Pharma’s Cutting Edge

I last wrote about Dendreon’s Provenge active immunotherapy for prostate cancer back in May of 2007, when I raised questions about FDA’s decision not to approve the therapy, despite a favorable advisory committee opinion.
Today, I am happy to pass along news of positive top-line results from a confirmatory Phase 3 study of Provenge (IMPACT), released [...]

April 14th, 2009 | Category: Technology | Leave a comment

OPKO Health has reported that bevasiranib, the most advanced siRNA in clinical trials, has failed its first (and probably only) Phase 3 test, as adjunctive therapy to Lucentis in the treatment of wet AMD, after an independent DMC recommended stopping the study due to futility. 
Whether this failure marks a setback for siRNA therapies in general [...]

March 9th, 2009 | Category: Technology | Leave a comment

This blog is becoming old enough to start revisiting posts to check for progress of immature technologies.  Yesterday, the WSJ wrote a story (sub req) that discussed, among other emerging technologies, nanobodies from Ablynx, one of the types of next-generation antibodies I briefly wrote about in September of 2005.
With Ablynx making news, now seems a good time [...]

February 18th, 2009 | Category: Technology | Comments (1)

I indicated in my year-end 2008 post that I was looking forward to a productive 2009 for the pharmaceutical/biopharmaceutical industry.  Indeed, there’s a good chance that the number of approved new molecular entities in 2009 in Europe and the US will be noticeably more than in the last several years.
I’ve selected some particularly interesting NMEs that have [...]

January 2nd, 2009 | Category: Technology | Comments (2)