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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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August 31, 2015
08:02 EDTENDPEndo announces Xiaflex for Dupuytren's contracture formal pricing in Japan
Endo announced that XIAFLEX for the treatment of Dupuytren's contracture has been listed on the Japanese National Health Insurance drug price standard. As a result, Endo partner Asahi Kasei Pharma expects to commercially launch the product in Japan on September 16, 2015. Under the terms of the partnership agreement, Endo will receive a $20M milestone payment upon the first commercial sale of XIAFLEX in Japan. In March 2011, Asahi Kasei Pharma received rights to develop and market XIAFLEX in Japan through an agreement with Auxilium Pharmaceuticals, which was subsequently acquired by Endo in January 2015. Under the agreement, Asahi Kasei Pharma was granted the exclusive right to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Japan upon receipt of applicable regulatory approvals. Asahi Kasei Pharma is also responsible for clinical development and regulatory activities for XIAFLEX and has a right of first negotiation to obtain exclusive rights to commercialize other XIAFLEX(R) pipeline indications in Japan. Endo is eligible to receive up to $217M in remaining potential milestone payments and up to $210M in connection with the achievement of aggregate annual net sales thresholds. In addition, Asahi Kasei Pharma will provide tiered payments based on net sales of XIAFLEX . Asahi Kasei Pharma obtained approval in Japan for the manufacture and marketing of XIAFLEX(R) for Dupuytren's contracture in July 2015.
August 28, 2015
09:50 EDTENDPAllergan plans for generic version of Endo's Fortesta blocked, Bloomberg reports
A judge upheld Endo's (ENDP) patents on Fortesta expiring in 2018 and blocked Allergan's (AGN) bid to launch a generic version of the testosterone gel, according to Bloomberg.

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