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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . November 19th, 2004

Non-Subscriber - Summaries Only

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

Abbott Laboratories - FDA clears AxSYM immunoassay system

Advanced Brain Monitoring, Inc. - FDA clears ARES for in-home diagnosis of obstructive sleep apnea

Advanced Magnetics - U.S. FDA accepts response to approvable letter for Combidex

Agenix Limited - Blood-clot imaging technology gets U.S. FDA approval for phase 2 clinical trial

American Pharmaceutical Partners - Generic equivalent to Paraplatin launched

Berlex, Inc. - Campath approved for marketing in new single-use vial

Boston Scientific Corporation - U.S. FDA grants clearance for new IQ Guide Wire

Carrington Laboratories, Inc. - Safety trials for flu vaccines nasal technology to be complete early next year

Cellegy Pharmaceuticals, Inc. - Cellegesic granted priority review by U.S. FDA

Centocor, Inc. - Results from two REMICADE studies presented at conference

Cyberonics, Inc. - Company receives FDA approval for treatment-resistant depression treatment IDE

Eisai Global Clinical Development - U.S. FDA approves orally disintegrating tablet formulation of ARICEPT

Erchonia Medical, Inc. - U.S. FDA approves use of laser during liposuction

Flu Vaccine - Illinois negotiating purchase of flu vaccine in Europe

Inamed Corporation - Hylaform named winner of Allure's 2004 Best of Beauty Breakthrough Award

AVVAA World Health Care Products - Biotech company reports loss of $0.03 per share

Aarhus University Hospital - Synthetic exendin-4 effect on insulin secretion investigated

Aastrom Biosciences, Inc. - Biotech firm initiates clinical trial for sinus lift bone graft procedures

Akorn, Inc. - Deal signed to license, supply Calcium-DTPA and Zinc-DTPA

Albany Medical College - Pharmacokinetic properties of reverse transcriptase inhibitors reviewed

Alchemia Limited - Breakthrough for antibiotic drug discovery technology reported

Am. College of Radiology Imaging Network - Trial explores whole-body MRI to detect cancer, focus treatment in children

Animal Health Trust - Current perspectives on control of equine influenza reviewed

Antigenics, Inc. - Immunotherapeutics firm reports loss of $0.41 per share

Asinex, Ltd. - Integrated drug discovery project initiated for micturition disorders

BioAdvance - Retreat highlights role of bioinformatics in 21st century drug research

BioProgress plc - Drug delivery company listed on NASDAQ

Biotherapeutics, Inc. - Drugmaker and USAMRIID to study ATryn for viral hemorrhagic diseases

Bowling Green State University - Adequate lighting necessary for proper inspection of food service operations

Business Update - GlaxoSmithKline's third-quarter profits fall 9%

Cancer Therapy - Onyx stock down as company awaits more cancer drug data

Case Western Reserve University - Antioxidants regulate normal human keratinocyte differentiation

Cedars-Sinai Medical Center - Study blocks mechanism that lets brain tumors sidetrack immune response

Centers for Disease Control & Prevention - Prevalence of tuberculosis in foreign-born patients in U.S. increasing

Centocor, Inc. - MRI data show monoclonal antibody treatment decreases spinal inflammation

Columbia University - Raw vegetable consumption decreases cancer risk

Cornell University - Portal CD4+ cells decline in hepatitis C virus HIV-coinfected patients

Coronado Industries, Inc. - Device maker names Sharkey president of ophthalmic international subsidiary

Cytokinetics, Inc. - Company provides Q3 update, reports on oncology, cardiovascular programs

Drug Addiction - Funding announced for substance abuse treatment to juveniles, young adults

Duke University - Ankyrin-B and beta2 -spectrin interact in neonatal cardiomyocytes

EXACT Sciences Corporation - Research data on a novel DNA purification method released

Emory University - Influenza vaccine enhances immune responses to SHIV antigens

Emory University - Key mechanism discovered in estrogen's role in preventing bone loss

Ethicon Endo-Surgery - Hemorrhoid treatment trial presented at the family doctors conference

GESI, Rome - Steal syndrome may be an adverse event in patients with a specific bypass graft

Gallstones - Arafat breaks Ramadan fast for treatment at urging of doctors

Geisinger Medical Center, Danville - Monitoring of cardiac enzymes is necessary after coronary intervention

GeneGo, Inc. - Novel computational method predicts P450 binding of drug candidates

Genzyme Drug Discovery & Development - Need exists for safe and effective weight loss therapies

Georgetown University - Ibuprofen inhibits bladder cancer cell survival by p75(NTR) protein induction

Georgetown University - Seville orange extracts may not be safe for weight loss

GlycoMimetics, Inc. - Colin Scott, MD, joins glycobiology company

H San Raffaele Scientific Institute - Role of gamma-delta T lymphocytes in tumor defense reviewed

Hennepin County Medical Center - Surge healthcare planning necessary for future epidemic and terrorist attacks

India Defence Research & Development - Dengue-2 genotype IV is the predominant and circulating strain in northern India

Integra LifeSciences Holdings Corporation - Terminally sterile dermal regeneration template receives FDA approval, CE Mark

La Jolla Pharmaceutical Company - FDA indicates Riquent is approvable, requires completion of additional study

Liponex Inc. - U.S. patent allowance granted for CRD5 cholesterol, atherosclerosis treatment

Medical Misconduct - Iowa board disciplines two nurses for drug recycling

Merck & Co. - Study showed ARCOXIA improved gastrointestinal tolerability

NAMI - Child psychiatrist comments on FDA warning labels for pediatric antidepressants

Neurocrine Biosciences, Inc. - New drug application submitted for insomnia treatment

OraSure Technologies, Inc. - Diagnostics company luanches OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

Royal Philips Electronics - Amazon.com offers home defibrillator for over-the-counter sale

Teva Pharmaceutical Industries Ltd. - Generic drug developer gets U.S. FDA approval for cefuroxime axetil tablets

U.S. Dairy Association - Pathogen distribution model developed for E. coli O157:H7 in ground beef

U.S. Food & Drug Administration - Antimicrobial resistance risk assessment in food safety reviewed

U.S. Food & Drug Administration - Encouraging consumer use of food label information needs innovative approaches

U.S. Food & Drug Administration - Mechanism of action of IL-13 antagonist in cells expressing IL-4R determined

U.S. Food & Drug Administration - New systematic tools to monitor adverse event reporting developed

U.S. Food & Drug Administration - Persistence of hepatitis C infection linked to low levels of heterogeneity

University of Iowa - FDA agency actions and nature of congressional influence investigated

West Nile Virus - West Nile cases in Iowa drop in 2004

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