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News Breaks
March 18, 2013
17:00 EDTENDP, BDSIBDSI updates Phase lll clinical trials for BEMA Buprenorphine
BDSI said in a press release that significant progress was made in the development of BioDelivery Sciences International, BDSI's (BDSI), two buprenorphine-containing products with the initiation, in partnership with Endo Health Solutions (ENDP) of two Phase 3 pivotal trials with BEMA Buprenorphine for the treatment of chronic pain. BDSI also completed key bioavailability and safety studies with BUNAVAIL (formerly BEMA Buprenorphine/Naloxone or BNX) for the treatment of opioid dependence. Phase 3 clinical trials for BEMA Buprenorphine in conjunction with Endo to complete in late 2013 or early 2014
News For BDSI;ENDP From The Last 14 Days
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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.
December 3, 2014
14:17 EDTENDPEndo repeats view of FY14 adjusted EPS $4.10-$4.25, consensus $4.23
Repeats FY14 revenue view $2.8B-$2.88B, consensus $2.85B. The company raised its guidance previously on November 5. Guidance repeated in slide presentation for Capital Research Global Investors disclosed in regulatory filing.

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