Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma

  • If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
  • The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma
  • US regulatory filing for Kymriah in r/r follicular lymphoma anticipated in 2021 

Basel, April 22, 2020 — Novartis today announced that the US Food and Drug …

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Novartis announces new Mayzent® (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis (SPMS)

  • New long-term data from EXPAND show patients with SPMS continuously treated with Mayzent® (siponimod) experienced lower risk of disability progression and cognitive decline than patients who delayed Mayzent treatment1
     
  • Separate post-hoc analysis from EXPAND demonstrated Mayzent reduced cortical grey matter (cGM) and thalamic atrophy in patients with SPMS2, outcomes associated with long-term irreversible disability accumulation3
     
  • Mayzent is the first and only oral disease modifying …
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Novartis announces new Mayzent® (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis (SPMS)

  • New long-term data from EXPAND show patients with SPMS continuously treated with Mayzent® (siponimod) experienced lower risk of disability progression and cognitive decline than patients who delayed Mayzent treatment1
     
  • Separate post-hoc analysis from EXPAND demonstrated Mayzent reduced cortical grey matter (cGM) and thalamic atrophy in patients with SPMS2, outcomes associated with long-term irreversible disability accumulation3
     
  • Mayzent is the first and only oral disease modifying …
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World Malaria Day 2020

This public health crisis highlights the importance of robust health systems to respond to outbreaks like COVID-19 and to control other deadly diseases such as malaria. On World Malaria Day, April 25, we are calling on the global health community to uphold progress and commitments made in the fight to end malaria.

Follow us on social media at #MalariaFuture

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Going the extra mile to keep clinical trials on track during the COVID-19 pandemic

Sofia* has breast cancer. Each month she travels from her home in Eastern Europe to a hospital in northern Italy to participate in a clinical trial. Traveling such distances for a clinical trial is uncommon, but Sofia was eager to participate in this particular trial for her condition.

But everything changed when the coronavirus (COVID-19) took hold on the continent. With transport links rapidly shutting down due to the pandemic, Sofia was no longer able to make the trip to Italy. With only two weeks’ worth of medication remaining and very little prospect of being able to obtain any …

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Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalized COVID-19 patients

  • Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial of hydroxychloroquine in hospitalized patients with COVID-19 disease

  • Trial is designed and implemented quickly to address the need for science-based investigation following early preclinical and clinical evidence1,2,3 that hydroxychloroquine may help hospitalized patients with COVID-19 disease 
     
  • Company will also make its hydroxychloroquine intellectual property available to support broad access if …
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Novartis acquires Amblyotech, pursuing novel digital therapy for children and adult patients with “lazy eye”

  • Technology has potential to reimagine treatment for amblyopia (“lazy eye”), a leading cause of vision loss in children and young adults1

  • Acquisition expands the Novartis refractive disorder pipeline in ophthalmology

  • Novartis will work with Ubisoft and McGill University to accelerate product development to enable faster uptake for patients—PoC studies planned later in 2020 

Basel, April 20, 2020 — Novartis announced today that it has completed the acquisition of Amblyotech, a US-based …

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Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalized COVID-19 patients

  • Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial of hydroxychloroquine in hospitalized patients with COVID-19 disease

     

  • Trial is designed and implemented quickly to address the need for science-based investigation following early preclinical and clinical evidence1,2,3 that hydroxychloroquine may help hospitalized patients with COVID-19 disease 
     
  • Company will also make its hydroxychloroquine intellectual property available to support broad access if …
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Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalized COVID-19 patients

  • Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial of hydroxychloroquine in hospitalized patients with COVID-19 disease

     

  • Trial is designed and implemented quickly to address the need for science-based investigation following early preclinical and clinical evidence1,2,3 that hydroxychloroquine may help hospitalized patients with COVID-19 disease 
     
  • Company will also make its hydroxychloroquine intellectual property available to support broad access if …
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Novartis joins the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative

Novartis is teaming up with R&D leaders throughout the industry as part of the National Institutes of Health (NIH) and the Foundation for NIH (FNIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership initiative. Collaboration and open innovation are essential elements of the fight against this global pandemic. Novartis is committed to doing our part as an active contributor to the global effort underway to combat COVID-19.

About ACTIV

The National Institutes of Health and the Foundation for the NIH are bringing together more than a dozen …

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