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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . May 1st, 2005

Non-Subscriber - Summaries Only

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

Antibiotics - Education increases approval of appropriate antibiotic prescription

Flavivirus - Topology in flavivirus stem-loop determines RNA replication competence

HIV/AIDS Transmission - Condom use and perceived risk of HIV transmission investigated

Influenza Virus - Rapid strategy to characterize influenza B reassortants developed

Pacemakers - Security system simulator to test pacemaker compatibility developed

Adenovirus - Five new adenovirus type 37 strains caused epidemic keratoconjunctivitis

Adverse Drug Reaction - Agency issues final risk minimization guidances

Advocacy - Consumer advocacy group submits Citizen Petition to FDA

Alcohol Use - Alcoholism reduces male heart's ability to synthesize protein

Allergy Medicine - FDA approves ASMANEX (mometasone furoate) for once-daily management of asthma

Angiology - Invasive MRI is feasible and apparently safe during peripheral angioplasty

HIV/AIDS Vaccines - Researchers describe findings in HIV/AIDS vaccines studies

Angiology - U.S. FDA clears Trellis-8 catheter

Antibacterial Agents - Study: E. Coli bacteria remains an important threat to U.S. health

Arthritis -  Ulmus davidiana extract suppresses collagen-induced arthritis

Arthritis Pathogenesis - Plasminogen activator system needed for joint inflammation of arthritis

Asthma - FDA publishes final rule on chlorofluorocarbons in metered-dose inhalers

Asthma Pathogenesis - Immunoglobulin-free light chains elicit allergic asthma

SARS - Researchers' data advance SARS research

Atrial Fibrillation - FDA approves Arctic Front IDE for the treatment of atrial fibrillation

Behavioral Health - Lexapro not approved for social anxiety disorder indication

Biochemistry - Study investigated the lifetimes of fluorescent components of matrix NADH

Biotechnology - Lipopolysaccharides removed from protein-lipopolysaccharide complexes

Breast Cancer - MTHFR 677T variant/low folate associated with increased risk of breast cancer

Breast Cancer Risk Factors - CHEK2 1100delC allele frequency is low in breast cancer families

SARS - Studies add new findings to SARS body of knowledge

Breastfeeding - Alcohol consumption disrupts breastfeeding hormones

Business Update - Biopharma files NDA for Enhanze SC

Business Update - FDA approves AcrySof ReSTOR intraocular lens

Business Update - FDA clears heparin-coated cardiopulmonary bypass blood reservoir

Business Update - Immunology-focused biotechnology company updates clinical development plans

Business Update - SinusPharma changes name to reflect focus on chronic rhinosinusisitis treatments

Business Update - Therapeutics co. enters comarketing, supply agreement for therapeutic apheresis

COX-2 - Market research firm predicts prescribing gains for pain drugs

Cancer Research - Therapeutics company offers regulatory update on Cerepro and Vitor

Cardiovascular Disease - Energy intake reduction crucial for weight loss in metabolic syndrome

Cervical Cancer - Killer cell immunoglobulin-like receptor population affects disease risk

Chemotherapy - Epoetin alfa for treatment of cancer-related anemia reviewed

Colorectal Cancer - Abnormal p53 increases risk of death in colorectal cancer

Colorectal Cancer - Beta-catenin and APOE SNPs associated with positive family history of cancer

Congestive Heart Failure - Heart assist device company files for CE Mark approval to market LVAS in Europe

Cord Blood Research - Legislation introduced to create inventory of cord blood stem cell units

Coronary Artery Disease - Increasing BMI improves outcome of stenting for coronary artery disease

Credentialing - Credentials certification deadline nears for NAFTA healthcare professionals

Cryptosporidium Diagnostics - Immunomagnetic separation-PCR discriminates C. parvum and C. hominis

Cystic Fibrosis - Biopharma company granted U.S. FDA fast track status for PTC124

Dengue Virus - New data illuminates research in dengue virus

Dermatology - FDA panels urged to maintain dermatologic corticosteroids as prescription drugs

Dermatology - Safety and efficacy of topical retinoids reviewed

Dermatology - U.S. FDA grants market approval of Fraxel laser for skin resurfacing

Diabetes Therapy - Exubera for treatment of type 1 and type 2 diabetes reviewed

Diagnostics - Blood glucose monitoring system gets FDA approval for alternate site testing

Diagnostics - DHPLC superior to SSCP in screening p53 mutations in esophageal cancer tissues

Diagnostics - FDA grants 510(k) clearance for imaging display system

Diagnostics - U.S. FDA clears Hycor Biomedical autoimmune test for diagnosing celiac disease

Diet & Nutrition - FDA's new rules provide reminder of fish benefits, risks, especially for women

