I attended the Annual GPhA meeting this past week. This event is attended by the CEO’s and other top brass of most of the major generic pharmaceutical companies. This year was highlighted by a presentation from the FDA Commissioner, Dr. Margaret Hamburg. In her remarks, Dr. Hamburg admitted to a need for FDA to step up [...]
Archive for the 'Events' Category
FDA approves Xanodyne’s tranexamic acid
Published November 16th, 2009 in Events and News Commentary. 0 CommentsXanodyne obtained 505(b)(2) approval for tranexamic acid for use in treating heavy menstrual bleeding (menorrhagia). The RLD is Cyklokapron(R) which is used to treat hemophilia and to reduce the need for replacement therapy during and following tooth extraction. The RLD received orphan approval in 1986. Initially, both tablet and injectable dosage forms were approved but [...]
Camargo is once again attending and exhibiting at the AAPS Annual Meeting and Exposition in Los Angeles November 8-12. We have complimentary passes to the exhibit floor. Please email your request to services@camargopharma.com and I will send one or more passes to you.
Yesterday, 5/7/09, I gave a 60-minute introductory presentation on 505(b)(2) submissions followed by 15 minutes of Q&A on a Thompson-Interactive audioconference. I enjoy the opportunity to reach out into the community to help people better understand the 505(b)(2) drug development process. Like many of these audioconferences/webinars and the like, there is a charge. Camargo doesn’t receive [...]
Drug Repurposing Strategies meeting in Philly December 10-11
Published November 7th, 2008 in Events. 0 CommentsRepurposing, repositioning - by whatever name, the 505(b)(2) drug development pathway is gaining traction. I will be giving a talk entitled “505(b)(2) Product Candidate Selection-Which Old Dog to Rejuvenate” on December 10 at the Drug Repurposing Strategies meeting. The conference costs $1695 but friends of Camargo can get a $400 discount - just contact me [...]
FDA announced on August 1, 2008 the user fees for fiscal year 2009 (the U.S. government 2009 fiscal year start on October 1, 2008). The fees are based on PDUFA IV approved last year. The application fee for an application requiring clinical data is $1,247,200, for an application not requiring clinical data or a supplement [...]
505(b)(2) - No patent, just exclusivity
Published July 2nd, 2008 in 505(b)(2) Issues and Events. 0 CommentsWe have all been confronted with the issue of patents and exclusivity for 505(b)(2) product development projects. Financial backers, VC’s, private equity are fixated on the ruggedness of patents - no patent = no money. Biomarin Pharmaceuticals made a presentation at the 2008 BIO conference to encourage others that patents are not always needed. The [...]
I attended the 2008 BIO Annual convention, my first. More than 20,000 registrants. There were the usual plenary sessions with lots of wonderful, flowery, well-meaning platitudes and well-deserved awards. The luncheons had the current governors of Massachusetts and California and Jeb Bush, the former governor of Florida (unabashedly representing John McCain), Colin Powell and other [...]
Margo paid a visit to Camargo this week. She helped us celebrate our 5 years of helping clients with their drug development needs.
Qutenza: Approval of a “DESI-inspired” drug
Published November 20th, 2009 in Events and News Commentary. 0 CommentsThis week, NeurogesX, Inc. announced the FDA 505(b)(2) approval of Qutenza(TM), its 8% capsaicin patch, for management of post-herpetic neuralgia (PHN) - the nerve pain that can follow an attack of shingles. While not strictly speaking a DESI product, Qutenza can be considered “DESI-inspired,” because it is a first Rx approval for an active ingredient [...]