07:00 , May 23, 2011 |  BC Week In Review  |  Clinical News

Aplenzin bupropion hydrobromide regulatory update

FDA updated the label of Alpenzin bupropion from Valeant to include a boxed warning about reports of serious neuropsychiatric events with use of bupropion for smoking cessation, including but not limited to depression, suicidal ideation,...
07:00 , Apr 19, 2010 |  BC Week In Review  |  Company News

sanofi-aventis pharmaceuticals news

sanofi-aventis will reduce its U.S. headcount by 400. The cuts will primarily come from its U.S. sales force, which had 5,700 employees prior to the move. sanofi-aventis will reduce promotional efforts for Ambien CR...
07:00 , Apr 13, 2009 |  BC Week In Review  |  Company News

Biovail, sanofi-aventis sales and marketing update

sanofi-aventis' sanofi-aventis U.S. unit launched once-daily Aplenzin bupropion in the U.S. to treat major depressive disorder (MDD) in adults aged 18 and older. The price is undisclosed. The product is available in 348 and...
08:00 , Feb 2, 2009 |  BC Week In Review  |  Clinical News

Zoloft sertraline neurology data

Researchers from the University of Verona and colleagues published in The Lancet a meta-analysis of 117 studies with 25,928 total subjects comparing 12 second-generation antidepressants. The analysis showed that 4 drugs - mirtazapine, escitalopram, venlafaxine...
08:00 , Jan 5, 2009 |  BC Week In Review  |  Company News

Biovail, J&J, sanofi-aventis sales and marketing update

Biovail recalled certain lots of Ultram ER 100 mg tablets after batches were found to be out-of-specification by about 1% with respect to maximum dissolution at the eight-hour mark. The company said the dissolution...
07:00 , Sep 29, 2008 |  BioCentury  |  Regulation

Acting on REMS

Acting on REMS Drug Company Med Guide/PPI Communication plan Elements to assure safe use 505(o) required postmarket study or trial NME approvals Cimzia certolizumab UCB (Euronext:UCB)...
07:00 , Apr 28, 2008 |  BC Week In Review  |  Clinical News

Aplenzin bupropion hydrobromide regulatory update

FDA approved an NDA from Biovail for once-daily Aplenzin bupropion hydrobromide (formerly BVF-033) to treat depression in adults. Biovail had received a not approvable letter for the compound last July, citing problems with the design...
07:00 , Apr 7, 2008 |  BioCentury  |  Finance

2Q milestones

2Q milestones Company Product Indication Event Milestone Accentia (NASDAQ:ABPI) Biovaxid Follicular non-Hodgkin's lymphoma (NHL) Interim Ph III data April Acusphere (NASDAQ:ACUS)/ Nycomed Imagify (AI-700) Detect coronary heart disease (CHD) Submit NDA April Adolor (NASDAQ:ADLR)/ GlaxoSmithKline...
08:00 , Dec 3, 2007 |  BC Week In Review  |  Clinical News

BVF-033 regulatory update

FDA accepted a complete response from BVF to a July not approvable letter for BVF-033 to treat depression. The company said the response was classified as a Class 2 resubmission, which results in a PDUFA...
07:00 , Oct 29, 2007 |  BC Week In Review  |  Clinical News

BVF-033 regulatory update

BVF submitted a complete response to FDA in response to a July not approvable letter for BVF-033 to treat depression. The company said the submission includes new analyses of the data included in the original...