22:15 , Aug 2, 2018 |  BC Innovations  |  Tools & Techniques

Model firsts

By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions. Advocates see it as part of...
16:57 , Jan 12, 2018 |  BC Week In Review  |  Company News

Fosun gets Chinese rights to Bial's PD drug

Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal) granted the Jiangsu Wanbang Biopharmaceutical Group Co. Ltd. subsidiary of Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKSE:2196) exclusive, Chinese commercialization rights to Parkinson's disease drug...
00:28 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

FDA approves sNDA for Sunovion's Aptiom

FDA approved an sNDA for Aptiom eslicarbazepine acetate (BIA 2-093, SEP-0002093) from the Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) to treat partial-onset seizures in patients age ≥4. Aptiom is already...
06:12 , Jul 28, 2017 |  BC Week In Review  |  Clinical News

EC approves label expansion for Bial-Portela's epilepsy drug Zebinix

In May, the European Commission approved a label expansion for Zebinix eslicarbazepine acetate (Aptiom - U.S.) (BIA 2-093, SEP-0002093) from Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal) to include its use as monotherapy...
00:34 , Jun 9, 2017 |  BC Extra  |  Clinical News

Team describes off-target effects of Bial's FAAH inhibitor

In a paper published in Science , researchers characterized off-target activities of fatty acid amide hydrolase (FAAH) inhibitor BIA 10-2474 that they say may have played a role in the compound’s clinical neurotoxicity that led...
19:49 , May 26, 2017 |  BC Week In Review  |  Clinical News

FDA accepts Sunovion's Aptiom sNDA for pediatric seizures

The Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said FDA accepted for review an sNDA for Aptiom eslicarbazepine acetate (Zebinix - EU) (BIA 2-093, SEP-0002093) as monotherapy or adjunctive therapy to...
00:56 , Mar 29, 2017 |  BC Week In Review  |  Clinical News

Zebinix regulatory update

EMA’s CHMP recommended a label expansion for Zebinix eslicarbazepine acetate from Bial-Portela to include its use as monotherapy to treat partial-onset seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy. The voltage-gated...
19:53 , Mar 14, 2017 |  BC Week In Review  |  Clinical News

Aptiom regulatory update

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. unit said it submitted an sNDA to FDA for Aptiom eslicarbazepine acetate as monotherapy or adjunctive therapy to treat partial-onset seizures in children ages ≥4. The voltage-gated sodium channel blocker...
20:14 , Feb 16, 2017 |  BC Week In Review  |  Company News

Bial-Portela, Neurocrine Biosciences deal

Bial-Portela granted Neurocrine Biosciences exclusive, North American rights to Parkinson's disease drug Ongentys opicapone (ONO-2370). Bial-Portela will receive $30 million up front and is eligible for up to $115 million in milestones, plus 37% of...
22:24 , Feb 10, 2017 |  BC Extra  |  Company News

Neurocrine gets rights to Bial-Portela's PD drug

Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal) granted Neurocrine Biosciences Inc. (NASDAQ:NBIX) exclusive, North American rights to Parkinson's disease drug Ongentys opicapone (ONO-2370). Bial-Portela will receive $30 million up front and is eligible...