Diet & Nutrition - Methods to determine relation between food and disease risk outlined

Drug Abuse - New findings could change the face of drug addiction treatment

Drug Development - Status of NDA for Tramadol ER updated

Endometriosis - FDA approves depo-subQ provera 104 for management of endometriosis pain

Enterobacter -  Enterobacter cloacae outbreak strain produced VEB-3 beta-lactamase

Environmental Health - DuPont reduces environmental footprint

Environmental Health - Endosulfan and metabolites in plasma and selected tissues analyzed

Environmental Health - Parents fail to set rules to limit children's exposure to tobacco smoke

Fascioliasis - ELISA developed to diagnosis human fascioliasis

Finance - Biopharma company announces net loss of $0.10 per share for the year

Finance - Gastro-focused pharmaceutical company reports Q4, full year 2004 results

Finance - German-American biotech company reports financial results

Finance - Imaging company completes $10.5 million private placement transaction

Finance - NIH grant will further metabolomics research

Finance - Photoselective medicine company announces financial results

Food-Borne Illness -  E. coli O157:H7 in apple juice inactivated by electric fields

Generic Drugs - Tentative approval granted for Levofloxacin Ophthalmic Solution

Genetics & Genomics - Company applauds new FDA guidance for pharmacogenomics

Genetics & Genomics - Study investigated proximate downstream effectors of Notch signaling

HIV/AIDS & Malaria Coinfection - Female adolescents in subSaharan Africa need care for HIV and malaria

HIV/AIDS & Nutrition - Poor nutrition adds to immune degradation in HIV-infected children

HIV/AIDS Pathogenesis - T cell activation in HIV infection higher in Uganda than Western countries

HIV/AIDS Prevention - HIV/AIDS treatment and prevention require a balanced approach

HIV/AIDS Prevention - Physical intimate partner violence does not lead to sexual HIV risk

HIV/AIDS Research - Pharma company submits two new filings of antiretrovirals to WHO

HIV/AIDS Therapy - Atazanavir, once-daily protease inhibitor, reviewed

HIV/AIDS Transmission - Nevirapine is safe, effective, shows new analysis of HIVNET 012 data

HIV/AIDS Tuberculosis Coinfection - PCR useful when microbiological M. tuberculosis diagnosis inconclusive

HIV/AIDS Vaccines - New data illuminates research in HIV/AIDS vaccines

Healthcare Coverage - Urban neighborhoods affect how people think about health

Healthcare Disparity - Health center expansion eliminates health differences

Heart Devices - FDA approves 2000 FlowMaker pivotal trial

Heparin - Approaches to diagnosis of heparin-induced thrombocytopenia reviewed

Hypertension - Increased superoxide anion contributes to hypertension

Imaging - U.S. FDA issues approvable letter for Combidex

Immunology - Long-term spaceflight affects immunoglobulin heavy chains

Immunology - Novel variant of acyl-CoA synthetase isoform 6 identified

Influenza - Complete genome of influenza H5N1 viral isolates from Thailand characterized

Influenza - Priority groups received majority of 2004-05 influenza vaccine

Influenza - Social stress boosts immune system's flu-fighting abilities

Injury Prevention - Golf-related head injuries in children increasing along with sport's popularity

Irritable Bowel Syndrome - 5-HT3 receptor antagonist for irritable bowel syndrome developed

Leukemia Vaccine - Multidrug resistance of leukemia cells decreases tumorigenicity

Listeria Monocytogenes -  L. monocytogenes type 2 outcompetes lineage 1 strains

Malaria - African immigrants living in France have long-term malarial immunity

Malaria Vaccines - Researchers report details of new studies and findings in the area of malaria vaccines

Measles Vaccine - Passive immunity to measles found in breast milk and cord blood of Nigerians

Medical Devices - FDA approval granted for new ECG technology

Medical Devices - U.S. FDA grants clearance for treatment table with 550-pound load capacity

Meningitis Vaccine - Bacterial meningitis vaccination program needed in rural Papua New Guinea

Meningococcal Disease - PorA protein relatively stable during meningococcal disease epidemic

Meningococcal Disease - Sequence variation in meningococci porB gene cause of New Zealand epidemic

Methicillin-Resistance Staphylococcus Aureus - Surgical-site MRSA infections began by healthcare worker with chronic sinusitis

Morbidity & Mortality - WHO report calls for new approach to save lives of mothers and children

Mycobacteria - Non-MTB mycobacteria not present in erythema induratum/nodular vasculitis

Mycobacterium Tuberculosis - Fast/simple flow cytometry determines M. tuberculosis susceptibility

Mycobacterium Tuberculosis - MTB Ag 85B phagosomal processing modulated independently of viability/maturation

