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News Breaks
January 24, 2013
15:19 EDTNVSNovartis says subpoenaed during 2012 over marketing practices
In its 2012 annual report, filed yesterday, Novartis Pharmaceuticals disclosed that during last year it received a subpoena from the United States Attorney’s Office for the Western District of Kentucky requesting the production of documents relating to marketing practices, including remuneration of healthcare providers, in connection with certain NPC products including Tekturna and its combination products. Novartis said it is cooperating with the investigation, which is civil and criminal in nature. Novartis also disclosed that in 2012 it received a civil investigative demand from the USAO for the Southern District of New York requesting information regarding its interactions with specialty pharmacies concerning certain NPC products including Gleevec and Gilenya. NPC again said it is cooperating with the civil investigation. Novartis also said that during the fourth quarter of 2012, it learned that the U.S. government is not pursuing further informed consent issues relating to clinical trials in China related to an investigation that began in 2010. The government continues to investigate marketing practices, including marketing practices concerning Zometa, Novartis said. Additionally, Novartis' Alcon Laboratories unit was notified that the USAO for the Northern District of Texas is conducting an investigation relating to the export of Alcon products to various countries subject to U.S. trade sanctions, including Iran, and received a grand jury subpoena requesting the production of documents for a period beginning in 2005 relating to this investigation, in which Alcon is cooperating.
News For NVS From The Last 14 Days
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March 30, 2015
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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