Keyword: GW Pharmaceuticals
The FDA has refused to review the new drug application for Zogenix's Fintepla because of missing and incomplete data.
With a nod for two rare forms of epilepsy, GW Pharma’s Epidiolex became the first cannabis-based prescription medicine in the U.S.
The pair will start three new trials in the third quarter, including a phase 2 pilot study in CDKL5 deficiency disorder and duplication 15q syndrome.
The efficacy and safety profile set the company up to compete with GW Pharmaceuticals in Dravet, sending Zogenix stock up 18% in premarket trading.
Kalytera is developing cannabidiol for the prevention and treatment of graft-versus-host disease, a serious complication of bone marrow transplant.
The panelists said the med's effects on the liver could be managed through labeling and education.
GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.
Therapix Biosciences' THX-110 reduced Tourette symptoms in adults who had failed other treatments.
While the trial linked GWP42006 to around a 40% drop in focal seizures, the placebo triggered a similarly sharp decline.
The failure of the study to hit a single goal or show a dose response raises big doubts about the prospects of the drug.
