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Showing 1045 results
July 2017
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Media ReleaseQ2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative productsNet sales in line with prior year (0% cc[1], -2% USD), as growth drivers offset Gleevec/Glivec Gx impact: Cosentyx (USD 490 million, +90% cc) continues strong growth in all three indications…
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Media ReleaseNovartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx® reinforcing sustained efficacy and safety profile in psoriasis5 year data from long-term Phase III extension study demonstrate sustained efficacy and safety of Cosentyx in patients with moderate-to-severe plaque psoriasis[1] Data planned to be…
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Media ReleaseNovartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALLRecommendation based on review of CTL019 r/r B-cell ALL development program, including the pivotal Phase II global ELIANA trial A Biologics License Application (BLA) for this indication is…
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Media ReleaseNovartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasisLabel update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx® versus Stelara® in psoriasis [1],[2] Update also includes use of Cosentyx in moderate-to…
June 2017
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Media ReleaseNovartis receives EU approval for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC)In ALK-positive advanced NSCLC patients, Zykadia demonstrated superior median progression-free survival (PFS) compared to SOC chemotherapy with maintenance[1] Zykadia benefit was also seen…
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Media ReleaseSandoz receives approval in Europe for Erelzi® (biosimilar etanercept) to treat multiple inflammatory diseasesEuropean Commission approves Sandoz Erelzi® to treat immunological diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis Approval of Erelzi provides more treatment options for…
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Media ReleaseNEJM publishes full analysis of Rydapt® (midostaurin) Phase III RATIFY trial in newly diagnosed FLT3-mutated acute myeloid leukemia (AML)Significant overall survival benefit observed for FLT3+ AML patients consistent across FLT3 mutation subgroups, including ITD and TKD Detailed data show Rydapt plus standard chemotherapy improved…
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Media ReleaseNovartis Kisqali® (ribociclib) receives positive CHMP opinion as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitorCHMP opinion based on pivotal Phase III trial that showed Kisqali plus letrozole reduced risk of disease progression or death by 44% over letrozole alone among postmenopausal women with HR+/HER2-…
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Media ReleaseNovartis data shows half of eligible Ph+ CML-CP patients remain in Treatment-free Remission nearly two years after stopping Tasigna®New 96-week data support durability and safety of Treatment-free Remission (TFR) in Ph+ CML-CP patients who stop taking Tasigna [1,2] More than 90% of Ph+ CML-CP patients in ENESTfreedom and ENESTop…
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Media ReleaseNovartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALL83% of patients achieved complete remission (CR) or CR with incomplete blood count recovery within 3 months of treatment with CTL019; consistent with interim ELIANA data Data evaluating 63…
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Media ReleaseNovartis combination targeted therapy Tafinlar® + Mekinist® receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC)Approval provides first targeted treatment in the US specifically for BRAF V600E mutation-positive metastatic NSCLC More than 60% of treatment-naïve and previously treated patients with…
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Media ReleaseNovartis Phase III study shows ACZ885 (canakinumab) reduces cardiovascular risk in people who survived a heart attackPhase III CANTOS study met the primary endpoint, a composite of heart attack, stroke and cardiovascular death, showing that ACZ885 (canakinumab) in combination with standard of care therapy reduces…
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