16:22 , Apr 5, 2019 |  BC Week In Review  |  Company News

FDA wants additional information on Evoke's Gimoti

Evoke said FDA issued a complete response letter to its NDA for Gimoti to treat acute and recurrent diabetic gastroparesis in women. Evoke Pharma Inc. (NASDAQ:EVOK) said the agency raised clinical pharmacology and product quality...
18:50 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

Lundbeck, Otsuka's brexpiprazole misses in Phase III for bipolar I disorder

H. Lundbeck A/S (CSE:LUN) and Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said brexpiprazole missed the primary endpoints in two Phase III trials to treat manic episodes associated with bipolar I disorder. The partners will evaluate...
00:08 , Jan 23, 2019 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Depression Mouse studies suggest agonizing CB1 could help treat depression. In a mouse model of depression, optogenetic activation of synaptic circuits involving cholecystokinin (CCK)-positive neurons in the basal lateral amygdala and dopamine D2 receptor...
19:29 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Intra-Cellular stops Phase II of lumateperone for agitation in dementia for futility

Intra-Cellular Therapies Inc. (NASDAQ:ITCI) discontinued the Phase III Study 201 of low-dose lumateperone (ITI-007) to treat agitation in patients with dementia, including Alzheimer's disease, after a prespecified interim analysis by an IDMC showed that the...
17:35 , Dec 7, 2018 |  BC Week In Review  |  Clinical News

Lundbeck, Otsuka combo meets in Phase II for PTSD

H. Lundbeck A/S (CSE:LUN) and Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said a combination of brexpiprazole and the generic serotonin reuptake inhibitor (SSRI) sertraline met the primary endpoint in a Phase II trial to treat...
16:39 , Oct 26, 2018 |  BC Week In Review  |  Company News

Dementia Discovery Fund, UK Dementia Research Institute partner to fund dementia research

The Dementia Discovery Fund (DDF) and UK Dementia Research Institute launched a partnership dubbed D3A to grant multiple awards of £100,000-£200,000 ($130,768-$261,536) to support clinical translation. D3A will fund translational projects from UK Dementia Research...
17:18 , Oct 24, 2018 |  BC Extra  |  Company News

Dementia Discovery Fund, UK Dementia Research Institute partner to fund dementia research

The Dementia Discovery Fund (DDF) and UK Dementia Research Institute launched a partnership dubbed D3A to grant multiple awards of £100,000-£200,000 ($130,768-$261,536) to support clinical translation. D3A will fund translational projects from UK Dementia Research...
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...