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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . February 19th, 2006

Non-Subscriber - Summaries Only

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

Cancer Therapy - Report presents useful techniques for evaluating cancer control efforts

Influenza Vaccine - Nucleoprotein vaccine protects against multiple influenza subtypes

Listeriosis Outbreak - Multistate U.S. outbreak of listeriosis is linked to turkey deli meat

Pneumonia - Study examined trends in hospitalization for pneumonia among elderly in U.S.

Smallpox Vaccine - Study characterized vaccinia virus antigens recognized by vaccinia immune globulin

Addiction Medicine - Review examines future advances in addiction treatment

Adolescent Health - Availability of fruits and vegetables is low in secondary schools

Adverse Drug Reaction - Antibiotic linked to severe liver problems

Age-Related Macular Degeneration - Preliminary phase III data shows Lucentis improves vision in AMD compared with Visudyne

Allergy & Immunology - Mold from moisture-damaged buildings causes occupational asthma in Finland

Allergy & Immunology - Study examined link between past infectious disease and allergic disease

Antimicrobials - Superoxidized water with neutral pH and disinfectant activity has been developed

Asthma Therapy - Geographic variation is found in asthma quality measures within and between health plans

Atrial Fibrillation - Ximelagatran is not non-inferior to warfarin

Awards - Three proposals funded through association's TREAT amyotrophic lateral sclerosis program

Behavioral Science - University study of owls finds link in brain between sight and sound

Bioethics - Human embryo cloning prohibited in Hong Kong

Bioterrorism - CombiMatrix awarded additional $2.4 million from the U.S. Department of Defense

Bioterrorism - Defense contractor files grant proposal for biological and chemical testing diagnostics

Blood Safety - Catheter-associated K. oxytoca and E. cloacae outbreak occurred in chemotherapy center

Blood Safety - Study questions recent policy on screening of U.S. blood donations for WNV

Blood Transfusion - RhD typing for blood transfusion is not needed in southeast Asian populations

Breast Feeding - Women need strong support systems to continue breast-feeding

Business Update - AIDS vaccine, neuroscience drug developer discusses corporate milestones

Cancer Research - New development enables longer survival of cells, allowing opportunity for measurement

Cancer Therapy - Positive early responses reported on use of HepaSphere Microsphere for liver cancer

Cancer Therapy - Study explored zebularine metabolism by aldehyde oxidase in hepatic cytosol

Cardiac Resynchronization Therapy - Novel transvenous approach enables pacing lead implantation in pericardial space

Cardiovascular Disease - Report addresses pharmaceutical therapy of pAVK in nonambulatory patients

Celiac Disease - Study identified immunodominant epitopes of alpha-gliadin after oral immunization

Cervical Cancer Vaccine - Transcutaneous immunization protects against HPV-induced tumors

Child Mortality - Economic growth is linked to widening poor-rich gap in under-five mortality

Clinical Trials - New U.S. FDA rules expedite testing of pharma company's phase I compounds

Clinical Trials - Positive new survival findings reported from phase II and III clinical trials of orBec

Collaborations - Coalition kicks off Community Pharmacy Safety Network

Dental Care - High-viscosity (ART) glass ionomer sealants have higher chance of preventing caries

Dental Care - Review examines oral and dental aspects of child abuse and neglect

Diabetes Pathogenesis - Elevated expression of alpha-crystallins may instigate diabetic complications

Diagnostics - Loop-mediated isothermal amplification assay detects C. difficile toxin B gene

Diagnostics - Standard anti-Tn antibodies and lectins have unexpected cross-reactivity

Diet & Nutrition - Sociodemographic factors affect food habits of adolescents in China

Drug Development - Dual orphan drug designation granted for Myodur for neurodegenerative diseases

Drug Development - Sanderling Ventures awards $1.5 million for clinical development of heart therapy product

Drug Development - U.S. FDA accepts supplemental NDA for 5-day pneumonia treatment with Factive

Drug Development - Update provided on regulatory status of Sparlon for ADHD

Drug Safety - Daily oral azithromycin prevents P. vivax malaria in adults

Emergency Medicine - Darkness, bad weather increase EMS helicopter crash fatality risk

Emergency Medicine - Trauma center care significantly lowers risk of death

Environmental Health - Metabolites of organophosphorus pesticides are common in U.S. population

Facilities - Medical imaging company relocates headquarters to accommodate growth

Finance - Biopharma company raises $14.5 million in series A financing

Finance - Surgical lasers maker reports 4.7% revenue increase for quarter ended September 20, 2005

Food Safety - pH and salt concentration of cooked food affects E. coli O157:H7 survival

Food-Borne Illness -  Salmonella in aquacultured shrimp is linked to fecal bacteria in pond water

Generic Drugs - Contract signed with Indian pharmaceutical company Wintac to manufacture generic drugs

