07:00 , Oct 1, 2012 |  BC Week In Review  |  Clinical News

Solorel macimorelin regulatory update

Aeterna Zentaris said FDA did not grant Fast Track designation for AEZS-130 to diagnose adult growth hormone deficiency. Aeterna declined to disclose details. The company said it still plans to submit an NDA for the...
07:00 , Mar 12, 2012 |  BC Week In Review  |  Clinical News

Solorel macimorelin: Phase IIa started

Aeterna Zentaris began a double-blind, placebo-controlled Phase IIa trial to evaluate AEZS-130 in 18-26 patients with cancer cachexia. The trial is being conducted under a cooperative research and development agreement (CRADA) with the Michael E....
07:00 , Sep 5, 2011 |  BC Week In Review  |  Clinical News

Solorel macimorelin: Phase III

Top-line data from an open-label, U.S. Phase III trial in about 100 subjects showed that a single dose of 0.5 mg/kg oral AEZS-130 met the primary endpoint of >90% sensitivity and specificity for diagnosing AGHD....
08:00 , Jan 3, 2011 |  BC Week In Review  |  Clinical News

Solorel macimorelin: SPA received

Aeterna Zentaris received an SPA from FDA after amending the protocol for an ongoing, open-label, U.S. Phase III trial evaluating Solorel to diagnose AGHD. The trial, which had enrolled 42 AGHD patients and 10 healthy...
07:00 , Oct 11, 2010 |  BC Week In Review  |  Clinical News

Macimorelin: Interim Phase III data

Interim data from an open-label, crossover, U.S. Phase III trial in 42 patients with confirmed AGHD or multiple pituitary hormone deficiencies and 10 healthy volunteers showed that growth hormone stimulation with oral AEZS-130 had 95%...
07:00 , Jul 12, 2010 |  BC Week In Review  |  Company News

Atlantic Healthcare management update

Atlantic Healthcare Ltd. , London, U.K.   Business: Autoimmune   Hired: Huw Jones as CEO of Atlantic's Atlantic Pharmaceuticals Ltd. division, formerly a director at Ardana plc and president for Europe at CV Therapeutics Inc....
07:00 , Jun 15, 2009 |  BC Week In Review  |  Company News

Aeterna Zentaris, Ardana deal

Aeterna acquired from Ardana's administrators additional assets related to AEZS-130 ( ARD-07 ) for $232,000. Aeterna regained the compound last year after Ardana entered administration. The assets include development data, compound inventory, regulatory authorizations, including...
07:00 , Jul 14, 2008 |  BC Week In Review  |  Company News

Ardana, Senetek deal

Senetek ended a 2004 deal that gave Ardana exclusive rights to manufacture, market, sell and distribute Senetek’s Invicorp vasoactive intestinal polypeptide (VIP)/phentolamine injection in Europe to treat erectile dysfunction (ED). Senetek said the decision was...
07:00 , Jul 7, 2008 |  BC Week In Review  |  Company News

Ardana genitourinary news

Ardana voluntarily appointed Ernst & Young LLP as administrators and suspended trading on the London Stock Exchange after the company was unable to complete a refinancing, sale, merger or out-licensing deal within the time available...
02:00 , Jul 1, 2008 |  BC Extra  |  Company News

Ardana stops operations, enters administration

Ardana (LSE:ARA) said it entered into voluntary administration after the genitourinary company was unable to complete a refinancing, sale or merger within the time available before exhaustion of the company's cash. The company also had...