A 505(b)(2) NDA has the same approval requirements as a 505(b)(1) NDA, the only difference is where the pivotal data comes from . 505(b)(2) is not a shortcut in the sense that you can get by with less information. Clients are often amazed (the polite word) when they learn about the studies need to get [...]
Archive for July, 2008
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication(s) in pediatric patients unless this requirement in waived, [...]
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 [...]
I attended a session at the 2008 BIO convention in San Diego celebrating the 25th anniversary of the Orphan Drug Act. Before the Act, there were almost no orphan drugs. The exemption from the PDUFA user fees (running $1.175MM today), 50% tax credit for clinical studies and a 7 year marketing exclusivity are powerful incentives [...]
Hospira expands into 505(b)(2) development
Published July 3rd, 2008 in 505(b)(2) Process and News Commentary. 0 CommentsHospira, best known as a generic injectable pharmaceutical company, is going to start developing a transdermal product. Yesterday (7/2/2008), Altea Therapeutics announced a partnership with Hospira for the development and commercialization of an undisclosed product. Altea is best known for its transdermal delivery system. You can see where this business deal is going. Hospira many injectables, many [...]