Guidance system lights a path for drug discovery

Land ho! Now what?

Without a map or the notion of a GPS, ancient explorers ventured into unfamiliar territory searching for a place to settle. Cliffs, steep mountains and impassable rivers thwarted their efforts as time ticked on and supplies dwindled.

Drug hunters face a similar challenge. When scientists discover a new disease-related biological mechanism, researchers looking for ways to interrupt that mechanism have a continent’s worth of possible chemical options to navigate – without a signpost in sight.

To help, Novartis researchers have developed a guidance system …

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Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran

  • Pooled data from Phase III ORION-10 and -11 showed highly consistent efficacy, tolerability and safety profile over 17 months on twice-yearly subcutaneous dosing in 2,300 patients (of which 1,164 were on inclisiran) 1
     
  • New post-hoc analysis demonstrates 99% of patients treated with inclisiran showed placebo-adjusted reduction in low-density lipoprotein cholesterol (LDL-C) of ≥30% with a mean reduction of 54.1% from baseline (observed values)2
     
  • 88% of inclisiran-treated patients achieved LDL-C …
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Novartis announces positive results from Phase II study of LNP023 in patients with paroxysmal nocturnal hemoglobinuria (PNH)

  • Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab

  • Seven of ten patients discontinued eculizumab and remained on LNP023 as monotherapy, retaining hemoglobin (Hb) levels with no changes in biomarkers of disease activity and with no signs or symptoms of breakthrough hemolysis
     
  • Phase II results are promising for treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder;1,2 second Phase …
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50 Climate Leaders

Windfarm to neutralize carbon footprint in USA and Canada.

Human health is inextricably linked to planetary health. As the impacts of climate change are being experienced around the globe, the impacts on global health are becoming more and more clear.

Heat events and …

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Novartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study

  • At primary analysis, ASCEMBL met its primary endpoint of significant superiority in major molecular response rate at 24 weeks for asciminib (ABL001) vs. bosutinib in patients previously treated with two or more tyrosine-kinase inhibitors (TKIs)1
     
  • Despite advances in chronic myeloid leukemia (CML) care, many patients are at risk of disease progression, and sequential TKI therapy may be associated with increased resistance and intolerance2-7
     
  • By specifically targeting the ABL myristoyl pocket, STAMP inhibition has …
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Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® + Mekinist® in advanced melanoma

  • Phase III COMBI-i trial did not meet primary endpoint for patients with advanced BRAF V600-mutated melanoma
  • Tafinlar + Mekinist remains an effective treatment option based on previously reported large, Phase III clinical trials1,2
     
  • Spartalizumab development program continues, investigating the immunotherapy in combination with other anti-cancer agents

Basel, August 22, 2020 — Novartis announced today that the Phase III COMBI-i study evaluating the investigational immunotherapy …

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Building collaborations to fight a pandemic

As an expert in infectious diseases, Jennifer Leeds could see the storm brewing. When COVID-19 began to emerge – first in Asia, then in Europe – she could see that its relative ease transmitting from person to person, along with the lack of tests and preventions or treatments for infection, made the virus a credible threat to humanity. Knowing that a pandemic was likely coming made watching the crisis unfold no less heartbreaking. Fortunately, as a member of the Novartis Business Development & Licensing (BD&L) department, she was in a position to try to help.

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FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

  • Kesimpta delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple sclerosis (RMS)1
     
  • Approval based on two Phase III ASCLEPIOS studies demonstrating significant reductions in risk of relapses, confirmed disability progression, Gd+ T1 brain lesions and new/enlarging T2 lesions1
     
  • Kesimpta may halt new disease activity in RMS patients as shown in a post hoc analysis, with 47.0% and 87.8% of …
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Novartis announces US District Court for the District of Delaware upholds validity of Gilenya® (fingolimod) dosage regimen patent

Basel, August 17, 2020 — Novartis welcomes the decision by the US District Court for the District of Delaware to uphold the validity of the Gilenya® (fingolimod) dosage regimen patent, as our intellectual property reflects the innovation and investment needed to invent and develop treatments that improve and extend people’s lives.

The decision also holds that the generic fingolimod product proposed by HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (“HEC”) in its Abbreviated New Drug Application (ANDA) will infringe the dosage regimen patent (US …

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Novartis appoints Marc Boutin as Global Head of Patient Engagement & Advocacy

Marc Boutin

Marc Boutin, currently CEO of the National Health Council (NHC), brings 20 years of international leadership experience in health advocacy, policy and legislation. Throughout his professional career, he has focused on creating access to care through …

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