News Archive

July 2019

• Ad-hoc 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…
• Press 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…
• Press 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.…
• Press 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…
• Press 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…
• Press 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, +…
• Press 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…
• Press 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…
• Press Release Jul 16, 2019

  FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101)

  FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from…
• Press Release Jul 11, 2019

  Novartis, Amgen and Banner Alzheimer's Institute discontinue clinical program with BACE inhibitor CNP520 for Alzheimer's prevention

  After review of clinical data from the Generation Program studies, the sponsors concluded that the potential benefit for participants taking CNP520 no longer outweighs the risk Basel, July 11…
• Press Release Jul 02, 2019

  Sandoz launches oncology generic gefitinib in 13 EU countries at loss of market exclusivity, expanding access to essential medicine

  Sandoz gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer[1] with activating mutations of EGFR-TK[1] More than 300,000 European men and women…
• Press Release Jul 02, 2019

  Novartis highlights cognition data in secondary progressive multiple sclerosis (SPMS)

  Data presented again at European Academy of Neurology (EAN) congress show that baseline neurofilament light chain (NfL) levels can predict cognitive impairment and disability worsening in secondary…