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June 2, 2014
09:07 EDTNVSNovartis presents LBH589 data at ASCO
Novartis data at ASCO show LBH589 significantly improved progression-free survival in patients with multiple myeloma. Processed and transmitted by NASDAQ OMX Corporate Solutions. Results show adding LBH589 to bortezomib and dexamethasone significantly improved PFS by 37%, meeting Phase III study primary endpoint. Median PFS increased by 4 months, effect of LBH589 observed across all patient subgroups. Most people with multiple myeloma will relapse or become refractory; if approved, LBH589 will be first in its class of anticancer agents available to this population. Based on these data, US FDA granted priority review in May; additional global regulatory filings are underway. The company said, "Almost all patients with multiple myeloma ultimately relapse and become resistant to treatment, so new therapies are critical for continuing to manage the disease and improve outcomes. These are the first Phase III results to show meaningful clinical benefit and provide scientific support for adding LBH589 to bortezomib-based treatment for patients with relapsed or relapsed and refractory multiple myeloma and provide a strong rationale for the use of histone deacetylase inhibitors as part of the therapeutic armamentarium in this setting."
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September 29, 2014
08:07 EDTNVSPhase 2 trial of binimetinib in NRAS melanoma shows promising clinical activity
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September 26, 2014
07:30 EDTNVSNovartis drug Signifor LAR recommended by CHMP for EU approval
The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion for Signifor long acting release, or LAR, formulation to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue, or SSA. If approved in the EU, this next-generation SSA could fill a current unmet need, providing a new therapeutic option for the approximately 45% of acromegaly patients whose growth hormone, or GH, or insulin-like growth factor-1, or IGF-1, levels remain inadequately controlled despite treatment with currently available SSAs.
September 25, 2014
05:28 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies
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September 22, 2014
16:07 EDTNVSAnacor announces commercial launch of KERYDIN topical solution in U.S.
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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.

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