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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . November 11th, 2004

Non-Subscriber - Summaries Only

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

Access Pharmaceuticals, Inc. - Update provided on OraDisc technology

Accordis - Grady Health System awards Medicare billing contract

Adventrx Pharmaceuticals, Inc. - CoFactor granted U.S. orphan drug status by the FDA

American Pharmaceutical Partners, Inc. - FDA grants approval for Flumazenil injection

American Soc. of Breast Surgeons - Enrollment of MammoSite patient registry completed

Assoc. for the Advmnt. of Medical Instrumentation - Plumbing codes put dialysis patients at risk

AstraZeneca - FDA does not approve Exanta (ximelagatran)

CV Therapeutics, Inc. - MERLIN TIMI-36 study of Ranexa initiated

Chad Therapeutics, Inc. - FDA clearance granted to market oxygen conserving device

Dyax Corp. - Fast-track designation announced for DX-88

Environmental Health - Five new cases of West Nile reported in New Mexico

Fibroids - Agency approves new device to treat fibroids

Generic Pharmaceutical Assoc. - Generics association: Flu vaccine shortage highlights need for biogenerics

Georgia Institute of Technology - Bilateral benefits with brain stem implant

ev3, Inc. - U.S. FDA grants marketing clearance for Protege GPS Long Stents

ASM Press - Biopharmaceutical manufacturing efficiencies signal reduced healthcare costs

Abiomed, Inc. - First European AB5000 patient recovers from acute fulminant myocarditis

Academic Center for Dentistry, Amsterdam - Antibody fusion protein coupled to glucose oxidase is bactericidal

AlgoRx Pharmaceuticals, Inc. - Pharmaceutical company appoints new members to clinical team

All India Inst. of Medical Science - Study reports a method for establishing the IC50 concentrations of ligands

Am. Society of Reproductive Medicine - Group issues report on freezing of eggs and ovarian tissue

Appleton Heart Institute, Wisconsin - Treatment fidelity is recommended as part of behavior intervention research

Assisted Reproduction - Researchers study ways to protect breast cancer patients' future fertility

AstraZeneca - Survey shows patients satisfied with Seroquel

Atherotech, Inc. - Cholesterol test featured in metabolic fitness treatment program

Atricure, Inc. - Minimally invasive cure for heart rhythm abnormality proves effective

Austin Research Institute - Dendritic cells induce immunity against blood-stage malaria

Awards - LeapFrog honored as winner and finalist of Annual Freddie Awards

Best Practices, LLC - Report finds oncology drug Web sites foster loyalty and brand growth

Bioenvision - Clofarabine data presented at hematology meeting

Boston Scientific Corporation - Thirty-day safety data reported from Taxus V drug-eluting stent trial

Brigham and Women's Hospital - Recurrent sinus attacks do not necessarily lead to antibiotic resistance

Business & Finance - IMC Global common shareholders approve combination with Cargill Crop Nutrition

CHU de Saint-Etienne - Coxsackievirus replication and duration in intestinal cells described

Cairo University - Schistosome cholesterol depletion promotes antibody binding to antigen

Calypso Medical - Agreement signed with Impac Medical Systems for radiation delivery

Cancer & Pregnancy - Doctors report safer ways to help cancer patients have children

Castle Hill Hospital - Benefits of fish oils for chronic heart failure reviewed

Cellegy Pharmaceuticals, Inc. - Pharmaceutical firm to acquire Biosyn

Centre National de la Recherche Scientifique - Arthropod-derived histamine-binding protein prevents allergic asthma

Children's Hospital & Medical Center, Seattle - Retroviral-mediated gene transfer corrects B-cell development in murine models

Children's Hospital Oakland Research Institute - Capsule of Bacillus anthracis behaves as type 2 antigen

Corcept Therapeutics - James A. Harper joins board of psych/neurological drug company

Cornell University - Drug protocols for IVF compared in breast cancer patients

Cryo-Cell International, Inc. - New research finds umbilical cord blood-derived stem cells reduce stroke damage

Dalhousie University - CD2-CD48 interactions promote T-cell activation by stabilizing cytokine mRNA

Diagnostic Ultrasound Corp. - Bladder Assessment Kit launched for primary care physicians

Drug Abuse - Sister of girl who died with cocaine in system taken from mother

Drug Abuse - U.S. HHS awards $23 million to fight club drug use at local level

Emory University - Vaccine efficacy estimated using a small validation sample

En-Chu Kong Hospital - Weight-loss surgery can help reduce metabolic syndrome in obese patients

Endocrinology - GnRH affects bone metabolism at the start of estradiol suppression in IVF

Entropin, Inc. - Company: Analysis supports continued development of ENT-103

Environmental Health - Environmental exposures before and after birth can harm children's lungs

Enzo Biochem, Inc. - Gene-identification company provides 2004 update

Fooyin University, Kaohsiung Hsien - Oxidative stress and caspase activation involved in paclitaxel-induced apoptosis

Fred Hutchinson Cancer Res. Ctr. - Combination HRT doubles breast density, quadruples risk of abnormal mammograms

Fred Hutchinson Cancer Research Center - Hepatitis C virus NS5A and nuclear factor-kappa B generate liver injury

Free University of Brussels - Prevalence of Streptococcus pneumoniae in Belgian infants reported

Fundacion Instituto de Inmunologia de Colombia - Acidic-basic repeat antigen protein peptide protects against malaria

GammaCan International, Inc. - GCAN101 maker appoints CEO and CFO

IVAX Corporation - U.S. FDA approves ANDAs for fluoxetine capsules, tablets

Legionnaires Disease - Ohio County man contracts Legionnairs disease

Lung Transplantation - Lung transplant program at Jackson Memorial Hospital now Medicare-approved

Quill Medical, Inc. - Medical devices and wound closure technology companies announce alliance

R2 Technology, Inc. - Novation signs agreement for enabling discounts on image checking systems

Transplant Medicine - Temporary artificial heart approved

U.S. Food & Drug Administration - In vitro human skin penetration of diethanolamine investigated

U.S. Food & Drug Administration - Subassemblies of pertussis toxin subunits analyzed in vivo

U.S. Food and Drug Administration - FDA releases 2004 produce safety action plan

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