08:00 , Jan 4, 2010 |  BioCentury  |  Finance

4Q setbacks

4Q setbacks Company Setback Acorda Therapeutics Inc. (NASDAQ:ACOR)/ Elan Corp. plc (NYSE:ELN) FDA extends the PDUFA date for an NDA for Fampridine-SR to improve walking ability in patients with multiple sclerosis by three months to...
08:00 , Dec 14, 2009 |  BC Week In Review  |  Clinical News

Nenad lisuride transdermal patch regulatory update

Axxonis withdrew an MAA for Nenad lisuride transdermal patch to treat moderate to severe idiopathic restless legs syndrome (RLS). In November, EMEA's CHMP issued a negative opinion on the application and suggested the data provided...
08:00 , Nov 23, 2009 |  BC Week In Review  |  Clinical News

Nenad lisuride transdermal patch regulatory update

EMEA's CHMP issued a negative opinion on an MAA from Axxonis for Nenad lisuride transdermal patch to treat restless legs syndrome (RLS). CHMP said there was not enough evidence to demonstrate Nenad's long-term effectiveness. The...
01:31 , Nov 21, 2009 |  BC Extra  |  Company News

Antigenics withdraws Oncophage MAA

Antigenics Inc . (NASDAQ:AGEN) withdrew an MAA for Oncophage vitespen after EMEA's CHMP formally adopted a negative opinion on the compound for the adjuvant treatment of renal cell carcinoma (RCC). CHMP told the company last...
07:00 , Jul 16, 2009 |  BC Innovations  |  Tools & Techniques

Parkinson's double take

Emory University researchers have found that a mouse model of Parkinson's disease they developed in 2007 could be more useful than expected. A second look at the mice showed that the model recapitulates not only...
07:00 , Jun 9, 2008 |  BC Week In Review  |  Clinical News

Nenad lisuride subcutaneous infusion regulatory update

Axxonis submitted an MAA to EMEA for Nenad lisuride subcutaneous infusion to treat advanced Parkinson's disease (PD). Lisuride, a dopamine agonist and serotonin (5- HT2B) receptor antagonist, was originally developed as an oral agent and...
07:00 , Jun 9, 2008 |  BC Week In Review  |  Clinical News

Nenad lisuride transdermal patch regulatory update

Axxonis submitted an MAA to EMEA for Nenad lisuride transdermal patch to treat restless legs syndrome (RLS). Lisuride, a dopamine agonist and serotonin (5- HT2B) receptor antagonist, was originally developed as an oral agent and...
07:00 , Jun 9, 2008 |  BC Week In Review  |  Clinical News

Nenad lisuride transdermal patch regulatory update

Axxonis submitted an MAA to EMEA for Nenad lisuride transdermal patch for adjunct treatment of Parkinson's disease (PD). Lisuride, a dopamine agonist and serotonin (5- HT2B) receptor antagonist, was originally developed as an oral agent...
07:00 , Mar 26, 2007 |  BC Week In Review  |  Company News

NeuroBiotec Pharma AG neurology news

NeuroBiotec changed its name to axxonis Pharma AG. NeuroBiotec Pharma AG , Berlin, Germany   Business: Neurology  ...