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...
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...
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...
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...
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...
19:30 , Sep 10, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Lung cancer Patient sample and mouse studies suggest promoting the expression of KIF16B, SELENOW and TESK2 could help prevent brain metastasis in lung cancer. In patients, low expression of KIF16B, SELENOW and TESK2 in...
20:15 , Jun 15, 2018 |  BC Week In Review  |  Clinical News

Sunovion's PD therapy NDA gets PDUFA date

Sunovion Pharmaceuticals Inc. said FDA accepted an NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson's disease (PD). The PDUFA date is Jan. 29, 2019. Sunovion, a unit of Sumitomo Dainippon Pharma...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
19:53 , Jul 28, 2017 |  BC Week In Review  |  Company News

Mitsubishi acquiring NeuroDerm

Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) will acquire neurology company NeuroDerm Ltd. (NASDAQ:NDRM) for $1.1 billion at a price of $39 per share. The price is 17% premium over the share’s July 21 close of $33.20....