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News Breaks
January 22, 2013
12:30 EDTNVSNovartis meningitis vaccine wins EU approval
In a press release from earlier today, Novartis announced that the European Commission has approved Bexsero, a meningococcal vaccine for use in individuals from 2 months of age and older. Novartis is committed to making Bexsero available as soon as possible.
News For NVS From The Last 14 Days
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October 22, 2014
07:44 EDTNVSGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
October 21, 2014
07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
October 14, 2014
11:23 EDTNVSBIND Therapeutics and The Conference Forum hold a conference
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October 10, 2014
05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.

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