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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . August 18th, 2006

Non-Subscriber - Summaries Only

Related 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

Asthma - The Inner-City Asthma Intervention implements findings from clinical trials to help children with asthma

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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