Pharma Blog Watch

Adaptive Trials Conference (Eye on FDA)
In his blog, Mark Senak laments a continuing lack of information about the FDA workshop on adaptive clinical trials supposedly scheduled for Nov. 13 and 14. "I have noticed a tremendous amount of interest in this conference expressed through this site, especially from outside of the U.S.," he writes. "A lot of people are waiting."

"Hopefully the organizers will take note that their inability to announce the details of the workshop in a timely manner has severely inhibited the ability of people to attend, despite the fact that this topic is key to the FDA's own Critical Path Initiative," he continues. "At this rate, it is the Not So Critical Path Initiative."

No Safety Study Needed From NicOx (PharmaGossip)
In this post, the pharma insider discusses NicOx's clinical plan for naproxcinod, which the company is developing for osteoarthritis. According to the blogger, "NicOx has circumvented what could have been a major obstacle en route to winning approval for its lead drug naproxcinod (HCT 3012) in Europe, after winning agreement from the regulatory authorities that a major, long-term cardiovascular safety study will not be required."

"Ongoing debate about the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs) — including naproxcinod's parent compound naproxen — has led to speculation that the European Medicines Agency might ask for a stringent safety study before giving a green light to NicOx' product," the blogger explains.