Susan Hasty, Publisher
Table of Contents . . . August 18th, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
Abbott - Abbott receives U.S. FDA approval for automated blood screening tests for hepatitis B
Abbott - Abbott receives U.S. FDA clearance for Cell-Dyn Ruby hematology instrument
Adeza - U.S. FDA advisory committee to review Gestiva to prevent preterm births
Alphatec Holdings - Alphatec Holdings announces U.S. FDA clearance of adjustable bridge product
AstraZeneca - AstraZeneca submits NDA for Seroquel for schizophrenia
AtriCure - AtriCure receives U.S. FDA 510(k) clearance for multifunctional isolator transpolar pen system
Aurobindo Pharma - U.S. FDA grants tentative approval for generic Didanosine chewable tablets for AIDS
Bayer - Nexavar receives fast track designation for melanoma from the U.S. Food and Drug Administration
BioDelivery Sciences - BioDelivery Sciences International submits two Emezine study designs to U.S. FDA
Biolase Technology - Biolase gets U.S. FDA clearance for Oculase MD Laser System for ophthalmology
Cambrex Bio Science - Cambrex and Ortec submit to U.S. FDA Humanitarian Device Exemption application for OrCel
Cangene - Cangene's human growth hormone drug submission is accepted for review by FDA
Corgenix Medical - Corgenix submits U.S. FDA Premarket Notification of AspirinWorks Test Kit
Cyberonics - Cyberonics gets U.S. FDA approval for harmonized/modularized VNS Therapy System
Eli Lilly - U.S. FDA approves Lilly's Gemzar for ovarian cancer treatment
AGA Medical - AGA Medical enrolls first patients in U.S. migraine study
Abbott - Small molecule-mediated activation of AMP-activated protein kinase may treat type 2 diabetes
Abiomed - Abiomed enrolls patients in Impella 2.5 pilot trial for high-risk angioplasty
AdvanDx - New rapid species identification test helps physicians identify infection sooner
Ailesbury Clinic, Ireland - Biopolymer polyalkylimide filler acceptable for HAART-related facial lipodystrophy
Almirall - Almirall extends its collaboration with Sareum
American Academy of HIV Medicine - Survey shows twice as many physicians than patients are concerned about HIV drug resistance
American Hospital Directory - Financial impact of Medicare IPPS ruling on hospitals available through ahd.com
American Institute of Physics - Lung tumors eradicated with super-intense radiation delivered by a robotic arm
American Liver Foundation - American Liver Foundation issues warning on dangers of excess acetaminophen
American Medical Association - Estrogen plus testosterone therapy may increase the risk of breast cancer
Arca Discovery - Arca Discovery discusses genetic basis for enhanced response to bucindolol
Arizona Heart Institute, U.S. - Recurrent aortic coarctation is safely treated with endovascular techniques
Avi BioPharma - Avi BioPharma initiates hepatitis C virus study modification
Baker Medical Research Institute, Australia - Researchers from Australia and the United States provide details of new studies and findings in the area of diabetes
Bayer - Bayer HealthCare introduces product trial program for Kogenate FS with Bio-Set
Baylor Health Care System, U.S. - Melanoma vaccine is focus of Baylor Institute for Immunology Research grant
Baylor University, Dallas - Recent studies from the United States and United Kingdom add new data to cardiology research
BioDiem - First patients complete Phase II study of BDM-E in treating diabetic macula edema
BioLineRx - BioLineRx in-licenses orally available peptide to treat obesity
Biomira - Liposomal vaccine increases prostate-specific antigen doubling time after prostatectomy
Brigham & Women's Hospital, Boston, U.S. - Community-based program treats children with multidrug-resistant tuberculosis
Canji - Adenovirus delivery augments treatment of metastatic carcinoma
Cardiff University, U.K. - Breast cancer resistance protein is obstructed by ginseng agents
Case Western Reserve University, U.S. - Dietary fatty acid affects cardiomyocyte apoptosis and PPAR-regulated gene expression
