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March 14, 2014
06:39 EDTBDSI, ENDPBioDelivery Sciences reports Bunavail PDUFA date of June 7
BioDelivery Sciences (BDSI) announced that in 2013, BDSI made important progress in significantly advancing and building its product portfolio in pain and addiction treatment and made meaningful strides in its continuing evolution from a development stage entity to a commercial enterprise. This included significant progress in the development of BDSI's two buprenorphine-containing products, BUNAVAIL for the maintenance treatment of opioid dependence and BEMA Buprenorphine, in partnership with Endo Pharmaceuticals, for the treatment of moderate to severe chronic pain. A New Drug Application, or NDA, for Bunavail was submitted to the FDA in mid-2013 and has a Prescription Drug User Fee Act, or PDUFA, date of June 7. In January, BDSI and Endo (ENDP) announced positive top-line results from the Phase 3 clinical trial of BEMA Buprenorphine in opioid naive patients. A second Phase 3 pivotal study for BEMA Buprenorphine, which is ongoing and being conducted in opioid experienced patients, is expected to report top-line results in mid-2014. In addition to the progress on its two buprenorphine containing products, BDSI expanded its product portfolio in 2013 by in-licensing Clonidine Topical Gel, a proposed treatment for painful diabetic neuropathy. Following a positive end of Phase 2 meeting with FDA in November, BDSI will begin this quarter enrolling patients in the first of two Phase 3 studies
News For BDSI;ENDP From The Last 14 Days
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July 20, 2015
08:09 EDTENDPBioSpecifics announces approval of Xiaflex in Japan
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July 17, 2015
10:05 EDTENDPOn The Fly: Analyst Upgrade Summary
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08:38 EDTENDPLeerink puts 25% odds on Teva, Mylan deal within 12 months
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06:43 EDTENDPEndo upgraded to Top Pick from Outperform at RBC Capital
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July 16, 2015
11:36 EDTBDSIBioDelivery Sciences management to meet with FBR Capital
Meetings to be held in Minneapolis on July 22 and in Dallas on July 23 hosted by FBR Capital.

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