Cancer didn’t stop for COVID-19

Throughout Myriam Mendila’s life, cancer has been ever-present. When she was only 8 years old, breast cancer took her mother. Later, her sister was diagnosed with the disease, and Mendila watched dear friends weather cancer odysseys of their own.

Witnessing the enduring impact of the disease is what inspired Mendila – now Chief Medical Officer and Global Head of Medical Affairs at Novartis Oncology – to dedicate her professional life to helping find potential treatments for people with cancer. It’s also what made her well aware that, while so much of the world stopped for COVID-19, …

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Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU

  • European Commission approves once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1*
     
  • Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions also covered by EC approval
     
  • Approval based on robust …
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Novartis resolves legacy litigation matters, finalizing settlement of speaker program litigation with Government in the US and positioning company for the future by fully scaling its next-generation digital engagement technologies

  • Company finalizes USD 678 million settlement relating to suit challenging speaker programs and other promotional events conducted from 2002 through 2011 in the US as well as USD 51.25 million related to the company’s support of certain independent charitable co-pay foundations from 2010 to 2014
  • As part of these settlements, Novartis has agreed to new corporate integrity obligations in the US through 2025
  • Novartis embarks on new approach to meet the educational needs of physicians by setting new standard through digitally enabled education programs …
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Sandoz reviewing options after Federal Circuit upholds lower court ruling in biosimilar Erelzi® case

  • Sandoz evaluating next steps, including potential appeal to US Supreme Court
     
  • Ruling continues to prevent launch of important, affordable treatment option for US patients affected by chronic autoimmune and inflammatory diseases
     
  • Sandoz remains deeply committed to making Erelzi available to US patients as soon as possible, contributing to a more sustainable healthcare system

Holzkirchen, Germany, July 1, 2020 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US …

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Novartis announces MET inhibitor Tabrecta™ approved in Japan for advanced non-small cell lung cancer with METex14

  • Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METex14) respectively
     
  • Lung cancer is the most common type of cancer in Japan and approximately 3,000 patients are diagnosed with METex14 metastatic NSCLC, a particularly aggressive form of the disease, in Japan each year1-2
     
  • Japan follows US approval earlier this year and demonstrates the company’s commitment to reimagining medicine for lung cancer …
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Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options

Basel, June 29, 2020 — Novartis Pharma K.K. (“Novartis Pharma”) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) simultaneously approved five new treatment options for Japanese patients:

  • Tabrecta™ (capmatinib, formerly INC280), an oral MET inhibitor for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC),
  • Entresto® (sacubitril valsartan sodium hydrate) in chronic heart failure,
  • Mayzent® (siponimod fumaric acid …
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Novartis Cosentyx® gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile

  • EMA CHMP positive opinion paves way for Cosentyx® to become a first-line systemic treatment in pediatric psoriasis
     
  • CHMP opinion based on two Phase III studies showing Cosentyx provides fast and strong skin clearance and significant improvement in quality of life1
     
  • Moderate-to-severe psoriasis affects more than 350,000 children worldwide2, with the physical and psychological burden disrupting important formative years3
     
  • Potential new indication reinforces Cosentyx …
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Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps

  • If approved, Xolair® (omalizumab) will provide patients who have severe chronic rhinosinusitis with nasal polyps, not adequately controlled by intranasal corticosteroids, with the first anti-immunoglobulin E (IgE) antibody specifically designed to target and block IgE, a key driver in the inflammatory pathway
     
  • Decision based on results from the Phase III POLYP 1 and 2 studies, in which omalizumab* significantly reduced the size of nasal polyps (defined by Nasal Polyp Score) and improved nasal congestion (defined by Nasal Congestion Score …
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Novartis Resolves Legacy FCPA Investigations

Basel, June 25, 2020 – Novartis has reached settlements with the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) resolving all Foreign Corrupt Practices Act (FCPA) investigations into historical conduct by the Company and its subsidiaries. As part of the settlements, Novartis and certain of its current and former subsidiaries will pay USD 233.9 million to the DOJ and USD 112.8 million to the SEC.

To resolve the DOJ investigation, Novartis Hellas S.A.C.I. has entered into a deferred prosecution agreement (“Novartis Hellas DPA …

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Novartis announces winners of the Innovation Prize for Assistive Tech, rewarding new technologies that could improve mobility and independence of people living with multiple sclerosis

  • The Novartis Innovation Prize: Assistive Tech for Multiple Sclerosis (MS) was initiated in 2019 as part of a commitment to innovation in Neuroscience to identify and encourage technology ideas from all over the world with the aim to improve mobility, accessibility and daily life for people living with MS
     
  • Canadian company AccessNow receives the first prize worth USD 250,000 for a mobile app and web platform that provides information about the accessibility status for people with disabilities of locations around the world, …
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