22:23 , Feb 2, 2018 |  BioCentury  |  Product Development

Local advantage

Theravance Biopharma Inc. is reaching a key inflection point for the first candidate to emerge from its program to develop me-better immunology therapies that act locally and avoid systemic side effects. The company will report...
07:00 , Jun 29, 2015 |  BC Week In Review  |  Clinical News

Velusetrag: Phase II data

The double-blind, 3-way crossover Phase II Study 0093 trial in 34 patients with diabetic or idiopathic gastroparesis showed that once-daily oral velusetrag for 1 week reduced gastric emptying half-time by 35 minutes at the 5...
07:00 , Jun 1, 2015 |  BioCentury  |  Regulation

Formalizing function

FDA agreed with patients at a workshop on functional GI disorders that patient-reported outcomes measures should tease out the relationship between symptom relief and corresponding quality of life. But doing so presents a catch-22 for...
07:00 , Mar 23, 2015 |  BC Week In Review  |  Clinical News

Velusetrag: Phase IIb started

Theravance began the double-blind, placebo-controlled, international Phase IIb Study 0099 to evaluate 5, 15 and 30 mg oral velusetrag once daily for 12 weeks in about 200 patients with diabetic or idiopathic gastroparesis. In 2012,...
08:00 , Jan 14, 2013 |  BC Week In Review  |  Clinical News

Velusetrag: Phase II started

Theravance and Alfa Wassermann began the double-blind, placebo-controlled, 3-way crossover Phase II Study 0093 trial in about 32 patients to evaluate 5, 15 and 30 mg oral velusetrag once daily for 1 week. The trial...
07:00 , Oct 15, 2012 |  BC Week In Review  |  Company News

Alfa Wassermann, Theravance deal

Theravance and Alfa Wassermann partnered to develop and commercialize Theravance's velusetrag ( TD-5108 ) to treat gastroparesis. The partners will conduct a two-part Phase II program funded by Alfa Wassermann. Following the program, Alfa Wassermann...
08:00 , Nov 21, 2011 |  BC Week In Review  |  Clinical News

Naronapride regulatory update

FDA's Gastrointestinal Drugs Advisory Committee voted 17-4 with 1 abstention against requiring companies to conduct a dedicated cardiovascular safety trial of serotonin (5-HT4) receptor agonists for GI indications. Of the 10 cardiologists on the panel,...
01:25 , Nov 18, 2011 |  BC Extra  |  Clinical News

GI panel: CV safety studies unnecessary

FDA's Gastrointestinal Drugs Advisory Committee on Thursday voted 17-4 with 1 abstention against requiring companies to conduct a dedicated cardiovascular safety trial of serotonin (5-HT4) receptor agonists for GI indications. Of the 10 cardiologists on...
01:42 , Nov 16, 2011 |  BC Extra  |  Company News

FDA posts 5-HT4 receptor agonist briefing documents

FDA posted briefing documents ahead of the agency's Gastrointestinal Drugs Advisory Committee meeting on Thursday to discuss cardiovascular safety programs for serotonin (5-HT4) receptor agonists in development for GI indications. FDA will ask the panel...
07:00 , Oct 24, 2011 |  BioCentury  |  Product Development

Alzheimer's rewind

A string of Phase II and III failures in Alzheimer's disease has prompted companies to look for new targets beyond the well-known players in the core mechanism of AD - the production and accumulation of...