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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . October 3rd, 2004

Non-Subscriber - Summaries Only

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

Angiology - Effects of vascular graft compliance mismatch on protein transport reported

Anthrax - U.S. FDA approves ciprofloxacin to manage postexposure inhalational anthrax

Malaria Transmission -  Anopheles quadrimaculatus distribution and role in malaria reported

Tick-Borne Disease - Method for longitudinally sampling individual Ixodes ticks developed

Vaccine Safety - Fever after immunization reviewed

AIDS/HIV Vaccine - SIVmac Gag p27 capsid protein gene expression in potato reported

Acne - NDA submitted to FDA for acne product

Adverse Drug Events - Erythromycin combined with common drugs may increase cardiac death risk

Age-Related Macular Degeneration - FDA advisory committee reviews Macugen data

Allergy Medicine - FDA approves Clarinex syrup for allergies and hives in children

Anthrax - Anthrax risk from contact with infected livestock increased by hand cuts

Asthma - "Planned-care method" of asthma care reduces kids' symptoms

Asthma - Customized program reduces asthma symptoms in inner-city children

Asthma - Reducing allergens in the home helps inner-city children with asthma

Bipolar Disorder - Newer anticonvulsants for treating bipolar disorder reviewed

Botulism - Symptoms predictive of death in patients with food-borne botulism reported

Bovine Spongiform Encephelopathy - Japanese panel recommends dropping testing of younger cows for mad cow disease

Business Update - Biotech company business update includes vaccine development, financing, growth

Business Update - Technology upgrade cuts costs, improves earnings for China-based company

Business Update - Utah company discloses recent U.S. sales activity and share repurchases

Cancer Risk Factor - Leucomalachite green is mutagenic in female Big Blue B6C3F1 mice

Cancer Risk Factor - Micronucleus test used on epithelial cells from oral cavity of beedi smokers

Cardiac Arrest - FDA approves Sprint Fidelis defibrillation leads for sudden cardiac arrest

Cardiovascular Care - New labels can tout heart-healthy ingredient

Catheters - FDA clears new hydrophilic antimicrobial catheter for U.S. sales

Chemical Hazard - Study shows high levels of dioxin in New Zealand residents near chemical plant

Childhood Immunization - Dominican Republic immunization project announced

Complementary and Alternative Medicine - Expert warns of dangers of self-medicating with herbal medicines

Constipation - FDA approves Zelnorm as therapy for chronic constipation

Cryptosporidium - Host-adapted Cryptosporidium species in Canadian geese reported

Deep Vein Thrombosis - Agenix files ThromboView application for Canadian trials

Depression - Sex and drug use increase teen suicide risk

Depression - Suicide huge but preventable public health problem, says WHO

Dermatology - Dermatology drug market expected to grow 8% per year through 2008

Diagnostics - FDA grants expedited PMA review for LUMA Cervical Imaging System

Diet and Nutrition - Public health nutrition and food policy reviewed

Disease Management - Cancer survivors' other medical problems poorly managed

Drug Development - Japanese drug company launches urinary incontinence, frequency treatment in E.U.

Environmental Health - Biotech company settles with U.S. Justice over alleged Clean Air Act violations

Environmental Toxins - World Trade Center workers find high rates of respiratory, mental problems

Epidemiology - Korean-American women need education, access to cancer screening

Epidemiology - New report maps women's health in the United States

Epilepsy - Pharma company receives tentative approval for Gabapentin capsules

Fabry Disease - Enzyme replacement therapy for Fabry disease reviewed

HIV/AIDS - HIV vaccine progresses towards next phase

HIV/AIDS Healthcare - Model estimates resource needs for global HIV/AIDS healthcare services to 2007

HIV/AIDS Healthcare - Rapid-feedback model improves retention rate of HIV/AIDS healthcare intervention

HIV/AIDS Therapy - Optimization of antiretroviral resources is necessary to provide better access

HIV/AIDS Therapy - UNAIDS Drug Access Initiative evaluated in Chile

Healthcare & Politics - Promises of big spending on health dominate election campaign in Australia

Healthcare Coverage - Children with special health needs not getting consistent care

Healthcare Coverage - Guidant applauds proposed coverage of carotid artery stenting

Hepatitis - Application filed to market Pegasys for hepatitis and AIDS coinfection

Hepatitis B Vaccine - Dendritic cell vaccine for hepatitis B infection therapy is promising

Hepatitis B Vaccine - Hepatitis vaccine nonresponse linked to impaired lymphocyte activation

Hepatitis B Virus - Structure of glycans in hepatitis B virus surface proteins determined

Herpesvirus - HSV-2 EIAs vary in sensitivity/specificity of sub-Saharan African samples

Herpesvirus Vaccine - HSV-1 vaccine prevents clinical changes of HSV-1 encephalitis

Human Growth Hormone - FDA defers decision on Omnitrope application

Infectious Disease - $18 million bioinformatics center to become weapon against deadly diseases

Influenza - Antiviral medication Tamiflu to play role in pandemic flu preparedness

Influenza - Number of flu-associated hospitalizations on the rise, especially for elderly

