Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the treatment of COVID-19
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.
Molecular Partners’ COVID-19 antiviral candidate, Ensovibep, maintains potent neutralization against emerging viral variants in vitro
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.
Novartis signs initial agreement to reserve capacity and implement the technology transfer for the production of the active pharmaceutical ingredient for Roche’s Actemra/RoActemra®
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.
Molecular Partners and Novartis report positive initial results from Phase 1 study of COVID-19 antiviral therapy
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.
Novartis signs initial agreement with CureVac to manufacture COVID-19 vaccine candidate
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.
Novartis signs initial agreement to provide manufacturing capacity for Pfizer-BioNTech COVID-19 vaccine
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.
Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19
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).
Study suggests there may be two stages of fatal lung disease in COVID-19
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.
Novartis provides update on CAN-COVID trial in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)
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.
Novartis announces collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19
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.
Life Science Companies and the Bill & Melinda Gates Foundation: Joint Communique
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.
New report shows how AI in health is critical for COVID-19 response and recovery
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.
New collaboration between Novartis and Africa Medical Supplies Platform to facilitate supply of COVID-19 related medicines
Basel, Switzerland, September 1, 2020 - Novartis and the African Union (AU) through the Africa Medical Supplies Platform (AMSP) have announced a new collaboration to facilitate the supply of medicines from the Novartis Pandemic Response Portfolio to the AU member states and Caricom countries.
Choice with Responsibility: Reimagining how we work
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.
Novartis launches first-of-its-kind not-for-profit portfolio of medicines for symptomatic treatment of COVID-19
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.
Novartis research shows technology talent increasingly drawn to pharma industry since COVID-19
On Wednesday 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.
AveXis joins AAVCOVID vaccine program from Massachusetts Eye and Ear and Massachusetts General Hospital
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.
Novartis update following WHO Solidarity trial announcement
On 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.
Sandoz responds to increased demand for antibiotics and other essential medicines for patients during COVID-19
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.
International Rescue Committee announces $1 million contribution from Novartis in support of COVID-19 response in East Africa
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.
Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia
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.
Novartis announces flexible return to office and on-site field activities, starting May 11, 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.
Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalized COVID-19 patients
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.
Novartis joins the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative
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.
Novartis COVID-19 Response Fund provides support to healthcare workers and communities
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.
Novartis US Foundation establishes USD $5 million US COVID-19 Community Response Fund
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.
Novartis announces first European donation of hydroxychloroquine to Switzerland
Rotkreuz, April 3, 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.
Novartis announces plan to initiate clinical study of Jakavi® in severe COVID-19 patients and establish international compassionate use program
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.
Novartis donates 20,000 doses of hydroxychloroquine for COVID-19 PEP clinical trial
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.
Novartis donation: Consignment of 30 million hydroxychloroquine tablets ships to US Department of Health and Human Services
Princeton - 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.
Novartis announces further steps to protect and support its associates during the COVID-19 Pandemic
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.
Novartis and life sciences companies commit expertise and assets to the fight against COVID-19 pandemic alongside Bill & Melinda Gates Foundation
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.
Novartis commits to donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response
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.
Novartis announces broad range of initiatives to respond to COVID-19 Pandemic and creates USD 20 million global fund to support impacted communities
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.”
Novartis coronavirus update (remote working, business travel restrictions)
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.
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.