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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . February 25th, 2005

Non-Subscriber - Summaries Only

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

AVANCA Medical Devices - FDA approves syringes that let physicians inject and aspirate with one hand

AXM Pharma, Inc. - Pharmaceutical firm receives Chinese approval to sell Sunkist line

Abbott - New trial initiated in stroke prevention

Abbott - U.S., European regulatory submissions made for Humira

Abbott Laboratories - FDA approves gene-based test for hematuria patients' bladder cancer

Advanced Biomaterial Systems - FDA clearance granted to market bone cement

Albert B. Sabin Vaccine Institute - FDA approves human hookworm vaccine for phase I safety trials

Anthrax Vaccine - U.S. military gets authority to give troops anthrax vaccines

Aspen Pharmacare - FDA grants tentative approval to generic AIDS drug regimen

Barr Pharmaceuticals, Inc. - FDA decision on Plan B OTC status delayed

Bracco Diagnostics, Inc. - FDA approval clears the way for addition of new MRI agent

Business Update - GSA awards construction contract for physics lab at White Oak facility

Cyberonics, Inc. - VNS developer submits response to FDA warning letter

CytoGenix, Inc. - Company conducts pre-IND FDA conference for CY301 antiherpes cream

Dana Farber Cancer Institute - Television drug ads require more understandable language

ADVENTRX Pharmaceuticals, Inc. - Endpoints met in first stage of CoFactor phase II study in colorectal cancer

AEterna Zentaris, Inc. - Targeted anticancer agent advances into clinical development

ActiveSight - FBPase diabetes target available for structure-based drug design

Adherex Technologies, Inc. - Phase Ib/II Exherin trial initiated in Europe

Advanced Magnetics, Inc. - New data shows feasibility of combidex-enhanced MRI

Affitech AS - Antibodies to varicella-zoster virus derived from antibody library

Aker University Hospital - Pegylated interferon and ribavirin eradicate hepatitis C genotypes 2 and 3

Alnylam Pharmaceuticals, Inc. - Progress reported on RSV program and systemic RNAi therapeutics

Alzheimer Disease - New test might help detect Alzheimer disease in early stages

American Council on Exercise - Exercise council endorses government regulation on dietary supplements

American Pharmaceutical Partners, Inc. - Launch date set for Abraxane for metastatic breast cancer

American Specialty Health - Scholarships given to students studying complementary healthcare

Argenta Discovery, Ltd. - Two-year diabetes drug discovery deal signed with Novartis

Auburn University - Findings advance knowledge in virology research

Australian National University - Vaccination program lowers invasive pneumococcal disease among elderly

Barrier Therapeutics, Inc. - Registration statement filed by pharmaceutical firm for stock offering

Baylor College of Medicine - Silenced SOCS1 enhances the stimulatory capacity of dendritic cells

Baylor University Medical Center - Bivalirudin treatment reduces recovery area stay after PCI

Boston Scientific Corporation - Millionth Taxus Express2 coronary stent system implanted

Boston University - Interventions become treatments in the world of psychology

Boston University - Study offers additional experimental paradigm for analyzing NO-donor metabolism

Business Update - Hill-Rom adds new pressure-relief mattress to VersaCare Bed System

C Poma Hospital, Mantova - Good infection control practices help prevent nosocomial infections

CHU Rangueil - Surgery for nasal obstruction in the asthmatic child rarely needed

CNRS UMR 6020A, Marseille - Quantitative PCR is a reliable method for determining antibiotic susceptibility

CSIRO Health Science & Nutrition, Parkville -  P. jirovecii FAS gene cloned and DHPS drug-resistant mutation evaluated

Campbell Soup company - Food company launches plan to help Americans achieve dietary guidelines

Capital University of Medical Science, Beijing - Transduced glioma cells stimulate anti-tumor immunity

Carbon Monoxide Illness - Dozens treated after carbon monoxide leak at Canadian hockey rink

Center Hospital University, Nantes 1 - HPLC/UV effective for therapeutic antiretroviral drug monitoring

Children's Hospital, Westmead - West Nile virus infection of embryo fibroblasts associated with TNF production

Chinese Academy of Sciences - Method discriminates diabetic patients from healthy controls

Chiron Corp. - Researchers' work adds to diagnostics body of knowledge

Columbia University of College Physics & Surgery, - Organ transplant recipients should receive treatment for osteoporosis

Compex Technologies - E-stim-focused company names Gary Blackford to board of directors

Corautus Genetics - Gene therapy used for heart patients with moderate to severe chest pains

Corgenix Medical Corp. - Corgenix announces establishment of bioterrorism defense development program

Cornell University, New York - Cellular enzyme plays key role in gene regulation

Covance, Inc. - Biopharmaceutical development services company grows 2004 EPS 26%

Cox Associates, Denver - Bayesian model predicts risk of emerging resistance to antimicrobials

DATATRAK International, Inc. - Company releases version 4.0 of its EDC Product Suite

Delta Dental Plans - Dental insurance company announces international plan

Diet & Nutrition - New Mexico lawmakers want to restrict junk food in schools

Diet & Nutrition - Popular diets tout new `good carb' government advice

Drug Importation - Some pharmacists reluctant to go along with Oklahoma Governor's idea

Edwards Lifesciences Corp. - ThermaFix tissue-treatment process launched

Eisai, Inc. - Cardinal Health, Aricept maker ink multiyear distribution service agreement

Endocrinology - New research in the area of endocrinology detailed

Fed University of Goias, Goiania - HAART immune reconstitution trigger adverse effects in M. leprae coinfection

Foothills Prov General Hospital, Calgary - Local ketorolac and bupivacaine are effective against postoperative pain

GMP Cos., Inc. - Company licenses Conversion Technology, Analysis processes to Mayo Medical

Gilead Science Inc. - Reports describe recent advances in HIV/AIDS therapy research

Gothenburg University - Combination therapy approaches for asthma management reviewed

Health Grades, Inc. - Healthcare quality company names top 5% of hospitals

Institut Pasteur - Institute retains rights on a patent based on use of homologous recombination

Legal Issues - Federal judge dismisses suit claiming hospital system charged more to uninsured

Legal Issues - Mother who drowned children found innocent by reason of insanity

Marshall Edwards, Inc. - FDA grants fast-track designation for phenoxodiol in oral dosage form

Medical Ethics - U.S. National Institutes of Health announces tighter ethics rules

Non-Invasive Monitoring Systems - AT-101 reclassified as therapeutic vibrator requiring 510k submission

Ranbaxy Laboratories Limited - Pharma company submits three filings of antiretroviral agents to WHO

U.S. Centers for Disease Control & Prevention - Advances in responding to bioterrorism and emerging diseases outlined

U.S. Food & Drug Administration - Methods to estimate allergenicity of novel proteins in mice reviewed

Van Andel Research Institute - Anthrax lethal factor analyzed, role of domain II in toxicity revealed

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