Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma

  • Global ELARA trial demonstrated clinically meaningful benefit in patients with relapsed or refractory (r/r) follicular lymphoma (FL) as measured by complete response rate
     
  • Kymriah previously received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in r/r FL based on preliminary ELARA trial findings, reflecting the unmet need for additional treatment options for this cancer type
     
  • ELARA trial findings will be included in regulatory submissions, with filing in the US anticipated in 2021, and the EU following. Results will be …
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Novartis Cosentyx® receives EU approval for first-line systemic treatment in pediatric psoriasis

  • EU approval is based on two Phase III studies showing Cosentyx® provides fast and strong skin clearance, along with significant improvement in quality of life and a favorable safety profile1
     
  • Moderate-to-severe psoriasis affects more than 350,000 children worldwide2, with the physical and psychological burden disrupting important formative years3
     
  • Cosentyx is a proven brand, supported by long-term five-year sustained efficacy and safety data across psoriasis, psoriatic arthritis ( …
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Collaborating to explore new gene regulation therapies

Novartis has entered into a research and development collaboration with Sangamo Therapeutics to explore potential gene regulation therapies for neurodevelopmental diseases. Proprietary technology platforms from both companies will be harnessed to facilitate progress toward potentially transformative treatments for life-long, debilitating conditions.

Sangamo is renowned for work on zinc finger proteins, which may be engineered to target select DNA sequences and switch specific genes on or off through the modulation of transcription. Novartis has deep experience with adeno-associated …

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Choice with Responsibility: Reimagining how we work

At Novartis, our people are our most valuable resource. We want everyone to feel able to be their best selves at work and at home, and we are committed to supporting and enabling them to be inspired, curious and unbossed. The global pandemic has accelerated our organizational need to explore new working models and our associates have expressed a strong desire for more flexibility in how, where and when they work. We believe we can create a future working model that optimizes both personal and business performance. Our journey toward that model is what we call Choice with Responsibility. …

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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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