BC Week In Review | Apr 30, 2012
Clinical News

Comfyde carisbamate regulatory update

FDA granted Orphan Drug designation for SK's carisbamate to manage infantile spasms. The oral anticonvulsant is in preclinical testing for the indication. Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.), which held worldwide rights to carisbamate...
BC Week In Review | Feb 1, 2010
Clinical News

Comfyde carisbamate regulatory update

Johnson & Johnson's Janssen-Cilag Ltd. unit said it withdrew an MAA for Comfyde carisbamate for the adjunctive treatment of partial onset seizures in patients 16 and older. The company said it withdrew the application after...
BC Week In Review | Aug 24, 2009
Clinical News

Carisbamate regulatory update

Johnson & Johnson 's Ortho-McNeil-Janssen Pharmaceuticals Inc. unit received a complete response letter from FDA for Comfyde carisbamate for the adjunctive treatment of partial onset seizures in patients 16 and older. Details of the letter...
BC Extra | Aug 22, 2009
Company News

J&J's Comfyde gets complete response

Johnson & Johnson (NYSE:JNJ) received a complete response letter from FDA for Comfyde carisbamate for the adjunctive treatment of partial onset seizures in patients 16 years and older. Details of the letter were not disclosed....
BioCentury | Jul 6, 2009
Finance

2H09 Milestones

2H09 Milestones Company Product Indication Event Milestone Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)/Biovail Corp. (TSX:BVF; NYSE:BVF) Pimavanserin tartrate (formerly ACP-103) Parkinson's disease psychosis (PDP) Ph III data 3Q09 Accentia Biopharmaceuticals Inc. (Pink:ABPIQ) Biovaxid Follicular non-Hodgkin's B cell...
BC Innovations | Jan 8, 2009
Cover Story

Taking the inflammation out of epilepsy

Italian and U.S. researchers have proposed treating epileptic seizures by targeting an inflammatory pathway outside the blood-brain barrier: leukocyte migration and recruitment. 1 The strategy potentially could help patients whose seizures are not adequately controlled...
BC Week In Review | Dec 15, 2008
Clinical News

Comfyde carisbamate: Phase III data

A double-blind, international Phase III trial in 555 patients showed that both 200 and 400 mg/day doses of Comfyde missed the co-primary endpoints of median percent reduction in seizure frequency vs. baseline and the proportion...
BC Week In Review | Dec 15, 2008
Clinical News

Comfyde carisbamate: Phase III data

A double-blind, international Phase III trial in 581 patients showed that 400 mg/day Comfyde met the co-primary endpoints of median percent reduction in seizure frequency from baseline and the proportion of patients with >=50% reduction...
BC Week In Review | Oct 27, 2008
Clinical News

Comfyde carisbamate regulatory update

Johnson & Johnson submitted an NDA to FDA for Comfyde carisbamate as an adjunctive treatment of partial onset seizures in epilepsy patients aged 16 and older. J&J received worldwide rights to the oral anticonvulsant from...
BC Extra | Oct 25, 2008
Company News

J&J submits carisbamate NDA

Johnson & Johnson (NYSE:JNJ) submitted an NDA to FDA for Comfyde carisbamate as an adjunctive treatment for partial onset seizures in epilepsy patients 16 and older. J&J received worldwide rights to the oral anticonvulsant from...
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