Food and Drug Law Weekly

Advanced Biotherapy, Inc. - FDA-approved study launched to treat AIDS patients in virologic failure

Aventis - Companies announce Genasense EAP for those with advanced melanoma

Aventis - FDA approval granted for rapid-acting insulin analogue Apidra

B. Braun - New Pinnacle parenteral nutrition management system to be introduced

Barr Pharmaceuticals, Inc. - Generic Ovcon-35 tablets approved by FDA

Bio-Rad Laboratories, Inc. - New high throughput diabetes monitoring system launched

Biomet - FDA grants premarket approval for free-floating meniscal knee system

Boston Scientific Corporation - FDA clears Express Biliary SD Monorail Premounted Stent System

Caraco Pharmaceutical Laboratories - FDA grants approval for generic form of Remeron

Cardiac Science, Inc. - Defibrillator manufacturer receives warning letter from FDA

Centocor, Inc. - FDA accepts BLA for Remicade

Conceptus, Inc. - Contraceptive device maker reports $0.31 per share loss

Cordis Endovascular - Carotid stent system recommended for approval by FDA panel

Cyberkinetics, Inc. - Pilot study of BrainGate Neural Interface system initiated

Genaera Corp. - Phase III squalamine trials slated for early 2005

UFR Sante Medecine et Biologie Humaine - Glucose and insulin preprandial profiles differentiate meals and snacks

AEterna Laboratories, Inc. - Study initiated for oral agent that stimulates growth hormone secretion

Academic Medical Center, Amsterdam - Rab6 membrane association dependent on cellular phosphorylation events

Adenosine Therapeutics, LLC - NIH awards company phase II SBIR grant to study diabetes

Alkermes, Inc. - Enrollment complete in study of Vivitrex for alcohol dependence

Alliance Pharmaceutical Corp. - Agreement signed for Oxygent in Korea

Alphapharm, Pty., Ltd. - Forest Laboratories receives notification of ANDA filing for a generic Lexapro

Alteon, Inc. - Phase II trial of Alagebrium initiated in diastolic dysfunction

American Healthways, Inc. - Health plan selects disease management program

Anika Therapeutics, Inc. - Trial commences for Incert-S anti-adhesion therapy

Arbios Systems, Inc. - Rights to bioartificial liver, other assets acquired from Circe Biomedical

Asthma - Program helps physicians prevent asthma attacks

AstraZeneca - Pharmaceutical firm opens compound management center in Delaware

Austin and Repatriation Medical Centre - Severe immune hemolysis after standard penicillin dose reported

Autonomous University of Madrid - Human neural stem cell lines are stable when cultured for long periods

Avant Immunotherapeutics, Inc. - Defense contract awarded for testing of plague/anthrax vaccine

Basel University Hospital - Intranasal influenza vaccine causes facial paralysis

Bayhill Therapeutics, Inc. - Mark Schwartz, PhD, to lead drug development at autoimmune-focused company