IP attorney Stephen Albainy-Jenai and I just concluded a webinar hosted by DIA entitled 505(b)(2) Patent & Exclusivity. 23 different companies attended, showing the increasing interest in 505(b)(2) issues. Earlier this year, DIA hosted my overview of the 505(b)(2) drug development process where the attendees had many questions asking specifically about patents and exclusivity, many of which I couldn’t [...]
Archive for April, 2008
NanoNews - Beads deliver drug to site of action
Published April 16th, 2008 in 505(b)(2) Issues and Events. 0 CommentsIn another fine example of a formulation change, Biocompatibles International reported that its very small beads were used to sequester Doxorubicin (adriamycin). The resulting beads were delivered via a catheter directly into the liver of patients with liver tumors. The tumor growth was suppressed for long enough in 12 of 18 patients to receive a [...]
Yikes! For the first time, Camargo has two (yes, 2!) pre-IND meetings denied. Same week. Not cancelled, not postponed, not re-scheduled - denied! In both cases, the review divisions said we were on the right track, no controversy exists and that we should simply file the IND.
Wow. The purpose of the pre-IND meeting is much more [...]
Is your drug project a 505(b)(2), ANDA or OTC?
Published April 15th, 2008 in How to: and Uncategorized. 0 CommentsI get a lot of requests to assure people that their project is, or is not, a 505(b)(2). A few questions about whether it is an OTC candidate. The question about whether the proposed drug is a 505(b)(1) or 505 (b)(2) is readily answered by the question: is any data essential for approval being obtained [...]
We gets lots of questions about how the patent system works for 505(b)(2)’s and how it relates (or not) to exclusivity provisions. A good friend and colleague who is an expert in patent law is going to join me on a webinar sponsored by DIA. It will be held April 22 from 11:00 to 12:30. [...]
