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February 26, 2014
11:19 EDTDARADara orphan drug could make it takeover target, Triangle Business Journal says
Dara BioSciences shares jumped after the company received orphan drug designation for its experimental cancer pain treatment, which Dara CEO David Drutz said "creates a lot of interest" for potential U.S. partners, according to Triangle Business Journal. “Some have told us they might be particularly interested if we get the [orphan drug] designation,” the report quotes Drutz as stating. Reference Link
News For DARA From The Last 14 Days
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October 29, 2014
06:11 EDTDARADara BioSciences petitions FDA to amend label for tamoxifen citrate, Soltamox
DARA BioSciences petitioned the FDA to amend the label for tamoxifen citrate and Soltamox, the only FDA-approved liquid bioequivalent of tamoxifen, by increasing the recommended duration of adjuvant therapy for women with estrogen receptor-positive breast cancer from five to 10 years. DARA submitted its Citizen's Petition under section 10.30 of the Federal Food, Drug and Cosmetic Act. According to the process, the FDA typically provides an initial response within 6 months of filing. Tamoxifen is indicated for the treatment of metastatic breast cancer, adjuvant treatment of breast cancer, the reduction of risk of invasive breast cancer in women with ductal carcinoma in situ, and to reduce breast cancer incidence in high risk women. More than 1.9M prescriptions of tamoxifen are written annually in the United States.

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