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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . July 4th, 2004

Non-Subscriber - Summaries Only

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

Bartonella - Diversity of Bartonella in rodents of Thailand determined

Cancer Screening - U.S. National Cancer Institute in vitro drug screening has expanded

Colon Cancer - States awarded grant for colorectal cancer prevention educational program

MMR Vaccine - Measles-mumps-rubella vaccination recommended at 12 to 15 months of age

Outbreaks - Model for disease outbreaks in realistic urban networks developed

Age-Related Macular Degeneration - SnET2 NDA accepted by FDA with priority review designation

Allergy Medicine - National study shows 82% of U.S. homes have mouse allergens

Amyotrophic Lateral Sclerosis - Link suspected between soccer and amyotrophic lateral sclerosis

Anemia - Special protocol assessment agreed on for approval-enabling study of Ranexa

Anthrax - CDC collaboration yields new test for anthrax

Anthrax - NIH supports phase I clinical trial of DNA-based anthrax vaccine

Anthrax - Public-private partnership extends Dutch-American cooperation in biodefense

Anthrax Vaccine -  B. anthracis antigens for testing anthrax immunity identified

Anti-Infectives - Antimicrobial drug development declining

Atrial Fibrillation - FDA issues non-approvable letter for Revelation Tx

Benign Prostatic Hyperplasia - Biotech firm submits response to FDA warning letter

Bioterrorism - Defense Department starts first responder tech center at Pitt

Biowarfare - Vaccines for the prevention of diseases caused by potential bioweapons

Blood Glucose Monitoring - TrueTrack Smart System receives FDA approval for alternate site testing

Breast Cancer - Application filed for European marketing approval of RSR13 (efaproxiral)

Breastfeeding - FDA warns against women using domperidone to increase milk production

Cancer Epidemiology - Annual report finds cancer incidence and death rates on the decline

Cancer Risk - Illinois holding international conference on PCBs

Cancer Therapy - Companies end Genasense expanded-access program in melanoma

Cancer Therapy - Near-infrared labeled endostatin localizes at tumors in animal models

Cardiac Arrest - FDA issues marketing clearance for AED Plus pediatric capability

Cardiovascular Stents - U.S. patent issued relating to biocompatible HAp coating technology

Clinical Studies - Company initiates Diquafosol phase III dry eye trial

Clinical Studies - Panel recommends CHARITE artificial disc for FDA approval

Contraception - Pregnancy more likely from one act of unprotected sex than previously believed

Cord Blood Stem Cells - U.S. Patent Office requested to re-examine cord blood stem cell patent

Coronary Angioplasty - FDA does not approve application to amend existing Angiomax label

Dengue Fever - IgG1 antibody for neutralization of dengue type 4 virus identified

Diagnostics - FDA approves Second Look 200 for breast-cancer detection

Diagnostics - FDA approves expanded labeling claims for SurePath Liquid-Based Pap Test

Diagnostics - Zargis Acoustic Cardioscan cleared for marketing

Disease Prevention - Connecticut receives $3 million for Lyme disease study

Drug Development - Recombinant anti-MUC1 scFv has improved stability

Endografts - FDA approves Zenith FLEX AAA endograft

Environmental Health - MS method to measure toxaphene congeners in human serum developed

Environmental Toxins - Lead levels not as safe as previously thought

Epidermolysis Bullosa - Thymosin Beta 4 receives Orphan Drug designation for Epidermolysis Bullosa

Erosive Esophagitis - Prevacid IV for Injection approved by the FDA for erosive esophagitis

Food-Borne Illness -  E. coli O157:H7 outbreak linked to salami in British Columbia

Food-Borne Illness - Bioassay suitable for screening of enrofloxacin residues in chicken

Food-Borne Illness - LC/MS analysis of brevetoxin metabolites in Eastern oyster reported

Gastroenterology Vaccine - Progress in enteric vaccine development outlined

Genetic Disorder - Aminoglycoside rescues disease-causing mutation in vasopressin receptor gene

Genomics - FDA, NIH drive clinical genomics: Is widespread application in the near future?

Global Health - Referral to district hospitals key to improving care for severely ill children

HIV/AIDS Prevention - Experts say AIDS prevention and treatment should be integrated to fight epidemic

HIV/AIDS Treatment - Drugs donated by AIDS patients in U.S.helps prolong lives worldwide

HIV/AIDS Treatment - G-8 adopts plan to speed HIV vaccine development

HIV/AIDS Trends - Cases of HIV-infected newborns decline in New York

Health - FDA certificate to export products to Japan granted for RespAide

Hemorrhagic Fever - West Nile virus trial expands to include additional lethal viruses

Hepatitis B Virus - Low-level viremia of hepatitis B found in antibody-positive blood donor

