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 primary...
18:40 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

Setback for Sunovion's dasotraline in ADHD

The Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said it received a complete response letter for dasotraline (SEP-225289) to treat ADHD. The company said FDA indicated the need for more efficacy...
15:53 , Aug 23, 2018 |  BC Innovations  |  Distillery Therapeutics

Gastrointestinal

INDICATION: Gastrointestinal Cell culture and mouse studies suggest deoxycholate-mediated PGE2 inhibition or agonism of FXR could help treat colonic injury. In a mouse model of colonic mucosal biopsy injury, PGE2 levels were higher during the barrier...
01:40 , Aug 18, 2018 |  BioCentury  |  Regulation

Pediatric push

FDA has endorsed extrapolation of therapeutic efficacy from adults to children for new drugs to treat partial onset seizures in a draft guidance and is now discussing in public meetings whether the approach can be...
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...
23:37 , Jul 20, 2018 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 18 profitable biotechs and pharmas are slated to report earnings this week. (A) Six-month EPS figures; (B) Fiscal 1Q CompanyDatePre/post mkt2Q18 EPS est2Q17 EPSExpected chgBiogen Inc. (NASDAQ:BIIB)7/24Pre$5.24$5.044%Eli Lilly and Co. (NYSE:LLY)7/24Pre$1.30$1.1117%Gilead Sciences...
19:28 , Jul 3, 2018 |  BC Extra  |  Company News

Management tracks: Cigna, Novocure, Voyager

Health services company Cigna Corp. (NYSE:CI) appointed Mark McClellan to its board, effective the earlier of Dec. 1 or the close of Cigna's acquisition of Express Scripts Holding Co. (NASDAQ:ESRX). McClellan is director of the...
17:49 , Jun 28, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Staphylococcus Cell culture studies identified three cadmium-based supramolecule coordination complexes (SCCs) that could help treat methicillin-resistant Staphylococcus aureus (MRSA) infection. The three SCCs consist of hexagonal-shaped rings that incorporate 12, 18 or 24 cadmium (II)-terpyridine...
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 Co....
18:10 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Boston Biomedical reports detailed data from Phase III gastric cancer trial of napabucasin

The Boston Biomedical Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) reported data from the Phase III BRIGHTER trial in 714 patients with previously treated advanced gastric or gastroesophageal junction cancer showing that second-line...