17:27 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Despite manufacturing concern, Acacia still expects 1H19 launch for PONV therapy

Acacia Pharma Group plc (Euronext:ACPH) said FDA raised a concern related to manufacturing deficiencies in a complete response letter issued for an NDA seeking approval of Barhemsys amisulpride to treat and prevent postoperative nausea and...
18:21 , Oct 8, 2018 |  BC Extra  |  Company News

Despite manufacturing concern, Acacia still expects 1H19 launch for PONV therapy

Acacia Pharma Group plc (Euronext:ACPH) said FDA raised a concern related to manufacturing deficiencies in a complete response letter issued Monday for an NDA seeking approval of Barhemsys amisulpride to treat and prevent postoperative nausea...
17:37 , Aug 31, 2018 |  BC Week In Review  |  Company News

CNS company Seelos reverse merging with Apricus

Seelos Therapeutics Inc. (New York, N.Y.) will reverse-merge with Apricus Biosciences Inc. (NASDAQ:APRI). Seelos shareholders are expected to own about 86% of the merged company. Apricus shareholders are expected to own the remaining 14%, and...
19:25 , Jul 5, 2018 |  BC Week In Review  |  Clinical News

Alkermes' Aristada Initio approved for schizophrenia

FDA approved Aristada Initio aripiprazole lauroxil from Alkermes plc (NASDAQ:ALKS) in combination with oral aripiprazole to initiate treatment of schizophrenia in adults. The company expects to launch the product mid-July. Aristada Initio is an extended-release injectable...
19:21 , Jul 2, 2018 |  BC Extra  |  Company News

New dose regimen for Alkermes' aripiprazole approved

Alkermes plc (NASDAQ:ALKS) said FDA approved Aristada Initio aripiprazole lauroxil in combination with oral aripiprazole for adult schizophrenia patients initiating treatment with Aristada. Aristada previously required three weeks of oral aripiprazole supplementation following the first...
18:29 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

CHMP recommendations include Aimovig, orphan candidates

Among a host of positive recommendations announced on June 1, EMA's CHMP backed approval of migraine therapy Aimovig erenumab and Orphan Drug designees Tegsedi inotersen for hereditary transthyretin (TTR) amyloidosis and Myalepta metreleptin for leptin...