Moving from speculation to science during a pandemic

It was the early ’90s, and a medical student in Caracas, Venezuela, named Florencia Segal was attending rounds at a state hospital as part of her training. She was struck by the number of patients with opportunistic infections due to acquired immunodeficiency syndrome (AIDS) and the grim picture that they faced. There were no effective therapies available to treat the roots of their disease.

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It takes an R&D village to fight a pandemic

Gervais Tougas never thought he’d have to face this again. In 2003, while serving as a division head in one of McMaster University’s teaching hospitals, a SARS outbreak in nearby Toronto, Canada tossed his organization into uncharted waters. Like its coronavirus cousin, COVID-19, SARS posed an imminent, deadly threat to public health. To ensure the safety of the hospital and the surrounding community, the entire organization had to pivot from its usual medical practice and prepare itself to weather the outbreak.

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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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