20:02 , Mar 25, 2019 |  BC Extra  |  Clinical News

Aimmune on track for EU submission of peanut allergy therapy

A week after Aimmune said an FDA decision on approval of its peanut allergy therapy may come a month late, the company said Monday its timeline for an MAA submission remains on schedule following a...
20:24 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

Omeros' OMS721 underwhelms in Phase II for IgA nephropathy

Omeros Corp. (NASDAQ:OMER) reported data from nine evaluable steroid-free patients with IgA nephropathy in a Phase II trial showing that once-weekly IV OMS721 for 12 weeks led to a 0.4% greater reduction in median proteinuria...
23:38 , Oct 2, 2018 |  BC Extra  |  Clinical News

Omeros' OMS721 underwhelms in Phase II

Shares of Omeros Corp. (NASDAQ:OMER) regained some ground Tuesday a day after the stock tumbled on data from nine evaluable steroid-free patients with IgA nephropathy in a Phase II trial showing that once-weekly IV OMS721...
16:43 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

Eureka's ET140202 leads to tumor regression in Phase I for HCC

Eureka Therapeutics Inc. (Emeryville, Calif.) said ET140202 led to one case of complete tumor regression and two cases of partial tumor regression in six evaluable patients with alpha fetoprotein (AFP)-positive hepatocellular carcinoma (HCC) in a...
21:52 , Sep 18, 2018 |  BC Extra  |  Company News

Management tracks: BioTime, Immune-Onc

Degenerative disease company BioTime Inc. (NYSE-A:BTX; Tel Aviv:BTX) named Brian Culley CEO, to replace co-CEOs Adi Mohanty and Michael West. Most recently, Culley was CEO of infectious disease company Artemis Therapeutics Inc. (OTCQB:ATMS). Immunotherapy company...
08:00 , Dec 7, 2015 |  BC Week In Review  |  Clinical News

Amatuximab: Phase II started

Eisai’s Morphotek Inc. subsidiary began the double-blind, placebo-controlled, international Phase II ARTEMIS trial to evaluate 5 mg/kg IV amatuximab once weekly with IV pemetrexed and IV cisplatin given on day 1 of each 3-week cycle...
08:00 , Feb 6, 2012 |  BioCentury  |  Strategy

Putting R&D into BD

AstraZeneca plc clearly has the restructuring bug, as last Thursday it announced it would shrink its neuroscience unit into a 40-50 person group exclusively focused on external opportunities. But it was not the first move...
07:00 , Oct 31, 2011 |  BC Week In Review  |  Clinical News

Prezista darunavir regulatory update

FDA approved an updated label for Johnson & Johnson's Prezista darunavir to include 192-week data from the open-label, international Phase III ARTEMIS trial to treat HIV-1 infection in 689 treatment-naive patients. Data from ARTEMIS showed...
07:00 , May 2, 2011 |  BC Week In Review  |  Company News

Verinata management update

Verinata Health Inc. , San Carlos, Calif.   Business: Diagnostic   Hired: Caren Mason as CEO and a director, formerly president and CEO of Quidel Corp. ; she replaces interim CEO Phyllis Whiteley, an executive-in-residence...
23:54 , Apr 26, 2011 |  BC Extra  |  Company News

New name, CEO for Artemis

Maternal and fetal health company Artemis Health Inc. (San Carlos, Calif.) changed its name to Verinata Health Inc. on Tuesday and hired Caren Mason as CEO and a director. Mason is the former president and...