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...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
21:45 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

Alkermes to start Phase III of Aripiprazole Lauroxil NanoCrystal Dispersion for schizophrenia

In October, Alkermes plc (NASDAQ:ALKS) said it will begin a double-blind, U.S. Phase IIIb trial of Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD) plus Aristada aripiprazole lauroxil vs. Invega Sustenna paliperidone palmitate from Johnson & Johnson (NYSE:JNJ)...
00:53 , Dec 31, 2016 |  BioCentury  |  Finance

Delivering takeouts

  BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are looking more...
07:00 , Aug 15, 2016 |  BC Week In Review  |  Clinical News

Aristada aripiprazole lauroxil regulatory update

Alkermes submitted an sNDA to FDA for a 2-month dosing interval of Aristada aripiprazole lauroxil to treat schizophrenia. Aristada is already approved for once monthly or once every 6 week dosing. The injectable, extended-release formulation...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Rethinking risk

Steve Edelson, Senior Editor   The second half does not contain the high-impact, sector-moving milestones seen in the first six months of the year, but investors still have at least 90 late-stage milestones from which to...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Abilify aripiprazole regulatory update

FDA issued a drug safety communication warning that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of the antipsychotic drug aripiprazole. FDA said the uncontrollable...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Abilify Maintena once-monthly aripiprazole regulatory update

FDA issued a drug safety communication warning that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of the antipsychotic drug aripiprazole. FDA said the uncontrollable...