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News Breaks
March 18, 2013
09:26 EDTINCY, NVSIncyte discloses patient treated with ruxolitinib develops PML
Incyte Corporation (INCY) disclosed in a regulatory filing that it was informed last week of a case of progressive multifocal leukoencephalopathy, or PML, in a 75 year old male patient from the United Kingdom with myelofibrosis treated with ruxolitinib. Ruxolitinib is marketed by the company as Jakafi in the United States and by Novartis (NVS) as Jakavi outside the United States, Incyte said. Incyte stated: "It has not been determined whether development of PML in this case was related to the use of ruxolitinib. An independent assessment to confirm the diagnosis and evaluate the causality assessment provided by the investigator is planned. This is the only known case of PML in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product...The Company has informed the U.S. Food and Drug Administration of this case and, as part of its standard procedure for sharing available information in a timely manner, is in the process of informing investigators in its clinical trials." The company added that there are reports in medical literature that "suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML." In pre-market trading, Incyte shares fell over 13% to $21.58.
News For INCY;NVS From The Last 14 Days
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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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August 18, 2014
07:35 EDTNVSApricus Biosciences launches topical ED treatment in Germany
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