Mycology -  Saccharomyces uvarum (Beijerinck) reinstated as distinct species

Mycology - Cycle time effect on fungal morphology during carbon addition studied

Myeloma - Association applauds VELCADE approval

Myeloma - U.S. DOD awards $1.6 million contract to develop bone-targeting nanocapsules

Myocardial Infarction - Differential heart attack risks among blacks, whites remain mystery

Narcolepsy Therapy - Sodium oxybate for treatment of narcolepsy reviewed

Nicotine Addiction - Consumers not getting accurate information about smokeless tobacco

Nicotine Addiction - Youth tobacco use does not decline significantly from 2002-2004

Obstetrics - Maternal iron deficiency disrupts mother/child interaction

Obstetrics - Researchers' findings advance obstetrics research

Oncogenesis - Green tea extract modulates actin remodeling via Rho activity

Oncology - Recent findings in oncology described

Ophthalmology - New corrective eye surgery system to be distributed in Asia

Ophthalmology - U.S. FDA approves ReZoom multifocal refractive lens

Osteoarthritis - Study compares Lidoderm patch and Celebrex in treating knee

Osteoporosis - FDA approves new Fosamax formulation containing vitamin D

Osteoporosis - FDA approves once-monthly Boniva for osteoporosis

Ovarian Cancer - U.S. FDA accepts IND for treatment of advanced ovarian cancer with MORAb-003

Pathogenic Escherichia Coli -  E. coli O157:H7 isolates causing hemolytic uremic syndrome characterized

Pediatrics - FDA approves ZOFRAN for use in children as young as 1 month of age

Pediatrics - Nine-month health visit reformatted to enhance developmental concerns

Pediatrics - Pediatricians must confront community-based threats to health

Personnel - Keith Yamamoto, PhD, appointed to chair of scientific advisory board

Philanthropy - Imaging company donates airway intubation system to Army Hospital in Iraq

Polio Vaccines - Researchers' data advance polio vaccines research

Psoriasis Therapy - Alefacept is a biologic for treatment of psoriasis

Pulmonary Medicine - Mitochondrial DNA damage triggers apoptosis in lung endothelial cells

Quality Assurance - New web site offers hospital performance data

Rabies - Predicted incidence of ruminant neurological disorders vary with species/area

Ralstonia Outbreak -  Ralstonia mannitolilytica outbreak strains molecularly characterized

Receptor Studies - Urokinase receptor binding regulates alpha5beta 1 integrin function

Renal Transplantation - Flow cytometric reactive antibody in renal transplant patients examined

Reproductive Health - WHO releases new online Reproductive Health Library

Reproductive Medicine - Study of cows' ovarian follicles may advance human fertility treatments

SARS - Findings advance knowledge in SARS research

SARS - Hospital Emergency Incident Command System implemented during SARS outbreak

SARS Coronavirus - Studies describe new findings in SARS coronavirus research

SARS Vaccines - New research in the area of SARS vaccines detailed

SARS Virus - Thermodynamics and kinetics of SARS virus glycoprotein folding investigated

Septicemia - New formulation of MethLock wins FDA approval for clinical trial

Sexual & Reproductive Health - Teens believe oral sex is safer, more acceptable to peers

Shaken Baby Syndrome - Education program reduces incidents of shaken baby syndrome

Sickle Cell Disease - Management of sickle cell disease reviewed

Sleep Disorders - Insomnia in elderly linked to risk of falls

Smoking Cessation - 75% who quit smoking with smokeless still smoke-free 7 years later

Spinal Stenosis - U.S. FDA IDE conditional approval granted for arthroplasty device

Stem Cell Research - Engraftment of transplanted mice with hematopoietic stem cells reported

Stem Cell Transplantation - Web-based system developed for QOL/symptom self-assessment after HSCT

Stomach Cancer Risk Factors - Stomach cancer risk not associated with exposure to radon or other radionuclides

Systemic Lupus Erythematosus - Infection with Epstein-Barr virus may increase SLE risk in African Americans

Transplant Medicine - Solution for perfusion and flushing of donor pancreata given U.S. FDA approval

Tuberculosis - Control of tuberculosis in Colombia reviewed

Tuberculosis - Gatifloxacin does not kill M. tuberculosis during stationary growth phase

Tuberculosis - Local characteristics of TB clustering identified via molecular fingerprinting

Tuberculosis Vaccines - Reports describe recent advances in tuberculosis vaccines research

Type 2 Diabetes - Lay perceptions of type 2 diabetes in Scotland outlined

Ulcerative Colitis - Drug development company reports on Nuvion meeting with U.S. FDA

Vascular Graft - FDA approves device to treat descending thoracic aneurysms

Virology - Papillomavirus-based transfection necessitates capsid maturation

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