Novartis receives FDA Orphan Drug Designation for NIS793 in pancreatic cancer

Novartis today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer. NIS793 is a potential first in class novel antibody specific for Transforming Growth Factor Beta (TGFβ), which is known to have an important role in metastatic pancreatic ductal carcinoma (mPDAC) and other solid tumors.

  • Pancreatic cancer has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment …
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Novartis Financial Results – Q2 2021

Media Release

English (PDF 0.4 MB) | Deutsch (PDF 0.4 MB) | Français (PDF 0.4 MB) 

Interim financial report (PDF …

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Novartis delivered strong Q2 performance, driven by momentum of key growth brands. FY 2021 guidance unchanged.

Ad hoc announcement pursuant to Art. 53 LR

  • Net sales in Q2 grew +9% (cc¹, +14% USD):
    • Pharmaceuticals BU grew +12% (cc, +18% USD) with continued strong growth from Entresto (+46% cc), Cosentyx (+21% cc) and Zolgensma (+48% cc). Kesimpta sales reached USD 66 million
    • Oncology BU grew +7% (cc, +11% USD) driven by Promacta/Revolade (+18% cc), Jakavi (+19% cc), Kisqali (+36% cc) and Tafinlar + Mekinist (+10% cc)
    • Sandoz grew +5 …
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In your neighborhood: a community-based approach to health equity in the US

Can a pharmaceutical company help close the racial healthcare gap in the US? Patrice Matchaba thinks so. His plans involve an initiative designed to bring about foundational change by tapping into the potential of underserved communities.

“We need to engage with the people whose problem we want to help solve, not create solutions for them,” says Matchaba, President of the Novartis US Foundation and Head of US Corporate Responsibility at Novartis.

Matchaba spent most of his two-decade career at Novartis steering experimental medicines through the drug development pipeline. He is …

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Beacon of Hope: Addressing health disparities through holistic community-based collective action

Black/African Americans have endured education and health disparities in the United States (US) for four centuries. Access to basic education was illegal for Black/African Americans in America, and health care where it existed was often denied. Dating back to the severe inequalities imposed by slavery, evidence suggests that the public health system in the US subsequently developed in ways that have sustained racially divided health care.1

Well-documented examples of disenfranchisement of Black/African Americans in health and science include the Tuskegee Syphilis Study, in …

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Novartis pledges 10-year commitment with Morehouse School of Medicine, 26 Historically Black Colleges, Universities, Medical Schools and other leading organizations to co-create effective, measurable solutions for health equity

  • Novartis and the Novartis US Foundation to join forces with Thurgood Marshall College Fund, Morehouse School of Medicine, 26 other Historically Black Colleges, Universities and Medical Schools and others to address root causes of disparities in health and education
  • This collaboration will create actionable solutions to target the systemic racism that drives inequitable health outcomes and work together for health equity progress through greater diversity, equity and inclusion across the research and development ecosystem …
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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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