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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . September 12th, 2004

Non-Subscriber - Summaries Only

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

Animal Models - Autoclave sterilization produces acrylamide in rodent diets

Ginkgo Biloba -  Ginkgo terpene trilactones quantified in foods

Haemophilus - Rapid assessment tool for Haemophilus influenzae type b developed

Immunology - I-Ed-restricted T-cell epitope of E. coli membrane protein identified

Mutagenesis - Alkaloid riddelliine induces mutations in liver cII gene of Big Blue rats

AIDS/HIV - Recombinant viruses and early global HIV-1 epidemic investigated

AIDS/HIV Diagnosis - Current CDC guidelines for HIV counseling, testing, and referral outlined

AIDS/HIV Therapy - Folding and dimerization of HIV-1 protease yields evidence for stable monomer

AIDS/HIV Therapy - HIV carrying D67N or K219Q/E mutation evolves to zidovudine resistance

AIDS/HIV Therapy - Support utilization patterns of HIV-positive American Natives reported

AIDS/HIV Vaccine - Candidate HIV type 1 vaccines elicit long-term memory B-cell responses

AIDS/HIV Vaccine - Heterologous envelope immunogens contribute to AIDS vaccine protection

AIDS/HIV Vaccine - Multi-subtype gp160 DNA immunization induces neutralizing anti-HIV antibodies

Acne - FDA clears MediLite for acne treatment

Adverse Drug Events - Cancer drug Avastin use increases risk of stroke, heart attack

Alcoholism - Topiramate a potential new medication for treating alcoholism

Angina - Company gets guidance from FDA on percutaneous procedure

Animal Model - Demographics of primate research in the United States analyzed

Animal Models - Organization advocates finding alternatives to animal testing

Anthrax - Dermatological aspects of anthrax reviewed

Antimicrobials - Linezolid-associated peripheral neuropathy reported

Atrial Fibrillation - Medical technology achieves 94% efficiency in treating atrial fibrillation

Attention Deficit Hyperactivity Disorder - FDA approves ADDERALL XR to treat ADHD in adults

Avian Influenza - Contract awarded to develop vaccine against H9N2 avian influenza

Bioterrorism - Company receives $16.4M contract to redesign chemical/biological shelter unit

Blood Products - BPAC recommends COBAS AmpliScreen HBV Test for donated blood

Breast Cancer - FDA approves early stage breast cancer drug

Cardiology - FDA approves extension of expiration date for stent system

Chemotherapy - FDA approves of Avastin manufacturing at Vacaville, California, facility

Cholera Vaccine - Biosafety aspects of live oral Vibrio cholerae vaccine strain examined

Cholera Vaccine - Oral cholera vaccination can play role in controlling cholera outbreaks

Congestive Heart Failure - $6.95 million NIH contract awarded for RVAD development

Crohn Disease - Adacolumn Apheresis System for Crohn disease initiated

DNA Research - Web server performs electronic PCR

Depression Therapy - Blue Cross Blue Shield of Missouri implements doctor notification program

Diabetes - VA beats managed care for diabetes

Diagnostics - New 3-minute rapid HIV test launched in the United States

Diagnostics - Phase I clinical trial initiated for EP-2104R

Diet Trends - Carbohydrate manufacturer asks for simplification of carbohydrate labeling

Drug Delivery - FDA approves OptiClik, new insulin pen system

Drug Delivery - Formulation of oral heparin selected after successful clinical study

Drug Delivery - Medical devices maker files with FDA for insulin infusion set product

Drug Development - Managing delegation in the FDA will reduce delay in new-drug review

Drug Discount Card - Medicare law triggers business model and procedure changes

Drug Importation - Bush says importing drugs makes sense, but only if it's safe

Drug Importation - FDA offers lighter touch on importation of Canadian drugs

Drug Importation - Irish officials call prescription drug import plan unusual

Emerging Disease - Rapid response research to emerging infectious diseases reviewed

Enzymology - Tissue inhibitor of metalloproteinase 2 uses novel mechanisms to control tumors

Eye Health - Lens implant study in final stages of FDA approval, company recruits patients

Finance - Gastro-focused pharmaceutical company reports second quarter financial results

Finance - Healthcare company announces record revenue and income results

Finance - Maker of nucleic acid testing products reports strong financial results in Q2

Finance - Pharmaceutical company announces second quarter 2004 financial results

Genomics - Polymorphic gene sequence type tool developed

HIV/AIDS Prevention - Boston Medical Center awarded $2.25 million to establish prevention program

Hepatitis C - "Self-recovery" from liver infection linked to genes

Hepatitis Diagnosis - FDA approves hepatitis B assay

Hepatitis E Diagnosis - ELISA for hepatitis E detects antibodies to genotypes 1, 2, 3, and 4

Herpesvirus Vaccine - Virus expressing HSV-2 glycoproteins protects against HSV-2 challenge

