Gilead Sciences Inc.'s Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) won FDA approval as expected, but the single-tablet formulation nicknamed "Btripla" likely will prove only a modest addition to the firm's HIV franchise should the highly anticipated Quad regimen yield strong Phase III data later this year. Read More
Dendreon's Corp's Provenge (sipuleucel-T), the first FDA-approved cancer immunotherapy, may have had an underwhelming welcome from the medical community. (See BioWorld Today, Aug. 5, 2011.) Read More
Jennerex Inc. completed a private placement of $8.6 million in gross proceeds to support development of its lead cancer candidate, JX-594. The product, an oncolytic virus, has shown antitumor activity in Phase I and Phase II trials, with demonstrated overall survival benefit in advanced liver cancer. Read More
This week's report of remissions in three advanced leukemia patients after immunotherapy has generated quite a lot of excitement in the media – which, in turn, has led to some backlash amongst the twitterati and in the blogosphere, noting that two complete remissions plus a partial one don't make a blockbuster. Or anything, really, that will be broadly useful within the next few years. Read More
• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, published Phase II data showing LX1031 was well tolerated and provided relief from pain and discomfort in non-constipating irritable bowel syndrome. The data were published in Gastroenterology. LX1031 is a tryptophan hydroxylase inhibitor. Read More
• Neoprobe Corp., of Dublin, Ohio, submitted a new drug application to the FDA for Lymphoseek (tilmanocept) for use in intraoperative lymphatic mapping. The procedure, which identifies and biopsies lymph nodes draining the area around a tumor, is used primarily in melanoma and breast cancer. Read More
