Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14


 

  • Tabrecta (capmatinib, formerly INC280) is the first and only therapy approved by the FDA to specifically target metastatic NSCLC with a mutation that leads to MET exon 14 skipping (METex14)1 
  • ~4,000-5,000 patients are diagnosed with METex14 metastatic NSCLC each year in the US and may face poor prognosis due to presence of the mutation2-3
     
  • Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated METex14 patients, …
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Clinical trial comes together in weeks to address coronavirus

Members of the global research community have joined forces in unconventional configurations to defeat the COVID-19 pandemic. And they’re working faster than ever before to find solutions.

A new clinical trial illustrates how quickly teams are assembling across industry, academia and government to meet patients’ needs. Planning for the large, Novartis-sponsored trial – which will evaluate the use of hydroxychloroquine for the treatment of …

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Novartis receives CHMP positive opinion for Enerzair® Breezhaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma

  • CHMP positive opinion advances efforts to provide first-in-class LABA/LAMA/ICS combination for patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment in the EU.
     
  • Digital companion with app and sensor that provide inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions also covered by positive opinion for Enerzair® Breezhaler® (QVM149; IND/GLY/MF).
     
  • Decision supported by robust efficacy and safety …
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AI Nurse set to transform standards of care for heart failure patients in China

A fast-paced Novartis joint development project with one of the world’s largest technology companies has created an innovative, AI-enabled digital nurse to support heart failure patients in China.

Co-developed with China’s internet multinational Tencent, together with leading Chinese medical organizations, AI Nurse launched on April 30 and will serve as a patient needs-led intelligent platform supporting patients, physicians and nurses to better manage heart disease.

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Novartis Cosentyx® gains fourth indication in EU with first-in-class approval in axial spondyloarthritis spectrum

  • Cosentyx® is the first fully-human IL-17A inhibitor indicated for patients in Europe with non-radiographic axial spondyloarthritis (nr-axSpA), which forms part of the axial spondyloarthritis (axSpA) disease spectrum
     
  • There are approximately 1.7 million patients with nr-axSpA in the top five EU countries and US1
     
  • Cosentyx is also approved for the treatment of moderate-to-severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)2-4
      …
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Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia

Novartis today announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia. CRS could lead to life-threatening complications in patients with COVID-191-3.

The study builds on early evidence from lab tests of COVID-19 patients who showed elevated IL-1β levels, among other cytokines2,4.

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Novartis maintains strong operational performance in Q1, confirms FY 2020 guidance at this time, and advances a broad range of efforts to support the global response to COVID-19

  •   Q1 2020 net sales from continuing operations1 grew 13% (cc2, +11% USD) with double digit growth (cc) in Innovative Medicines and Sandoz:
    • Key growth drivers include Entresto USD 569 million (+62% cc), Zolgensma USD 170 million, Cosentyx USD 930 million (+19% cc), Kisqali USD 161 million (+82% cc) and Piqray USD 74 million
    • Biopharmaceuticals grew 31% (cc) to USD 450 million, with strong growth in Europe
    • Excluding COVID-19 related forward purchases, we estimate3 sales …
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Novartis maintains strong operational performance in Q1, confirms FY 2020 guidance at this time, and advances a broad range of efforts to support the global response to COVID-19

  • Q1 2020 net sales from continuing operations1 grew 13% (cc2, +11% USD) with double digit growth (cc) in Innovative Medicines and Sandoz:
    • Key growth drivers include Entresto USD 569 million (+62% cc), Zolgensma USD 170 million, Cosentyx USD 930 million (+19% cc), Kisqali USD 161 million (+82% cc) and Piqray USD 74 million
    • Biopharmaceuticals grew 31% (cc) to USD 450 million, with strong growth in Europe
    • Excluding COVID-19 related forward purchases, we estimate3 sales …
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Novartis maintains strong operational performance in Q1, confirms FY 2020 guidance at this time, and advances a broad range of efforts to support the global response to COVID-19

  • Q1 2020 net sales from continuing operations1 grew 13% (cc2, +11% USD) with double digit growth (cc) in Innovative Medicines and Sandoz:
    • Key growth drivers include Entresto USD 569 million (+62% cc), Zolgensma USD 170 million, Cosentyx USD 930 million (+19% cc), Kisqali USD 161 million (+82% cc) and Piqray USD 74 million
    • Biopharmaceuticals grew 31% (cc) to USD 450 million, with strong growth in Europe
    • Excluding COVID-19 related forward purchases, we estimate3 sales …
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