Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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April 2022
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Media ReleaseNovartis announces anti-PD-1 tislelizumab accepted by EMA for regulatory review in esophageal and lung cancersEuropean Medicines Agency validated MAAs for tislelizumab in multiple non-small cell lung cancer and esophageal squamous cell carcinoma indicationsSubmissions based on data from Phase III RATIONALE…
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Media ReleaseSandoz extends collaboration agreement to drive cutting-edge digital solutions in global fight against antimicrobial resistance (AMR)Extending existing master services agreement with Ares Genetics, to develop digital platform for development and life cycle management of antibiotics, to January 31, 2025Both parties strengthening…
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Media ReleaseFDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1 PROS is a spectrum of rare conditions and is…
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Media ReleaseNovartis presents new four-year data on efficacy and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosisPhase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension demonstrated the efficacy and safety of continuous Kesimpta® (ofatumumab) treatment and in those switched from teriflunomide, with…
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Media ReleaseNovartis expands Zolgensma manufacturing capacity with approval of multi-product North Carolina facilityClearance of critical milestone expands capability for production of gene therapies, starting with Zolgensma® Basel, April 5, 2022 – Novartis today announced the U.S. Food and Drug Administration (…
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Key ReleaseNovartis announces new organizational structure to accelerate growth, strengthen pipeline and increase productivityAd hoc announcement pursuant to Art. 53 LRNew simplified structure and operational set-up supports Novartis strategy as a focused medicines company and is designed to power next phase of…
March 2022
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Media ReleaseNovartis announces European Commission approval of Beovu® for people living with diabetic macular edemaDiabetic macular edema (DME) is a leading cause of blindness in adults in developed countries; unmet needs in DME include improving fluid resolution in the retina and addressing the burden of…
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Media ReleaseNovartis receives positive CHMP opinion for Jakavi® to treat acute and chronic graft-versus-host diseaseCHMP opinion based on Phase III REACH2 and REACH3 trials that showed Jakavi improved response rates and failure-free survival compared to best available therapy1,2 Graft-versus-host disease (GvHD)…
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Media ReleaseNovartis receives positive CHMP opinion for Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in EuropePositive opinion paves way for third indication in Europe for Kymriah, a potentially definitive single infusion CAR-T cell therapy treatment optionCHMP opinion based on Phase II global ELARA trial…
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Key ReleaseNovartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancerAd hoc announcement pursuant to Art. 53 LR FDA also approved complementary diagnostic imaging agent, Locametz®, after radiolabeling with gallium-68 for the identification of PSMA-positive…
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Media ReleaseNew peer-reviewed research shows no increased risk of serious COVID-19 infections in Kesimpta® (ofatumumab)-treated adults with multiple sclerosisThe study published in ‘Neurology and Therapy’ also shows the fatal outcomes and hospitalization rates due to COVID-19 in those treated with Kesimpta were in line with the rates in the general MS…
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Media ReleaseSandoz targets growth opportunities in respiratory and complex generics through acquisition of respiratory device company CoalesceSandoz gains significant capabilities and assets in medical and drug device development that target major growth opportunities in respiratory and complex generics Respiratory diseases are leading…
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