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November 13, 2012
07:06 EDTATRSAntares Pharma announces positive results from MTX Medi-Jey study
Antares Pharma announced positive results from an open-label, randomized, crossover study comparing the systemic availability of MTX Medi-Jet to oral methotrexate in adult patients with rheumatoid arthritis. This study was designed to compare the relative systemic availability of MTX following oral administration to subcutaneous (SC) self-administered MTX using the Medi-Jet device. Patients were assigned to one of four dose levels of MTX, 10 mg, 15 mg, 20 mg, and 25 mg. Results showed that the systemic availability of methotrexate following oral dosing plateaus above 15 mg. Following administration of MTX with Medi-Jet, the systemic availability increased proportionally at every dose, which will extend the range of exposure compared to patients receiving oral therapy.
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January 26, 2015
07:02 EDTATRSAntares says FDA issues complete response letter for Sumatriptan Injection ANDA
Antares Pharma announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the Abbreviated New Drug Application for Sumatriptan Injection USP for the acute treatment of migraine. The complete response letter from the FDA provided revisions to labelling and cited minor deficiencies. If approved, Sumatriptan Injection USP would represent the Company’s first ANDA approval and second device approved from the VIBEX auto injector platform. As previously disclosed, Teva Pharmaceutical Industries, Ltd. would distribute the product and share the profits equally with Antares Pharma. Eamonn P. Hobbs, President and CEO, stated, “We are pleased with the feedback received from the FDA in the complete response letter. The FDA has outlined the steps necessary to support approval of the ANDA, and we plan to work closely with the Agency on a response.”
06:16 EDTATRSAntares Pharma announces complete response letter for Sumatriptan ANDA
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January 16, 2015
10:20 EDTATRSAntares Pharma management to meet with JMP Securities
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