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News Breaks
March 6, 2014
05:30 EDTNVSNovartis announces Xolair approved in EU
Novartis announced that the European Commission has approved the use of Xolair, omalizumab, as an add-on therapy for the treatment of chronic spontaneous urticarial, or CSU, in adult and adolescent patients with inadequate response to H1-antihistamine treatment. The approved dose is 300 mg by subcutaneous injection every four weeks. The EU approval follows the Committee for Medicinal Products for Human Use positive opinion on Xolair, which was adopted based on positive and consistent results from three pivotal Phase III registration studies that involved nearly 1,000 patients with CSU not responding to H1-antihistamines. Xolair 300 mg met all primary and pre- specified secondary endpoints across these studies, which showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms. Quality of life was also significantly improved for patients treated with Xolair 300 mg across the Phase III study program.
News For NVS From The Last 14 Days
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September 16, 2014
07:31 EDTNVSEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
September 15, 2014
07:27 EDTNVSIBC Life Sciences to hold a conference
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07:21 EDTNVSHeart Failure Society of America to hold annual meeting
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September 12, 2014
05:18 EDTNVSNovartis announces new data confirms high efficacy of Gilenya in achieving NEDA
Novartis announced new analyses presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, which confirmed the high efficacy of Gilenya in achieving 'no evidence of disease activity', or NEDA, in people with relapsing-remitting multiple sclerosis, or RRMS, across four key disease measures - relapses, MRI lesions, brain shrinkage and disability progression. Specifically, patients taking Gilenya had a more than four-times greater likelihood of achieving NEDA across these four key measures. NEDA is currently defined as having no relapses, MRI lesions and disability progression. These new analyses from the phase III FREEDOMS and FREEDOMS II trials reinforce the value of including brain shrinkage to the definition of NEDA. The inclusion of brain shrinkage into the NEDA definition would allow physicians to obtain a more complete assessment of a patient's disease, including the underlying damage in MS.
September 10, 2014
05:17 EDTNVSNovartis Gilenya data confirms reducing brain shrinkage matter for MS patients
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September 9, 2014
07:55 EDTNVSOphthotech earlier than expected Novartis payment positive, says Oppenheimer
After Ophthotech (OPHT) received a $50M Phase 3 enrollment payment from Novartis (NVS) earlier than expected, Oppenheimer thinks the payment highlights an underappreciated stock driver for Opthotech, and demonstrates that recent suggestions of Phase 3 enrollment timelines possibly slipping are unwarranted. The firm believes the company is executing well on the Fovista Phase 3 program and keeps an Outperform rating on the stock.
September 8, 2014
09:27 EDTNVSLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
08:38 EDTNVSMerus Labs acquires Sintrom from Novartis
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07:33 EDTNVSOphthotech achieves $50M milestone under ex-agreement with Novartis for Fovista
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