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APONTIS PHARMA saw impressive revenue growth in H1 2024, driven by Single Pill combinations and a new partnership with Novartis. The company turned profitable and raised its forecast, aiming for further expansion. Jetzt den vollständigen Artikel lesen
Novartis has reached a pivotal moment in the treatment of rare kidney diseases with the US Food and Drug Administration (FDA) granting accelerated approval for Fabhalta (iptacopan), a novel therapy designed to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). This rare, progressively debilitating condition affects the kidneys by attacking the glomeruli, the […]
On Thursday, Viatris Inc . (NASDAQ: VTRS ) reported second-quarter revenues of $3.797 billion, marginally above the consensus of $3.777 billion, up ~2% on a divestiture-adjusted operational basis . Brands net sales reached $2.36 billion, reflecting strong growth in Greater China and the expansion of the company’s portfolio in Emerging Markets and JANZ, partially offset by unfavorable channel dynamics in North America and the impact of government price regulations in Japan and Australia. Related: Novartis And Viatris Sued Over Unlawful Use Of HeLa Cells Used For Cancer Treatment Drugs . Generic net sales of $1.42 billion reflect strong growth from new product … Full story available on Benzinga.com
On Thursday, the FDA granted accelerated approval to Novartis AG’s (NYSE: NVS ) Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. In December 2023, the FDA approved Fabhalta as the first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria . This indication is granted under accelerated approval based on the pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study, which measured a reduction in proteinuria at nine months compared to placebo. Whether Fabhalta slows kidney function decline in patients with IgAN has not been established. The continued approval of Fabhalta may be contingent upon verification and description of … Full story available on Benzinga.com
Sandoz, the generics drugmaker spun off from Novartis, is going to get into making cheap versions of the wildly popular GLP-1 class of drugs to treat diabetes and weight loss. But it may take a while.
Novartis (NVS) has released an update. Novartis AG has announced the FDA accelerated approval of Fabhalta (iptacopan) for reducing proteinuria in p…
Jason Tardio, Experienced Multiple Sclerosis Drug Commercialization Executive, Formerly with Novartis and Biogen, Appointed Chief Operating Officer and President Strengthened Board of Directors with Appointment of Simona Skerjanec, Senior Pharmaceutical Executive and Thought Leader…
Novartis received accelerated approval from the FDA for a treatment for IgA nephropathy, an autoimmune disease in which too many of an antibody build up in the kidney. The drug, known as iptacopan, is marketed as Fabhalta. It was first approved in December for a rare blood disorder called paroxysmal
BASEL (dpa-AFX) - Novartis (NVS) announced that the U.S. Food and Drug Administration has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduc…