Novartis announces NEJM publication of positive Phase III REACH3 data for Jakavi in chronic GvHD

  • REACH3 data show Jakavi significantly improved overall response rate (ORR) at week 24 (49.7% vs. 25.6%) with a higher best overall response rate (76.4% vs. 60.4%) vs. best available therapy, among steroid-refractory/dependent chronic graft-versus-host disease (GvHD) patients1

  • Additional new subgroup analysis demonstrated higher ORR for Jakavi-treated patients regardless of the individual organs involved at baseline1
  • Chronic GvHD, a life-threatening disease and long-term complication …
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Novartis announces Complete Response Resubmission for inclisiran New Drug Application

Novartis today announced the Complete Response resubmission to the US Food and Drug Administration (FDA) for the inclisiran New Drug Application (NDA). Novartis is listing its own site in Schaftenau, Austria, as the manufacturing location for the final finished product within the resubmission.

  • The inclisiran Complete Response resubmission addresses the FDA Complete Response Letter (CRL) issued in December 2020, stating unresolved facility inspection-related conditions at a third-party manufacturing facility. The FDA did not raise any concerns related to the efficacy or safety of …
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Novartis appoints Rob Kowalski as Chief People & Organization Officer

Basel, June 28, 2021 — Novartis announced today the appointment of Rob Kowalski, Pharm.D., Global Head Regulatory Affairs and US Head of Drug Development as Chief People & Organization Officer. He will report to Vas Narasimhan, M.D., CEO of Novartis and become a member of the Executive Committee of Novartis (ECN), effective September 1, 2021.

Steven Baert, currently Chief People & Organization Officer, will step down from the Executive Committee of Novartis, effective June 30, 2021 after 15 years with the company and almost 8 years in position. Vicki …

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Sandoz announces EU launch of ready-to-dilute generic Pemetrexed to treat most prevalent form of lung cancer

  • Pemetrexed is indicated for patients with non-squamous Non-Small Cell Lung Cancer (NSCLC), who represent over 3 in 4 patients with lung cancer1

  • New ready-to-dilute format and 1,000 mg strength option helps avoid unnecessary handling steps to reduce associated contamination risks and patient waiting times2

  • The Pemetrexed launch will expand the Sandoz hospital portfolio in key European markets, strengthening access to treatment …
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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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