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July 2017
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Press Release
Q2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative products
Net 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… -
Press Release
Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx® reinforcing sustained efficacy and safety profile in psoriasis
5 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… -
Press Release
Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL
Recommendation 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… -
Press Release
Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis
Label 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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Press Release
Novartis 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… -
Press Release
Sandoz receives approval in Europe for Erelzi® (biosimilar etanercept) to treat multiple inflammatory diseases
European Commission approves Sandoz Erelzi® to treat immunological diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis Approval of Erelzi provides more treatment options for… -
Press Release
NEJM 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… -
Press Release
Novartis Kisqali® (ribociclib) receives positive CHMP opinion as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor
CHMP 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-… -
Press Release
Novartis 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… -
Press Release
Novartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALL
83% 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… -
Press Release
Novartis 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… -
Press Release
Novartis Phase III study shows ACZ885 (canakinumab) reduces cardiovascular risk in people who survived a heart attack
Phase 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…