Camargo’s clients are financially backed by the usual funding sources - family & friends, angels, equity investors, etc. Equity sources tend to invest in later stages of development and these funds have been harder to access in this economic climate. As a result, more financial deals are being funded by angels.
Angels are groups of high [...]
Archive for May, 2009
Quick-release bromocriptine mesylate approved
Published May 15th, 2009 in News Commentary. 0 CommentsThe FDA approved VeroScience’s Cycloset (bromocriptine mesylate) 0.8mg tablets on May 5 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The NDA was first submitted in 1997 - before the 505(b)(2) guidance. The API, bromocriptine mesylate was approved under NDA 017962 in 1978 as Parlodel in [...]
Cadence Pharmaceuticals announced yesterday 5/14/2009 that it had submitted an NDA for Acetavance(TM) - intravenous acetaminophen. It is instructive to look at the clinical development plan for this 505(b)(2) product. According to the company, the FDA required 2 pivotal Phase 3 trials: one clinical trial for the treatment of acute pain in patients following orthopedic surgery [...]
Multiple Dosage Strength Products - CMC Considerations
Published May 11th, 2009 in 505(b)(2) Process. 0 CommentsDeveloping a product with multiple strengths? How do you go about filing multiple strengths in an IND? Lynn Gold, Ph.D., Camargo VP of CMC explains:
How and when to draft one CMC section covering multiple drug strengths for the same dosage form?
Long-term drug development goals may include multiple strengths of a drug product to support the market [...]
505(b)(2) Combination Products
Published May 8th, 2009 in 505(b)(2) Issues and 505(b)(2) Process. 0 CommentsDuring the Q&A after my audioconference yesterday a participant asked if a proposed drug product containing 1 new drug and 2 already approved drugs would be a 505(b)(2). Although she didn’t say so, I assumed that the 2 approved drugs did not belong to her company.
The answer is yes, the inclusion of these 2 already [...]
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 [...]
Polypill: a 505(b)(2) candidate
Published May 4th, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsFDA approved Novartis’ Exforge HCT on April 30, 2009 for the second-line treatment of hypertension. Exforge, approved in 2007, contains the calcium channel blocker amlodipine and the angiotensin receptor blocker valsartan. The new product adds to Exforge the well known diuretic HCTZ - hydrochlorothiazide. The product was approved based on a single “8-week, multi-center, randomized, [...]
MAP Pharmaceutials 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals
Published May 29th, 2009 in 505(b)(2) Process and News Commentary. 1 CommentMAP Pharmaceuticals recently reported good Phase 3 data on its new product in development, Levadex - dihydroergotamine (DHE) orally inhaled. DHE is an old drug that has been used for a long time as an injectable - a couple of generics exist. MAP says that their product is a new formulation and their website compares it [...]