07:00 , May 25, 2009 |  BC Week In Review  |  Clinical News

Sanvar vapreotide regulatory update

An FDA advisory committee voted unanimously that Debiopharm has not demonstrated that the potential benefits outweigh the potential risks of Sanvar vapreotide as an adjunctive therapy to endoscopic intervention for the control of acute esophageal...
07:00 , May 25, 2009 |  BioCentury  |  Regulation

Sanvar trials & tribulations

Sanvar trials & tribulations VAP-14 study VAP-07 study VAP-02 study VAP-06 study VAP-301 study Location; years France; 1997-98 Egypt; 2002 Hong Kong; 1997-2001 Eastern Europe; 2003-04 U.S.; 2006-08 Study design Phase III, multicenter, double-blind, randomized,...
07:00 , May 25, 2009 |  BioCentury  |  Regulation

The market moved

Based on the outcome of its FDA advisory committee meeting last week, Debiovision Inc.'s effort to get agency approval for Sanvar vapreotide is likely to fail because of two advances in medical practice. One made...
01:01 , May 20, 2009 |  BC Extra  |  Company News

FDA panel votes against Debiopharm's Sanvar

An FDA advisory committee voted unanimously on Tuesday that Debiopharm S.A. (Lausanne, Switzerland) has not demonstrated that the potential benefits outweigh the potential risks of Sanvar vapreotide as an adjunctive therapy to endoscopic intervention for...
01:26 , May 16, 2009 |  BC Extra  |  Company News

FDA posts Sanvar briefing documents

FDA posted briefing documents ahead of Tuesday's Gastrointestinal Drugs Advisory Committee meeting to discuss an NDA from Debiopharm S.A. (Lausanne, Switzerland) for Sanvar vapreotide as an adjunctive therapy to endoscopic intervention for the control of...
07:00 , Apr 13, 2009 |  BC Week In Review  |  Clinical News

Sanvar vapreotide regulatory update

FDA's Gastrointestinal Drugs Advisory Committee will meet on May 19 to discuss an NDA from Debiopharm for Sanvar vapreotide to treat acute esophageal variceal bleeding. Last November, Debiopharm submitted a complete response to a 2005...
08:00 , Nov 10, 2008 |  BC Week In Review  |  Clinical News

Sanvar IR vapreotide regulatory update

Debiopharm submitted a complete response to a 2005 FDA approvable letter for Sanvar to treat acute esophageal variceal bleeding. The approvable letter requested additional efficacy data and information related to manufacturing (see BioCentury, Jan. 10,...
08:00 , Feb 25, 2008 |  BC Week In Review  |  Company News

Debiopharm, Medical Futures Inc. sales and marketing update

Debiopharm granted Medical Futures an exclusive license to market Sanvar vapreotide acetate to treat acute esophageal variceal bleeding (EVB) in Canada, where the somatostatin analog is under review. In 2004, the somatostatin analog received an...
08:00 , Mar 5, 2007 |  BC Week In Review  |  Company News

Salix, Merck sales and marketing update

SLXP acquired gastrointestinal drugs Pepcid famotidine oral suspension and Diuril chlorothiazide oral suspension from MRK for $55 million up front. MRK is eligible for up to $6 million in sales-based milestones. Pepcid had $20 million...
08:00 , Oct 30, 2006 |  BC Week In Review  |  Company News

Debiopharm S.A., EMS Sigma Pharma, LG Life, Ranbaxy, Tzamal Bio-Pharma Ltd. deal

Debiopharm granted the companies exclusive licenses to Sanvar vapreotide acetate to treat acute esophageal variceal bleeding (EVB). Ranbaxy received rights in India, Bangladesh and Nepal; EMS in Brazil; Tzamal in Israel; and LG Life Sciences...