Find all coronavirus (COVID-19) news from Novartis regarding clinical trials, collaborations, aid contributions, and more.

Mar 18, 2022

New peer-reviewed research shows no increased risk of serious COVID-19 infections in Kesimpta® (ofatumumab)-treated adults with multiple sclerosis

Basel, March 18, 2022 - Novartis today announced that the peer-reviewed journal Neurology and Therapy1 has published new data on COVID-19 infections in people living with relapsing multiple sclerosis (RMS) treated with Kesimpta® (ofatumumab). This data was compiled from the ongoing, open-label, long-term extension phase 3b ALITHIOS study and from post-marketing reports submitted through the Novartis Global Safety Database.

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Basel, January 10, 2022 - Novartis and Molecular Partners today announced that Part A of the EMPATHY clinical trial that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo to treat COVID-19, met the primary endpoint of viral load reduction over eight days. The two secondary endpoints also showed clinically meaningful benefit over placebo – (1) composite endpoint of hospitalization and/or Emergency Room (ER) visits or death, and (2) time to sustained clinical recovery. Novartis confirms it will now exercise its option to in-license ensovibep from Molecular Partners and, following exercise of the option, will seek expedited access globally, first via the FDA’s EUA process.

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Basel, October 21, 2021 - Novartis announced today that it has signed an initial agreement to leverage its manufacturing capacity and capabilities to address the COVID-19 pandemic by expanding its support of the fill and finish of the Pfizer-BioNTech COVID-19 vaccine. Novartis will use its sterile manufacturing facilities at its Novartis Technical Operations site in Ljubljana, Slovenia, to fill at least 24 million doses in 2022.

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Basel, October 01, 2021 - 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.

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Basel, May 27, 2021. Novartis and Molecular Partners announced today the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin® therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies. In March 2021, Molecular Partners reported positive initial Phase 1 results in healthy volunteers.

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Zurich-Schlieren, Switzerland, May 06, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced results from parallel laboratory studies conducted in collaboration with academic and government partners in Switzerland and the United States. The studies assessed the inhibition of new viral variants by leading SARS-CoV-2 anti-infective molecules, including ensovibep and MP0423. New variants are often associated with faster transmissibility and a potential ability to evade the currently available monoclonal antibodies and the immunity induced by some vaccines. On top of the previously reported inhibition of the variants first identified in the UK and South Africa, the new results reported today show that ensovibep continues to retain full potency against the new viral variants of SARS-CoV-2, including the variants first identified in Brazil, California, and New York as well as the key mutations in the Indian variant.

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Basel, April 15, 2021 - Novartis has signed an initial agreement with Roche to reserve capacity and implement the technology transfer for the production of the active pharmaceutical ingredient (API) for Roche’s Actemra/RoActemra® (tocilizumab), a treatment for rheumatoid arthritis which is also being tested in various clinical trials investigating the safety and efficacy in COVID-19 associated pneumonia.

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Zurich-Schlieren, Switzerland, March 09, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, and its collaborator Novartis, today announced initial results from its ongoing phase 1 study of its first tri-specific COVID-19 antiviral treatment, ensovibep (MP0420), in healthy volunteers.

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Basel, March 4, 2021 - Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway. Following final agreement, Novartis plans to start production in the second quarter of 2021. First deliveries of the bulk drug product to CureVac are expected in the summer 2021.

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Basel, January 29, 2021 - Novartis announced today that it has signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 Vaccine. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland.

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Basel, December 14, 2020 - Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint. Initial data show there was no statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by Day 29, compared to SoC alone. The trial also did not show clinically relevant benefit among secondary and exploratory endpoints including mortality rate by Day 29, and time to recovery (no longer infected, or ambulatory with no or minimal limitations).

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Translational immunologists from the Novartis Institutes for BioMedical Research (NIBR), along with researchers from Swiss hospitals and data scientists, have identified two distinct patterns of fatal lung disease progression in COVID-19. The study, which analyzed post-mortem lung tissue to better understand the immune response against SARS-CoV-2 at the cellular and molecular level, suggests that there may be two stages of the disease in the lungs.

