Novartis Gene Therapies Recommits to Global Managed Access Program for 2021

Dear SMA community,

One year ago we launched a global Managed Access Program (MAP), the first for a one-time gene therapy, to make Zolgensma® (onasemnogene abeparvovec) available to eligible patients with spinal muscular atrophy (SMA) who are under the age of two in countries where Zolgensma has not received regulatory approval. Today we are pleased to share that we allocated 100 doses free-of-charge in 2020, and …

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Novartis ligelizumab (QGE031) receives FDA Breakthrough Therapy designation for patients with chronic spontaneous urticaria (CSU)

  • Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria (CSU) in patients with an inadequate response to H1-antihistamines1
     
  • Currently there are limited approved therapies for patients with CSU, also known as chronic idiopathic urticaria (CIU)
     
  • Breakthrough Therapy designation suggests ligelizumab has the potential to provide a substantial benefit over existing available treatments
     
  • U.S. regulatory filing in CSU is anticipated in 2022 …
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Novartis expands Oncology pipeline with in-licensing of tislelizumab from BeiGene

  • Agreement expands Novartis Oncology portfolio, adding late-stage PD-1 for monotherapy and potential proprietary PD-1 combinations, driving mid- and long-term growth

  • Novartis secures development and commercialization rights in North America, Europe, and Japan

  • Accelerates Novartis immuno-oncology combination strategy with multiple potential tislelizumab plus Novartis therapy combinations

  • Tislelizumab already approved for patients with classical Hodgkin’s lymphoma and metastatic urothelial …
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Turning the sound up on patient voices in lung cancer research and development

For Pierre-Alexis Ruffié, managing clinical trials at Novartis is personal. “I don’t usually share this, but I was a cancer patient when I was younger. I had surgery and chemotherapy, so I know how it feels to be on the other side,” says Ruffié, who serves as Associate Global Trial Director in Oncology at Novartis. “You’re always wondering, ‘What are they going to find? Is it going to be worse?’ My own experience makes me pay close attention to the feelings and experiences of the people participating in our trials.”

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AI Nurse evolving for health failure patients in China

Dozens of improved versions of our new digital platform for heart failure disease management in China have been developed since roll-out a few months ago.

Why? Because the digital product team in Novartis China has quickly learned from user feedback – evolved its approach to Health Care Professionals (HCPs) – and rapidly developed product enhancements.

Realizing the onboarding experience for patients was too complicated in a busy hospital environment – and patients were struggling to manage their condition in lockdown during the COVID-19 pandemic, the AI Nurse …

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