Novartis receives Piqray® approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation

  • Piqray (alpelisib) is the only treatment approved specifically to address PIK3CA mutation, underscoring Novartis commitment to reimagining cancer care
     
  • Approval based on SOLAR-1 Phase III trial showing Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. 5.7 months), compared to fulvestrant alone1,2
     
  • 334,000 people are diagnosed with advanced breast cancer worldwide each year, and approximately 40% of those with HR+/HER2- subtype have a PIK3CA mutation, which is associated with a poor prognosis3-12 …
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Sandoz announces plans for joint investment to help strengthen future of antibiotics manufacturing in Europe

  • Sandoz and Austrian government announce joint plans to drive long-term competitiveness of European production for key antibiotics in Europe
     
  • Planned combined investment of more than EUR 150 million would include major innovative technology development and implementation for large-scale manufacture of active ingredients for leading penicillin products
     
  • Kundl manufacturing site in Austria is hub of last vertically integrated antibiotics production chain in Europe; Sandoz is #1 global supplier of generic antibiotics …
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New Novartis analysis shows wet AMD patients achieved sustained fluid control faster with Beovu® versus aflibercept

  • A post-hoc analysis of the HAWK and HARRIER trials presented at ASRS showed >=50% of patients achieved sustained retinal dryness by weeks 8 and 4 with Beovu and by weeks 12 and 8 with aflibercept, respectively1
     
  • The analysis also showed >=75% of patients reached sustained dryness by weeks 32 and 20 with Beovu and by weeks 56 and 52 with aflibercept in HAWK and HARRIER, respectively1
     
  • Retinal fluid is a key sign of wet AMD disease activity and drying the retina is a core aim of treatment2 …
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Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease

  • If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe

  • CHMP opinion supported by data showing Adakveo significantly reduced the rate of vaso-occlusive crises, with patients on Adakveo spending fewer days in hospital

  • Vaso-occlusive crises are sudden, unpredictable, and associated with an increased risk of organ damage and mortality1

Basel, July 24, 2020 — Novartis announced today that the Committee for Medicinal …

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Expanding CAR-T manufacturing in Europe to serve more patients

As we continue to expand our manufacturing capacity for transformative CAR-T cell therapy (Chimeric Antigen Receptor T-cell therapy), the European Medicines Agency (EMA) recently approved two European sites for commercial manufacturing. The sites located in Les Ulis, France, and Stein, Switzerland, will now support the supply of CAR-T cell therapy for patients in both commercial and clinical settings. This adds to the commercial capacity that already exists in our global network.

Commitment to patients

At Novartis, we are committed to serving advanced blood cancer patients …

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Breaking a vicious cycle of inflammation

In response to dry soil, a sensor in a garden triggers a sprinkler to deliver a shower of rain. Disaster strikes, though, if the sensor gets stuck in the “on” position. The shower turns into a stalled storm that floods the garden.

A similar problem can occur in the body. Immune cells contain danger sensors. They respond to danger with a sprinkling of signals that trigger healing inflammation. But if the danger sensor gets stuck on, the result is chronic inflammation that can cause more damage than good.

Novartis researchers aim to break this pattern by silencing part of the …

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Novartis announces Phase III study of Jakavi® in chronic graft-versus-host disease met primary and key secondary endpoints

  • Jakavi® demonstrated superior overall response rate in patients with chronic graft-versus-host disease (GvHD) compared to best available therapy, building on previous positive findings in acute GvHD1
     
  • Study also met key secondary endpoints, significantly improving failure-free survival and patient-reported symptoms1
     
  • GvHD is a serious and common complication of stem cell transplants with no widely approved treatment options for patients who do not respond to steroids2,3 …
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Helping clinical trial patients during a lockdown

Streets were empty in Wuhan, China. Transportation was suspended, travel restricted and social contacts reduced to a minimum. Hospitals postponed surgeries and limited routine care. While the world’s attention was focused on those infected with COVID-19 in the city earlier this year, other patients struggled to get the treatment they needed.

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Novartis delivered strong H1 performance. FY 2020 guidance confirmed at higher end for core operating income and lower end for sales.

  • Due to COVID-19 first half results are more representative of underlying performance than Q2, sales growth of 6%  (cc1, +3% USD) and core¹ operating income growth of 19% (cc, +14% USD):
    • Innovative Medicines grew sales 7% (cc, +5% USD) and core operating income 16% (cc, +11% USD)
    • Sandoz grew sales 1% (cc, -2% USD) and core operating income 26% (cc, +19% USD)
  • Net sales in Q2 from continuing operations2 declined 1% (cc, -4% USD) largely reversing forward purchasing from Q1:
    • Key …
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