Hypogonadism - Study demonstrates Striant is effective treatment for testosterone replacement

Imaging - Biopharmaceutical company receives milestone payment from Mallinckrodt Imaging

Inflammation - Wood smoke increases expression of two mucin genes in rat airways

Injury Prevention - One in three abused babies likely to be abused again

Legal Issues - Medical device company files preliminary injunction to stop Syneron shipment

Legal Issues - Pharmaceutical supplier drops legal fight to help Americans buy drugs from Canada

Legal Issues - Vermont sues FDA over drug importation

Leishmaniasis - Leishmaniasis transmission by sand flies enhanced by regurgitation of fPPG

Leishmaniasis Vaccine -  Quillaja saponaria sapogenins protect against visceral leishmaniasis

Lung Cancer - BRM/BRG1 expression has prognostic value in NSCLC

Lung Cancer - FDA approves lung cancer drug

Lupus - Agreement reached with FDA regarding phase IV trial design for lupus therapy

Lyme Disease - Sustained-release doxycycline provides prophylaxis of tick bite infection

Macular Degeneration - Ophthalmology company files IND for therapeutic RNAi

Malaria - Artesunate plus amodiaquine effective for treatment of uncomplicated malaria

Malaria - Molecular analysis of Plasmodium ovale variants reported

Malaria Vaccine -  Plasmodium antigen region elicits antibodies reactive with placental isolate

Malaria Vaccine - Small peptide induces complete protection against malaria

Malaria Vaccine - Splenic dendritic cell subsets prime and boost CD8 T cells

Medical Devices - Cardiovascular device company receives FDA approval to market IVAD in U.S.

Medical Devices - U.S. FDA approves rabbit monoclonal antibody kit for GI tumor diagnosis

Medication Compliance - Rural drinkers more likely to miss doses of HIV meds

Meningococcal Vaccine -  N. meningitidis vesicles and lipo-oligosaccharide protect against septic shock

Mental Health - FDA approves adult attention deficit hyperactivity disorder drug

Mental Health - New FDA analysis backs continuing antidepressant-suicide concern

Mergers & Acquisitions - Medical device maker acquires Irvine Biomedical to expand electrophysiology line

Migraine - FDA approves drug for prevention of migraine headaches in adults

Obesity Survival & Mortality - Nitrogen dioxide air pollution is atherogenic risk in obese subjects

Occupational Health - Economic cost of fatal occupational injuries in the U.S. reported

Ovarian Cancer - Primary infertility due to endometriosis found to be cancer risk factor

Pain - Pain management company, U.S. FDA discuss injectable non-narcotic analgesic

Parkinson Disease - FDA clears gene therapy trial for Parkinson disease

Patents - Company discusses "abandoned" patents

Personnel - Drug-discovery company names George Poste to board of directors

Plague - Strategies for managing suspected plague cases outlined

Plague Vaccine - Vaccine expressing Yersinia pestis antigen protects against plague

Policy - Tobacco firm launches mobile trailers to counter smoking bans

Prion Disease - Transmissible spongiform encephalopathies in ruminants reviewed

Rheumatoid Arthritis - FDA approves HUMIRA to improve physical function in RA patients

Rheumatoid Arthritis - FDA approves use of Mobic tablets for treatment of rheumatoid arthritis

SARS Therapy - ACE2 is target for SARS virus therapies

SARS Therapy - Data collection to assess SARS interventions should be standardized

SARS Therapy - Environmental and occupational health response to SARS, Taiwan, 2003

SARS Vaccine - Structural proteins of SARS coronavirus contribute to protective immunity

Salmonella - VIDAS Salmonella assay should include Rappaport-Vassiliadis medium

Sexual and Reproductive Health - Positive self-concept linked to refusal of unprotected sex

Sexually Transmitted Disease - STD care linked to provider sex, patient sex, high-risk behavior

Smallpox Vaccine - Basics of smallpox reviewed

Smallpox Vaccine - Smallpox vaccine reactions and contraindications reviewed

Smoking Cessation - MDs have more influence on quitting smoking than other healthcare providers

Spinal Fusion - FDA clears resorbable spinal plate and screw system with radiopaque marker

Stem Cell Research - Scientists, engineers seek virtual audience

Tetanus - BLA submitted to FDA for Adacel vaccine

Traumatic Brain Injury - Pharma company receives FDA orphan drug designation for Dexanabinol

Tuberculosis - Kansas prisoner possibly infected scores with tuberculosis

Tuberculosis Vaccine - Mycobacterial lipoarabinomannan and related lipoglycans reviewed

Tuberculosis Vaccine - New vaccines against tuberculosis entering human clinical trials

Vaccine Research - BioPort gets approval for new anthrax vaccine tests

Vaccine Research - Eligible plasma donors defined under new CDC program

Vaccine Research - Government collecting blood from soldiers to create anthrax vaccine

West Nile Virus - Arizona city is epicenter for West Nile virus

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