Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

  • FDA Priority Review for capmatinib based on Phase II data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC)1
     
  • Substantial unmet need exists among patients with METex14 mutated advanced NSCLC as there are no treatment options approved to specifically target this aggressive form of lung cancer
     
  • Capmatinib review expected to be completed within six months

Basel, February 11, 2020 — Novartis announced …

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AVXS-101 Managed Access Program

Statement

Feb 05, 2020

We are aware of the recent Ministry of Health (MoH) announcement, that five EU states (Belgium, the Netherlands, Luxembourg, Austria and Ireland) have issued a joint statement regarding our Global Managed Access Program (MAP). 
 
In December, we announced a global MAP to make AVXS-101 available to eligible patients in countries where it is not approved by regulatory authorities. We collaborated with an independent bioethics advisory committee, including a range of experts including clinicians, bioethicists, patient …

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World Cancer Day 2020

World Cancer Day is an international day marked on February 4 to raise awareness of cancer and to encourage its prevention, detection, and treatment. Cancer is the leading cause of disease-related death among working-age adults in high-income and middle-income countries.

This World Cancer Day, we’re shining a light on our commitment to our employees impacted by cancer. We are reimagining cancer in the workplace through the global program ‘Ensemble – Caring for colleagues’ with oncology experts and human resources personel, who serve as internal volunteers.

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Reimagining cancer in the workplace

“You have cancer.”

These three words have the power to alter the course of one’s life – whether they’re receiving the news, or divulging the information to a loved one. A cancer diagnosis can be difficult to process, and for many, the diagnosis and corresponding treatment plan will not be the sole consideration.

Cancer affects, and claims the lives of, people at a younger age than any other highly prevalent chronic disease – often while they are in the midst of their careers, supporting their families, raising children, and building toward their dreams and aspirations in life. …

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Sandoz completes acquisition of Aspen’s Japanese operations, strengthening its position in world’s third largest market for generics and off-patent medicines

  • Successful acquisition of Aspen’s Japanese operations and assets reinforces strategic focus on Japan, world’s third largest market for generics and off-patent medicines
  • Acquired portfolio complements existing Sandoz portfolio and consists primarily of off-patent branded medicines with focus on anaesthetics and specialty brands
  • Transaction enables Sandoz to increase portfolio and pipeline offerings in hospital setting, expanding number of patients who can gain access to these important medicines  

Holzkirchen, …

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Novartis Cosentyx® builds on its axSpA leadership with US label update for dosing flexibility in ankylosing spondylitis

  • New Cosentyx® (secukinumab) US label to include 300 mg up-titration option is based on Phase III MEASURE 3 study results in ankylosing spondylitis (AS)1
     
  • Label update provides clinicians with greater choice for their patients, based on clinical response to treatment
     
  • Novartis has submitted to FDA and EMA for approval in non-radiographic axial spondyloarthritis (nr-axSpA)2,3; potentially providing patients with a treatment that addresses the axSpA disease spectrum
     

    • …

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Novartis 2019 Financial Results

Download the media release
English (PDF 0.1 MB )  |  Deutsch (PDF 0.1 MB)  |  Français (PDF 0.1 MB)

Condensed financial report (PDF 0.7 MB) …

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Novartis delivered strong sales growth, margin expansion and breakthrough innovation launching five NMEs in 2019

  • Full year net sales for continuing operations1 up 9% (cc2, +6% USD):
    • Pharmaceuticals BU growing 12% (cc) driven by Cosentyx USD 3.6 billion (+28% cc), Entresto USD 1.7 billion (+71% cc) and Zolgensma USD 361 million
    • Oncology BU growing 10% (cc) driven by Promacta/Revolade USD 1.4 billion (+23% cc), Kisqali USD 0.5 billion (+111% cc) and Lutathera USD 0.4 billion (+160% cc)
    • Sandoz sales grew 2% (cc, -1% USD) driven by Biopharmaceuticals …
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Novartis at the World Economic Forum Annual Meeting Davos 2020

Planting a Better Future

Novartis CEO Vas Narasimhan moderated a panel of some of the youngest leaders to discuss which actions should leaders prioritize to secure prosperity for the next generation.

Watch the session

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Novartis announces EU approval of Mayzent® (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease

  • Mayzent® (siponimod) is the first and only oral treatment specifically indicated for patients with secondary progressive multiple sclerosis (SPMS) with active disease in Europe1
     
  • Mayzent addresses an unmet need for SPMS patients with active disease who, until now, did not have an oral treatment that has been shown to be effective in delaying progression in this patient population
     
  • Approval is based on the Phase III EXPAND trial, the largest randomized clinical study in a broad range of SPMS patients, …
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