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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . June 14th, 2006

Non-Subscriber - Summaries Only

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

Addiction Medicine - Unintentional prescription drug overdose deaths increase in New Mexico

Diabetes Epidemiology - Diabetes incidence is increasing in U.S. adults

Food Safety - Method to quantify tetrabromotetrachloro-fluorescein analog in color additives is developed

Hepatitis B Outbreak - Methamphetamine injectors are at high risk for hepatitis B virus infection

Streptococcal Vaccine - Opsonophagocytic assays to identify Streptococcus pneumoniae antibodies were evaluated

Adenovirus Vaccine - Adenoviral respiratory illness in U.S. military recruits is increasing

Aspergillosis Diagnostics - MDVI measures therapeutic response to antifungal therapy in invasive pulmonary aspergillosis

Avian Influenza - Checklist helps long-term care and other residential facilities prepare for an influenza pandemic

Avian Influenza - Survey shows North Americans still don't understand avian influenza risks

Awards - Cyberkinetics' collaborator and inventor of Andara OFS device honored

Behavioral Medicine - Cyberonics announces patient enrollment in new dosing study for treatment of resistant depression

Business & Finance - Advancis Pharmaceutical receives U.S. FDA approval letter for new strengths of Keflex

Business & Finance - Chembio reports 238% increase in net product sales over same period last year

Business & Finance - Corautus Genetics reports update on therapeutic development program, announces quarterly results

Business & Finance - DOR BioPharma, Inc. reports first quarter financials, reviews achievements

Business Update - Elsevier MDL unveils PharmaPendium, a new drug safety product

Business Update - U.S. FDA grants clearance for Sysmex' new hematology analyzer for clinical use

Cancer Diagnosis - Neoprobe receives U.S. FDA clearance for Lymphoseek clinical study

Cancer Therapy - U.S. FDA grants marketing approval to Valeant for cannabinoid oral capsules to treat nausea

Cardiac Medical Devices - St. Jude Medical's new electrophysiology devices get U.S. FDA approval and CE Mark

Cardiac Medical Devices - U.S. FDA grants approval of St. Jude Medical's OCD and CRT heart failure devices

Cardiac Medical Devices - U.S. FDA grants marketing approval for smallest implantable cardioverter defibrillator

Cardiology - U.S. FDA approves IDE for added enrollment in Thoratec's HeartMate II pivotal trial

Clinical Trials - Threshold Pharmaceuticals reports changes to TH-070 clinical development program

Cytomegalovirus - Fetal effects of cytomegalovirus infection in pregnancy are the focus of review

Dengue Fever - Sample-size requirements for strategies to control dengue have been reported

Dengue Vaccine - Fusion protein dengue vaccine is protective in nonhuman primates

Dermatology - Barr receives approval for Isotretinoin Capsules USP, 30 mg

Diabetes Therapy - Community health workers improve knowledge of people with diabetes

Diet & Nutrition - Vitamin D deficiency and secondary hyperparathyroidism risk is higher in obese Black Americans

Drug Development - Dendreon presents data on potential new active immunotherapy for treating renal cell cancer

Drug Development - Dyax provides update on regulatory pathway for DX-88; Phase III trial on track to complete 2H06

Drug Safety - Survey data show 7 in 10 doctors concerned about prescription medicines safety

Environmental Health - Perfluorinated chemical exposure is widespread in U.S. population

Finance - Cellegy reports drop in R&D expenses in first quarter

Finance - Iomai reports net loss in Q1 2006 of $5.5 million compared to $5 million in Q1 2005

Finance - Tunnell Consulting awarded multimillion dollar U.S. HHS contract to fight avian flu

Gene Research - Canine X-linked severe combined immunodeficiency was corrected by gene therapy

HIV/AIDS Epidemiology - High syphilis rates among STI patients contribute to HIV-1 spread in India

HIV/AIDS Healthcare Costs - Lifetime treatment costs remain relatively stable for perinatally HIV-infected children

HIV/AIDS Quality of Life - Quality of life similar with long-cycle structured intermittent versus continuous HAART

HIV/AIDS Risk Factors - Early initiation of injection and needle-sharing high among heroin users in China

HIV/AIDS Vaccine - Subtype C in-frame gagpol fusion gene vaccine shows promise against HIV/AIDS

HIV/AIDS Vertical Transmission - Girls at higher risk for in utero and perinatal HIV infection

Hair Loss - Researchers offer help - but no miracle cure - for receding hairlines

Hantavirus Vaccine - Vesicular stomatitis virus containing Hantaan virus envelope glycoproteins was used for vaccine

Hepatocellular Cancer - New prognostic subtype of human hepatocellular carcinoma derived from hepatic progenitor cells

Hip Replacement - U.S. FDA grants approval for hip resurfacing product as alternative to replacement

Human Papillomavirus Vaccine - Parental acceptance of adolescent HPV vaccine is critical for success

Hunter Syndrome - U.S. FDA extends review period on license application for Hunter syndrome treatment

Influenza Vaccine - Influenza A NP-expressing vaccinia virus protects against human and avian influenza

Influenza Vaccine - Influenza vaccine containing A/Panama/1999 induces broad protection against influenza

Influenza Vaccine - Mitigation strategies for pandemic influenza in U.S. are presented

Japanese Encephalitis Virus - Nationwide survey of encephalitis virus antibodies in Japan is reported

Legal Issues - Securities class action filed against Discovery Laboratories, Inc.

