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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . May 27th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Food and Drug Law Weekly | Other Publications

AMTSystems - Identification device for surgical safety introduced in healthcare industry

Adeza - Test assesses risk of preterm birth

Adventrx Pharmaceuticals, Inc. - U.S. FDA grants clearance for CoFactor phase III trial in colorectal cancer

Alcon, Inc. - New intraocular lens launched

BioAlliance Pharma - U.S. FDA grants orphan drug designation for doxorubicin Transdrug

Cellegy Pharmaceuticals, Inc. - Pharmaceutical firm responds to U.S. FDA inquiries about Cellegesic

Cook Biotech, Inc. - FDA clears Surgisis AFP Fistula Plug for fistula repair

Cordis Corporation - FDA grants approval of MRI immediately after stent implantation

Dade Behring - Company submits 510k for its Dimension Vista 1500 Analyzer

Exelixis, Inc. - Company files IND application for anticancer compound XL820

GlaxoSmithKline - Agreement reached on consent decree re Cidra, Puerto Rico, manufacturing site

Northwestern University, Chicago - Monitoring program finds serious, unreported adverse drug reactions

Paradigm Medical Industries, Inc. - 510k filed with FDA for ultrasound biomicroscope, company financials reported

Perrigo Company - Over-the-counter pharmaceutical company announces approval for Naproxen tablets

Prestwick Pharmaceuticals, Inc. - Pharma company submits NDA to U.S. FDA to market tetrabenazine

Adverse Drug Reaction - Nearly half of patients have lapses in doctors' office drug monitoring

Ariad Pharmaceuticals, Inc. - Patient enrollment begins in two trials of AP23573

Baylor College of Medicine, Houston - Recent findings in head and neck cancer provide new insights

Baylor College of Medicine, Houston - The PDX-1 gene is an early marker for a variety of human cancers

Baylor Institute Immunology Research - Dendritic cells as therapeutic cancer vaccines reviewed

Bioject Medical Technologies, Inc. - Medical device firm reports product sales increase of 42.9%

Boston University - Apolipoprotein A-I deletions corrupt lipid metabolism in study models

Botaniex, Inc. - Manufacturer of botanical extracts appoints chief operating officer

Bristol-Myers Squibb Company - Pharmaceutical firm reports 1Q results in line with expectations

CHU de Poitiers - Integra artificial skin can be used to reconstruct large defects

CancerVax Corporation - Anti-angiogenesis monoclonal antibody inhibits tumor growth

Catholic University of Daegu - Novel reverse micellar technique effective for PLGA microsphere loading

Catholic University of Louvain - Insulin-like growth factor-I gene transfer prevents steroid-induced atrophy

Celera Genomics Group - Data characterizes human histone deacetylase as cancer therapeutic

Cell Genesys, Inc. - Potential breakthrough reported in antibody production technology

Cephalon, Inc. - Company announces positive phase III results for ORAVESCENT fentanyl

Chiba University - Proteome-based identification of molecular markers predicted chemosensitivity

Children's Hospital, Boston - Strategies for prevention and management reviewed

Chonbuk National University Medical School - Genes involved in fenretinide-induced apoptosis identified

Chugai Pharmaceutical Co. Ltd, Shizuoka - Bivalent single-chain antibody fragments induce apoptosis in myeloma cells

Chung Hwa College of Medical Technology, Tainan - Phosphorylated and hypoacetylated mutant p53 enhanced apoptosis

Cincinnati Children's Hospital - Researchers' findings advance trichomoniasis research

Ciphergen Biosystems, Inc. - Agreement signed to evaluate proteomic system for ovarian cancer diagnostics

Columbia University, New York City - Variation in immune response gene causes eye disease when triggered

Commonwealth Biotechnologies, Inc. - Assay work delayed since 3Q 2004 begins

Congestive Heart Failure - New GP contract may not improve treatment for heart failure patients

Copenhagen University - Milk thistle does not reduce deaths from liver diseases

Cordis Corporation - Trial begun to evaluate stent technologies versus balloon angioplasty for PAD

Cornell University, New York - High expression of interferon-induced genes associated with disease severity

Curacyte AG - Drug discovery firm names David Ebsworth as chairman of supervisory board

Dalhousie University - G protein vaccine against RSV modulates protective immunity

Durham VA Medical Center - Understanding of HT risks, benefits associated with initial and continued use

Eli Lilly & Co. - Findings describe new data in osteoporosis research

Elite Pharmaceuticals, Inc. - IND filing for abuse-resistant technology for narcotic analgesics announced

Emory University - Senescence of the immune system is a risk factor for rheumatoid arthritis

Enzo Biochem, Inc. - Company reports data on laboratory studies at European Liver Conference

ExonHit Therapeutics - Company wins patent related to detection of mRNAs

Favrille, Inc. - Immunotherapy company reports first-quarter net loss of $8.4 million

Federal University of Rio De Janeiro - Multidrug resistance protein 1 expressed in murine thymoma cell line

Finance - Kindred Healthcare announces first quarter financial results

Forest Laboratories, Inc. - Campral is safe, well-tolerated in long-term treatment of alcohol dependence

Hamilton General Hospital - Studying gene-environment interaction across heterogeneous groups is recommended

National Institute Infection Diseases, Tokyo - ELISA system is a promising technique for fast diagnosis of Marburg virus

Sanguine Corp. - Biopharmaceutical company provides research update for shareholders

St. Jude Children's Research Center - Giving children access to drug trials is crucial, clofarabine approval shows

Teva Pharmaceutical Industries Ltd. - Pharmaceutical company gets U.S. FDA approval of antipsychotic generic drug

U.S. Centers for Disease Control & Prevention - Epidemiology of E. coli O157:H7 outbreaks in U.S. reported

U.S. Food & Drug Administration - Permeability of coenzyme Q10 in rat gastrointestinal tracts located

U.S. Food & Drug Administration - Re-use of ion chromatography media does not decrease virus removal

University of Michigan - Clot drug still meets resistance from doctors wary of its risks

University of Toronto - Healthcare ethics practical, smart, claims U of T study

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