Thallion Pharmaceuticals will postpone the start of a phase II/III trial in Latin America for financial and weather-related reasons. There is seasonality to the Shiga-toxin E. Coli infections the company hopes to treat. “Deferring the start of the trial in South America will extend our existing cash runway by approximately six months, into the fourth quarter of 2009. If we can start the program later in the year, we can benefit from the South American summer and still maintain very similar timelines for a potential registration,” said Lloyd Segal, CEO.
The BIO organization is having a venture-capital-oriented meeting in Boston from April 22-3, 2008. Here’s the link.
Lilly settled a suit brought by the state of Alaska over its controversial Zyprexa anti-psychotic. Price: $15 million. The Associated Press says that Lilly will not have to admit any wrongdoing. “The deal ensures that Alaska will be treated as well as any other state that may settle with Lilly over similar claims involving the drug, which is used to treat schizophrenia and bipolar disorder,” the wire service says. On April 22 and 23, ClinPhone is having a one-hour webinar on scaling electronic data capture (EDC). The firm’s Paula McHale, product director for data management solutions, and Kyle Flickinger, vice president of EDC professional services, will discuss the issues and solutions in taking EDC from pilot mode to full scale use in global trials.
The FDA issued new guidance on drug-coated stents and is soliciting public comment. Harvard’s Daniel Carpenter, writing in the New England Journal of Medicine (NEJM) this week, says drugs approved exactly on FDA deadline have more safety problems. Medicines approved right on schedule, he says, are more likely to have safety problems later than those cleared with more time to spare. Carpenter works for the Ivy League university’s school of government. The FDA disputed the NEJM analysis but did not offer any evidence. Here’s a Boston Globe story. Boehringer Ingelheim used the eCTD submissions tool from Image Solutions. The key is the software jargon “software as a service,” or SAAS. (Nontechies can think of it as anything that runs on the internet.) The eCTD project at Boehringer started in April 2007 and was delivered in December of the same year. “This was a very impressive collaboration,” says Gilbert Kampfner, managing director of ISI Europe. “Nobody had to push back the timelines; everything was ready on schedule. Choosing a SAAS solution allowed Boehringer Ingelheim’s internal support costs to be cut by approximately 40 percent.” Here’s the release. Have a news release? Send it to .d9A2t49mkex

