07:00 , Oct 17, 2016 |  BC Week In Review  |  Clinical News

IV carnexiv carbamazepine regulatory update

FDA approved an NDA from H. Lundbeck for IV Carnexiv carbamazepine as short-term replacement therapy for oral carbamazepine to treat seizures in adults who temporarily cannot take their oral formulation. Carnexiv is indicated for partial...
07:00 , Sep 26, 2016 |  BC Week In Review  |  Clinical News

Zebinix: Phase III data

Data from the PP population of 785 patients with newly diagnosed partial-onset seizures in a double-blind, Portuguese Phase III trial showed that once-daily oral Zebinix met the primary endpoint of non-inferiority to twice-daily carbamazepine CR...
07:00 , May 2, 2016 |  BC Week In Review  |  Clinical News

IV Carnexiv carbamazepine regulatory update

H. Lundbeck said FDA accepted for review a resubmitted NDA for IV Carnexiv carbamazepine to treat epilepsy in patients who temporarily cannot take their oral carbamazepine. The company expects an FDA decision before year end....
07:00 , Oct 19, 2015 |  BC Week In Review  |  Clinical News

Vimpat lacosamide: Phase III data

Top-line data from a double-blind, international Phase III trial in 888 newly or recently diagnosed adult patients with partial-onset seizures showed that lacosamide met the primary endpoint of non-inferiority to carbamazepine-CR in the proportion of...
07:00 , Oct 19, 2015 |  BC Week In Review  |  Clinical News

Vimpat lacosamide: Phase III data

Top-line data from a double-blind, international Phase III trial in 888 newly or recently diagnosed adult patients with partial-onset seizures showed that lacosamide met the primary endpoint of non-inferiority to carbamazepine-CR in the proportion of...
07:00 , Apr 30, 2015 |  BC Innovations  |  Distillery Techniques

Therapeutics: Theiler's murine encephalomyelitis virus (TMEV)-infected mouse model of infection-induced epilepsy

Disease models TECHNOLOGY: Animal models A TMEV-infected mouse model could could help assess and predict the effects of anti-seizure therapeutics on infection-induced epilepsy, an infrequently occurring condition with little treatment history. Mice infected with TMEV...
07:00 , Jun 23, 2014 |  BioCentury  |  Product Development

Nav(1.7)igating pain

Data reported by Convergence Pharmaceuticals Ltd. last week for CNV1014802 to treat trigeminal neuralgia gave the first Phase II evidence that systemic Nav1.7 blockers can treat pain safely and effectively. The data also lend further...
07:00 , Mar 17, 2014 |  BC Week In Review  |  Clinical News

IV Carbella carbamazepine regulatory update

H. Lundbeck said FDA accepted for review an NDA for IV Carbella carbamazepine as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types when the...
07:00 , Aug 19, 2013 |  BC Week In Review  |  Clinical News

IV carbamazepine regulatory update

H. Lundbeck disclosed in its 2Q13 earnings that in June FDA granted Orphan Drug designation for IV carbamazepine to treat epilepsy in patients who cannot take anything by mouth. The sodium channel blocker is in...
07:00 , Jun 7, 2012 |  BC Innovations  |  Tools & Techniques

HLA in sequence

A group of Australian researchers and an FDA -led team have independently identified a mechanism behind human leukocyte antigen allele-mediated autoimmune reactions to certain drugs. 1,2 The findings could expand the use of human leukocyte...