07:00 , Sep 21, 2015 |  BC Week In Review  |  Clinical News

Axelopran/oxycodone FDC: Clinical trial data

An open-label, 4-way crossover trial in 28 healthy volunteers showed that 10/20 mg axelopran/oxycodone FDC was bioequivalent to axelopran and oxycodone co-administered as 2 separate tablets. Additionally, axelopran did not significantly alter systemic exposure to...
23:32 , Jun 12, 2014 |  BC Extra  |  Top Story

FDA panel discusses CV outcomes trials in OIC

The majority of panelists on FDA's Anesthetic and Analgesic Drug Products Advisory Committee felt cardiovascular outcomes trials weren't warranted for peripheral mu opioid receptor ( OPRM1; MOR) antagonists to treat opioid-induced constipation (OIC) in patients...
07:00 , Apr 29, 2013 |  BC Week In Review  |  Company News

Theravance infectious, gastrointestinal, pulmonary news

Theravance plans to split into two publicly traded companies to separate its partnered late-stage respiratory assets from its R&D. One company - Royalty Management Co. - will manage all development and commercial responsibilities, plus potential...
01:04 , Apr 26, 2013 |  BC Extra  |  Company News

Theravance splitting up

Theravance Inc. (NASDAQ:THRX) announced plans late Thursday to split into two publicly traded companies to separate its late-stage, partnered respiratory assets from its R&D. One company -- Royalty Management Co. -- will manage all development...
07:00 , Jul 16, 2012 |  BC Week In Review  |  Clinical News

TD-1211: Phase IIb data

Top-line data from the 5-week, double-blind Phase IIb Study 0084 trial in 217 OIC patients with chronic, non-cancer pain showed that 5, 10 and 15 mg doses of oral TD-1211 each met the primary endpoint...
07:00 , Jul 16, 2012 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones BioMimetic Therapeutics Inc. (NASDAQ:BMTI) gained $0.66 (24%) to $3.46 on Tuesday after submitting to FDA an amendment to the PMA for Augment Bone Graft, which is under review for use as an alternative to...
08:00 , Nov 8, 2010 |  BC Week In Review  |  Clinical News

TD-1211: Phase I data

Top-line data from a double-blind, placebo-controlled, multiple ascending-dose, U.S. Phase I trial in 102 healthy volunteers showed that 2-30 mg doses of once-daily oral TD-1211 for 14 days were well tolerated. GlaxoSmithKline plc (LSE:GSK;...
08:00 , Nov 8, 2010 |  BC Week In Review  |  Clinical News

TD-1211: Phase II data

Top-line data from a double-blind, dose-escalation, U.S. Phase II trial in 70 patients showed that once-daily 5 and 10 mg oral TD-1211 met the primary endpoint of significantly improving the average number of SBMs per...
07:00 , Apr 26, 2010 |  BC Week In Review  |  Clinical News

TD-1211: Phase I started

Theravance began a double-blind, placebo-controlled, multiple ascending-dose Phase II trial to evaluate oral TD-1211 given once daily for 14 days in about 50 patients. Theravance Inc. (NASDAQ:THRX), South San Francisco, Calif.   Product: TD-1211   Business:...