BioCentury | Feb 10, 2014
Product Development

Furiex's run at IBS-D

While Furiex Pharmaceuticals Inc. has hit its marks in two Phase III studies of eluxadoline to treat diarrhea-predominant irritable bowel syndrome, it is hard to say how the response rates measure up to the only...
BC Week In Review | Oct 28, 2013
Clinical News

Lotronex alosetron hydrochloride regulatory update

FDA denied a Citizen's Petition from Nestle's Prometheus Laboratories Inc. unit asking the agency to provide guidance on how to develop a single, shared REMS. Prometheus filed the petition in June. The company is in...
BC Extra | Oct 21, 2013
Company News

FDA refuses to provide guidance on shared REMS

FDA denied a Citizen's Petition from Prometheus Laboratories Inc. asking the agency to provide guidance on how to develop a single, shared REMS. Prometheus filed the petition in June. The company is in discussions to...
BC Extra | Jul 11, 2013
Company News

FDA panel votes to ease Lotronex REMS

FDA's Drug Safety and Risk Management Advisory Committee recommended modifying the REMS with elements of safe use (ETASU) for irritable bowel syndrome drug Lotronex alosetron from Prometheus Laboratories Inc. to ease the burden on pharmacists....
BC Extra | Jul 8, 2013
Company News

FDA panel to consider easing Lotronex REMS

FDA reviewers said the REMS with elements of safe use (ETASU) for irritable bowel syndrome drug Lotronex alosetron from Prometheus Laboratories Inc. is effective but may include a requirement that is "unduly burdensome." The reviewers...
BC Week In Review | Jun 10, 2013
Clinical News

Lotronex alosetron hydrochloride regulatory update

Nestle's Prometheus Laboratories Inc. unit filed a Citizen's Petition asking FDA to provide guidance on how to develop a single, shared REMS and the circumstances under which a party can obtain a waiver from the...
BC Extra | Jun 7, 2013
Company News

Prometheus seeking clarity on shared REMS

Prometheus Laboratories Inc. filed a Nestle S.A. (SIX:NESN), is in discussions to develop a single shared REMS for irritable bowel syndrome drug Lotronex alosetron with generic company Roxane Laboratories Inc., part of Boehringer Ingelheim GmbH...
BC Week In Review | May 27, 2013
Clinical News

Lotronex alosetron hydrochloride regulatory update

FDA's Drug Safety and Risk Management Advisory Committee will meet on July 10 to discuss the REMS with elements of safe use (ETASU) for Lotronex alosetron from GlaxoSmithKline and Nestle's Prometheus Laboratories Inc. unit. Lotronex's...
BC Extra | May 23, 2013
Company News

FDA to discuss Lotronex's REMS

FDA's Drug Safety and Risk Management Advisory Committee will meet on July 10 to discuss the Lotronex alosetron from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Prometheus Laboratories Inc. , a unit of Nestle S.A. (SIX:NESN). Lotronex's...
BioCentury | May 9, 2011
Finance

Menu of choices for Wilex

Investors in Wilex AG (Xetra:WL6) liked last week's deal with Prometheus Laboratories Inc. , which allows the German biotech the opportunity to forgo more cash for chance to acquire a product to market in Europe. On...
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