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Basel, November 6, 2020 - Novartis today announced new data from an interim analysis for the randomized, double-blind, placebo-controlled CAN-COVID trial evaluating the efficacy and safety of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)6. The ongoing trial failed to meet its primary endpoint showing that treatment with canakinumab plus standard of care (SoC) did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus SoC up to Day 291. The trial did not meet its key secondary endpoint of reducing the COVID-19-related death rate during the 4-week period after treatment. The safety profiles of canakinumab plus SoC and placebo plus SoC were comparable.

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Basel, October 28, 2020 - Novartis and Molecular Partners AG today announced a collaboration in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program, consisting of two therapeutic candidates, MP0420 and MP0423. The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.

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Basel, September 30, 2020 - COVID-19’s existence anywhere poses a threat to communities everywhere. The health, social, and economic impacts can only be addressed through the collective actions of stakeholders across private, public, and philanthropic sectors in partnership with civil society. As organizations dedicated to improving and protecting global health, with our varied skills, roles, and resources, we remain committed to doing our part in ending this pandemic worldwide.

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Bassel, September 09, 2020 - A major new report led by the Novartis Foundation and Microsoft shows how investment in data and AI is critical to drive the health system improvements needed to respond to and recover from the COVID-19 pandemic and the world’s other greatest healthcare challenges.

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A major new report led by the Novartis Foundation and Microsoft shows how investment in data and AI is critical to drive the health system improvements needed to respond to and recover from the COVID-19 pandemic and the world’s other greatest healthcare challenges.

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Basel, July 29, 2020 - At Novartis, our people are our most valuable resource. We want everyone to feel able to be their best selves at work and at home, and we are committed to supporting and enabling them to be inspired, curious and unbossed. The global pandemic has accelerated our organizational need to explore new working models and our associates have expressed a strong desire for more flexibility in how, where and when they work. We believe we can create a future working model that optimizes both personal and business performance. Our journey toward that model is what we call Choice with Responsibility.

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Basel, July 16, 2020 - Today, Novartis announced a new initiative to help patients in low-income and lower-middle-income countries (LIC; LMIC) access affordable medicines to treat the major symptoms of COVID-19 – a critical need in the absence of a vaccine or curative treatment. Inflammation and respiratory problems linked to COVID-19 can cause severe medical complications and can lead to death in some people, putting immense strain on fragile healthcare systems.

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Basel, June 24, 2020 - Novartis revealed the healthcare and pharma industry has emerged as a desired career destination for tech talent during the COVID-19 pandemic, in the Powerful Pairing research report launched today. The report, which includes insights from Microsoft, MIT and Benevolent AI highlights.

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May 28, 2020 - Massachusetts Eye and Ear and Massachusetts General Hospital, members of Mass General Brigham, have entered into a manufacturing agreement to produce their novel genetic vaccine with AveXis, a Novartis Company. AveXis will begin manufacturing the vaccine this month while AAVCOVID undergoes further safety and efficacy testing in preclinical studies taking place at academic medical institutions including Mass. Eye and Ear.

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Basel, May 25, 2020 - The World Health Organization (WHO) announced a temporary pause of the hydroxychloroquine (HCQ) arm within the Solidarity trial. The decision was based, in part, on publication in The Lancet 1 of an analysis of hydroxycholoroquine and chloroquine and their effects on hospitalized COVID-19 patients. Novartis has taken note of this retrospective, observational study of existing multinational hospital registry data and our medical teams are evaluating the findings reported in the publication.

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May 19, 2020 - With millions of patients affected by COVID-19, the raging pandemic has put enormous pressure on critical medicine safety stocks. Healthcare workers are using every tool available to treat COVID-19 and related (or secondary) infections, resulting in a heavy pull on several medicines, including antibiotics. The pull on the system has been significant with increased demand for key medicines from patients and governments.

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May 07, 2020 - As the global COVID-19 pandemic begins to reach fragile and conflict-affected countries, the International Rescue Committee (IRC) today announced a $1 million contribution by Novartis to its COVID-19 response efforts in Uganda, Kenya and Somalia. This funding will help the IRC mitigate the spread of the disease among some of East Africa's most vulnerable communities and ensure the IRC’s life-saving work can continue to reach those in need.

April 28, 2020 - Novartis today announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia. CRS could lead to life-threatening complications in patients with COVID-19.

