BioSante Pharmaceuticals, Inc.
BioSante Pharmaceuticals Reports Positive LibiGel(R) Safety Data in Phase III Program
Published in Medical Letter on the CDC and FDA, August 30th, 2009
BioSante reported that with over 1,250 women enrolled and almost 825 women-years of exposure in its LibiGel Phase III clinical development program, there have been no deaths and only five cardiovascular events. This analysis of blinded data indicates a very low cardiovascular event rate has occurred thus far. Therefore, in view of the excellent LibiGel safety profile, BioSante's LibiGel Phase III development program will continue as planned. BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.
...
Want to see the full article?
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA
More Articles from Medical Letter on the CDC and FDA
- CombinatoRx, Incorporated
CombinatoRx Reports Financial Results for the Second Quarter 2009 - ETHICON, Inc.
ETHICON Introduces New Product Enhancement and Packaging for BIOPATCH(R) to Improve Ease of Application for Patients with Catheters - Hyponatremia
New hyponatremia study results reported from Emory University - Life Sciences
Ethicon Introduces New Product Enhancement and Packaging for Biopatch(R) to Improve Easeof Application for Patients with Catheters - Life Sciences
Studies from V.L. Fulgoni and colleagues provide new data on life sciences - OmniComm Systems, Inc.
Leading European Contract Research Organization Selects OmniComm to Provide eClinical Solutions for Important Phase III Study - More from this issue of Medical Letter on the CDC and FDA
NewsRx is Social
Follow us on your favorite social network by clicking on a button below:
Top Medical Newsletters
Awards
Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005
Facts & Stats
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.
- Google 2010 PageRank: #2 Among Top Health News and Media Publications
- Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
- Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
- Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry
