BILBAO, Spain – Visitors to the opening day of BioSpain 2012 this week had to pass through airport-style security in the foyer of the Bilbao Exhibition Center (BEC). Read More
There are clinical trials that miss hitting their primary endpoints by that tiny but critical amount that separates 0.051 from 0.049. And then there are clinical trials that tell you unequivocally that there is no there there – no hint of any efficacy whatsoever. Read More
The senate is preparing to vote on a Continuing Resolution that will fund the federal government from Oct. 1, 2012, through March 31, 2013, by limiting all agencies to monies received in fiscal year 2012. As reasonable as that sounds, the resolution could have a disproportionately large affect on the FDA, because it omits language that would have allowed the FDA to collect user fees provided for in FDASIA for 2013. Read More
• Alkermes plc, of Dublin, Ireland, disclosed the pricing of new term loans to be used in the refinancing of its existing senior secured bank debt. Syndication has completed for the new senior secured bank debt, comprising first lien term loan facilities consisting of a $300 million, seven-year term loan bearing interest at London Interbank Offer Rate plus 3.5 percent and a $75 million four-year term loan bearing interest at LIBOR plus 3 percent. Read More
• Ablynx NV, of Ghent, Belgium, said it and partner Merck Serono, a division of Darmstadt, Germany-based Merck KGgA, advanced Nanobody candidate ALX-0751 into preclinical development in cancer. Read More
• Medivir AB, of Huddinge, Sweden, said HCV NS3/4A protease inhibitor simeprevir (TMC435) and non-nucleoside inhibitor TMC647055 will enter a Phase IIa interferon-free combination trial for hepatitis C virus (HCV). The open-label trial will enroll about 40 patients chronically infected with HCV genotype-1a, and the primary endpoint will be sustained virologic response 12 weeks after the end of treatment. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it submitted a marketing authorization application to the European Medicines Agency for approval of afatinib, an irreversible ErbB family blocker, as a treatment for patients with EGFR mutation-positive non-small-cell lung cancer. Read More
