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News Breaks
March 14, 2014
06:39 EDTENDP, BDSIBioDelivery 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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November 20, 2014
07:33 EDTENDPEndo launches generic version of Hoffmann-La Roche's Valcyte
Endo's Qualitest subsidiary has launched a generic version of Hoffmann-La Roche's Valcyte. For the 12 months ending September 30, Valcyte had total U.S. sales of approximately $440M, according to IMS Health data.
November 19, 2014
10:21 EDTENDPHigh option volume stocks
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07:33 EDTENDPEndo, Auxilium receive early termination of HSR waiting period for deal
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07:09 EDTBDSIJefferies to hold a conference
2014 Global London Healthcare Conference is being held in London, England on November 19-20.
November 14, 2014
09:38 EDTENDPJANA Partners gives quarterly update on stakes
NEW STAKES: AMD (AMD), AECOM Technology (ACM), Alibaba (BABA), McDonald's (MCD), Amgen (AMGN), Gaming and Leisure Properties (GLPI), Iron Mountain (IRM), iRobot (IRBT), Seadrill Partners (SDLP), Valeant (VRX). INCREASED STAKES: eBay (EBAY), Charter (CHTR), Groupon (GRPN), HD Supply (HDS), Hertz (HTZ). DECREASED STAKES: Apache (APA). LIQUIDATED STAKES: CBS (CBS), Endo (ENDP), FMC Corporation (FMC), SeaWorld (SEAS), SunEdison (SUNE).
November 10, 2014
08:17 EDTENDPEndo receives final approval for generic version of Valcyte
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