Many companies are attempting to reduce the GI bleeding, ulcers and perforations caused by administration of NSAIDS (e.g., ibuprofen, naproxen, aspirin). Since Vioxx was removed from the market (and it was a safer NSAID with respect to GI), there has been an surge of NSAID activity around these existing actives. We understand that the FDA’s [...]
Archive for June, 2008
Raptor announces Orphan designation for cysteamine bitartate
Published June 10th, 2008 in News Commentary. 0 CommentsRaptor Pharmaceuticals announced that the FDA has granted orphan drug designation for cysteamine bitartrate for the treatment of Huntington’s disease. Cysteamine is currently approved by the FDA and European Medicines Agency to treat nephropathic cystinosis*, also an orphan designation. In addition to the targeted orphan designation, it appears that Raptor is also trying to improve on the [...]
Margo paid a visit to Camargo this week. She helped us celebrate our 5 years of helping clients with their drug development needs.
Indevus’ Stock drops 70% on FDA’s request for more safety data
Published June 7th, 2008 in News Commentary. 0 CommentsOn June 4, Indevus Pharmaceuticals reported that the FDA is likely to request additional safety data before approving NEBIDO®, its depot testosterone product for the treatment of male hypogonadism. The news sent the stock on a tumble – losing $2.46 to $1.26/share (a 70% decline) in the subsequent trading period (it has since recovered a bit, Friday’s [...]
Suicidal behavior: Ignore therapeutic area at your own risk
Published June 5th, 2008 in 505(b)(2) Issues and Events. 0 CommentsWe hope a common theme emerges from this blog and our public interactions: it is vital when planning 505(b)(2) drug development to look at the entire therapeutic class to learn what studies are needed for approval of the drug . Not including the class in your background of public information can be suicidal. FDA regulates [...]
I recently used the saga of Abbott’s TriCor (fenofibrate) product life extension tactics for an FDA citation to support the use of multiple RLD’s in a 505(b)(2) application. I also think the story is instructive to the 505(b)(2) industry as to how even slight changes can be used to develop your own strategy. Recall that [...]
Today, June 2, 2008 marks the 5th year we have been in business serving drug development needs of emerging companies. We also just passed the 20th country in which clients are located. Many thanks to these wonderful clients who are responsible for us being in business and the Camargo staff that enjoys serving them! Ken [...]
In speaking with prospective clients, we often discuss the potential competition to their proposed drug product. In order to have success in the market, the proposed product needs market differentiation. Some thoughts on a couple of categories: Existing Products - What other drugs are available for the same therapeutic indication(s)? Why would the medical profession select yours? Generic [...]
Improved Bioavailability Allows Return to Sleep and wake-up fresh
Published June 15th, 2008 in News Commentary. 0 CommentsTranscept Pharmaceuticals presented a poster June 11, 2008 at the Associated Professional Sleep Societies (APSS) regarding their investigational product, a low-dose, sublingual version of zolpiderm (RLD: Sanofi-Aventis’ Ambien®). In the press release announcing this poster, Transcept indicated that their new formulation, Intermezzo®, “delivered overall bioavailability that was significantly greater than that produced by a swallowed Ambien® tablet containing [...]