08:00 , Jan 14, 2013 |  BC Week In Review  |  Clinical News

PHT101 regulatory update

PharmaIN and LAT Pharma said FDA granted Orphan Drug designation for PHT101 to treat ascites due to all etiologies except for cancer. The companies are developing PHT101 to reduce the need for paracentesis and to...
08:00 , Nov 21, 2011 |  BC Week In Review  |  Clinical News

Xeplion regulatory update

The Scottish Medicines Consortium reversed a prior decision and recommended use of Xeplion paliperidone palmitate from Johnson & Johnson on the National Health Service (NHS) in Scotland for maintenance treatment of schizophrenia in adult patients...
07:00 , Jul 18, 2011 |  BC Week In Review  |  Clinical News

Xeplion paliperidone palmitate regulatory update

The Scottish Medicines Consortium recommended against Xeplion paliperidone palmitate from Johnson & Johnson on the National Health Service (NHS) in Scotland for maintenance treatment of schizophrenia in adult patients stabilized with paliperidone or risperidone. The...
07:00 , Mar 14, 2011 |  BC Week In Review  |  Clinical News

Invega Sustenna regulatory update

The European Commission approved an MAA for Xeplion paliperidone palmitate from Johnson & Johnson for the maintenance treatment of schizophrenia in adult patients stabilized with paliperidone or risperidone. The once-monthly intramuscular injection is a long-acting...
01:39 , Mar 10, 2011 |  BC Extra  |  Company News

EC approves J&J's Xeplion

The European Commission approved an MAA for Xeplion paliperidone palmitate from Johnson & Johnson (NYSE:JNJ) for the maintenance treatment of schizophrenia in adult patients stabilized with paliperidone or risperidone. The once-monthly intramuscular injection is a...
08:00 , Jan 3, 2011 |  BC Week In Review  |  Clinical News

Xeplion regulatory update

CHMP issued a positive opinion recommending approval of an MAA for Xeplion paliperidone palmitate from Johnson & Johnson to treat schizophrenia. The once-monthly intramuscular injection is a long-acting therapy (LAT) formulation of J&J's Invega paliperidone...
07:00 , Jun 28, 2010 |  BC Week In Review  |  Company News

Probactive Biotech Inc., Dalat Nuclear Research Institute deal

Probactive partnered with Dalat to co-develop combinations of antitumor antibodies and radioactive compounds to treat cancer. Probactive, which is leading development, said the lead candidate is a combination of Iodine-131 with an antinuclear antibody that...
08:00 , Dec 14, 2009 |  BC Week In Review  |  Clinical News

Invega Sustenna: Phase III data

In a 13-week, double-blind, placebo-controlled Phase III trial in 1,220 patients, once-monthly Invega Sustenna met the primary endpoint of non-inferiority to biweekly Risperdal Consta risperidone in decrease from baseline in PANSS total score (18.6 vs....
08:00 , Dec 14, 2009 |  BC Week In Review  |  Clinical News

Invega Sustenna regulatory update

Johnson & Johnson submitted an MAA to EMEA for paliperidone palmitate to treat schizophrenia. The once-monthly intramuscular injection is a long-acting therapy (LAT) formulation of J&J's Invega paliperidone ER that utilizes NanoCrystal formulation technology from...
07:00 , Aug 10, 2009 |  BC Week In Review  |  Clinical News

Invega Sustenna paliperidone palmitate regulatory update

FDA approved an NDA from Johnson & Johnson for Invega Sustenna paliperidone palmitate for the acute and maintenance treatment of schizophrenia. The company plans to launch the product this quarter. The once-monthly intramuscular injection is...