Food and Drug Law Weekly
Susan Hasty, Publisher
Table of Contents . . . September 29th, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
Adeza - U.S. FDA Advisory Committee recommends approval of Adeza's NDA for Gestiva to prevent preterm birth
BioForm Medical - U.S. FDA Advisory Panel recommends approval of RADIESSE for two facial aesthetic applications
Card Guard - Card Guard receives U.S. FDA 510(k) approval for ambulatory cardiac telemetry solution
Cardinal Health - Cardinal Health suspends production of infusion pump following U.S. FDA actions
CardioVascular BioTherapeutics - CardioVascular BioTherapeutics signs agreement with Kendle for phase II trial
Cas Medical Systems - Cas Medical gets U.S. FDA clearance for expanded use of Fore-Sight Absolute Cerebral Oximeter
China Biopharma - China Biopharma Inc. manufacturing partner receives SFDA approval to deliver flu vaccine
Columbia Laboratories - Columbia Labs comments on U.S. FDA Reproductive Drugs Advisory Committee recommendation on 17-OHPC
Cutting Edge Information - All eyes are on Plan B's over-the-counter switch
EPIX Pharmaceuticals - EPIX receives response from U.S. FDA regarding appeal of Vasovist Approvable Letters
Emergent BioSolutions - U.S. Department of Homeland Security certifies anthrax vaccine adsorbed as approved product
Food and Drug Administration, U.S. - U.S. FDA proposes new rule to automate drug registration and listing
Genta - Genta briefing documents posted for U.S. FDA panel review of Genasense application
ImmuneRegen BioSciences - ImmuneRegen continues Radilex study at Oak Ridge National Laboratory
International Bottled Water Association - Bottled water is safe under U.S. FDA's comprehensive regulatory system
Accera - Accera initiates phase II trial for age associated memory impairment therapy
Adolor - Adolor initiates phase I study of Delta opioid agonist for the management of pain
Aga Khan Foundation, Pakistan - Oral cotrimoxazole acceptable for nonsevere pneumonia at first-level health care facilities
Allos Therapeutics - Allos Therapeutics completes patient enrollment in phase III study of Efaproxyn
American Society for Therapeutic Radiology & Oncology - New study shows three-dimensional radiation therapy improves lung cancer survival rate
American Thoracic Society - Low vitamin E intake during pregnancy can lead to childhood asthma
Applied Biosystems - Alzheimer, Parkinson, dementia targeted in protein study
Barrier Therapeutics - Barrier Therapeutics launches Denavir in Canada
Barts & The London Queen Mary's School of Medicine & Dentistry, U.K. - Periodontitis risk factor for poor response to treatment is smoking
Baylor University, U.S. - Researchers offer advice regarding nutritional supplements
Beijing Institute of Radiation Medicine, People's Republic of China - Endothelial cell mRNA antisense oligodeoxynucleotides designed and screened
Bioxel Pharma - Bioxel continues Europe expansion
Blackwell Publishing - Recent study confirms the warning signs of opioid abuse
Boston College, U.S. - New discovery promises faster, cheaper drug production
Boston University, U.S. - Fentanyl transdermal system in a low-dose is tested in a Phase III study
BrainStorm Cell Therapeutics - BrainStorm Cell Therapeutics receives upgrade by research firm
Bundeswehr Central Hospital, Koblenz, Germany - Researchers' work from Germany, Austria and the South Korea adds to cardiology body of knowledge
Business Update - Invivodata, Medidata to integrate DiaryPRO and Medidata Rave software for clinical trials
Business Update - avVaa World Health Care develops wholesale, Internet sales division with sales agents
Calando Pharmaceuticals - Calando announces initial RNAi product, goals for 2007
Catholic University of Louvain, Belgium - High colonic proglucagon expression may produce observed beneficial effects of oligofructose
Catholic University of Louvain, Belgium - Research from Belgium, Spain and the United States in vaccines provides new insights
Cellegy Pharmaceuticals - Cellegy announces results of committee review of Savvy Nigeria phase III HIV trial
Centers for Disease Control and Prevention, U.S. - Carbapenem resistance in Klebsiella is not detected by susceptibility testing
Chaim Sheba Medical Center, Tel Hashomer, Israel - Researchers from Israel, the South Korea and the United States detail new studies and findings in the area of obesity
Charles University, Czech Republic - Findings from the Czech Republic, Portugal and United States advance knowledge in diabetes research
ChemDiv - ChemDiv, Yale University receive Phase II NIH STTR grant
Chemokine Therapeutics - Dutton Associates updates coverage of Chemokine Therapeutics with Neutral rating
Children's Hospital at Westmead, Westmead, Australia - Delayed adverse events following intravenous immunoglobulin infusions are common
Children's Hospital, Westmead, Australia - Recent findings in diabetes described by researchers from Australia, the United Kingdom and Japan
China Medical University, Taiwan - Glucose tolerance improved using electroacupuncture on bilateral Zusanli acupoints
Chinese Academy of Science, People's Republic of China - Atropurosides A-G evaluated for cytotoxicities against human cancer cell lines
Cidade Universitaria, Brazil - Thyroid cancer patients receiving I-131 radiotherapy evaluated for potential absorbed doses
Cleveland Clinic, U.S. - Research from the United States and Israel add new data to angiology body of knowledge
Columbia Presbyterian Medical Center, New York City, U.S. - Myocardial lesion was formed using high-intensity focused ultrasound
Compound Solutions - Compound Solutions announces CoQ10 agreement with premier manufacturer in China
Cytori Therapeutics - Cytori authors review use of adipose stem and regenerative cells in cosmetic, reconstructive surgery
Dairy Council of California - Nutrition education program effectively conveys basic nutrition concepts to elementary age children
Dana-Farber Cancer Institute, U.S. - Advanced neuroendocrine tumors continue to grow despite antiangiogenic therapy
Dana-Farber Cancer Institute, U.S. - Study uncovers genetic mechanism for drug resistance in lung cancer
Danylo Halytsky Lviv National Medical University, Ukraine - Anticancer thiopyrano[2,3-d][1,3]thiazol-2-ones synthesized
Diabetes Therapy - Clinical endocrinologists team with Lilly to offer tips on diabetes disaster preparation
Diet & Nutrition - More kids are overweight than ever; Del Monte expert provides nutrition tips for parents
March of Dimes, U.S. - March of Dimes: Drug to prevent preterm birth needs prompt U.S. Food & Drug Administration approval
Medical Devices - Stryker receives U.S. FDA clearance for anatomic femoral heads with X3 polyethylene liners
National Institutes of Health, U.S. - U.S. national health leaders issue statements on the totally implanted permanent artificial heart
Pall Corporation - Pall EBDS system detects bacteria in red blood cells
Quest International - Quest International announces clearance for ME551i2 5MP monochrome digital mammography display
Schneider Children's Medical Center of Israel, Petah Tiqwa, Israel - West Nile encephalitis mimics herpes encephalitis
Shire - Shire submits NDA for guanfacine extended release for treating ADHD in children ages 6-17
University of Malaya, Malaysia - World Health Organization criteria for dengue hemorrhagic fever does not always apply
University of Vermont, U.S. - Risk of contrast-induced nephropathy is highest for iohexol
WayPoint Biomedical - U.S. FDA grants clearance for OTC home use drug tests for marijuana, cocaine, others
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