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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . February 15th, 2004

Non-Subscriber - Summaries Only

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

Meningitis - Echovirus type 13 emerging as prominent enterovirus

Adolescent Health - Survey finds 8,000 clandestine abortions occur yearly in Burkina Faso capital

Alzheimer Disease - Namenda now available nationwide

Amyotrophic Lateral Sclerosis - AEOL 10150 clears toxicology hurdle; company makes initial draw on financing

Animal Models - Diets with different levels of soy affect toxicity assessments in rats

Anticancer Therapy - Recent developments in antitumor taxoids reviewed

Avian Influenza - Vietnam last on vaccine list

Avian Influenza - WHO says SARS helped Asia on bird flu

Avian Influenza - WHO suggests quarantine for bird flu

Bacteriology - Accuracy of six systems for Vibrionaceae identification compared

Tularemia - PCR assay for enhanced detection of Francisella tularensis developed

Baylisascaris -  Baylisascaris procyonis found in metropolitan Atlanta area

Biosample Archiving - BioServices division wins contract to establish NIDDK biosample repository

Bipolar Disorder - FDA approves Zyprexa to delay relapse into mania, depression

Bipolar Mania - FDA grants approval for Seroquel

Bone Cancer - Orthopedic implant designed to restore function

Botulinum Toxin - Hemagglutinin element of toxin from Clostridium botulinum identified

Breast Cancer - FDA grants clearance to market Ariol HerSight

Cancer Therapy - CRADA inked for pancreatic, ovarian, and lung cancer antibody development

Chemotherapy - Helsinn signs licensing agreement for palonosetron with Japanese firm

Clinical Trials - Proper metrics for clinical trials outlined

Food-borne Illness - Rugged LC-MS/MS survey analysis developed for acrylamide in foods

Cochlear Implants - Penetrating electrode auditory device successfully implanted

Collaborations - Biopharmaceutical company enters joint SARS clinical program with Vanderbilt

Collaborations - M&H Informatics enters agreement to provide packaging solution

Collaborations - Pharmaceutical company identifies SARS antisense drug candidates

Colon Cancer - Eloxatin approved in U.S. for treatment of metastatic colorectal cancer

Colon Cleaning - Phase II study to begin on new purgative product

Colorectal Cancer - Tumor-related Rac1b not regulated by Rho-GDP dissociation inhibitors

Coronary Artery Bypass - Veterans' healthcare agency has more care problems than private sector hospitals

Dermatology - FDA clears phototherapy technology developed in Israel

Diabetes Pathogenesis - Insulin resistance found in offspring of rats using alcohol while pregnant

Melanoma - Canvaxin therapeutic polyvalent vaccine shows promise against melanoma

Drug Approvals - FDA grants approval for generic contraceptive, manic disorder drug

Drug Costs - FDA says U.S. generics a better bargain than many Canadian drugs

Drug Development - FDA approves generic drug manufacturer based in India

Drug Development - Report: FDA will be pressed to do more with less

Drug Development - UMass medicine hunter tracks plants with healing promise

Enterococcus - Glycopeptide-resistant Enterococcus faecium found in ICU

Environmental Health - Method for dual measurement of urinary bisphenol A and alkylphenols developed

Ephedra - Methods of addressing potential risks associated with ephedra use reviewed

Epilepsy - Expanded indication for Lamictal offers additional treatment options

Fabry Disease - Biopharmaceutical company to ceases to seek U.S. approval of Replagal

Outbreaks -  Vibrio cholerae outbreak linked use of chlorinated water source

Food-borne Illness - Main bacteria contributing to histamine formation in seafood identified

Food-borne Illness - Results from viral monitoring of oysters in polluted estuary reported

HIV/AIDS Pathogenesis - Serum SDF-1 inactivated during HIV infection

HIV/AIDS Prevention - Incorporating HIV prevention into the medical care of persons living with HIV

HIV/AIDS Risk Factor - Transmission risk data lacking in HIV/AIDS surveillance system

HIV/AIDS Vaccine - Multispecific mucosal cytotoxic T cells fail to control SIVmac239

Heart Attack - NIH grant awarded to study the use of adipose-derived regenerative cells

Hepatitis E Vaccine - HEV-neutralizing antibodies recognize antigen of ORF2 protein vaccine

Hereditary Angioedema - Positive phase II study results with Icatibant

Human Papillomavirus - Women's Health Connecticut adopts DNAwithPap test

Weight Gain - Adolescents tend to gain excessive weight during pregnancy

Influenza - Flu continues to decline; just five states now reporting widespread illness

Information Technology - CMS strengthens initiatives with clinical evidence-based criteria

Legal Issues - Makers of OxyContin made unsubstantiated claims, report says

Legionnaires Disease - Type I secretion system in Legionella pneumophila described

Limb Ischemia - Treatment for critical limb ischemia submitted to FDA

Malaria Therapy - Trends in antimalarial drug deployment in sub-Saharan Africa reported

Mergers and Acquisitions - FTC closes review of Novazyme acquisition

Mycobacteria - Clinical management of Mycobacterium fortuitum skin infection outlined

Mycology - Antigens shared by Aspergillus and Penicillium species identified

Obesity - CDC: Obesity costs states billions in medical expenses

AIDS Therapy - IND application filed for protease inhibitor GS 9005

Obesity Prevention - Governments back WHO's anti-obesity plan

Osteoporosis - New phase III study shows positive results for oral monthly Boniva

Pain Medicine - FDA launches consumer campaign on safe use of OTC pain products

Panic Disorder - Emotion-regulating protein lacking in panic patients

Patents - Geron receives favorable ruling in nuclear transfer patent interference matter

Pediatrics - Development of rational therapeutics in children reviewed

Poliomyelitis - WHO considers rapid response to halt polio spread in Africa

Prescription Drug Abuse - Petition requests FDA to require risk management plans for OxyContin generics

Prescription Drug Importation - FDA scrutinizing county's plan to bring in drugs from Canada

Prescription Drug Importation - Iowa governor seeks HHS authorization for pilot program

AIDS and HIV - Gene product restricts HIV-1 replication in resting CD4+ lymphocytes

Product Safety - U.S. regulators uphold ban on silicone gel breast implants to market

Rabies Virus - Novel lyssaviruses isolated from bats in Russia

Regulatory Issues - FDA implements broader requirements for tissue bank registration

Regulatory Issues - FDA sees rebound in approval of innovative drugs in 2003

Regulatory Issues - FDA takes actions against illegal drug import operations

Renal Cell Cancer - Interim clinical results of GTI-2040 in combination chemotherapy announced

Robotics - Robotic mitral valve surgery reviewed

SARS - Flu season helps U.S. prepare for SARS

SARS - WHO finds evidence that animals play SARS role

Salmonella -  Salmonella enterica isolated from humans and food animals characterized

Adolescent Health - New reproductive health program informs girls in Nairobi slums

Schistosomiasis - IL-10 regulates immune responses induced by schistosome vaccine

Seborrheic Dermatitis - Results reported from phase III studies of Sebazole

Smallpox - Smallpox vaccines to be delivered to CDC

Streptococcus - Researchers map pneumococcal surface protein A of strain Rx1

TB Prevention - WHO launches program to curb TB/HIV co-infection

Urology - Bladder screening device approved in U.S.

Veterans Affairs - Group is suing Veterans Affairs' secretary over "rationing" of healthcare services

West Nile Virus - CDC: 2003 West Nile outbreak largest yet

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