Short Squeeze Potential in Arena as Vivus Panel Date Looms
Ruthanne Williams Roussel submits:As expected, and as management discussed as a possibility a few weeks ago on the Q1 conference call, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee will review Arena Pharmaceuticals (ARNA)'s weight-loss drug candidate lorcaserin at its already scheduled Sept. 16 meeting. We rate this news as good. In the small-cap world, it is always especially reassuring when outside agencies behave as management expects them to. While lorcaserin's cardiovascular safety has been extensively studied and independently reviewed, we still were never in the camp that believed that this might give lorcaserin some sort of free pass to FDA approval with no further review. The PDUFA (approval decision) date for lorcaserin is in late October.Complete Story » seekingalpha.com |
Geron to Resume Stem-Cell Study
Geron can proceed with early testing of an embryonic-stem-cell treatment for spinal-cord injuries after the FDA lifted a nearly yearlong hold on the trial. online.wsj.com |
GeneLink Reports Second Quarter Improvement (PR Newswire)
GeneLink, Inc. , a leading applied genomics biotech company, reported financial results for the fiscal quarter ended June 30, 2010. us.rd.yahoo.com |
BMS, Sanofi May Get Boost From Curious Plavix Study
Pharmalot submits: Last year, the FDA urged doctors not to combine proton pump inhibitors such as Prilosec and Nexium with Plavix after research suggested these heartburns med could lessen the effects of the bloodthinner and, therefore, raise the risk of a heart attack. But a study published last week in The New England Journal of Medicine found the opposite result - there was no evidence of increased heart risk among patients who took both drugs compared with those taking Plavix and a placebo. “For the rank-and-file clinician and patient, I’d say right now I wouldn’t worry about this interaction,” Deepak Bhatt, a cardiologist at Brigham and Women’s Hospital in Boston and lead author of the study, told The Wall Street Journal. There are, however, some caveats. For one thing, the study - which was known as Cogent - used a version of Prilosec with different release characteristics than what is currently on the market, suggesting the results are less likely to be duplicated in the prescribing world.Complete Story » seekingalpha.com |
New Study Questions Value of Expanded Genetic Testing for Cystic Fibrosis
[PR Newswire] - Testing for genetic mutations beyond those medically recommended is unlikely to prevent the birth of children with classic cystic fibrosis and may detect mutations causing only mild disease, according to a study published online in Genetics in Medicine, the official publication of the American College of Medical Genetics . The findings raise the possibility that expanded panels may promote ill-informed decisions and anxiety for physicians and couples seeking testing to determine their risk of passing the disease to their children. us.rd.yahoo.com |