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 zolpidem...
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 522...
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 variance...
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) P P Entereg alvimopan Adolor (NASDAQ:ADLR)/GlaxoSmithKline (LSE:GSK; NYSE:GSK) P...
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...