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Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab

Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab
arcticnovartis

  • Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data
  • Breast and gastric cancers are among most common types of cancer, accounting together for nearly half a million new cases every year in Europe alone1,2
  • Sandoz is committed to accelerating access to potentially life-changing treatments and continues to strengthen its oncology and supportive care portfolio

Basel, September 18, 2023 —

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Aktionärinnen und Aktionäre von Novartis stimmen dem geplanten 100% igen Spin-off von Sandoz zu

Aktionärinnen und Aktionäre von Novartis stimmen dem geplanten 100% igen Spin-off von Sandoz zu
arcticnovartis

  • Die Aktionärinnen und Aktionäre stimmen dem geplanten 100%igen Spin-off von Sandoz, dem Generika- und Biosimilars-Geschäft von Novartis, zu.
  • Die Aktionärinnen und Aktionäre stimmen ausserdem einer Herabsetzung des Aktienkapitals im Zusammenhang mit dem Spin-off zu.
  • Die Aktionärinnen und Aktionäre von Novartis und Inhaberinnen und Inhaber der Novartis ADR erhalten durch die Ausschüttung einer Sachdividende eine Sandoz Aktie für jeweils fünf Novartis Aktien oder ein Sandoz ADR für jeweils fünf Novartis ADRs.
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Novartis to present broad range of portfolio data at ECTRIMS, reinforcing long-standing commitment to people living with multiple sclerosis
  • Novartis will present 41 abstracts from a wide-ranging multiple sclerosis (MS) portfolio, including new data on Kesimpta® (ofatumumab) and Mayzent® (siponimod)

  • Novartis will be commencing Phase III pivotal trials investigating remibrutinib in RMS. Remibrutinib is a highly selective, potent oral BTK inhibitor with a potential best-in-class profile1
  • Late-breaking safety data will be presented, including outcomes of COVID-19 in relapsing forms of …
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Novartis to present broad range of portfolio data at ECTRIMS, reinforcing long-standing commitment to people living with multiple sclerosis
  • Novartis will present 41 abstracts from a wide-ranging multiple sclerosis (MS) portfolio, including new data on Kesimpta® (ofatumumab) and Mayzent® (siponimod)

  • Novartis will be commencing Phase III pivotal trials investigating remibrutinib in RMS. Remibrutinib is a highly selective, potent oral BTK inhibitor with a potential best-in-class profile1
  • Late-breaking safety data will be presented, including outcomes of COVID-19 in relapsing forms of …
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Sandoz Resolves Legacy Federal Government Civil Investigation in the U.S. Regarding Generic Drugs
  • Company previously disclosed settlement agreement in principle and fully provisioned for this resolution

Basel, October 1, 2021 – Sandoz Inc., the U.S. subsidiary of Sandoz, has entered a settlement agreement with the Civil Division of the U.S. Department of Justice (DOJ) concerning the Department’s years-long pricing investigation into the U.S. generic drug industry. This settlement is an expected outcome of the resolution the company reached in March 2020 with the DOJ Antitrust Division regarding the same investigation and underlying …

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Enabling our associates to work safely on our sites

As a leading healthcare company, Novartis is playing an important part by supporting vaccination to help overcome the pandemic. The safety of all associates, our customers, business partners and the communities where we run our operations remain a top priority for us. As company we have agreed on a long-term strategy supporting the global vaccination efforts and the COVID-19 vaccines are proven to be a powerful tool enabling us to move back to a more regular life.

In countries, where sufficient vaccine is available – and where it is in line with local law and regulations – we …

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Novartis data show rapid and effective disease activity control with remibrutinib (LOU064) in patients with chronic spontaneous urticaria
  • Results from a Phase IIb study show all remibrutinib doses provided significant improvements in UAS7 change from baseline at week 4 and week 12 compared to placebo, and a favorable safety profile across the entire dose range tested
  • All doses provided clinically meaningful improvements with respect to the proportion of patients achieving UAS7=0 (complete absence of hives and itch) and UAS7≤6 (well-controlled disease activity) vs. placebo over the treatment period, starting as early as Week 1

…

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Novartis accelerates efforts toward ESG targets to increase access to medicines, improve health equity and achieve net-zero carbon emissions
  • Reached nearly 29 million patients to date in 2021 through our flagship programs and strategic innovative brands

  • Announced a planned 10-year commitment with historically black colleges and universities to address root causes of systemic disparities in health outcomes

  • Continued our global health leadership with positive phase 2b results for our next generation antimalarial therapy ganaplacide in combination with lumefantrine which support its continued development

  • Committed to achieving net zero …
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Novartis and Medicines for Malaria Venture report positive results for Phase 2b study of novel ganaplacide/lumefantrine combination in children with malaria
  • Novartis and Medicines for Malaria Venture (MMV) report positive Phase 2b study results for novel non-artemisinin combination to treat uncomplicated malaria
  • In the Phase 2b study conducted in children less than 12 years of age, ganaplacide/lumefantrine met the primary study objective
  • The positive Phase 2b results for the next generation antimalarial therapy support continued development of the combination

Basel, September 29 …

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New data reinforce efficacy and convenience of Novartis Cosentyx® (secukinumab) 300 mg autoinjector in adults with psoriasis
  • New findings show Cosentyx® (secukinumab) 300 mg single dose autoinjector (the UnoReady® pen) resulted in superior efficacy vs placebo1
  • Patient satisfaction with 300 mg autoinjector was high – reaching 100% – with no new safety signals observed over 52 weeks1
  • Cosentyx is a proven medicine supported by sustained efficacy and safety data across several systemic inflammatory conditions2-6, with more than 500 …
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