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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . May 26th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in FDA 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

Centers for Medicare & Medicaid Services - CMS proposes FY 2006 rate increases for inpatient stays in acute care hospitals

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

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

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

Cytopia, Ltd. - Company gets green light for CYT997 trial

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

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

Finance - Kindred Healthcare announces first quarter financial results

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

A.P. Pharma, Inc. - APF530 phase II trial program initiated in cancer patients

AEterna Zentaris, Inc. - Positive phase I results reported on oral growth hormone

Academy of Sciences of the Czech Republic - Vaccine generated by fusing dendritic cells and HPV-related tumor cells

Acadia Pharmaceuticals, Inc. - Pharmaceutical firm elects Mary Ann Gray to board of directors

Acusphere, Inc. - Hydrophobic drug delivery system reported in journal

Agriculture University of Warsaw - 2-Substituted halogenobenzimidazoles have antimycobacterial activity

Akdeniz University - Antioxidant vitamins prevent inflammatory effects of exhausting exercise

Albert Einstein College of Medicine - Efficacy of taxol affected by mitogen-activated protein kinase inhibitor CI-1040

Amylin Pharmaceuticals, Inc. - Exenatide improves insulin sensitivity and beta-cell mass

Anika Therapeutics, Inc. - Medical device firm reports 19% increase in first quarter revenue

Bentley Pharmaceuticals, Inc. - Approval granted to market generic versions of risperidone in Spain

Biomarker Technologies LLC - Participants sought for upcoming clinical trial of blood test

Biovac Institute - Recent findings in tuberculosis vaccines described

BrainStorm Cell Therapeutics - Neurologists appointed to scientific advisory board at stem cell company

Bristol Royal Infirmary - Preoperative clopidogrel exposure raises morbidity/mortality risk

Brown University - Studies describe new findings in tuberculosis vaccines research

CNRS, Chatenay Malabry - Drugs of the styrylquinoline class inhibit HIV-1 integrase

CNRS, Montpellier - Molecular changes associated with agonist activity of hydroxy-tamoxifen

Calando Pharmaceuticals, Inc. - Delivery technology achieves tumor knockdown with targeted siRNA

Callerio Foundation Onlus, Trieste - NAMI-A exhibited antimetastatic effects on KB tumor cells

Catholic University of Korea, Seoul - p53 may have a role in adriamycin-induced caspase-independent apoptosis

Cell Genesys, Inc. - Company launches phase I trial of CG0070 in recurrent bladder cancer

Chang Gung University, Taoyuan - Damaged DNA-binding protein 2 plays a major role in resistance to apoptosis

Chicago Medical School - Insulin gene therapy may overcome the drawbacks of islet transplantation

Chinese Academy of Science, Shanghai - SARS CoV 3CL(pro) indispensable for proteolytic activity/not enzyme dimerization

Christie Hospital NHS Trust, Manchester - Anti-VEGF antibody possesses clinical activity in advanced cancer patients

Chung Shan Medical University, Taichung - Chingwaysan induced apoptosis in human oral cancer cell lines, OC2 and TSCCa

CombinatoRx, Inc. - Biopharmaceutical firm receives $4.4M grant for anthrax research

Corgentech, Inc. - Maker of DNA-based therapeutics reports Q1 revenue of $5.5 million

CuraGen Corp. - Genomics-based pharma reports Q1 net loss of $19.4 million

Dade Behring - Company announces availability of Emit II Plus Ecstasy Assay

Danish Institute for Food & Vet. Research, Soeborg - Recent findings in cardioprotection provide new insights

Deaconess Arthritis Center, Cincinnati - Options for treatment of bone loss in postmenopausal women reviewed

Depomed, Inc. - Company to develop extended-release form of compound for Boehringer

Diet & Nutrition - U.S. FPA director comments on Institute of Medicine report

Drexel University - Treatment adherence associated with lower quality of life in children

DrugMax, Inc. - Pharmacy announces fourth-quarter and full-year 2004 results

Dynavax Technologies Corp. - Immuno-focused company reports Q1 revenue of $12.7 million

EIC Laboratories, Inc. - Star amphiphilic block copolymer developed as drug carrier

Eastern Virginia Medical School - Multi-country Phase III clinical trials to test microbicides against HIV

Emory University - Best heart-healthy diet combines parts of popular plans

Endocyte Inc. - Folate receptor expression in cancer determined by radioligand binding assay

Erasmus Medical Center - Kidney growth in diabetic mice not affected by IGF binding protein

Evotec OAI, AG - Company extends global medicinal chemistry agreement with Roche

HealthGrades - Gap widens between best and worst hospitals

Insurance Federation of Minnesota - Insurance federation warns about legal issues with dog bites

Pennsylvania Department of Health - Health department reminds public of precautions for West Nile virus

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

SpinalMotion, Inc. - U.S. FDA grants approval for clinical studies of lumbar, cervical disk implants

U London Royal Holloway & Bedford New Coll, Egham - T cell vaccine might work against high- but not low-dose HIV exposure

U.S. Food & Drug Administration - Diethanolamine measured in shampoo containing fatty acid diethanolamide

U.S. Food & Drug Administration - Method to determine oxytetracycline in salmon developed

U.S. Food & Drug Administration - Peptide vaccine excludes antigen-specific T cells from splenic lymph

U.S. Food & Drug Administration - Rapid method for phenotypic characterization of Salmonella developed

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