Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis
01 juin 2021 16h30 HE
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Novartis Pharma AG
Approval for moderate to severe pediatric patients six years and older is based on pivotal trial data showing Cosentyx demonstrated superior improvements of skin symptoms compared to placebo1 The...
Novartis Entresto® granted expanded indication in chronic heart failure by FDA
16 févr. 2021 13h23 HE
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Novartis International AG
Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction...
Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis
29 janv. 2021 12h05 HE
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Novartis International AG
Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in MS1CHMP opinion is based on...
Novartis receives complete response letter from U.S. FDA for inclisiran
18 déc. 2020 16h50 HE
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Novartis International AG
The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related...
Novartis announces positive results from a Phase IV study showing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention
02 nov. 2020 01h15 HE
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Novartis International AG
The first randomized, double blind, head-to-head study of Aimovig® (erenumab) against topiramate in patients with episodic and chronic migraine (HER-MES) achieved superiority in its primary and...
Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran
30 août 2020 02h30 HE
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Novartis International AG
Pooled data from Phase III ORION-10 and -11 showed highly consistent efficacy, tolerability and safety profile over 17 months on twice-yearly subcutaneous dosing in 2,300 patients (of which 1,164 were...
FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
20 août 2020 13h30 HE
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Novartis International AG
Kesimpta delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple...
Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis
05 août 2020 17h01 HE
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Novartis International AG
Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis1...
Novartis Cosentyx® receives EU approval for first-line systemic treatment in pediatric psoriasis
03 août 2020 01h15 HE
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Novartis International AG
EU approval is based on two Phase III studies showing Cosentyx® provides fast and strong skin clearance, along with significant improvement in quality of life and a favorable safety...
Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU
07 juil. 2020 01h15 HE
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Novartis International AG
European Commission approves once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with...