The 2009 RV144, or Thai AIDS vaccine trial, was the proverbial half-full glass. The vaccine did confer protection against AIDS; but at about 30 percent risk reduction, the vaccine was not effective enough to justify its further development. Read More
• Astellas Pharma Inc., of Tokyo, said the FDA's Reproductive Health Drugs Advisory Committee voted 7 to 4, with one abstention, that the overall risk/benefit assessment supported approval of mirabegron (YM178) in overactive bladder. The FDA is not bound to follow the recommendation of advisory panels, but the agency generally does so. Mirabegron's PDUFA date is June 29. Read More
• Tonix Pharmaceuticals Holding Corp., of New York, completed a trial of TNX-102 for fibromyalgia syndrome. The pharmacokinetic study suggested the drug could have similar benefits as low-dose cyclobenzaprine in fibromyalgia patients. That is the first of a number of formulations that the company will be testing. Read More
WASHINGTON – The Supreme Court is being asked to curb a growing cottage industry of shareholder lawsuits by raising the bar for class actions alleging companies have frauded the market. Read More
When Warp Drive Bio LLC emerged on the biotech scene earlier this year, the start-up's unique business model, jointly backed by Third Rock Ventures LLC and Sanofi SA, garnered plenty of buzz. But equally innovative, if not equally attention-getting, is the Cambridge, Mass.-based biotech's take on drug discovery. Read More
Two papers have identified a receptor pair that links the circadian rhythm to metabolism – a finding that might lead to new approaches to treating both sleep and metabolic disorders. Read More
Hunter Immunology Ltd. gained a back door listing on the Australian Stock Exchange Wednesday by completing its reverse takeover of publicly quoted probiotics firm Probiomics Ltd. Read More
• American Oriental Bioengineering Inc., of Newark, N.J., said the New York Stock Exchange notified the firm that it was not in compliance with listing rules due to the firm's failure to timely file its annual Form 10-K report with the SEC. The company has until Oct. 29 to file the 10-K. Read More
