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Tag: novartis

Novartis secures exclusive rights for potential acute respiratory distress syndrome cell therapy

• Novartis enters into exclusive worldwide license with Mesoblast to develop, commercialize and manufacture remestemcel-L for treatment of acute respiratory distress syndrome (ARDS) and other indications • Addition of remestemcel-L could expand Novartis respiratory portfolio by adding potential first-in-class ARDS therapy using innovative cell-based technology with platform potential • Deal includes $50 million upfront cash […]

Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps

• If approved, Xolair® (omalizumab) will provide patients who have severe chronic rhinosinusitis with nasal polyps, not adequately controlled by intranasal corticosteroids, with the first anti-immunoglobulin E (IgE) antibody specifically designed to target and block IgE, a key driver in the inflammatory pathway • Decision based on results from the Phase III POLYP 1 and […]

Novartis Cosentyx® gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile

• EMA CHMP positive opinion paves way for Cosentyx® to become a first-line systemic treatment in pediatric psoriasis • CHMP opinion based on two Phase III studies showing Cosentyx provides fast and strong skin clearance and significant improvement in quality of life1 • Moderate-to-severe psoriasis affects more than 350,000 children worldwide2, with the physical and […]

Novartis Resolves Legacy FCPA Investigations

Novartis has reached settlements with the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) resolving all Foreign Corrupt Practices Act (FCPA) investigations into historical conduct by the Company and its subsidiaries. As part of the settlements, Novartis and certain of its current and former subsidiaries will pay USD 233.9 million […]

Novartis Cosentyx® receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis

• FDA approval for Cosentyx® is based on the Phase III PREVENT trial, demonstrating efficacy in active non-radiographic axial spondyloarthritis (nr-axSpA), which is part of the axial spondyloarthritis (axSpA) disease spectrum • There are an estimated 2.7M people living with axial spondyloarthritis (axSpA) in the US; however, it remains significantly underdiagnosed1,2 • nr-axSpA approval is […]

Novartis PREVENT data show Cosentyx® helps patients realize early and lasting relief in axial spondyloarthritis

• Phase III PREVENT data show Cosentyx® 150 mg provided significant and sustained improvement in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) up to Week 521 • nr-axSpA is the fourth EU indication for Cosentyx, providing patients in Europe with a first-in-class treatment that addresses the axial spondyloarthritis (axSpA) disease spectrum • There are […]

Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149)

….versus a free combination of two existing inhaled treatments in uncontrolled asthma • Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life in people with uncontrolled asthma1. • Among secondary analyses, improvements in lung function, asthma control, health […]

Novartis provides update on FDA review of ofatumumab

… a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing […]

Novartis Piqray® receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation

• Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast cancer patients whose tumors harbor a PIK3CA mutation in Europe • Phase III trial showed Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. 5.7 months) in this patient population, compared to fulvestrant alone • PIK3CA mutations affect […]

Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery

• More than half of patients with BRAF-mutated advanced melanoma taking Tafinlar + Mekinist were alive and free of a relapse at 5-years1 • Study conclusions are drawn from the largest dataset and longest follow-up to date of patients with BRAF-mutated melanoma treated with targeted therapy following the surgical removal of their cancer1,2 • Data […]

Novartis announces new late-breaking ofatumumab data

…at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS) Rapid and profound depletion of B-cells contributed to a halt in disease activity in RMS patients1 A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab achieved no evidence of disease activity (NEDA-3) within the […]