00:51 , Feb 24, 2018 |  BioCentury  |  Strategy

Patients as pawns

In an apparent game of chicken between Vertex Pharmaceuticals Inc. and French health authorities over the price of the cystic fibrosis drug Orkambi, patients say the decision to use access to investigational therapies as a...
17:01 , Aug 10, 2017 |  BC Week In Review  |  Clinical News

FDA approves Eisai's seizure drug Fycompa for monotherapy use

FDA approved an sNDA from Eisai Co. Ltd. (Tokyo:4523) for Fycompa perampanel (E2007) as monotherapy to treat partial-onset seizures with or without secondarily generalized seizures in epileptics ages ≥12. Fycompa was already approved as an...
20:19 , Dec 15, 2016 |  BC Innovations  |  Translation in Brief

Fore score

Cerecor Inc. (NASDAQ:CERC) has picked up a forebrain-selective anti-epileptic compound from Eli Lilly and Co. (NYSE:LLY) that could treat seizures by blocking AMPA glutamate receptor (GRIA; GLUR) without the dose-limiting motor side effects associated with...
17:59 , Nov 2, 2016 |  BC Week In Review  |  Clinical News

Fycompa: Ph III started

Eisai began the open-label, international Phase III Study 311 to evaluate up to 12 mg Fycompa oral suspension once daily in about 160 patients ages 4-11. Patients will receive Fycompa for up to 11 weeks...
17:33 , Nov 2, 2016 |  BC Week In Review  |  Clinical News

Fycompa: Ph III started

Eisai began the double-blind, placebo-controlled, international Phase III Study 338 to evaluate up to 8 mg/day Fycompa oral suspension for up to 22 weeks in 142 patients ages ≥2 receiving 1-3 concomitant antiepileptic drugs. The...
07:00 , Oct 20, 2016 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Parkinson’s disease (PD) Rat studies suggest GRIA antagonists or GABA A receptor agonists could help treat L-DOPA-induced dyskinesia in PD. In a rat model of L-DOPA-induced dyskinesia in PD, infusion into the primary motor...
07:00 , Oct 3, 2016 |  BC Week In Review  |  Clinical News

Fycompa perampanel regulatory update

Eisai said it submitted an sNDA to FDA for Fycompa perampanel as monotherapy to treat partial-onset seizures with or without secondarily generalized seizures in epileptics ages >=12. Fycompa is approved as an adjunctive therapy in...
07:00 , Jun 6, 2016 |  BC Week In Review  |  Company News

Eisai sales and marketing update

Eisai launched Fycompa perampanel in Japan as an adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures in epileptics who have an inadequate response to other antiepileptics. The Japanese National Health Insurance (NHI) list...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Fycompa perampanel regulatory update

FDA approved Fycompa perampanel oral suspension from Eisai as an adjunctive therapy in the treatment of partial-onset seizures, with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in epileptics ages >=12. Eisai...
07:00 , Apr 4, 2016 |  BioCentury  |  Finance

1Q approvals

1Q approvals Company Approval Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) Japan approves Kanuma sebelipase alfa to treat lysosomal acid lipase deficiency (LAL-D) Amgen Inc. (NASDAQ:AMGN) Japan approves Repatha evolocumab to treat familial hypercholesterolemia or hypercholesterolemia in patients...