Susan Hasty, Publisher
Table of Contents . . . September 22nd, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in FDA Law Weekly | Other Publications
Abaxis - CLIA waived status reported for analytes when used with Piccolo analyzer
Abbott Laboratories - U.S. FDA grants clearance to market blood glucose monitoring system
Advanced Medical Institute - Dr. Jack Vaisman receives Australian patent for PE therapy
Alcon - Nevanac gets U.S. FDA approval for pain associated with cataract surgery
Allergan - New formulation of Alphagan P receives U.S. FDA approval
Alliance for Better Bone Health - U.S. FDA approves prescription risedronate with calcium tabs for osteoporosis
Allon Therapeutics - Alzheimer drug maker reports clinical update, $0.05 per share loss
Antisoma - Antisoma granted U.S. orphan drug status for AS1411 in renal cancer
Anulex Technologies - U.S. FDA 510(k) clearance granted for the Inclose surgical mesh system
Ariad Pharmaceuticals - Orphan drug designations granted for AP23573
Arpida - Intravenous iclaprim granted fast track status by U.S. FDA
Array BioPharma - Anticancer compound cleared to advance into human clinical trials
Auburn University - Acamprosate for treatment of alcohol dependence reviewed
Barco - Flat panel display added to PACS display solutions
BioView - U.S. FDA clears Duet System for automated FISH scanning
ABC Foundation School of Medicine, Sao Paulo - Complementary and alternative medicine used by Brazilian oncologists
Albert Einstein College of Medicine - Further research needed on HIV in an aging population
Altnagelvin Area Hospital, Londonderry - Experience recommended for performing D2 gastrectomy
Amgen - Biotech company names David R. Parkinson VP
Amylin Pharmaceuticals - Phase 2 study of long acting Byetta released
Anadys Pharmaceuticals - Study of isatoribine in hepatitis C demonstrates proof of concept
Ankara University - Outcome of dentoalveolar distraction evaluated in canine model
AstraZeneca - In vitro device enables analysis of shear-induced drug release in fed stomach
Austin Health Hospital, Heidelberg - Thalidomide arrests colorectal cancer metastasis without affecting angiogenesis
Azienda Hospital Careggi, Florence - Low-protein diets may help prevent CV disease in patients with ESRD
Basil-Gerald Felsenstein Med. Center, Petah Tikva - Vitamin D sensitized breast cancer cells to H2 O2
Baylor College of Medicine, Houston - Biomarkers related to obesity and metabolic syndrome analyzed
BioDelivery Sciences International - Drug delivery company names Mark Sirgo as CEO
Bionomics - Australian biotech company reports operating loss of AU$4.632M
Burnham Institute - Apoptosis-based therapies for hematologic malignancies discussed
CHU Lille - Recent findings in hematology described
CHUR Dupuytren - Recent findings illuminate research in human papillomavirus vaccines
California Physical Therapy Association - California physical therapists offer help to those suffering from pain
Caraco Pharmaceutical Laboratories - U.S. FDA grants approval for additional Clozapine strength
Cerenis Therapeutics SA - Pharma completes $30.5M financing to progress drugs for heart diseases
Changzheng Hospital, Shanghai - 2-Methoxyestradiol at low dose induced differentiation of myeloma cells
China Medical University, Taichung City - Induced aortic relaxation studied, role of cGMP signals defined
Cima Labs - OraSolv technology used in Clarinex (desloratadine)
CryoCor - Company reports progress in U.S. FDA review of atrial flutter PMA
Crystal Clinic, Akron - Synthes Modular Hand Set not suitable for use in first MTPJ arthrodesis
CytRx Corp. - U.S. FDA issues explanation on phase II study of ALS drug
Dana Farber Cancer Institute - Researchers report details of new studies and findings in the area of cancer vaccines
Diet & Nutrition - HealthAllies offers deals on Jenny Craig
Duke University, Durham - Engineered chromosomes not yet viable gene-delivery platforms
Duke University, Durham - Vaccine development for gastric cancer and Helicobacter reviewed
Duska Therapeutics - ATP developer reports Q2 net loss of $559,473
EPIX Pharmaceuticals - Studies conclude MS-325 (Vasovist) improves imaging in MRA
Emergent BioSolutions - BioThrax maker expands global marketing reach
EntreMed - Disease-modifying activity of 2ME2 demonstrated in preclinical RA studies
Federal University of Sao Paulo - Rosuvastatin is most effective for achieving LDL-C goals
Finance - Active drug delivery company reports 7% decrease in sales
Franz Volhard Clinic Research Center, Berlin - Reports describe recent advances in obesity and diabetes research
GlycoGenesys - Carbohydrate drug-development company comments on Q2 loss
Goethe-University, Frankfurt - C. elegans studied, nicotinic receptor-associated proteins identified
Guidant Corp. - Company announces full availability of cardiac rhythm management product line
Guidant Corp. - Company gets approval to expand U.S. drug-eluting stent trial
HaptoGuard - IND filed for BXT-51072 for diabetics at risk for cardiovascular complications
Harris Interactive - U.S. adults only moderately concerned about avian flu, but endorse preparation
ID Biomedical Corp. - DNA diagnostic test maker reports loss of CDN $0.75 per share
Legal Issues - Chamber of Commerce group lauds Illinois medical liability reforms
NeoPharm - U.S. FDA approves special protocol assessment for phase III PRECISE trial
Neurobiological Technologies - U.S. FDA agrees on design of Viprinex trial, Xerecept trial enrollment announced
Novavax - Positive preclinical results reported on vaccine for pandemic influenza
Pharsight Corp. - Clinical drug development software provider releases DMX 1.4 server
Public Health Agency of Canada - Effects of Ebola virus glycoproteins on endothelial cell activation outlined
St. Jude Medical, Inc. - First U.S. double implant of new heart valve reported
Teva Pharmaceutical Industries - Generic drug company gets tentative approval of antinauseant, antiemetic agent
U.S. Food & Drug Administration - New findings in the area of immunology described
U.S. Food & Drug Administration - Semicarbazide in bread products measured by LC-MS
Utah Medical Products - Medical devices company notified that U.S. FDA lawsuit trial start postponed
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