Center Hospital, Lausanne, Switzerland - Well-correlated plasma levels are valid surrogates for cellular concentrations of HAART
Centers for Disease Control and Prevention, U.S. - Marburg virus was linked to large hemorrhagic fever outbreak in Angola
Centre Rene Gauducheau, Nantes, France - New findings from France, the South Korea and Poland in the area of rectal cancer detailed
Charles Darwin University, Australia - Muraglitazar requires more safety testing as a treatment for type 2 diabetes
Children's Cancer Institute Australia for Medical Research - Recent studies from Australia, the South Korea and Brazil add new data to neurology research
Chinese Academy of Medical Sciences, People's Republic of China - Stem cell factor fused with erythropoietin mimetic peptide expressed in Escherichia coli
Chinese University of Hong Kong - Researchers' data from the People's Republic of China, South Africa and France advance HIV/AIDS research
Christie Hospital NHS Trust, Manchester - Researchers from the United Kingdom and Austria report recent findings in ovarian cancer
City University of New York, U.S. - Caregiver feedback increased appointments, reduced emergency room visits in inner city study
Cleveland Clinic Foundation, U.S. - Researchers' findings from the United States and Germany advance imaging research
Cleveland Clinic, U.S. - Early satiety in cancer patients discussed
Cleveland Clinic, U.S. - Head and neck cancer management by induction chemotherapy assessed
Cleveland Clinic, U.S. - Long-term suppression of atrial fibrillation induction may not occur after fat pad ablation
Cleveland Clinic, U.S. - Reverse remodeling is associated with left ventricular pacing at site of maximal mechanical delay
CoVaccine BV - Research from Netherlands, United Kingdom and People's Republic of China add new data to vaccines body of knowledge
Cordis - Data compares clinical indicators of Cypher Sirolimus-Eluting Coronary Stents to bare metal stents
Cortex Pharmaceuticals - Cortex issues CX717 Clinical Hold update
CuraGen - CuraGen and TopoTarget announce initiation of Phase I/II trial of PXD101 for hepatocellular cancer
Dana-Farber Cancer Institute, U.S. - Characterization and development of AMN107 discussed
Food and Drug Administration, U.S. - Real-time quantitative PCR assays to detect virus-specific DNA have been developed
Food and Drug Administration, U.S. - U.S. FDA approves first once-a-day three-drug combination tablet for treating HIV-1
Innovasis - Innovasis announces U.S. Food and Drug Administration clearance for Opteryx Cervical Plate System
Intracel - Intracel gets SPA from U.S. FDA for pivotal Phase III study of OncoVAX colon cancer vaccine
Massachusetts General Hospital, Boston, U.S. - Ovarian cancer stem cells identified; may shed light on recurring tumors
MedImmune - U.S. FDA issues complete response letter to MedImmune's new formulation of FluMist
Nuvo Research - Nuvo's resubmits Pennsaid new drug application to the U.S. Food and Drug Administration
Progenics Pharmaceuticals - Wyeth, Progenics report methylnaltrexone for postop ileus gets U.S. FDA fast track status
St. Francis Medical Technologies - St. Francis Medical Technologies names David Clapper, Joseph Cutts to board of directors
Teva Pharmaceutical Industries - Teva announces final U.S. FDA approval of AB-rated generic equivalent arthritis drug
Texas Children's Hospital, Houston - Reports from the United States, Brazil and Greece describe recent advances in surgery research
The SmartPill - U.S. FDA grants market approval for ingestible GI monitoring, data transmitting device
University of Glasgow, Scotland - Reports from Scotland and Spain advance knowledge in heart attack research
University of Texas, U.S. - Two susceptibility test methods to determine daptomycin MICs are compared
Vion Pharmaceuticals - Aileen Ryan joins Vion Pharmaceuticals' senior management team
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