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Showing 1045 results
August 2019
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Key ReleaseNovartis ofatumumab demonstrates superiority versus Aubagio® in two head-to-head Phase III multiple sclerosis studiesIn ASCLEPIOS I and II, ofatumumab (OMB157) met primary endpoints to reduce the annualized relapse rate over Aubagio®* (teriflunomide) in patients with relapsing forms of MS (RMS)[1] Key secondary…
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Media ReleaseNovartis to present new Entresto HFpEF and HFrEF data at ESC Congress 2019PARAGON-HF trial will provide Entresto® (sacubitril/valsartan) Phase III full results in heart failure with preserved ejection fraction (HFpEF)[1] New PROVE-HF and EVALUATE-HF studies will…
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Media ReleaseAveXis Statement on Changes to Senior Leadership TeamAveXis announces Page Bouchard, DVM has been appointed Senior Vice President of Research and Chief Scientific Officer, effective August 5, 2019. Dr. Bouchard is a 27-year industry veteran with…
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Media ReleaseSandoz will appeal District Court of New Jersey ruling in biosimilar Erelzi® (etanercept-szzs) US patent caseSandoz to appeal court ruling to United States Court of Appeals for the Federal Circuit Ruling prevents launch of important, affordable treatment option for US patients affected by chronic…
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Media ReleaseNovartis stands behind Zolgensma® (onasemnogene abeparvovec-xioi) for the treatment of children less than 2 years of age with spinal muscular atrophyBasel, 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…
July 2019
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Media ReleaseNovartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trialsIn 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…
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Key ReleaseNovartis 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…
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Media ReleaseNovartis receives positive CHMP opinion for Lucentis® treatment in preterm infants with retinopathy of prematurity (ROP), a disease causing visual impairment and blindnessLucentis (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…
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Media ReleaseAveXis 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.…
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Media ReleaseSandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosisIntegrated 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…
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Media ReleaseNovartis key multiple sclerosis product Gilenya® approved in ChinaChinese 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…
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Media ReleaseNovartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increasedContinuing 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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