19:54 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

FDA wants more info on Sunovion Parkinson’s therapy

Sunovion Pharmaceuticals Inc. said late Jan. 30 that FDA issued a complete response letter for its NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson’s disease patients. The subsidiary of Sumitomo Dainippon...
00:53 , Feb 1, 2019 |  BC Innovations  |  Product R&D

BlueRock’s PD purity play

Regenerative medicine company BlueRock is gearing up to submit its first IND this year, banking on its approach to Parkinson’s disease to overcome the legacy of failed fetal transplants by offering a more stable and...
20:36 , Jan 31, 2019 |  BC Extra  |  Company News

FDA wants more info on Sunovion Parkinson’s therapy

Sunovion Pharmaceuticals Inc. said late Wednesday that FDA issued a complete response letter for its NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson’s disease patients. The subsidiary of Sumitomo Dainippon Pharma...
21:42 , Jan 25, 2019 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 15 profitable biotechs and pharmas are slated to report earnings this week. (A) Before U.S. markets open; during trading hours in Europe; (B) Six-month EPS estimate; (C) Fiscal 3Q; (D)...
19:52 , Jan 17, 2019 |  BioCentury  |  Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
05:11 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Sunovion's SEP-363856 meets in Phase II for schizophrenia

Sunovion Pharmaceuticals Inc. and partner PsychoGenics Inc. (Paramus, N.J.) said SEP-363856 met the primary endpoint in the Phase II SEP361-201 trial to treat hospitalized patients with acute exacerbations of schizophrenia. On the primary endpoint, SEP-363856...
01:26 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

FDA approves Acorda's Inbrija for Parkinson's

FDA approved Inbrija levodopa inhalation powder from Acorda Therapeutics Inc. (NASDAQ:ACOR) to treat "off" periods in Parkinson's disease patients receiving carbidopa/levodopa. The approval comes after multiple delays and gives Acorda a new product to bring...
13:43 , Jan 3, 2019 |  BC Innovations  |  Distillery Therapeutics

Endocrine/metabolic

INDICATION: Obesity Cell culture, mouse and non-human primate (NHP) studies suggest inhibiting the GIP receptor alone or in combination with GLP-1R agonists could help treat obesity. In a mouse model of diet-induced obesity, a mouse...
19:53 , Dec 24, 2018 |  BC Extra  |  Company News

FDA approves Acorda's Inbrija for Parkinson's

Acorda Therapeutics Inc. (NASDAQ:ACOR) said FDA approved its Inbrija levodopa inhalation powder to treat "off" periods in Parkinson's disease patients receiving carbidopa/levodopa. The approval comes after multiple delays and gives Acorda a new product to...