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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . December 16th, 2004

Non-Subscriber - Summaries Only

Related Areas: Other Issues in FDA Law Weekly | Other Publications

Amnesty International - Violence against women fuels spread of HIV/AIDS

Aventis - Third pandemic influenza vaccine agreement signed

Becton, Dickinson and Co. - U.S. FDA alternate site clearance helps blood glucose meter users

Berlex, Inc. - Approvable letter granted for oral contraceptive containing drospirenone

BioPort Corporation - U.S. government to procure BioThrax for nation's stockpile

Biocon Limited - Indian company launches bio-insulin

Bioterrorism - Computer program developing to track disease, biological attacks

Biovail Corporation - FDA issues approvable letter for Ralivia ER

BlueSky Medical Group - FDA clears V1 Wound Vacuum System for marketing, Medicare confirms coding

Caraco Pharmaceutical Laboratories, Ltd. - FDA approval granted for Citalopram Hydrobromide tablets

Duke University - Relationship between substance abuse and HIV-infected women explored

Facilities - U.S. GSA/FDA break ground for central shared-use building

Government Accountability Project - FDA tried to discredit whistleblower over drug safety claims

Greer Laboratories, Inc. - Company receives FDA approval to begin sublingual-oral immunotherapy trial

Hawaii Department of Health - Airplane measles exposure offers lessons on disease contact response

ALK-Abello - Epitope modulation of Bet v 1 reduces IgE binding but retains protein folding

Alnylam Pharmaceuticals, Inc. - In vivo demonstration of RNAi via systemic delivery announced

American Diabetes Association - Cardiovascular treatment drug used for smoking cessation also keeps weight off

American Scientific Resources - National respiratory dealer group engaged for sales of asthma product

Amnis Corporation - ImageStream 100 cell analysis systems placed at research institutions

Ankara Training and Research Hospital - Leeches effective for treatment of class IIC ring avulsion injuries

Astex Technology - Apo and inhibitor complex structures of beta-secretase determined

Avant Immunotherapeutics, Inc. - Vaccine maker opens new manufacturing facility

Avian Influenza - Bird flu vaccine expected to be ready by 2007

Barrier Therapeutics, Inc. - European distribution agreement signed for dermatology products

Basilea Pharmaceutica AG - Data presented on ceftobiprole and BAL8557 at conference

Baxter Healthcare Corporation - Findings released from long-term kidney disease research program

Beijing Institute of Pharmacology & Toxicology - Choline acetyltransferase supplementation may slow Alzheimer disease

Biomedical Primate Research Center - Three vectors encoding SIV antigens protected against SIV CD4+ T-cell loss

Bionomics Limited - Alliance signed to commercialize new genetic tests for epilepsy

Bionomics Limited - Gene silencing molecules inhibit tumor growth

Boston University - Study identifies factors associated with long-term opioid treatment of veterans

CHU Vaudois, Lausanne - HPLC method monitors atazanavir therapy in HIV-infected patients

Cambridge Antibody Technology - Preliminary results of Trabio phase II/III trial released

Canadian Food Inspection Agency - Novel immunoassay suitable for bovine Campylobacter fetus screening

Case Western Reserve University - Bacterial heat shock proteins enhance class II MHC antigen processing

Cellectricon - New system launched for ion channel drug screening

Chinese University of Hong Kong - Pharmacogenetics enhances the management of patients on warfarin therapy

Complementary & Alternative Medicine - Parish nurses promote spiritual, physical health

Council for Responsible Nutrition - Group questions conclusions in recent vitamin E meta-analysis

CytRx Corp. - RNAi company reports reduced losses in Q3

DOV Pharmaceutical, Inc. - CVD/CNS-focused company reports Q3 net loss of $12.0

Dalhousie University - Antibacterial principle of Caesalpina sappan revealed

Drexel University - Membrane antigen and merozoite protein protect against P. chabaudi malaria

Duke Comprehensive Cancer Ctr. - Tamoxifen acts quickly to prevent damaged breast cells from turning cancerous

East Carolina University - Sp1 may interact with with PKCdelta and MAPK in type I collagen expression

Elusys Therapeutics, Inc. - Drug demonstrates survival benefits when given after anthrax exposure

Emisphere Technologies, Inc. - Company presents new oral drug-delivery data at AAPS meeting

Entropin, Inc. - ENT-103 reported effective in preclinical model for pain

Framingham Heart Study - Obesity appears to be modifiable risk factor for atrial fibrillation

Fudan University - Fusing molecular adjuvant to hCG protein antigen enhances humoral immunity

Futura Medical, plc - Company announces preliminary results from FLD500 study

GPC Biotech, AG - Revenues decrease 44% for satraplatin maker

Gamida-Cell, Ltd. - Study: StemEx for the treatment of leukemia safe and efficacious

GammaCan International, Inc. - Biopharmaceutical firm develops anticancer immunotherapy based on IVIg

Geron Corp. - Research: Cells derived from hESCs can be immortalized by telomerase

GlaxoSmithKline - Recent advances in cannabinoids reviewed

Goteborg University - Role of antibodies to oxidized LDL in atherosclerosis development reviewed

Guilford Pharmaceuticals, Inc. - AGGRASTAT trial data presented at American Heart Association meeting

Hannover, Germany - Active-controlled trials can develop valuable data

Hovione - U.S. FDA inspects company's API manufacturing plant in Macau

IVAX Corporation - Pharmaceutical company receives FDA approval for citalopram hydrobromide tablets

National Institute of Infectious Diseases, Japan - Immunization law revisions affect incidence of congenital rubella in Japan

Netherlands Vaccine Institute - Methods to reduce numbers of animals in quality control testing presented

OSI Pharmaceuticals, Inc. - U.S. FDA approves Tarceva for patients with advanced non-small-cell lung cancer

Ortho-McNeil Pharmaceutical, Inc. - Patient-controlled pain control system compares to IV PCA morphine, study shows

Sexual Violence - Effective partnerships key to combating gender-based violence

Tobacco Use - Sioux City, Iowa, bans smoking on sidewalks near clinics

Ullevaal University Hospital - Hiding drugs in food in nursing homes is common

Yamanouchi Pharmaceutical Co. - U.S. FDA approves new medication

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