The many roles of commensal gut bacteria in the gut are by now widely appreciated. Those roles can be for better or for worse: The composition of gut bacteria affects the ability to metabolize food and so, weight. Regulation of the gut immune system affects diseases like inflammatory bowel disease. It also plays both sides of the fence in cancer, with some species contributing to colon cancer and others wreaking havoc through their metabolism of certain chemotherapies. (See BioWorld Today, Aug. 26, 2009, and Nov. 5, 2010.) Read More
Xenoport Inc.'s stock took a 6.2 percent hit Monday as it reported that its gastroesophageal reflux (GERD) candidate, arbaclofen placarbil, failed to show significant benefits over placebo in a Phase IIb trial. The Santa Clara, Calif.-based company will not pursue the drug any further in GERD, but plans to initiate a Phase III trial in spasticity. Read More
Privately held Synageva BioPharma Corp. closed a $25 million private equity financing that it said would support an early stage clinical program for lead candidate SBC-102, an enzyme replacement therapy for lysosomal acid lipase (LAL) deficiency, and four preclinical compounds for rare disorders. The Lexington, Mass.-based biotech has raised a total of $70 million since early 2009. Read More
OxiGene Inc., of South San Francisco, is weighing the next steps for developing Zybrestat as a potential treatment for anaplastic thyroid cancer (ATC), following a Type C meeting with the FDA. Data from the company's FACT trial showed that nearly 24 percent of the 84 ATC patients treated with Zybrestat (fosbretabulin) survived one year or longer, compared with a historical rate of less than 10 percent. Read More
United Therapeutics Corp., of Silver Spring, Md., completed enrollment in the FREEDOM-C(2) registration trial of its sustained-release oral formulation of treprostinil diethanolamine (UT-15C). The 16-week, international, double-blind, randomized, placebo-controlled trial enrolled 313 subjects with pulmonary arterial hypertension. Read More
Gemin X Pharmaceuticals Inc., a firm that had been on the prowl for a partner after wowing Wall Street a couple of years ago with early stage data for small-cell lung cancer (SCLC) candidate obatoclax, was snatched up by Cephalon Inc. for $225 million up front. Read More
WASHINGTON – As the big patents die off, biopharmaceutical companies may be looking to expanded labels to breathe life into their bottom line. Read More