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April 23, 2020 - Starting May 11, 2020, Novartis will introduce company-wide a flexible working model that invites associates, country-by-country, to return to the office and restart on-site field activities, when possible and appropriate, based on the respective local situation and risk assessment. This is applicable to all countries and markets.

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Basel, April 20, 2020 - Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.

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Novartis is teaming up with R&D leaders throughout the industry as part of the National Institutes of Health (NIH) and the Foundation for NIH (FNIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership initiative. Collaboration and open innovation are essential elements of the fight against this global pandemic. Novartis is committed to doing our part as an active contributor to the global effort underway to combat COVID-19.

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April 07, 2020 - Novartis is making rapid progress in distributing the allocated USD 20 million of the Novartis COVID-19 Response Fund, announced mid-March, to impacted countries around the world. The fund aims to support public health initiatives designed to help communities manage the challenges posed by the pandemic, such as programs to strengthen healthcare infrastructure, digital platforms for data collection or dissemination of important public health information, and community health programs.

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April 03, 2020 - In response to the COVID-19 pandemic, the Novartis US Foundation has established the US COVID-19 Community Response Fund to support local initiatives and communities in the US impacted by the outbreak. The fund will provide up to USD $5 million over a one-year period for immediate response and recovery efforts related to the pandemic.

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Rotkreuz, April 03, 2020 – Today, Novartis, announced the donation of a substantial amount of hydroxychloroquine to treat hospitalized COVID-19 patients within Switzerland. The aim of the donation is to enable patients to access a potential treatment while also advancing clinical research in the fight against COVID-19. Switzerland is the second country in the world after the USA, and the first in Europe, to receive a donation of this medication. The Swiss authorities are responsible for distributing the drug to hospitals.

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Basel, April 2, 2020 — Novartis today announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-191-3.

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East Hanover, NJ, March 30, 2020 – Novartis announced today that it is donating 20,000 doses of hydroxychloroquine to the University of Washington for a COVID-19 PEP clinical trial. Sandoz, the company’s generics and biosimilars division, is facilitating the donation.

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Princeton, March 30, 2020 - Novartis announced today that Sandoz, its generics and biosimilars division, has started to ship a consignment of 30 million doses of hydroxychloroquine tablets to the US Department of Health and Human Services (HHS) for immediate use in controlled clinical studies. The study will evaluate the medicine’s effectiveness in people who have tested positive for COVID-19. The shipment is part of the previously announced global Novartis donation of 130 million tablets in total to be distributed across a variety of clinical trials and stakeholders internationally.

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March 27, 2020 - As the coronavirus (COVID-19) situation continues to evolve, our primary concern at Novartis remains the health and safety of our associates and patients globally. With that in mind, this week Novartis announced a range of additional measures to protect and support our associates around the world.

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Basel, March 26, 2020 — Today, Novartis and a consortium of life sciences companies announced an important collaboration to accelerate the development, manufacture and delivery of vaccines, diagnostics, and treatments for COVID-19 in response to the pandemic. The industry brings a range of assets, resources, and expertise needed to identify effective and scalable solutions to the pandemic that is affecting billions worldwide. Effects on health systems, economies, and livelihoods are significant, and effective response requires an unprecedented collaboration across government, academia, private sector, and philanthropy. 

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Basel, March 20, 2020 - Novartis announced today its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of COVID-19. Novartis is supporting ongoing clinical trial efforts, and will evaluate needs for additional clinical trials.

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Basel, March 17, 2020 - Vas Narasimhan, CEO of Novartis, said: “We are dealing with an extraordinary and unprecedented public health crisis that requires an incredible level of involvement and collaboration across government, society and business. As a medicines company present in over 140 countries, we are stepping in to provide additional financial support to critical community or national programs that can help address urgent public health needs resulting from the COVID-19 pandemic. Recognizing the power of working together as an industry, we are also bringing the talent and capabilities of our industry-leading R&D organization to two leading and important collaborative R&D initiatives.”

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March 13, 2020 - As the coronavirus (COVID-19) continues to spread globally, our primary concern at Novartis remains the health and safety of our associates and patients globally, and it is important that we protect them. 

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March 11, 2020 - As Novartis continues to closely monitor the coronavirus situation, our primary concern is the health and safety of our associates and patients globally. We will continue to deliver our medicines to patients around the world and we do not anticipate supply chain disruption at this time.

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