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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . July 15th, 2005

Non-Subscriber - Summaries Only

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

Amylin Pharmaceuticals, Inc. - Pharmaceutical companies offer injection for type 2 diabetes control

Analytical - Software released to enhances drug manufacturing performance, productivity

Avantogen, Ltd. - Company receives milestone payment for vaccine adjuvant

BioArray Solutions, Ltd. - New bead array technology test system receives FDA market clearance

Cardima, Inc. - Heart device maker meets with U.S. FDA regarding revelation TX PMA

CardioVascular BioTherapeutics, Inc. - Cardio Vascu-Grow appears safe, well tolerated in cardiac patients

Cardiogenesis Corporation - U.S. FDA issues letter for percutaneous myocardial channeling trial

Connetics Corp. - Company receives FDA nonapprovable letter for Velac

Cyberonics, Inc. - Company provides TRD update, announces quiet period

Encysive Pharmaceuticals, Inc. - Company to retain European rights to Thelin

Epilepsy Foundation of America - Foundation: FDA pregabalin approval a much-anticipated and welcome development

Exelixis, Inc. - IND application filed for anticancer compound XL184

Heller Ehrman LLP - Supreme Court overturns lower court, protects U.S. FDA safe harbor provision

Hi-Tech Pharmacal Co., Inc. - Company receives approval for Acyclovir Oral Suspension

Immtech International, Inc. - Immtech Completes U.S. FDA Special Protocol Assessment

AMA - Heart valve infection linked with staphylococcal infection

AMDL, Inc. - Diagnostics company to meet with U.S. FDA in response to submission

Abbott Laboratories - Inhibitor of Bcl-2 family proteins induced regression of solid tumors

Advitech, Inc. - Second study on XP-828L for psoriasis completed

AgION Technologies - University of Arizona study shows ionic silver effective against SARS

Alchemia Limited - Partner issues stock shares under synthetic heparin agreement

American Academy of Allergy, Asthma & Immunology - Web site offers resources to reduce second hand smoke exposure in children

American College of Cardiology - Sleep apnea treatment benefits extends to sympathetic nervous system

American Society of Hemotology - Thalidomide treatment proves better than conventional chemotherapy

Andhra University - Research in diabetes therapy provides new insights

Ankara University - Studies advance knowledge in hepatitis b therapy research

Ark Therapeutics Group plc - Marketing deal signed for Kerraboot in South Korea

Astellas Pharma Inc. - Oral tablet for treating benign prostatic hyperplasia to be available in Japan

AstraZeneca - Encouraging phase II results reported for Galida

Avantogen Limited - Preclinical study initiated to develop genital herpes vaccine

Best Practices, LLC - Sustainability of mature pharmaceutical drugs is topic of survey

Beth Israel Deaconess Medical Center, Boston - Elevations in air pollution may trigger cardiac decompensation in HF patients

Beth Israel Medical Center, New York - Antibiotic therapy does not reduce mortality or CV events in patients with CAD

Biogen Idec - Phase II study data demonstrates galiximab may be used with RITUXAN

Bioniche Life Sciences, Inc. - Data presented on anticancer activity of mycobacterial cell wall-DNA complex

Boston University - Platelet-derived growth factor intensifies ischemic flap revascularization

Brigham & Women's Hospital, Boston - Recent findings in cardiology described

Bristol-Myers Squibb - Abatacept inhibits progression of joint damage in rheumatoid arthritis

Burnham Institute, La Jolla - Novel and efficient inhibitors of anthrax lethal factor identified

CABG Medical, Inc. - Approval granted to expand trials of Holly Graft System into Europe

CHAD Therapeutics, Inc. - Oxygen therapeutics firm reports net income increased to $0.06 per share

CHU Rangueil, Toulousse - Adipose tissue-derived adult SCs share immunosuppressive properties with BM-MSCs

CV Therapeutics, Inc. - Biopharmaceutical firm reports option grants

Chiba University - Interleukin-2 gene delivery sends glioblastoma into remission in rats

Children's Hospital of Pittsburgh - Adult stem cells can multiply like embryonic stem cells do

Colorado Center for Bone Research, Lakewood - New findings in the area of osteoporosis described

Compound Therapeutics - Dr. John Mendlein named CEO; to help accelerate oncology pipeline

Coronado Industries, Inc. - Company announces publication of PNT monotherapy manuscript

Cranberry Institute - Industry group: Cranberries fight H. pylori, guard against stomach cancer

Crucell Holland BV, Leiden - Rabies virus-neutralizing epitope recognized by human monoclonal antibody

Crucell, NV - Human monoclonal antibody against West Nile shows promise in animal studies

Duke University - Prostate-specific antigen rose after primary prostate cancer therapy

Duska Therapeutics, Inc. - Company, U of Pennsylvania ink agreement for ATPotent preclinical studies

ETAP de Nancy-Brabois - Oligofructose-enriched inulin improves cognition and mood in rats

Eli Lilly & Company - Blood sugar controlled by inhaled insulin as well as by injection, study shows

Eli Lilly and Company - New data show effective treatment for painful diabetic neuropathy

Epigenomics AG - DNA methylation of PSAT1 determines response to tamoxifen treatment

Foundation Ciencia Vida, Santiago - B-cell epitopes recognized by sera from Andes virus-infected persons identified

Friedrich Loeffer Institute, Greifswald - Researchers' work adds to herpesvirus vaccines body of knowledge

Inst. for Trade, Standards, and Sustainable Dev. - ITSSD: Brazil Will Break International Law with Theft of U.S. Drug Patents

Lorus Therapeutics Inc. - U.S. FDA accepts proposal for rolling NDA for pancreatic cancer drug

Methodist DeBakey Heart Center - FDA approves first blood test to predict risk for stroke

Northwestern University - African-American screening rates higher in VA hospital

Pfizer Inc - Pharma company to acquire Vicuron Pharmaceuticals, Inc.

Philanthropy - Coalition for Pulmonary Fibrosis, partners to raise money for IPF

Phytomedics, Inc. - Biopharma company is exclusive licensee of inflammatory treatment

Regeneration Technologies, Inc. - Implant company receives FDA clearance for STERLING Interference Screw ST

SALVAT Laboratorios SA - FDA new drug application filed for CETRAXAL Otic solution

Scripps Research Institute - Lassa virus nucleoprotein protects against arenavirus challenge

Syneron Medical, Ltd. - FDA clears VelaSmooth for cellulite treatment

U.S. Centers for Disease Control & Prevention - Cost-effectiveness of meningococcal vaccine strategies in U.S. examined

U.S. Food & Drug Administration - Developing bacterial vaccines to prevent diarrheal diseases reviewed

U.S. Food and Drug Administration - FDA Tentatively Approves First Generic Nevirapine

Watson Pharmaceuticals, Inc. - Somerset files response to U.S. FDA letter on selegiline transdermal system

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