HIV/AIDS Diagnostics - Studies add new findings to HIV/AIDS diagnostics body of knowledge

HIV/AIDS Vaccine Trials - European commission recommends criteria for European and African HIV/AIDS vaccine trials

HIV/AIDS Vaccines - Reports add new data to HIV/AIDS vaccines research

Herpes Vaccine - CpG ODN enhances HSV DNA vaccine efficacy against genital herpes

Hypertension - Pharma company announces phase III results of SPP100 as hypertension therapy treatment

Influenza - Changes recommended for use of antivirals for influenza

Influenza - Fewer than half of U.S. healthcare workers get flu shots

Influenza Vaccine - Universal influenza immunization is cost-effective in children 6 - 23 months old

Injury Prevention - Children's movies are lacking in depiction of injury prevention practices

Legal Issues - Implant maker granted FCC waiver

Leishmaniasis - K39 ELISA to detect visceral leishmaniasis is improved

Magnetic Resonance Imaging - Method estimates nonstationary noise in functional MRI

Malaria - Older drugs may be good stopgap treatment for malaria in Africa

Malaria - WHO issues new malaria treatment guidelines

Malaria Vaccines Development - New findings in malaria vaccines development described

Medical Devices - Company announces U.S. FDA 510(k) filing for antibiotic eluting surgical mesh

Medical Devices - Company submits 510(k) application to U.S. FDA for embolic protection system

Medical Devices - Left driving pressure slope useful for estimating valve cavitation in electro-hydraulic heart

Medical Devices - Third party testing initiated for U.S. FDA certification of air purification device

Medical Devices - U.S. FDA grants regulatory clearance for system to treat wrinkles in periorbital face area

Medicare - DSS survey finds half of seniors will not enroll for Part D benefits

Medicare - Pennsylvania provides help during Medicare transition

Meningitis Vaccines - Researchers detail new studies and findings in the area of meningitis vaccines

Norovirus Outbreaks - Norovirus gastroenteritis outbreak associated with contaminated wedding cakes

Obesity Epidemiology - Increasing obesity prevalence in U.S. poses challenges

Obesity Epidemiology - Obesity in patients with the Leu34Phe proCART mutation maybe caused by a CART deficiency

Obesity Therapy - U.S. FDA panel recommends approval of orlistat 60 mg as over-the-counter weight loss drug

Obstetrics - Findings describe new data in obstetrics research

Obstetrics - Health problems are common in Turkish women discharged early after delivery

Obstetrics - Many pregnancy-related deaths can be prevented

Osteoarthritis - Phase III Pennsaid clinical trail results reconfirm efficacy demonstrated in previous trials

Osteoporosis - U.S. approves quarterly IV injection for postmenopausal osteoporosis

Pain Management - Clinical program to expand use of post-operative pain relief drug

Patents - U.S. patent office grants allowance in biopharm company's second organic arsenic case

Pediatric Vaccine - Model examines parental beliefs about child immunizations

Pelvic Inflammatory Disease - Most pelvic inflammatory disease is diagnosed in ambulatory settings

Philanthropy - Pharma company offers to help local manufacturers produce HIV medicine for sub-Saharan Africa

Pompe Disease - Drugmaker provides update on U.S. marketing application for Myozyme

Product Licensing - Companies sign agreements for U.S. development and marketing of dry eye syndrome therapy

Prostate Cancer - Company realigns to focus on Provenge biologic license application for prostate cancer therapy

Public Health - Americans believe quarantines are helpful in combating disease, but don't support tough enforcement

Quality Assurance - U.K. Stem Cell Bank role reviewed in providing access to human stem cell seed stock lines

Rheumatoid Arthritis - Etanercept is the focus of review

Ricin Vaccine - RiVax milestone achieved

Rotavirus Vaccine - Standardized approaches to monitor rotavirus vaccines are needed

Sexually Transmitted Diseases - Vaginal swabs are specimens of choice when screening for chlamydia and gonorrhea

Smallpox - Studies in mice show potential of antibodies from chimps and humans to protect against smallpox

Smallpox Vaccine - Review examines neurologic adverse events linked to smallpox vaccine in U.S.

Stents - U.S. FDA approves updated IFU for the Cypher sirolimus-eluting coronary stent

Systemic Lupus Erythematosus - Drugmaker updates options for its investigational lupus drug after U.S. FDA meeting

Tick-Borne Disease - Baculovirus that expresses chitinase from hard ticks is potential bioacaricide

Tobacco Use - Increased mortality associated with tobacco and smokeless tobacco use

Vaccine Delivery - Study examined delivery of ODN into saphenous veins and adjunct effect of ultrasound

Vaccine Efficacy - Malaria chemoprophylaxis does not impair response to measles and DPT vaccines

Venous Leg Ulcers - Tissue engineering company anticipates completing enrollment in venous leg ulcer trial

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