Positive survival data for Novartis investigational radioligand therapy 177Lu-PSMA-617 published in The New England Journal of Medicine

  • VISION manuscript shows that 177Lu-PSMA-617 plus standard of care (SOC) significantly improved overall survival and radiographic progression-free survival for patients with metastatic castration-resistant prostate cancer (mCRPC) compared to SOC alone1
  • US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to 177Lu-PSMA-617; regulatory submissions to US and EU Health Authorities on track for 2H21
  • Novartis is a …
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Novartis and Hewlett Packard Enterprise join forces to advance Novartis global health efforts

  • Novartis is collaborating with Hewlett Packard Enterprise to accelerate the use of data and digital technologies within its efforts to reimagine global health and improve access to healthcare and medicines.
  • The collaboration will focus on three global health enablers: identifying and integrating complex data sources related to health; advancing the application of artificial intelligence, machine learning and geo-spatial analytics to these data; and expanding access to technology in remote and underserved locations.
  • The first use …
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Kesimpta® (ofatumumab) data show long-term preservation of IgG/IgM levels and no increased risk of serious infections in people living with multiple sclerosis

  • New ALITHIOS data show mean immunoglobulin G (IgG) levels in people treated with Kesimpta remained unchanged over 3.5 years and mean immunoglobulin M (IgM) levels remained within the reference range1 
  • Lower serum immunoglobulin levels, known to occur with other anti-CD20 therapies in MS patients, have been linked to an increased risk of infection, while immunoglobulin data with Kesimpta showed no association with risk of serious infections1, 2, 3 
  • Data …
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The search for new options for patients with lung cancer

“She was the picture of health,” recalls Andrea Myers, a cancer physician and scientist at Novartis. Seven years ago, Myers’ young and fit former medical school classmate was diagnosed – inexplicably – with lung cancer. She died two years later. 

A lung cancer diagnosis often comes as a shock. The disease tends to progress silently, with few symptoms. For most people it is not discovered until it has already advanced. At this point, the disease is very difficult to treat. Fewer than 20% of patients survive more than five years.

Innovative medicines have helped, but lung cancer …

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Discover how inflammation could fan the flames of cancer

Your body has a built-in sensor that self-assembles inside cells in response to a threat. This danger-sensing system is a large piece of cellular machinery, but until 20 years ago, no one knew it existed.

Today, however, scientists have learned that this system can get stuck in the “on” position. When it does, it could fuel the flames of diseases such as cancer. 

What if we could inhibit an overactive danger-sensing system? Medicines that target this system have the potential to help stop damaging …

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New Zolgensma data demonstrate age-appropriate development when used presymptomatically and rapid, clinically meaningful efficacy in symptomatic children, even those with severe SMA at baseline

  • All children (100%) treated presymptomatically in the SPR1NT two-copy cohort survived without respiratory or nutritional support, and sat independently for ≥30 seconds, most (11/14) within the WHO window of expected normal development
  • The majority of children (82%) treated in STR1VE-EU achieved developmental motor milestones not observed in the natural history of SMA Type 1, including patients with more severe disease
  • More than 1,200 patients have now been treated with Zolgensma globally across …
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Novartis receives FDA Breakthrough Therapy designation for investigational 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC)

Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to 177Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC).  Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy1.

  • Breakthrough therapy designation granted based on positive data from the pivotal, Phase III VISION …
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Novartis investigational oral therapy iptacopan (LNP023) shows benefit as monotherapy in treatment-naïve patients with rare and life-threatening blood disorder paroxysmal nocturnal hemoglobinuria

  • First-in-class, oral, targeted factor B inhibitor iptacopan substantially reduced both intra- and extravascular hemolysis when given as monotherapy in a Phase II study of anti-C5 naïve paroxysmal nocturnal hemoglobinuria (PNH) patients1

  • New results are promising for potential use of iptacopan as monotherapy in PNH, a rare and life-threatening blood disorder2,3; results from a previous Phase II study showed iptacopan substantially improved hematological response as add-on to standard-of-care (eculizumab …
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Novartis Entresto® indicated for treatment of hypertension in China

Novartis today announced that Entresto® (sacubitril/valsartan) has received a new indication in China for the treatment of patients with essential hypertension, a disease affecting approximately 245 million adults in the country1. This National Medical Products Administration (NMPA) decision follows the 2017 approval of Entresto for the treatment of heart failure with reduced ejection fraction (HFrEF). 

  • The prevalence of hypertension in China is expected to rise to approximately 300 million2 by 2025 with control rates generally lower than in other parts of …
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Novartis announces new interim analysis Phase II data for iptacopan in rare kidney disease C3 glomerulopathy (C3G)

  • Data shows investigational iptacopan improved estimated glomerular filtration rate (eGFR) slope and stabilized kidney function in patients with C3G1; Phase III clinical trial to start in 2021
  • Results add to body of information on iptacopan, with previous interim analysis data from same trial showing significant reduction in proteinuria, improved plasma C3 levels, and favorable safety and tolerability profile over 12 weeks2
  • There …
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