Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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August 2020
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Press Release
Novartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study
At primary analysis, ASCEMBL met its primary endpoint of significant superiority in major molecular response rate at 24 weeks for asciminib (ABL001) vs. bosutinib in patients previously treated with… -
Press Release
Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® + Mekinist® in advanced melanoma
Phase III COMBI-i trial did not meet primary endpoint for patients with advanced BRAF V600-mutated melanoma Tafinlar + Mekinist remains an effective treatment option based on previously reported… -
Ad-hoc Releases
FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
Kesimpta delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple… -
Ad-hoc Releases
Novartis announces US District Court for the District of Delaware upholds validity of Gilenya® (fingolimod) dosage regimen patent
Basel, August 17, 2020 — Novartis welcomes the decision by the US District Court for the District of Delaware to uphold the validity of the Gilenya® (fingolimod) dosage regimen patent, as our… -
Press Release
Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps
EC approves Xolair® (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first anti-immunoglobulin E antibody approved in this indication1 Chronic… -
Press Release
Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis
Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis1… -
Press Release
Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma
Global ELARA trial demonstrated clinically meaningful benefit in patients with relapsed or refractory (r/r) follicular lymphoma (FL) as measured by complete response rate Kymriah previously… -
Press Release
Novartis Cosentyx® receives EU approval for first-line systemic treatment in pediatric psoriasis
EU approval is based on two Phase III studies showing Cosentyx® provides fast and strong skin clearance, along with significant improvement in quality of life and a favorable safety profile1 …
July 2020
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Press Release
Novartis receives Piqray® approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation
Piqray (alpelisib) is the only treatment approved specifically to address PIK3CA mutation, underscoring Novartis commitment to reimagining cancer care Approval based on SOLAR-1 Phase III trial… -
Press Release
Sandoz announces plans for joint investment to help strengthen future of antibiotics manufacturing in Europe
Sandoz and Austrian government announce joint plans to drive long-term competitiveness of European production for key antibiotics in Europe Planned combined investment of more than EUR 150… -
Press Release
New Novartis analysis shows wet AMD patients achieved sustained fluid control faster with Beovu® versus aflibercept
A post-hoc analysis of the HAWK and HARRIER trials presented at ASRS showed >=50% of patients achieved sustained retinal dryness by weeks 8 and 4 with Beovu and by weeks 12 and 8 with aflibercept… -
Press Release
Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe CHMP opinion supported by data showing Adakveo significantly reduced the rate of vaso-…