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Press release / Sep 30, 2019

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…
Press release / Dec 03, 2018

Novartis announces FDA filing acceptance and Priority Review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1

The AVXS-101, now known as ZOLGENSMA® (onasemnogene abeparvovec-xxxx)[1], filing is supported by data from the START trial which demonstrated a dramatic increase in survival and transformative…
Press release / Sep 05, 2017

Novartis landmark Phase III trial shows fingolimod significantly reduces relapses in children and adolescents with MS

Phase III PARADIGMS study in pediatric MS met its primary endpoint, showing a significant reduction in relapses occur with fingolimod versus interferon beta-1a There is a significant unmet…
Press release / Oct 02, 2015

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

Etanercept is an anti-TNF medicine used to treat a range of immunological diseases including rheumatoid arthritis and psoriasis. Sandoz is seeking approval for all indications included in the…
Press release / Sep 07, 2020

Novartis post hoc analysis shows high-dose Enerzair® Breezhaler® reduces asthma exacerbations versus medium-dose, complementing key pivotal IRIDIUM study findings

High-dose, once-daily Enerzair® Breezhaler® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks1 Once-daily Enerzair…
Press release / May 01, 2020

Novartis receives CHMP positive opinion for Enerzair® Breezhaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma

CHMP positive opinion advances efforts to provide first-in-class LABA/LAMA/ICS combination for patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment in the EU. Digital…
Press release / Aug 07, 2019

Novartis stands behind Zolgensma® (onasemnogene abeparvovec-xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy

Basel, August 6, 2019 – Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma® (onasemnogene abeparvovec-xioi). First and…
Ad hoc release / Mar 09, 2021

Novartis provides update on Phase III study evaluating canakinumab (ACZ885) as second or third-line treatment in combination with chemotherapy in non-small cell lung cancer

Phase III CANOPY-2 trial did not meet primary endpoint of overall survival in patients with advanced or metastatic non-small cell lung cancer whose cancer progressed…
Press release / Jul 07, 2020

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

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…
Press release / Oct 03, 2018

Novartis licenses three novel anti-infective programs to Boston Pharmaceuticals

Clinical and pre-clinical stage programs focused on addressing growing need for new treatments against drug resistant Gram-negative bacteria Agreement is part of Novartis strategy to…