US FDA approves updated Novartis Beovu® label, to include additional safety information

  • Novartis worked with US Food and Drug Administration (FDA) to update Beovu (brolucizumab) prescribing information to guide healthcare professionals in their treatment of wet AMD patients1
     
  • The update includes characterization of adverse events, retinal vasculitis and retinal vascular occlusion, as part of the spectrum of intraocular inflammation observed in the HAWK & HARRIER trials and noted in the original prescribing information1
     
  • Novartis has convened a fully dedicated team collaborating with …
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Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma

  • Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life in people with uncontrolled asthma1.
  • Among secondary analyses, improvements in lung function, asthma control, health status, and a reduction in moderate exacerbations were observed with once-daily high-dose IND/GLY/MF compared to a free combination of high-dose Sal/Flu plus Tio1. …
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Novartis PREVENT data show Cosentyx® helps patients realize early and lasting relief in axial spondyloarthritis

  • Phase III PREVENT data show Cosentyx® 150 mg provided significant and sustained improvement in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) up to Week 521
     
  • nr-axSpA is the fourth EU indication for Cosentyx, providing patients in Europe with a first-in-class treatment that addresses the axial spondyloarthritis (axSpA) disease spectrum
     
  • There are approximately 1.7 million patients with nr-axSpA in the top five EU countries and US2
     
  • PREVENT is …
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Sandoz launches once-daily generic tacrolimus for transplant patients in Europe
  • Sandoz is first and only company offering complete range of dosing options in several European markets*, with 2 mg capsule allowing for fine dose titration
  • Sandoz 2 mg slow-release capsule offers simplified once-daily treatment protocol that may reduce a patient’s daily pill burden1
  • Launch builds on Sandoz experience with Adoport® — #1 twice-daily generic tacrolimus in Europe2

Holzkirchen, June 4, 2020 – Sandoz today announced the launch of once-daily generic tacrolimus capsules known as Dailiport® in …

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Pride @ Novartis 2020 – inspired to make a difference

We each have a story to tell.  A community that contributes to who we are today.  Heroes who hold us up in the face of challenges.

Our stories are what make us exceptional – they inspire those around us but also future generations.  At Novartis, we want to build an inclusive environment that values each of our unique stories, because it’s our differences that enable our global impact.  Our shared stories offer new ways of seeing the world that can help us to reimagine medicine for people everywhere.

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Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

Basel, June 2, 2020 —  Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020.

“Novartis will continue to work with the FDA to complete the review as soon as possible,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “We are well prepared …

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European Patient Innovation Summit publishes call for action to ensure greater patient involvement in digital health solution development

A new ‘Call to Action’ has been published by the European Patient Innovation Summit (EPIS) Steering Committee, calling for multiple stakeholders to ensure patients have a voice in the future of digital health solution development.

It will take the united efforts of all stakeholders to ensure the patient voice is stronger in digital health solution development,

Patrick Little, European Migraine & Headache Alliance (EMHA), Ireland

The new call to action challenges all parties involved in the …

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Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery

  • More than half of patients with BRAF-mutated advanced melanoma taking Tafinlar + Mekinist were alive and free of a relapse at 5-years1
     
  • Study conclusions are drawn from the largest dataset and longest follow-up to date of patients with BRAF-mutated melanoma treated with targeted therapy following the surgical removal of their cancer1,2
     
  • Data are from the five-year follow-up of the COMBI-AD trial presented at the ASCO20 Virtual Scientific Program1

Basel, May 29, 2020 …

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Novartis Piqray® receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation

  • Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast cancer patients whose tumors harbor a PIK3CA mutation in Europe
     
  • Phase III trial showed Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. 5.7 months) in this patient population, compared to fulvestrant alone
     
  • PIK3CA mutations affect approximately 40% of HR+/HER2- advanced breast cancer patients and are linked to cancer growth and a poorer disease prognosis in the metastatic setting

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Novartis data highlight benefit of early treatment initiation in patients with secondary progressive multiple sclerosis (SPMS)

  • Novartis presented a total of 34 abstracts at the Congress of the European Academy of Neurology (EAN), emphasizing its strong multiple sclerosis (MS) portfolio with 20 abstracts
  • Long-term efficacy data from EXPAND, previously presented at the American Association of Neurology Congress, show patients with SPMS continuously treated with Mayzent® (siponimod) experienced a sustained effect in delaying disability for up to 5 years, demonstrating the advantages of early treatment1
     
  • These …
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