00:20 , Mar 21, 2019 |  BC Extra  |  Company News

FDA approves Jazz's Sunosi for daytime sleepiness

FDA approved late Wednesday Sunosi solriamfetol from Jazz to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Jazz Pharmaceuticals plc (NASDAQ:JAZZ) expects to launch Sunosi following a...
01:17 , Mar 13, 2019 |  BC Extra  |  Company News

FDA approves Aerie glaucoma therapy Rocklatan

Aerie said late Tuesday FDA approved Rocklatan netarsudil/latanoprost to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The product is a fixed-dose combination of Aerie's Rhopressa netarsudil 0.02%, a dual inhibitor of...
04:45 , Feb 22, 2019 |  BC Innovations  |  Targets & Mechanisms

Solid checkpoint for CARs

PD-L1 family member B7-H3 could put CAR T cells in play for a slew of difficult-to-treat solid tumors, including pediatric cancers that lack targeted therapies, according to a pair of preclinical studies published this year....
19:02 , Aug 10, 2018 |  BC Week In Review  |  Financial News

Zogenix, Progenics raise follow-ons

Zogenix Inc. (NASDAQ:ZGNX) and Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) each priced follow-on offerings late Aug. 7th. Zogenix raised $312 million through the sale of 6 million shares at $52 in an offering underwritten by BofA Merrill...
17:08 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Sunovion's high-dose dasotraline meets primary in Phase III for binge eating disorder

The Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said the once-daily 6 mg dose of dasotraline (SEP-225289) met the primary endpoint of reducing the number of binge days, defined as days...
18:18 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Aerie's Roclatan under FDA review with March PDUFA

Aerie Pharmaceuticals Inc. (NASDAQ:AERI) said FDA accepted for review an NDA for Roclatan netarsudil/latanoprost to reduce intraocular pressure (IOP) in glaucoma or ocular hypertension. The PDUFA date is March 14, 2019. Roclatan met its primary...
19:57 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

FDA accepts resubmitted NDA for Ironshore's HLD200 for ADHD

The Ironshore Pharmaceuticals & Development Inc. subsidiary of Highland Therapeutics Inc. (Toronto, Ontario) said FDA accepted a resubmitted NDA for HLD200 to treat ADHD. The PDUFA date is Aug. 8. HLD200 is a modified-release formulation...
23:12 , Jan 3, 2018 |  BC Week In Review  |  Clinical News

Progenics gets Priority Review for Azedra in rare NETs

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said FDA accepted and granted Priority Review to an NDA for Azedra iobenguane I 131 (Ultratrace I-131-MIBG, Ultratrace iobenguane I 131) to treat malignant recurrent and/or unresectable pheochromocytoma and paraganglioma. Its...
18:41 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

FDA approves Aerie's Rhopressa to lower IOP

FDA approved Rhopressa netarsudil 0.02% from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company plans to launch the drug in 2Q18. The approval...
21:38 , Dec 19, 2017 |  BC Extra  |  Company News

FDA approves Aerie's Rhopressa

FDA approved Rhopressa netarsudil 0.02% from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company plans to launch the drug in 2Q18. The approval...