07:00 , Oct 17, 2016 |  BC Week In Review  |  Clinical News

Kazano regulatory update

Japan approved an NDA from Takeda for Inisync alogliptin/metformin to treat Type II diabetes. The fixed-dose combination of alogliptin and metformin is approved as Kazano in the U.S. and as Vipdomet in the EU for...
07:00 , Jun 1, 2015 |  BC Week In Review  |  Clinical News

Viberzi eluxadoline regulatory update

FDA approved an NDA for Viberzi eluxadoline from Actavis to treat irritable bowel syndrome with diarrhea (IBS-D). Actavis said the agency recommended the locally acting mu opioid receptor (MOR; OPRM1) agonist and delta...
07:00 , May 18, 2015 |  BioCentury  |  Finance

Gassing up for royalties

Royalty Pharma has refilled its tank with a $1 billion equity raise and plans to use a portion of the money to ramp up its search for royalty streams from sources other than marketed products. ...
07:00 , Sep 8, 2014 |  BC Week In Review  |  Clinical News

Eluxadoline regulatory update

FDA accepted and granted Priority Review to an NDA from Actavis for eluxadoline to treat diarrhea and abdominal pain in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). The company said it plans to submit an...
01:20 , Sep 3, 2014 |  BC Extra  |  Company News

Priority Review for Actavis' eluxadoline

FDA accepted and granted Priority Review to an NDA from Actavis plc (NYSE:ACT) for eluxadoline ( JNJ-270189066) to treat diarrhea and abdominal pain in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). The company said it...
07:00 , Jun 16, 2014 |  BC Week In Review  |  Company News

Aerocrine management update

Aerocrine AB (SSE:AERO), Solna, Sweden   Business: Diagnostic   Hired: Anders Murman as chief technology officer; and Marshall Woodworth as CFO, formerly CFO of Furiex Pharmaceuticals Inc.; he succeeds Michael Colerus   ...
07:00 , Jun 2, 2014 |  BC Week In Review  |  Clinical News

Nesina alogliptin regulatory update

Takeda said Japan's Ministry of Health, Labor and Welfare (MHLW) approved an application to expand the label of Type II diabetes drug Nesina alogliptin to include concomitant therapy with all oral anti-diabetic agents and insulin....
07:00 , May 5, 2014 |  BC Week In Review  |  Company News

Forest Laboratories, Furiex Pharmaceuticals, Royalty Pharma deal

Forest will acquire Furiex for $95 per share in cash, or about $1.1 billion, plus a contingent value right (CVR) worth up to $30 per share, or up to $360 million, tied to approval and...
07:00 , May 5, 2014 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones Acorda Therapeutics Inc. (NASDAQ:ACOR) fell $3.51 (10%) to $32.39 on Friday after FDA asked for an additional clinical trial in a complete response letter for Plumiaz diazepam nasal spray to treat acute repetitive seizures...
07:00 , May 5, 2014 |  BioCentury  |  Finance

Pulling off the AZ gambit

Pfizer Inc. (NYSE:PFE) still has room to maneuver if it is really intent on using its bid for AstraZeneca plc (LSE:AZN; NYSE:AZN) to relocate in the more tax-friendly U.K. The trick is to provide enough cash...