Influenza - The doctors' view of flu vaccines for infants and toddlers

Information Technology - CDC invests $73 million to improve health information services for the public

Insulin - Exenatide new drug application accepted for review by the FDA

Irritable Bowel Syndrome - Cilansetron NDA granted priority review for IBS with diarrhea predominance

Legal Issues - Agency gets guilty pleas

Legal Issues - Biopharmaceutical company updates enzyme-related U.S. patent litigation

Listeria -  Listeria innocua strains with L. monocytogenes genes reported

Liver Cancer - FDA will allow trials for the use of ThermoDox with RFA for liver cancer

Lung Cancer - Lung carcinogenesis in hamsters is inhibited by green tea

Lyme Disease - Identifying tick genes could halt disease, bioterrorism threat

Macular Degeneration - Confidence in Visudyne's potential reiterated for macular degeneration

Malaria - Math model studies effect of environmental fluctuations on malignant malaria

Mammography - Company gets FDA clearance to add digital mammography to PACS

Medical Devices - Company gets additional U.S. FDA clearance for neonatal, pediatric nasal device

Medical Devices - German company gets U.S. patent for artificial heart insert method, device

Medical Devices - Little-known FDA labs push medical devices to their limits

Medical Devices - Lumbar treatment device manufacturer disagrees with FDA panel's recommendation

Medical Devices - Maker of implantable artificial heart seeks approval for commercial model

Medical Equipment - Diagnostic systems maker receives U.S. FDA clearance on antibacterial test label

Medical Imaging - Coronis 5MP Mammo technology receives FDA 510k approval

Medication Compliance - Many patients never tell doctors they underuse medications because of costs

Meningitis - Growing numbers of colleges vaccinating against deadly brain disease

Mental Health - U.N. says suicide preventable if authorities and individuals take precautions

Myeloma - Foundation receives million-dollar grant from CDC

Myocardial Infarction - Canadian regulatory clearance received for RAMP Cardiac Marker Tests

Nerve Healing - FDA issues 510(k) clearance for NeuraWrap Nerve Protector

Obesity Pathogenesis - IGF-I stimulates cell growth and lipogenesis during adipocyte differentiation

Obstetrics - Some pregnant women are prescribed unsafe drugs

Occupational Safety - Ventilation in bars, casinos doesn't control health risk for hospitality workers

Orthopedics - Tissue repair technology company receives bone graft substitute FDA clearance

Pacemakers - FDA approves advanced digital pacemaker

Pancreatic Cancer - FDA orphan drug designation granted for AGRO100 in pancreatic cancer

Parkinson Disease - FDA approves Parcopa orally dissolving tablets for Parkinson disease

Parkinson Disease - FDA grants final approval for Parcopa

Patents - Company announces termination of litigation with Novartis

Patient Education - Government web site too complicated for U.K. diabetes sufferers

Patient Safety - Government study finds nearly half a million medical device injuries a year

Personnel - Lynda Sutton named director and VP of regulatory affairs by biopharm company

Pneumocystis Infection - DHPS gene mutation found in P. jiroveci isolates from sulfonamide-naïve patients

Polio Vaccination - Inoculation teams deploy after end of polio-vaccine boycott

Prescription Drugs - Common antibiotic can trigger cardiac deaths when used with other drugs

Proteomics - Gas-phase fractionation by mass spectrometry can improve protein identification

Proteomics - Nucleotide exchange factor ECT2 regulates PKC xi activity

Psychotropic Drugs - FDA grants SPA for 2 pivotal phase III trials of CORLUX

Quality Assurance - Washington state hospitals volunteer for CMS quality improvement initiative

Regulatory Issues - FDA makes correction: Extina user fee goal date is November 26, 2004

Respiratory Medicine - Multitarget vaccine against respiratory infections may be possible

SARS - Simultaneous multigene DNA sequencing identifies SARS coronavirus

SARS Virus - Method to detect coronavirus nucleocapsid protein in SARS patients developed

Salmonella - Multidrug-resistant typhoid result of 1-2 clones with single resistant plasmid

Smallpox Vaccine - Virus B5R protein antibodies neutralize vaccinia immune globulin

Staphylococcus Aureus - Math model explains MRSA outbreaks and success/failure of control measures

Stents - FDA approves new stent system to help prevent stroke

Substance Abuse - Surrogate parenting may help undo damage of prenatal cocaine exposure

Tobacco Use - No ethnic differences observed in smoking topography or cardiovascular response

Transfusion Medicine - Fatalities caused by transfusion-related acute lung injury reviewed

Transplant Medicine - FDA issues approvable letter for Certican

Transplantation Medicine - Korean government regulations on cellular therapy outlined

Tuberculosis - Hierarchy of control technologies improve health care facility infection control

Tuberculosis Risk Factor - Tuberculosis associated with etanercept, a tumor necrosis factor inhibitor

Tuberculosis Vaccine - IL-4 expression increased in cells from contacts of M. tuberculosis

Varicella - Chicken pox vaccine saves money, protects whole population

Varicella-Zoster Virus - Three major genotypes of varicella-zoster virus identified

Vibrio - Diversity and dynamics of north Atlantic coastal Vibrio community reported

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