FDA Classifies Medtronic’s Notification Related To Improper Connection Of Sutureless Intrathecal Catheters As A Class I Recall

Medtronic, Inc. (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has classified its safety alert about the proper connection of sutureless catheters used with implantable drug infusion systems as a Class I recall. The notification relates to the improper connection of its sutureless connector intrathecal catheters (referred to [...]

Drug Information Association 2nd Annual Clinical Forum: Data Driven Drug Development Decisions

Following a very successful first event in 2007, the Drug Information Association’s (DIA’s) 2nd Annual Clinical Forum: Data Driven Drug Development Decisions (October 20-23, 2008; Ljubljana, Slovenia) will focus on clinical data. New and experienced colleagues in the field of clinical and safety data management, clinical research and operations, statistics, medical information, pharmacovigilance, information [...]

GI Dynamics Announces Promising Multi-Center Safety And Efficacy Data Of EndoBarrier™ Gastrointestinal Liner For Pre-Surgical Weight Loss

GI Dynamics, a medical device company pioneering the development of new approaches to treat obesity and metabolic disorders, today announced new data regarding the EndoBarrier™, its novel, noninvasive device currently in clinical trials to treat obesity and type 2 diabetes. New data from a multi-center, randomized clinical trial indicate that the EndoBarrier is a safe, [...]

FDA Updates Health Information Advisory On Melamine Contamination

The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. The products, manufactured by China’s Shandong Duqing Inc., are:

Bionovo’s VG101 Shows Greater Efficacy Than Estrogen In The Treatment Of Vaginal Dryness

Bionovo, Inc. (Nasdaq: BNVI) will present an abstract in a presentation on their new drug candidate, VG101, for the treatment of vaginal dryness, at the 19th Annual Meeting of the North American Menopause Society in Orlando, Florida on September 26, 2008. Dr. Mary Tagliaferri, president and chief medical officer [...]