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Industry news, News / 1 February 2012 / Novartis
Novartis announced today that following a priority review, the US Food and Drug Administration (FDA) has approved an update to the Glivec® (imatinib)* label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial. This treatment regimen has been shown to improve recurrence-free survival (RFS) and overall survival (OS) for KIT+ GIST patients compared to 12 months of treatment[3].
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Industry news, News / 30 January 2012 / Novartis
Novartis will continue its work with the World Health Organization (WHO) toward a world free of leprosy by extending its drug donation of multidrug therapy (MDT) medicines to treat leprosy through the year 2020. This new five-year commitment includes treatments worth an estimated USD 22.5 million and up to USD 2.5 million to support the WHO in handling the donation and logistics, and is expected to reach an estimated 850,000 patients.
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Industry news, News / 20 January 2012 / Novartis
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to update the Glivec® (imatinib)* label to include 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST). This extended treatment regimen has been shown to improve recurrence-free survival and overall survival for KIT+ GIST patients[1].
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Industry news, News / 19 January 2012 / Novartis
Sandoz announced today that it has initiated two milestone Phase III clinical trials – one for biosimilar filgrastim (Amgen’s Neupogen®) in the US market, the other for its global pegfilgrastim development program (Amgen’s Neulasta®).
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Industry news, News / 18 January 2012 / Novartis
Novartis announced today that it received regulatory approval in China from the State Food and Drug Administration (SFDA) for Lucentis® (ranibizumab) to treat wet (neovascular) age-related macular degeneration (AMD), and is launching Galvus® (vildagliptin), an oral treatment for patients with type 2 diabetes approved in China as an add-on to metformin, the standard of care[3],[4] .
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Industry news, News / 13 January 2012 / Novartis
Novartis Pharmaceuticals announced today that the company plans to strengthen its long-term competitive position in anticipation of the Diovan® (valsartan) patent expiration and an expected reduction in demand for Rasilez®/Tekturna® (aliskiren) following termination of the ALTITUDE clinical study. The company will reduce its cost base with the current restructuring focused on the US market.
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Industry news, News / 8 January 2012 / Novartis
Novartis Consumer Health Inc. (NCH) informed customers, that it is voluntarily recalling all lots of select bottle packaging configurations from retailers of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.
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Industry news, News / 15 December 2011 / Novartis
Novartis announced today new data from the Phase III 2309 study showing patients with relapsing-remitting multiple sclerosis (RRMS) treated with Gilenya® (fingolimod) had a statistically significant 48% reduction in annualized relapse rates (ARR) at 24 months compared to placebo. Study 2309 is the third Phase III clinical trial to demonstrate a significant reduction of relapse rates with Gilenya treatment in patients with RRMS. The two previous Gilenya studies involved a two-year, placebo-controlled trial and a one-year, head-to-head trial against interferon-beta-1a (IM) in which the once-daily oral medicine showed a 54% and a 52% relative reduction in ARR, respectively[1],[2].
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Industry news, News / 13 December 2011 / Novartis
Novartis today announced additional results from two pivotal Phase III trials evaluating Janus kinase (JAK) inhibitor INC424 (ruxolitinib) in myelofibrosis. These data demonstrate the important potential role of INC424 in treating patients with myelofibrosis, a life-threatening blood cancer characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms.
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Industry news, News / 8 December 2011 / Novartis
Updated results of a Phase III study of Afinitor® (everolimus) tablets plus exemestane, a hormonal therapy, show everolimus provided additional time women with advanced breast cancer lived without their disease progressing (progression-free survival)[1].
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Industry news, News / 5 December 2011 / Novartis
Novartis announced today that the European Commission has approved Galvus® (vildagliptin) (50 mg once a day) for the treatment of type 2 diabetes patients with moderate or severe renal impairment1. Galvus is currently available for patients with no or mild renal impairment and this approval expands treatment options for patients with moderate or severe renal impairment1.
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Industry news, News / 2 December 2011 / Novartis
Novartis will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.
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