Legal Issues - Stratagene Corporation settles litigation on proprietary enzyme blends

Leishmaniasis Vaccine - Three vaccination strategies against Leishmania major were compared

Liver Cancer - Study finds radioactive microspheres prolong survival in metastatic liver cancer patients

Malaria Vaccine - Clinical trial of candidate malaria vaccines RTS,S/AS02A and MVA-CS is reported

Market Analysis - Report suggests China expected to become fifth largest drug market in the world by 2010

Measles Vaccine - Serology indicates greater measles vaccine coverage than immunization records

Medical Devices - Approval granted for BioForm Medical's Coaptite implant to treat urinary incontinence

Medical Devices - CE Mark granted to market the Excor Mobile Driving Unit with the CardioWest TAH-t in Europe

Medical Devices - St. Jude Medical announces U.S. FDA clearance of software for cardiac mapping, navigation

Mental Health - Parents can help children cope with violence

Neuroscience - NF-kappa B has roles in nerve cell survival, plasticity, and disease

Obstetrics - Rubella infection in pregnancy is focus of review

Occupational Health - Pesticide-related illness is common among emergency responders in U.S.

Otorhinolaryngology - Cochlear implant users may respond better to sine-wave speech signals

Ovarian Cancer - U.S. FDA grants orphan drug status to combretastatin A4P for treating ovarian cancer

Pain Management - BioElectronics announces new 510(k) market clearance application filed for pain relief device

Parkinson Disease - Parkinson drug receives U.S. FDA approval

Parkinson Disease - U.S. FDA approves Azilect to treat Parkinson disease

Parkinson Disease - U.S. FDA approves Teva's generic once-daily rasagiline tablet for Parkinson disease

Patents - Carrington gets added U.S. patent protection for antigen-sparing influenza vaccines

Personnel - Mason Diamond elected industry representative to U.S. FDA advisory dental products panel

Pneumococcal Vaccine - Method for evaluating antipneumococcal surface adhesin A antibodies has been developed

Pneumococcal Vaccine - Number of doses of pneumococcal conjugate vaccine may be reduced in children

Pneumococcal Vaccine - Pneumococcal vaccine is changing bacteremia epidemiology in children

Prostate Cancer - Cell Genesys receives Fast Track status for GVAX immunotherapy for prostate cancer

Stroke - Biosite to withdraw Triage Stroke Panel premarket application

Surgical Technology - PLC Systems' CO2 TMR Heart Laser Technology receives marketing approval in Japan

Vascular Disease - Dade Behring launches CardioPhase hsCRP test for use on its Dimension systems

Yellow Fever Vaccine - Yellow fever booster response is affected by prevaccination serology

Contraception - Researchers from the United States publish new studies and findings in the area of contraception

Depression - Findings from the United States, United Kingdom and Czech Republic describe new data in depression research

Diabetes - Data from the United States and Japan advance knowledge in diabetes research

HIV/AIDS - Recent studies from the United States add new data to HIV/AIDS research

HIV/AIDS - Studies from the United States, France and People's Republic of China add new findings to HIV/AIDS body of knowledge

Influenza - Findings from the United States, Brazil and United Kingdom describe new data in influenza research

Influenza - Research from the United States in influenza provides new insights

Influenza - Researchers from Italy, the United Kingdom and Chile provide details of new studies and findings in the area of influenza

Influenza - Researchers from Japan and the United States detail new studies and findings in the area of influenza

Influenza - Researchers from the United States and United Kingdom report recent findings in influenza

Leishmania - New findings in leishmania described from India, Germany and the United States

Malaria - Researchers from the United States and Australia publish new studies and findings in the area of malaria

Meningitis - New findings from Cuba, the United Kingdom and Switzerland in the area of meningitis described

Oncology - Researchers from the United States and Japan detail new studies and findings in the area of oncology

Polio - Recent findings in polio described by researchers from the United States and South Africa

Respiratory System - Research from Netherlands, United States and United Kingdom in respiratory system provides new insights

SARS - Reports from the United States, People's Republic of China and United Kingdom add new data to SARS research

Tuberculosis - Findings from Mexico, the United States and India describe new data in tuberculosis research

Tuberculosis - Researchers from the United Kingdom, India and Kuwait detail new studies and findings in the area of tuberculosis

Tuberculosis - Researchers from Wales, Switzerland and Turkey publish new studies and findings in the area of tuberculosis

Vaccines - Recent studies from Canada and the United States add new data to vaccines research

Vaccines - Reports from Japan and the United States add new data to vaccines research

Vaccines - Reports from the United States and Japan advance knowledge in vaccines research

Vaccines - Research from Taiwan, the United States and the United Kingdom add new data to vaccines body of knowledge

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