccine confers resistance to Leishmania donovani in mice

Leukemia - FDA approves Cladribine injection for hairy cell leukemia

Macular Degeneration - SnET2 trial shows promise for AMD

Malaria - Benin gets mosquito nets to protect children, pregnant women

Mental Health - Psychotropic drug interactions reviewed

Metabolic Syndrome - Scientists push forward understanding of "epidemic" diseases

Microencapsulation - All-trans-retinoic acid release nanoparticles reported

Minority Health - Latino/Hispanic diabetes media awareness campaign described

Mosquito-Borne Disease - Devices for monitoring Aedes aegypti in Peru evaluated

Mosquito-Borne Disease - Rainfall and evapotranspiration effects on Anopheles dynamics reported

Neoplasm Therapy - MTH-68/H oncolytic viral treatment promising for high-grade gliomas

Neurotoxin - Electroencephalographic and c-fos responses to dombic acid reported

Nicotine Addiction - Exotic cigarettes popular with minority youth

Nutrition - Group urges FDA to reconsider fat disqualifying level for health claims

Obstetrics - Success in assisted reproduction may be singleton live birth rate

Parkinson Disease - Study suggests levetiracetam may benefit patients with Parkinson disease

Peripheral Vascular Disease - FDA approves laser technology for total occlusions in leg arteries

Pertussis - Levels of pertussis subunits and Ptl proteins in B. pertussis reported

Prostate Cancer - Focus signs agreement with USHIFU to fund prostate cancer clinical trials

Rotavirus - NIAID rotavirus vaccine licensed for commercialization

Rotavirus - NIH attempts to revive controversial rotavirus vaccine

Saccharomyces - Bbp1p required for mitotic functions of Cdc5p in Saccharomyces

Spina Bifida - CDC report compares birth defect rates before and after folic acid mandate

Stroke - Too few Americans aware of stroke warning signs

Trypanosomiasis - FDA grants fast track designation to DB289, for African sleeping sickness

Varicella Vaccine - Two cases of congenital varicella syndrome reported

Ventricular Assist Devices - NIH awards contract to develop heart pump for children

Ventricular Assist Devices - NIH awards contract to develop implantable blood pump for babies

Visual Acuity - FACT tests yield different results due to features affecting viewing

West Nile Fever - West Nile virus present in Guadeloupe animals

Whooping Cough - Pertussis vaccination program may be cost-effective in face of rising incidence

Zoonoses - Only some Enterocytozoon bieneusi isolates have zoonotic potential

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