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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . November 30th, 2003

Non-Subscriber - Summaries Only

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

Salmonella - Serogroup-specific PCR assay for Salmonella enterica O:6,14 developed

Virology - Simian virus 2 and other simian picornaviruses represent new genus

Addiction Medicine - Social support reduces depressive symptoms in HIV-positive drug users

Obstetrics - Drinking before pregnancy increases risk of small-for-gestational-age birth

Poliovirus - Serial recombination found in type 1 wild-vaccine recombinant polioviruses

Typhus - Flying squirrel-associated typhus reported in United States

AIDS Prevention - New CDC-funded HIV program at UNC integrates treatment with prevention

AIDS Therapy - Doctors announce first NIH-funded AIDS treatment research in Africa

AIDS Therapy - HDL increases observed in study of new protease inhibitor Lexiva

Acute Bipolar Mania - New drug application submitted for acute bipolar mania treatment

Addiction - HHS announces $17.5 million grant to fund intervention services in Illinois

Adenovirus - Adenovirus mounts strategic attack on host cell gene expression

Angina - FDA issues approvable letter for Ranexa

Awards - NewsRx wins 2003 eHealthcare Leadership awards

Biowarfare - Applied epidemiology and training improves response to bioterrorism

Biowarfare - Prevention and treatment of bacterial bioterrorism agent diseases reviewed

Bipolar Disorder - Approvable letter granted for Seroquel (quetiapine fumarate)

Bladder Cancer - Tocosol Paclitaxel receives expedited review for bladder cancer indication

Blood Clotting Disorders - FDA clears 11 diagnostic tests for risk of cardiovascular disease

Childhood Immunization - Study eyes kids' problems, mercury link

Cholesterol - Cholesterol's role in mechanism of cytolysins redefined

Clinical Studies - Firm to pursue differentiation of Parkinsonian from non-Parkinsonian syndromes

Collaborations - Agreement inked for first drug-eluting stent to undergo trials in Japan

Community-Acquired Pneumonia - Levaquin receives FDA approval for 5-day treatment of CAP

Compliance - Indiana injectable- and dry-products facilities meet FDA GMP standards

Corynebacteria - Iron limitation affects adherence and carbohydrates of Corynebacterium

Depression - PMA supplement submitted to FDA for VNS therapy

Diabetes Management - Company launches Paradigm 712 insulin pump with larger reservoir

Diabetic Peripheral Neuropathy - New drug application submitted for neuropathic pain treatment

Emergency Medicine - Current status of research without consent reviewed

Environmental Health - Levels and chiral signatures of organochlorines in human tissues reported

Environmental Health - Polybrominated diphenyl ethers found in Japanese mother's milk

Environmental Health - Polybrominated diphenyl ethers found in breast milk of Swedish mothers

Ethics - Grants support health disparities in biomedical research

Finance - CAMPATH momentum leads to improved 2003 sales guidance

Finance - Ganite maker reports reaching major corporate milestones in third quarter

Finance - Hectorol maker reports 50% increase in sales

Finance - Smallpox vaccine maker gives clinical update, reports DKK 414.3M in revenue

Generics - Company gets final FDA approval for fenofibrate capsules ANDA

Glycemic Control - Tentative FDA approval granted for generic Glucophage

HIV/AIDS Epidemiology - Experiences of Puerto Rican family with an HIV-positive member related

Health Statistics - Pregnancy, birth, and abortion rates dropped in U.S. during the 1990s

Healthcare Benefits - Cancer screening help plug healthcare gaps for women

Histoplasmosis - Severe histoplasmosis found in travelers to Nicaragua

Imaging - PoleStar N20 launched for intraoperative MRI

Infectious Disease - Cutaneous leishmaniasis outbreak in Israel reveals novel L. tropica focus

Information Technology - 510k application submitted to FDA to market VeriChip's applications

Information Technology - CDC will use Unisys data center to support public health, safety functions

Injury Prevention - More cycle deaths seen in states not requiring helmets

Leishmaniasis -  Psychdopygus davisi is important vector of zoonotic leishmaniasis

Monkeypox - FDA issues interim rule to prevent transmission

Neuropathic Pain - Plans underway for phase I trial to determine the safety of T-62

Non-Hodgkin Lymphoma - Therapies under development promise improved NHL relief

Obstetrics - Greater pregnancy risks warrant extra counseling for women over age 35

Pancreatic Cancer - SBIR grant will help with development of MagneTarg drug-delivery system

Pharmacoeconomics - Survey confirms drug prices cheaper in Canada

Pharmacogenomics - More data sought on drug-gene interaction

Polymerase Chain Reaction - PCR method identifies Shiga toxin genes and E. coli O157:H7/H-serotype

Prescription Drug Importation - FDA criticizes report on Canadian drugs

Psoriasis - FDA approves Raptiva for chronic moderate-to-severe plaque psoriasis

Public Health - Data for Decision-Making Project improves public health

Pulmonary Hypertension - Intravenous to subcutaneous prostacyclin in pulmonary hypertension reported

Radiation Therapy - FDA clearance granted for Elekta Synergy

Research - NIH establishes rare diseases clinical research network

Research Trends - NIH-sponsored research gets good report card - with room for improvement

Rheumatoid Arthritis - FDA data shows differences in number of serious infections among RA treatments

SARS - First half-hour of SARS infection characterized

SARS - Study: Fewer people can be quarantined in an outbreak

SARS - Vertical transmission of SARS not seen in first liveborn cohort

SARS - WHO says vaccine will take 2 years

Salmonella - Biological options for control of salmonella in poultry reviewed

Schizophrenia - FDA approves Risperdal Consta, a new, long-acting antipsychotic

Smoking Cessation - Young people can help peers resist urge to smoke

Staph Infections - Quebec company submits new diagnostic test for MRSA to Health Canada and the FDA

Stem-Cell Transplantation - Quantitative real-time PCR improves post-SCT CMV detection

Tuberculosis Diagnostics - Chest radiography unnecessary to identify TB among HIV patients

Vaccine Efficacy - Preparing active patients for international travel

Vascular Lesions - Phototherapy system receives FDA approval to treat vascular lesions

West Nile Virus - Neugene antisense for RNA viruses program updated

West Nile Virus - West Nile encephalitis reported in two hematopoietic stem-cell graft recipients

West Nile Virus - West Nile fever-related paralysis caused by motor neuron loss

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