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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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December 19, 2014
10:17 EDTBDSIOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Aviva (AV) upgraded to Outperform from Market Perform at Bernstein... Basic Energy (BAS) upgraded to Buy from Accumulate at Tudor Pickering... BioDelivery Sciences (BDSI) upgraded to Buy from Neutral at Roth Capital... CVS Health (CVS) upgraded at SunTrust... CVS Health (CVS) upgraded to Buy from Neutral at SunTrust... EPR Properties (EPR) upgraded to Hold from Underweight at KeyBanc... Ensco (ESV) upgraded to Accumulate from Hold at Tudor Pickering... First Marblehead (FMD) upgraded to Buy from Neutral at Compass Point... GOL Linhas (GOL) upgraded to Outperform from Neutral at Credit Suisse... Medical Properties Trust (MPW) upgraded to Hold from Underweight at KeyBanc... NVIDIA (NVDA) upgraded to Neutral from Underperform at BofA/Merrill... NewStar Financial (NEWS) upgraded to Buy from Neutral at Sidoti... Orange SA (ORAN) upgraded to Buy from Hold at Deutsche Bank... Parker Drilling (PKD) upgraded to Buy from Accumulate at Tudor Pickering... Potash (POT) upgraded to Buy from Neutral at UBS... Teekay Tankers (TNK) upgraded to Buy from Neutral at BofA/Merrill... Tidewater (TDW) upgraded to Accumulate from Hold at Tudor Pickering... Unum Group (UNM) upgraded to Buy from Neutral at Compass Point... WPP PLC (WPPGY) upgraded to Buy from Neutral at Citigroup... Weatherford (WFT) upgraded to Buy from Hold at Tudor Pickering.
09:11 EDTENDPEndo price target raised to $90 from $77 at Sterne Agee
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08:27 EDTBDSIBioDelivery Sciences upgraded to Buy from Neutral at Roth Capital
Roth Capital upgraded BioDelivery Sciences to Buy based on recent share weakness. Price target lowered to $18.
December 16, 2014
08:58 EDTENDPEndo a top pick for 2015, says Sterne Agee
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December 11, 2014
17:04 EDTENDPEndo registration statement relating to Auxilium declared effective by SEC
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December 9, 2014
07:08 EDTENDPEndo completes acquisition of rights to Natesto from Trimel BioPharma
Endo International announced the completion of the acquisition of rights to Natesto, a testosterone nasal gel, the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel BioPharma, a wholly-owned subsidiary of Trimel Pharmaceuticals for $25M including additional payments upon the achievement of certain regulatory and sales milestones. Endo will collaborate with Trimel on all regulatory and clinical development activities regarding Natesto. Endo intends to launch the product, through its Endo Pharmaceuticals subsidiary, in the Q1 of 2015.
December 8, 2014
09:32 EDTENDPSyneron Medical signs agreement with AMS to supply holmium laser for urology
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07:01 EDTBDSIBioDelivery Sciences completes randomization in trial of clonidine topical gel
BioDelivery Sciences announced that it has completed the randomization of all patients in BDSI's ongoing initial pivotal Phase 3 clinical trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy. BDSI anticipates that topline results of the study will be available by the end of March 2015. The Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with PDN. In the trial, known as the RHAPSODY Study, subjects were randomized to receive either Clonidine Topical Gel or a placebo gel. Two hundred and sixty three adult subjects were randomized into the 12 week double-blind treatment phase of the study. This is the first of two pivotal trials that would be required for submission of a New Drug Application to the U.S. Food and Drug Administration. FDA has granted Fast Track designation for the program, which recognizes the need of developing new therapies for this serious condition. BDSI plans to begin the second Phase 3 study during the first quarter of 2015.

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