Tag: Novartis

Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market cap and sales.

FDA and EMA Filing Acceptance of Ofatumumab, a Novel B-cell Therapy for Patients with RMS

Novartis announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing A...

Novartis receives EC Approval for Beovu®

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Novartis announced the European Commission (EC) has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF t...

Novartis May Begin Laying off Workers in April at U.K. Manufacturing Site

CEO Vas Narasimhan recently told investors Novartis is well along toward its goal of consolidating its manufacturing into one "that’s much more focused on high-end technologies." One of the facilit...

Novartis Announces MET Inhibitor Capmatinib (INC280) Granted Priority FDA Review

Novartis announced that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA). Capmatinib is a MET inhibitor being evaluate...

Novartis Announces Intent to Collaborate with NHS to Tackle Burden of Cardiovascular Disease

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Novartis announced its intent to collaborate with NHS England focused on addressing cardiovascular disease (CVD); a significant cause of disability and death in the UK. The current proposal is to c...

Oxford Biomedica to Manufacture Lentiviral Vectors for Novartis CAR-T Portfolio

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Oxford Biomedica plc, a leading gene and cell therapy group, announced that it has extended its commercial supply agreement with Novartis for the manufacture of lentiviral vectors for the Novartis CAR...

Novartis Could Launch New Age-Related Macular Degeneration Drug in Europe in 2020

Novartis could launch its new age-related macular degeneration drug in Europe early next year after getting a green light from the EMA’s main advisory committee. The Committee for Medicinal Products ...

Novartis Fevipiprant Failed to Meet Clinically Relevant Threshold in Luster Phase III Studies

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Novartis announced that its asthma treatment fevipiprant has failed to meet the clinically relevant threshold in Luster phase III studies. The company has unveiled the topline results from its ...

Forendo Pharma Signed License and Collaboration Agreement with Novartis

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Forendo Pharma, a clinical stage drug development company focusing on novel treatments in women's health, announced the signing of a License and Collaboration Agreement with Novartis. The joint resear...

Positive Results of QMF149 Clinical Trials Unveiled by Novartis

Novartis has unveiled positive phase 3 data for its dual combination asthma drug QMF149, strengthening its case for approval with regulators.  The asthma combination regimen, QMF149, is a once-dail...

Novartis to Submit 80 Major Marketing Applications for its Drugs from 2020 to 2022

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Novartis said Thursday ahead of a meeting with analysts and investors that it expects to submit more than 80 major marketing applications for its drugs from 2020 to 2022 in the US, Europe, Japan and C...

Novartis Opened New Manufacturing Facility for Cell and Gene Therapies in Switzerland

Swiss pharmaceutical company Novartis has opened a new manufacturing facility for cell and gene therapies at Stein in Switzerland. The new facility also facilitates the production of advanced a...

Pfizer, Novartis and 11 Drugmakers Set Aside $2bn to Invest in Gene Therapy Manufacturing

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Eleven drugmakers led by Pfizer and Novartis have set aside a combined $2 billion to invest in gene therapy manufacturing since 2018, according to a Reuters analysis, in a drive to better control the ...

FDA Approved Adakveo for Frequency of Vaso-Occlusive Crisis Reduction

The U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease tha...

Novartis to Broaden Patient Reach and Availability of Portfolio of Medicines in sub-Saharan Africa

Novartis announced a new strategy to broaden patient reach and availability of its portfolio of medicines in sub-Saharan Africa (SSA), which is home to the largest underserved patient population in th...

U.S. Regulators Halted Trial of Novartis’s Zolgensma Treatment

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U.S. regulators have halted a trial of Novartis’s Zolgensma treatment after an animal study raised safety concerns, the company said, in a setback for the drugmaker’s plan to expand its use to older p...