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News Breaks
January 10, 2013
18:38 EDTNVSNovartis drug Afinitor shows benefit in Phase III trial data
Data published today in The Lancet showed that patients on Afinitor tablets with non-cancerous kidney tumors known as renal angiomyolipomas associated with tuberous sclerosis complex experienced a significant reduction in tumor size and the absence of tumor progression. Additionally, a recent issue of The Lancet featured results from a separate everolimus trial demonstrating a reduction in the size of non-cancerous brain tumors known as subependymal giant cell astrocytomas associated with tuberous sclerosis complex. The Phase III EXIST-2 trial published in The Lancet reported that 42% of patients taking everolimus experienced an angiomyolipoma response versus 0% of patients in the placebo arm. Everolimus also demonstrated superiority to placebo for both secondary endpoints assessed. Results from a separate Phase III trial of TSC patients called EXIST-1, also published in a recent issue of The Lancet, showed that 35% of patients with SEGAs associated with TSC treated with everolimus experienced a 50% or greater reduction in SEGA volume versus 0% of patients on placebo.
News For NVS From The Last 14 Days
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March 30, 2015
17:46 EDTNVSNovartis announces FDA approval for Jadenu
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05:18 EDTNVSNovartis enters multiyear aliance with Aduro Biotech
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March 26, 2015
11:13 EDTNVSBofA/Merrill European pharma analyst holds an analyst/industry conference call
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10:18 EDTNVSHigh option volume stocks
High option volume stocks: BTX ALL FIVE SGYP SWFT RHT IDCC NVS WGO XBI
March 24, 2015
11:05 EDTNVSNovartis granted orphan status for medulloblastoma treatment
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March 23, 2015
09:45 EDTNVSUBS to hold a field trip
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09:03 EDTNVSLeerink analysts hold a meeting with a conference call hookup
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March 20, 2015
12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
07:41 EDTNVSAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says
March 17, 2015
12:51 EDTNVSNovartis hit with $100M gender discrimination lawsuit, Reuters reports
A proposed class action lawsuit against Novartis claims the drug maker routinely denied female employees equal pay and promotional opportunities, reports Reuters. The $110M lawsuit filed on Tuesday says Novartis' Alcon Laboratories maintains a "boy's club atmosphere" that is hostile to women and bars them from leadership positions. Reference Link
05:32 EDTNVSIncyte announces Novartis receives EC approval for Jakavi
Incyte (INCY) announced that Novartis (NVS) received approval from the European Commission for Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Jakafi is approved by the FDA for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
05:30 EDTNVSNovartis receives EU approval for Jakavi in polycythemia vera
Novartis announced that the European Commission has approved Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Jakavi is the only JAK 1/2 inhibitor available to treat PV and is also currently approved in more than 80 countries to treat myelofibrosis.

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