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News Breaks | | | | February 11, 2013 | | 16:12 EDT |  | UNIS | Unilife reports Q2 adjusted EPS (12c), consensus (13c)
Reports Q2 revenue $699,000, consensus $2.05M. | |
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News For UNIS From The Last 14 Days Check below for free stories on UNIS the last two weeks. |
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| June 6, 2013 | | 06:10 EDT |  | UNIS | Biodel to commercialize glucagon rescue device for severe hypoglycemia
Biodel (BIOD) announced plans to submit a New Drug Application to the FDA in 2015 for a novel glucagon rescue device to treat severe hypoglycemia. Having previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy and appoint a contract manufacturing partner during the current calendar quarter. The submission of an Investigational New Drug application to the FDA is expected during the next 12 months. Initiation of a pivotal clinical study is expected to occur during 2H14, putting the company in a position to file an NDA to the FDA under the 505(b)(2) regulatory pathway in 2015. In preparation for the anticipated regulatory filing and commercial launch of its glucagon rescue product, Biodel has signed a 15-year supply agreement with Unilife (UNIS) for a customized proprietary device from its EZMix platform of dual-chamber devices with worldwide exclusivity for use with glucagon. | | | June 4, 2013 | | 12:48 EDT | | UNIS | Unilife drops 11% to $3.40 amid Jefferies conference presentation
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