Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
Showing 962 results
March 2023
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Media ReleaseSandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulationBiosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will…
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Media ReleaseNovartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing; 100% achievement of all assessed milestones in children treated prior to SMA symptom onsetChildren in LT-001 treated after SMA symptom onset maintained or achieved additional milestones up to 7.5 years post one-time intravenous infusionAll children (100%) in the presymptomatic intravenous…
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Media ReleaseNovartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancerNew approval based on TADPOLE trial showing overall response rate (ORR) of 47% and median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist compared to 11% ORR and 7.4 months…
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Media ReleaseSandoz signs Memorandum of Understanding to build new biologics production plant in Slovenia, to support increasing global demand for biosimilar medicinesSandoz investment expected to be at least USD 400m – MOU signed today in Ljubljana at ceremony led by Slovenian Prime Minister and Sandoz CEONew project underpins Sandoz ambition to drive future…
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Media ReleaseNovartis shareholders approve all resolutions proposed by the Board of Directors at the Annual General MeetingShareholders approve 26th consecutive dividend increase to CHF 3.20 (+3.2%) per share for 2022; representing a 4.0% yield1 and approximately 61% payout of free cash flowShareholders confirm Joerg…
February 2023
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Media ReleaseNovartis announces the appointment of the Chairman-Designate of Sandoz Board of DirectorsGilbert Ghostine, CEO of the Swiss multi-national fragrances business Firmenich appointed Chairman-Designate of the future Sandoz BoardMr Ghostine to begin role as Sandoz Chairman following the spin-…
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Media ReleaseSandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDASubmission supported by comprehensive analytical and clinical data packageDenosumab indicated for treating variety of conditions including osteoporosis in postmenopausal women1,2Sandoz continues to…
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Media ReleasePatients with hidradenitis suppurativa experienced sustained efficacy and symptom improvement at one year when treated with Novartis Cosentyx®In two of the largest Phase III trials conducted in hidradenitis suppurativa (HS), Cosentyx® (secukinumab) treatment response rates continued to improve beyond the primary endpoint analysis at Week…
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Key ReleaseNovartis continues to grow with further core margin expansion and achieves important innovation milestonesAd hoc announcement pursuant to Art. 53 LR Full year Net sales grew +4% (cc1, -2% USD) with core operating income growing +8% (cc, 0% USD) IM sales grew +4% (cc, -2% USD) and core operating income…
January 2023
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Media ReleaseSandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab biosimilarSandoz is seeking approval of high concentration formulation (HCF) adalimumab for use in all indications of reference medicine Upon approval, HCF formulation will offer patients enhanced yet familiar…
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Media ReleaseSandoz announces agreement to acquire leading antifungal agent Mycamine® from Astellas, reinforcing hospital offering and leading Anti-Infectives portfolioSandoz plans to acquire worldwide product rights for Mycamine®(micafungin sodium) from AstellasAcquiring leading global echinocandin, one of three major antifungal classes, will significantly…