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Stock Market & Financial Investment News

News Breaks
August 18, 2014
07:35 EDTAPRI, NVSApricus Biosciences launches topical ED treatment in Germany
Apricus Biosciences (APRI) announced the launch in Germany of Vitaros, Apricus' novel topical on-demand treatment for erectile dysfunction, or ED, by Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies (NVS). Earlier this month, Sandoz launched Vitaros in Sweden.
News For APRI;NVS From The Last 14 Days
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October 23, 2014
11:57 EDTNVSNovartis management to meet with Jefferies
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05:21 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies in AS
Novartis announced that AIN457 met primary and key secondary endpoints in two pivotal Phase III studies, MEASURE 1 and MEASURE 2, in patients with ankylosing spondylitis, or AS. Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin- 17A, a protein that is central to the development of inflammatory diseases, including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress. Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate- to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.
October 22, 2014
07:44 EDTNVSGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
October 21, 2014
07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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06:13 EDTAPRIApricus Biosciences to host conference call
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05:27 EDTAPRIApricus licensed U.S. development, commercialization rights for fispemifene
Apricus Biosciences announced that it has licensed the U.S. development and commercialization rights for a novel selective estrogen receptor modulator, or SERM, fispemifene, an investigational treatment for urological conditions in men, from Forendo Pharma, a private therapeutics company based in Finland. This license agreement combines Apricus' expertise in men's health with Forendo's established leadership in SERM drug discovery, to advance the development of fispemifene as an investigational treatment for urological conditions in men. Under the terms of the agreement, Forendo and its advisors received an upfront license fee of $12.5M comprised of a $5M cash payment and the issuance of $7.5M in Apricus common stock; approximately 3.6M shares priced at the 360-day average market price of $2.08 per share. The agreement includes additional potential clinical and regulatory milestone payments to Forendo of up to $45M, including for potential FDA approval, as well as potential commercial milestone payments totaling up to $260M, based on achieving specified annual net sales levels up to $1B in the U.S. Apricus will also pay tiered low double-digit royalties based on net sales once the product is commercialized. Apricus will be responsible for the clinical development of fispemifene in the U.S., as well as all future commercialization efforts in the U.S. and its territories.
October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
October 14, 2014
11:23 EDTNVSBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
07:13 EDTAPRIApricus Biosciences awarded U.S. patent for RayVa
Apricus Biosciences announced that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/110,348. The patent application generally is directed to methods and compositions for treating Raynaud's phenomenon, including claims related to treating Raynaud's phenomenon that is secondary to systemic sclerosis. Raynaud's phenomenon secondary to systemic sclerosis affects an estimated three to five percent of people in the U.S., disproportionately affecting women and currently has no approved therapy in the U.S., representing an unmet medical need. The FDA has indicated that Apricus' RayVa™ product may qualify for priority review, given the unmet medical need and lack of approved products to treat secondary Raynaud's phenomenon. The FDA will determine if the RayVa New Drug Application qualifies for priority review following its submission, which could occur as early as 2017.

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