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November 05, 2019 01:15 ET | Source: Novartis International AG

Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez)

Ziextenzo™ is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy With approval of Ziextenzo™ , Sandoz is first and only company to offer...
November 01, 2019 02:15 ET | Source: Novartis International AG

Novartis Cosentyx® shows encouraging results versus Humira®* from first-of-its-kind head-to-head trial in psoriatic arthritis

Cosentyx narrowly missed statistical significance for superiority in ACR 20, the primary endpoint of the EXCEED trial, while showing numerically higher results versus Humira®*[1] Statistically...
October 30, 2019 02:00 ET | Source: Novartis International AG

Novartis announces AVXS-101 intrathecal study update

FDA placed a partial hold on AVXS-101 intrathecal clinical trials for SMA patients based on findings in a small pre-clinical animal studyAdverse events that might be expected from the pre-clinical...
October 24, 2019 01:15 ET | Source: Novartis International AG

Novartis receives approval for Cosentyx® label update in Europe to include dosing flexibility in ankylosing spondylitis

New Cosentyx® (secukinumab) label to include 300 mg up-titration option is informed by results from the Phase III MEASURE 3 study[1] Approval provides clinicians with greater choice for their...
October 08, 2019 01:15 ET | Source: Novartis International AG

Novartis receives FDA approval for Beovu®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept

In two head-to-head clinical trials, patients on Beovu (brolucizumab) achieved vision gains that were non-inferior to aflibercept at year one with longer treatment intervals in a majority of...
October 08, 2019 01:15 ET | Source: Novartis International AG

Novartis receives FDA approval for Beovu®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept

In two head-to-head clinical trials, patients on Beovu (brolucizumab) achieved vision gains that were non-inferior to aflibercept at year one with longer treatment intervals in a majority of...
October 02, 2019 01:15 ET | Source: Novartis International AG

Novartis positive 52-week PREVENT data confirm Cosentyx® efficacy in addressing entire axSpA spectrum

Phase III PREVENT study met 52-week primary endpoint of ASAS40, showing a sustained response in patients with non-radiographic axial spondyloarthritis (nr-axSpA)[1] Novartis plans FDA submission for...
October 01, 2019 10:00 ET | Source: Novartis International AG

Novartis and Microsoft announce collaboration to transform medicine with artificial intelligence

Multiyear alliance underpins the Novartis commitment to leverage data & Artificial Intelligence (AI) to transform how medicines are discovered, developed and commercializedNovartis to establish AI...
September 30, 2019 01:20 ET | Source: Novartis International AG

Novartis announces positive results from Phase III PALLADIUM study of inhaled combination QMF149 in patients with uncontrolled asthma

Once-daily QMF149 demonstrated superior improvement in lung function versus mometasone furoate, meeting primary endpoint[1] PALLADIUM is part of Phase III PLATINUM clinical development program, which...
September 30, 2019 01:15 ET | Source: Novartis International AG

Novartis announces positive results from Phase III IRIDIUM study of inhaled combination QVM149 in patients with uncontrolled asthma

Once-daily QVM149 demonstrated statistically significant improvement in lung function versus QMF149, meeting primary endpoint[1],[2] IRIDIUM is largest study in Phase III PLATINUM clinical...