Novartis
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News
PHARMA NEWS | FDA Approves Iptacopan for Paroxysmal Nocturnal Hemoglobinuria
Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside…
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DRUGS | EU Pulls Authorization of Adakveo for Sickle Cell Disease
The decision comes after the Committee on Medicinal Products for Human Use (CHMP) recommended in May 2023 to pull the approval following a review of additional Phase III data. The EC’s decision…
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CLINICAL NEWS | Novartis Releases Data for Potentially “Practice-Changing” PNH Medicine
The results, announced via news release, were presented at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation in Paris. “The APPOINT-PNH results are consistent with…
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CLINICAL UPDATE | Novartis Builds Case for Iptacopan as Oral Rival to PNH Injectables
On December 8, the Swiss pharma group announced that the top-line results of the APPOINT-PNH clinical trial showed that iptacopan provided “clinically meaningful” increases in haemoglobin levels in patients with…
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EU Approves Adakveo to Treat Vaso Occlusive Crises in Sickle Cell Disease Patients
The European Commission has approved Novartis’ Adakveo (crizanlizumab) as a preventive treatment for recurrent Vaso-Occlusive Crises (VOCs) in patients, 16 and older, with sickle cell disease (SCD). This approval follows a recommendation for conditional approval issued in July…
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Novartis sickle cell drug Adakveo put on path to EU approval
Novartis announced last Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of Adakveo® (crizanlizumab)…
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