CBRX submits PROCHIEVE NDA, SGMO data release update

Apr 29, 2011 No Comments by

Sangamo BioSciences, Inc. (Nasdaq: SGMO) today said they expect top-line efficacy data of their Phase 2b Clinical Trial in Diabetic Neuropathy in 2H 2011. Previous guidance released in February was for data during 4Q 2011.

Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that they had submitted their NDA for PROCHIEVE (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. A 6-month priority review was requested. If a priority review is accepted, an end-of-September PDUFA date is expected. A standard 10-month review would result in a likely PDUFA date during late February 2012.

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Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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