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Media 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…
Media Release / Jul 31, 2019
Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials
In MONALEESA-3, Kisqali plus fulvestrant achieved statistically significant improvement in overall survival in post-menopausal women in first- and second-line setting Kisqali is the only CDK4/6…
Key Release / Jul 29, 2019
Novartis provides update on Phase III PARAGON-HF trial in heart failure patients with preserved ejection fraction (HFpEF)
PARAGON study narrowly misses statistical significance on the primary endpoint; overall safety profile confirmed Totality of evidence suggests potential clinically important benefit; results will…
Media Release / Jul 26, 2019
Novartis receives positive CHMP opinion for Lucentis® treatment in preterm infants with retinopathy of prematurity (ROP), a disease causing visual impairment and blindness
Lucentis (ranibizumab), if approved in the EU for this indication, will be the first and only pharmacological therapy for ROP in these vulnerable infants Positive opinion is based on the landmark…
Media Release / Jul 25, 2019
AveXis Statement on Access to Zolgensma® (onasemnogene abeparvovec-xioi)
The FDA's May 2019 approval of Zolgensma ®, a gene therapy for spinal muscular atrophy (SMA) in pediatric patients less than 2 years of age, marked an important milestone within the SMA community.…
Media Release / Jul 22, 2019
Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis
Integrated Phase I/lll study for proposed biosimilar denosumab to confirm matching efficacy, safety and immunogenicity with reference medicine[1] Osteoporosis accounts for 8.9m bone fractures…
Media Release / Jul 19, 2019
Novartis key multiple sclerosis product Gilenya® approved in China
Chinese National Medical Products Administration (NMPA) approved Gilenya® for relapsing forms of multiple sclerosis (RMS) for adults and children 10 years and older. Multiple sclerosis (MS) is…
Media Release / Jul 18, 2019
Novartis au 2e trimestre: fortes ventes, croissance à deux chiffres du résultat opérationnel core et lancements de Zolgensma et de Piqray; prévision des ventes et du résultat revue à la hausse
Chiffre d'affaires net des activités poursuivies[1] en hausse de 8% (tcc[2], +4% USD) soutenu par: Cosentyx: USD 858 millions, +25% (tcc) stimulé principalement par le maintien de la forte…
Media Release / Jul 18, 2019
Novartis erzielt im zweiten Quartal starke Umsätze, eine zweistellige Steigerung des operativen Kernergebnisses und lanciert Zolgensma und Piqray; Anhebung der Umsatz- und Gewinnerwartung
Der Nettoumsatz der fortzuführenden Geschäftsbereiche[1] steigt aufgrund folgender Beiträge um 8% (kWk[2], +4% USD): Cosentyx erzielt einen Umsatz von USD 858 Millionen (+25% kWk), vor allem dank…
Media Release / Jul 18, 2019
Novartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increased
Continuing operations[1] net sales up 8% (cc[2], +4% USD) driven by: Cosentyx at USD 858 million, +25% (cc) mainly driven by continued strong US growth (+31%) Entresto grew to USD 421 million, +…

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