Hereditary Angioedema - FDA permission granted to resume DX-88 clinical trials

Hypercholesterolemia - U.S. FDA grants tentative approval to market fenofibrate tablets

Immunology - Interferon-gamma attenuates interferon-alpha activity in liver cells via STAT1

Immunology - Interleukin-6 obstructs T cell-mediated hepatitis

Injury Prevention - CDC study shows impact of water dangers

Injury Prevention - Frequency of violent behavior among youths similar in different countries

Legal Issues - Federal appeals court says Arizona twins should get Social Security benefits

Legal Issues - United States senators target dietary supplement law

Leukemia - FDA begins priority review of NDA for clofarabine in pediatric acute leukemia

Liver Metastases - Hepatic artery infusion has high partial response but no longevity benefit

MMR Vaccine - Economic analysis of two-dose MMR vaccination program in U.S. reported

Malaria Research - UCSD partners with Peru in NIH grant to battle world's number 2 killer

Measles - CDC lifts suspension of adoptions from Chinese agency

Measles Epidemiology - Epidemiology of measles in the United States from 1997-2001 reported

Measles Epidemiology - Measles outbreak epidemiology in the U.S. in 1993-2001 reported

Measles Epidemiology - Minimum investigation rate for evaluating measles monitoring proposed

Measles Epidemiology - Surveillance is adequate to detect endemic measles in the U.S.

Measles Survival and Mortality - Acute measles mortality in the United States during 1987-2002 reported

Measles Survival and Mortality - Measles hospitalizations during 1985-2002 in U.S. reported

Measles Vaccine - Disparity in measles vaccine coverage in minority children eliminated

Measles Vaccine - Vaccination levels associated with lack of measles in preschoolers

Measles Vaccine - Vaccine-induced antibodies to measles persist 26 to 33 years

Measles Virus - Genetic analysis of measles viruses in U.S. performed

Measles Virus - Measles elimination goals assessed

Measles Virus - Measles elimination in U.S. aids global measles elimination efforts

Measles Virus - Measles virus shedding does not occur with inapparent measles infections

Measles Virus - Overview of measles surveillance in the United States released

Medical Device - Noise in flat-panel displays with subpixel structure investigated

Medical Ethics - Ethics of vaccine research reviewed

Meningitis - Unique variant of disease-causing meningococci characterized

Migraine - FDA issues not-approvable letter for MT 100 migraine treatment

Multiple Sclerosis - Application submitted to European Medicines Agency for Antegren approval

Myelodysplastic Syndromes - First component of Dacogen New Drug Application submitted to FDA

Nutrition - Exercise, fish oil supplements great for the heart

Oncology - New models offer insight into the mechanics of thalidomide analogues

Osteoporosis - PAI complete for nasal-spray facility

Overactive Bladder - Company announces FDA approval of SANCTURA

Overactive Bladder - U.S. FDA approves Sanctura for treatment of overactive bladder

Pharmaceutical Drugs - FDA accuses maker of antiretroviral of misleading promotions

Pneumococcal Vaccine - Pneumococcal vaccine not cost-effective for all elderly adults

Pneumococcal Vaccine - Pneumococcal vaccine prevents pneumococcal disease but not pneumonia

Polio Vaccine - Vaccine-derived poliovirus isolated from sewage in Estonia

Postoperative Ileus - Second portion of NDA submitted for Entereg

Prion Disease - Scrapie protein degraded by cysteine proteases in dendritic cells

Prostate Cancer - Positive phase IIb data reported for ACAPODENE

Public Health - Fluoroscopic safety program at large research hospital described

Public Health - Smoking, obesity connected to income levels and education, analysis shows

Regulatory Issues - Dietary supplement law said inadequate

Regulatory Issues - FDA rejects Illinois drug import pilot program

Rotavirus - Simple method for storage of rotavirus RNA in stool samples developed

SARS Vaccine - DNA vaccines target nucleocapsid protein of SARS coronavirus

Salmonella -  Salmonella enterica Javiana infections linked to amphibian contact

Sexually Transmitted Disease - Guide to sexually transmitted disease resources on Internet released

Smallpox - Smallpox as biological weapon reviewed

Thrombosis - New Arixtra indications: Acute deep venous thrombosis, acute pulmonary embolism

Transduction - Electric field-induced molecular vibration forges DNA transfer

Tuberculosis Vaccine - Pantothenate auxotroph of M. tuberculosis protects guinea pigs

Uterine Fibroids - FDA panel recommends ExAblate System for approval

Virology - Proteasome inhibition boosts viral replication in an HBX-dependent manner

Water-Borne Illness - Filtration protects patients from pathogens in hospital water

West Nile Virus - Company receives approval for WNV protocol with Alferon N treatment

West Nile Virus - SYBR green-based assay detects 100% of West Nile virus target region variants

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