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News Breaks
May 19, 2014
16:10 EDTOPHT, NVSOphthotech, Novartis enter into ex-U.S. licensing, commercialization agreement
Ophthotech (OPHT) announced that the company has entered into an ex-US licensing and commercialization agreement with Novartis Pharmaceuticals (NVS) focused on the treatment of wet age-related macular degeneration, or AMD. Under the agreement, Ophthotech grants Novartis exclusive rights to commercialize Ophthotech’s lead product candidate, Fovista, in markets outside the United States while Ophthotech retains sole rights to commercialize Fovista in the U.S. Potential payments to Ophthotech under the agreement could total over $1B in upfront and milestone payments, not including future royalties. Ophthotech will continue to lead the global Fovista Phase 3 wet AMD pivotal clinical program which is expected to have initial, topline data available in 2016. Ophthotech will continue its lead role in the potential registration of Fovista in the U.S., while Ophthotech and Novartis will collaborate to seek regulatory approvals outside the U.S. This collaboration continues the Fovista development strategy to remain agnostic with respect to the choice of the anti-VEGF agent administered in combination with Fovista. Separate injections of the anti-VEGF agent and Fovista would allow physicians to choose their preferred anti-VEGF agent for the combination therapy. The collaboration also provides for the potential development of a fixed combination delivery of a co-formulation of Fovista with a Novartis proprietary anti-VEGF product which would result in additional flexibility for physicians. Novartis will also seek to develop and commercialize alternative innovative delivery technologies such as a Fovista pre-filled syringe as part of this collaboration.
News For OPHT;NVS From The Last 14 Days
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August 31, 2014
14:04 EDTNVSWorldwide Business Research to hold a conference
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13:47 EDTNVSNovartis heart failure drug LCZ696 shows superiority to enalapril in study
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12:50 EDTNVSEuropean Society of Cardiology to hold a conference
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August 29, 2014
16:21 EDTNVSOn The Fly: Closing Wrap
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12:23 EDTNVSNovartis drug data to be presented this weekend
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12:18 EDTNVSOn The Fly: Midday Wrap
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11:07 EDTNVSHigh option volume stocks
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10:51 EDTNVSUnited Therapeutics jumps after court rules generic will infringe
United Therapeutics (UTHR) alleged patent infringement against Sandoz, a unit of Novartis (NVS), related to the latter's filing for approval of a generic version of United Therapeutics' remodulin drug. A New Jersey court ruled today that Sandoz's proposed ANDA product will infringe the claims of UTC's '117 patent, according to a court filing. Following the court ruling, shares of United Therapeutics are up 15% to $105.39 in morning trading.
10:17 EDTNVSInnoPharma announces FDA approval of generic Dacogen
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10:04 EDTNVSNovartis hematopoietic support for ALL patients granted orphan status
Novartis' hematopoietic stem and progenitor cells expanded ex-vivo with a low molecular weight aryl hydrocarbon receptor antagonist was granted orphan designation as a hematopoietic support in patients with acute lymphoblastic leukemia, or ALL, the FDA stated. Reference Link
08:46 EDTNVSNovartis has a conference call hosted by JPMorgan
JPMorgan Analyst Vosser hosts a conference call with CEO Joe Jimenez on September 5 at 8 am.
August 28, 2014
08:40 EDTNVSPositive data on Novartis LCZ696 could raise sales outlook, says Leerink
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August 20, 2014
12:06 EDTNVSNovartis treatment for pigmented villonodular synovitis gets orphan designation
According to a post on the FDA's website, Novartis' recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor received orphan designation. Reference Link
05:17 EDTNVSNovartis provides drug candidate compounds to TB Alliance
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August 19, 2014
05:11 EDTNVSGamida Cell announces investment, option agreement with Novartis
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