07:00 , Apr 6, 2009 |  BioCentury  |  Finance

1Q setbacks

1Q setbacks Company Setback Acorda Therapeutics Inc. (NASDAQ:ACOR) FDA refuses to file an NDA for Fampridine-SR to improve walking ability in patients with multiple sclerosis, raising issues with the formatting of the electronic application and...
01:03 , Apr 4, 2009 |  BC Extra  |  Company News

Pfizer provides pipeline update

Pfizer Inc. (NYSE:PFE) unveiled an updated pipeline on Thursday, saying it met its goal of advancing 12 programs into Phase III trials since March 2008. The company also said it dropped 26 clinical programs in...
08:00 , Mar 2, 2009 |  BC Week In Review  |  Clinical News

Esreboxetine: Development discontinued

Pfizer discontinued development of esreboxetine, which was in Phase III testing to treat fibromyalgia. The company said data for the compound showed that it was unlikely to provide meaningful benefit beyond the current standard of...
03:06 , Feb 25, 2009 |  BC Extra  |  Clinical News

Pfizer drops two Phase III compounds

Pfizer (NYSE:PFE) discontinued development of a pair of compounds in Phase III testing after data showed they were unlikely to provide "meaningful benefit" to patients beyond the current standard of care. Esreboxetine, an oral selective...
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 , Dec 22, 2008 |  BioCentury  |  Product Development

Fibromyalgia pipeline

Fibromyalgia pipeline Company Product Product description Status Eli Lilly (NYSE:LLY) Cymbalta duloxetine Selective serotonin and norepinephrine reuptake inhibitor (SSNRI) Mkt (A) Pfizer (NYSE:PFE) Lyrica pregabalin GABA receptor agonist Mkt (A) Cypress (NASDAQ:CYPB)/Forest (NYSE:FRX)/Laboratoires Pierre Fabre...
08:00 , Nov 3, 2008 |  BC Week In Review  |  Clinical News

Esreboxetine: Phase II data

In an 8-week, double-blind, dose-escalating, U.S. Phase II trial in 267 patients with fibromyalgia, esreboxetine produced significant improvements across all 3 primary endpoints. Esreboxetine patients' adjusted mean weekly pain score change from baseline improved by...
08:00 , Dec 4, 2006 |  BC Week In Review  |  Clinical News

[S: Phase II started

PFE disclosed that [S,S]-Reboxetine is in a double-blind, placebo- and active-controlled Phase II trial in up to 280 patients to treat PHN. Pfizer Inc. (PFE), New York, N.Y.   Product: [S,S]-Reboxetine   Business: Neurology  ...
07:00 , May 21, 2001 |  BC Week In Review  |  Clinical News

Vestra reboxetine selective norepinephrine reuptake inhibitor regulatory update

PHA received a non-approvable letter from the FDA for Vestra to treat depression. The original Vestra NDA was submitted in 1998, and contained data from studies primarily outside the U.S. The FDA requested that PHA...
07:00 , May 18, 2001 |  BC Extra  |  Company News

Non-approvable letter for Pharmacia's Vestra

PHA received a non-approvable letter from the FDA for its Vestra reboxetine selective norepinephrine reuptake inhibitor to treat depression. The original Vestra NDA was submitted in 1998, and contained data from studies primarily outside the...