Ziopharm Oncology Inc.'s Phase III trial with the alkylating agent palifosfamide for first-line, metastatic soft tissue sarcoma failed to meet the primary endpoint of progression-free survival (PFS), but the company – shifting its efforts to synthetic biology programs partnered with Intrexon Corp. – will continue to follow patients' overall survival (OS) rates. Read More
A synthetic capped royalty financing of $110 million will help Vivus Inc., of Mountain View, Calif., buy time while it awaits a decision on its risk evaluation and mitigation stragegy (REMS) modification amendment and a more opportune time for an equity financing. Read More
Though it is no match for fat-laden modern diets, the body does have ways of getting rid of cholesterol. This reverse cholesterol transport system removes cholesterol from tissues and transports it to the liver and, ultimately, out of the body. Read More
While the government continues to spend billions of dollars on more drugs everyone hopes will never be used, it has yet to safeguard or account for the growing number of high-containment laboratories where those medical countermeasures (MCMs) are being developed, the Government Accountability Office (GAO) said in a new report that echoes an alarm the office first sounded three years ago. Read More
With the cost of clinical trials climbing, the FDA is worried about its ability to obtain sufficient information to make determinations about safety and efficacy claims when examining new drug applications and biologics license applications. Read More
• BioDelivery Sciences International Inc. (BDSI), of Raleigh, N.C., signed a worldwide licensing agreement with privately held Arcion Therapeutics Inc., of Baltimore, in which BDSI will develop and commercialize topical clonidine gel (formerly ARC4558) for the treatment of painful diabetic neuropathy and potentially other indications. Read More
• GlaxoSmithKline plc, of London, and the Texas A&M University System said the Department of Health and Human Services approved the establishment of a $91 million influenza-vaccines manufacturing facility as the anchor for the Center for Innovation in Advanced Development and Manufacturing in Bryan-College Station, Texas. Read More
• Gentium SpA, of Villa Guardia, Italy, said a medical team from the National University Corporation Hamamatsu University School of Medicine, Fukushima Medical University, administered defibrotide to the first subject in a Phase I study. Read More
