00:06 , Jul 24, 2019 |  BC Extra  |  Company News

July 23 Company Quick Takes: FDA approves Pfizer’s Rituxan biosimilar; plus Intra-Cellular, OTC Tamiflu, Cimzia and more

Pfizer’s Rituxan biosimilar approved in U.S.  FDA approved Ruxience rituximab-pvvr from Pfizer Inc. (NYSE:PFE) for non-Hodgkin lymphoma, chronic lymphocytic leukemia and granulomatosis with polyangitis and microscopic polyangitis. Ruxience is the second biosimilar of Rituxan, an...
22:25 , Jul 8, 2019 |  BC Extra  |  Clinical News

Intra-Cellular optimistic on lumateperone's future in bipolar despite mixed Phase III results

While one of its trials missed the primary endpoint, Intra-Cellular is hopeful that the robust treatment response seen in the other Phase III lumateperone trial along with a lack of tolerable treatment options for bipolar...
00:12 , May 31, 2019 |  BC Innovations  |  Translation in Brief

New target for Oncoceutics' GPCR-targeting compounds

Two academic teams have discovered Oncoceutics’ GPCR-targeting products kill cancer via an alternative mechanism: triggering apoptosis by activating a mitochondrial protease. Oncoceutics Inc. is developing a pipeline of imipridones to antagonize or agonize GPCRs including...
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...
19:08 , Jan 4, 2019 |  BC Week In Review  |  Financial News

Cydan spins out rare endocrine company Tiburio with $31M, Ipsen compounds

Tiburio Therapeutics Inc. (Cambridge, Mass.) launched Jan. 3 with a $31 million series A round and two clinical compounds licensed from Ipsen Group (Euronext:IPN; Pink:IPSEY) that it plans to develop for rare neuroendocrine tumors and...
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...
12:06 , Jan 3, 2019 |  BC Extra  |  Financial News

Cydan spins out rare endocrine company Tiburio with $31M, Ipsen compounds

Tiburio Therapeutics Inc. (Cambridge, Mass.) launched Thursday with a $31 million series A round and two clinical compounds licensed from Ipsen Group (Euronext:IPN; Pink:IPSEY) that it plans to develop for rare neuroendocrine tumors and rare...
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...
19:29 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Intra-Cellular stops Phase II of lumateperone for agitation in dementia for futility

Intra-Cellular Therapies Inc. (NASDAQ:ITCI) discontinued the Phase III Study 201 of low-dose lumateperone (ITI-007) to treat agitation in patients with dementia, including Alzheimer's disease, after a prespecified interim analysis by an IDMC showed that the...