FDAnews
www.fdanews.com/articles/90689-pharma-blog-watch

Pharma Blog Watch

January 16, 2007

Novo to Focus on Peptides (In the Pipeline)
Responding to news that Novo Nordisk has decided to shift R&D focus away from small molecules and toward peptides, Derek Lowe writes, "In a time when the big protein-based biotech companies (Amgen and Genentech) are trying to expand their small-molecule capabilities, Novo has decided to break the other way."

"Whether this is a trend, or the beginning of a trend, is a good question. I'm not at all convinced that it's cheaper to do protein therapies as opposed to small molecules," he writes. "They must have seen more opportunities in their own biologics pipeline and not had enough money to realize them if they kept working on the organic chemistry side of things. I'm not sure that this is a good long-term strategy, but they might be figuring that if they don't cut costs somewhere, there's not going to be a long term."

MDS Pharma Flap (QDIS Blog)
In his blog, Ed Vawter discusses an announcement by the FDA last week that some companies need to reevaluate pharmacokinetic studies that were conducted for them by MDS Pharma Services after inspections turned up problems at MDS facilities. "What is even more interesting is it occurred over the course of four years from 2000 to 2004 but it is only now that the FDA is sending notices to those potentially impacted."

"This should be a warning to many companies when they rely on others for results. I think it will be a blow to MDS Pharma services and find it very confounding that they have yet to get on top of this issue and put out any sort of statement," he writes. "This is also what many refer to as the cockroach syndrome. If you see one, you know there are more in hiding."