Novartis

Novartis AG is a holding company, which engages in the development, manufacture, and marketing of healthcare products. It operates through the following segments: Innovative Medicines, Sandoz, and Corporate. The Innovative Medicines segment researches, develops, manufactures, distributes and sells patented pharmaceuticals, and is composed of two business units: Novartis Oncology and Novartis Pharmaceuticals. The Sandoz segment develops, manufactures and markets finished dosage form medicines as well as intermediary products, including active pharmaceutical ingredients. The Corporate segment refers to group management and central services. The company was founded on February 29, 1996 and is headquartered in Basel, Switzerland.

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Novartis AG is a holding company, which engages in the business of developing, manufacturing, and marketing healthcare products. It operates through the following segments: Innovative Medicines, Sandoz, and Corporate. The Innovative Medicines segment includes researching, distributing and selling patented pharmaceuticals. The Sandoz segment focuses on marketing finished dosage form medicines and intermediary products including active pharmaceutical ingredients. The Corporate segment is involved in group management and central services. The company was founded on February 29, 1996 and is headquartered in Basel, Switzerland.

Basel, September 14, 2020 — Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP), has approved an update to the Beovu® (brolucizumab) Summary of Product Characteristics (SmPC) to include additional information regarding retinal vasculitis and retinal vascular occlusion1. Typically, these events occurred in the presence of intraocular inflammation. This approval follows Novartis’ announcement that it would pursue worldwide label updates after a review and further characterization of post-marketing safety events reported to Novartis.

European Medicines Agency (EMA) approves safety label update for Novartis Beovu®

Basel, September 14, 2020 — Novartis today reported the first interpretable results of the Phase III KITE study, assessing the efficacy and safety of Beovu® (brolucizumab) 6 mg in diabetic macular edema (DME). The trial met its primary and key secondary endpoints, demonstrating non-inferiority for Beovu versus aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52)1.

Novartis reports positive topline results from the first Phase III trial of Beovu® versus aflibercept in patients with diabetic macular edema (DME)

The digital press release with multimedia content can be accessed here:

Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS)

Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumumab) in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis

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Novartis (NVS) posts favorable data on asthma treatment Enerzair Breezhaler at the ERS International Congress 2020.

Novartis (NVS) Releases Positive Data on Enerzair Breezhaler

Basel, September 8, 2020 — Novartis announced today it will present 48 abstracts at the upcoming MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting, September 11–13, 2020. The breadth of data being presented highlights the strength and promise of the company’s MS portfolio to improve the lives of patients across the MS spectrum.

Novartis data at ACTRIMS-ECTRIMS highlight the strength of leading multiple sclerosis (MS) portfolio with life-changing therapies for people across the MS spectrum

Basel, September 7, 2020 — Novartis today announced that high-dose, once-daily Enerzair® Breezhaler® (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) significantly reduces both moderate-or-severe and severe asthma exacerbation rates in patients whose asthma is uncontrolled on medium- or high-dose long-acting beta2-agonist (LABA)/inhaled corticosteroids (ICS), when compared with a once-daily medium-dose of the same treatment. The post hoc analysis from the pivotal Phase III IRIDIUM study—presented virtually at the European Respiratory Society (ERS) International Congress 2020— also showed the safety profile for high-dose Enerzair Breezhaler was in line with previous studies in the Phase III/IIIb PLATINUM clinical development program.

Novartis post hoc analysis shows high-dose Enerzair® Breezhaler® reduces asthma exacerbations versus medium-dose, complementing key pivotal IRIDIUM study findings

Basel, September 1, 2020 — Novartis will host a virtual investor event today to provide a comprehensive overview of the company’s progress in its Environmental, Social and Governance (ESG) strategy.

Novartis announces ambitious ESG targets to increase access to medicines and achieve full carbon neutrality

Novartis (NVS) announces new positive data on its PNH drug, LNP023, and an investigational cholesterol-lowering treatment, inclisiran.

Novartis Announces Positive Data on PNH & Cholesterol Drugs

Basel ,  August 30, 2020 — Novartis today announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults. This new analysis of inclisiran showed a highly consistent effect, with a safety and tolerability profile similar to placebo, on a twice-yearly dosing schedule after an initial dose and one 3 months later, across individual patients with atherosclerotic cardiovascular disease (ASCVD) or risk equivalents over 17 months of treatment.

Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran

Basel, August 29, 2020 — Novartis today announced new Phase II data for LNP023, an investigational oral treatment for paroxysmal nocturnal hemoglobinuria (PNH), presented at the virtually held 2020 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting.

Novartis announces positive results from Phase II study of LNP023 in patients with paroxysmal nocturnal hemoglobinuria (PNH)

Novartis' (NVS) chronic myeloid leukemia candidate meets primary endpoint in a phase III study.

Novartis' (NVS) Leukemia Drug Meets Goal in Late-Stage Study

       Basel, August 26, 2020 — Novartis announced today that, at primary analysis, the Phase III ASCEMBL study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib (ABL001) vs. bosutinib1. The study evaluates asciminib – a novel investigational treatment specifically targeting the ABL myristoyl pocket (STAMP) – in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors (TKIs)1. Patients with failure or intolerance to the most recently administered TKI therapy were included in the trial1.

Novartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study

Novartis' (NVS) phase III study evaluating the investigational immunotherapy, spartalizumab, in combination with the targeted therapies, Tafinlar and Mekinist, fails to achieve goals.

Novartis' Immunotherapy Fails in Late-Stage Skin Cancer Study

Swiss pharmaceutical company Novartis AG (NYSE: NVS) announced Saturday that the phase three COMBI-i trial for a combination of drugs against a type of advanced skin cancer didn't meet the clinical requirements of the evaluation.

Novartis Skin Cancer Drug Combination Involving Spartalizumab Fails Clinical Trial

Swiss drugmaker Novartis AG has financial firepower for acquisitions even with net debt of $26 billion, though the COVID-19 pandemic has made it more difficult to value takeover candidates, Chief Executive Vas Narasimhan said in an interview.

Novartis CEO says COVID-19 makes valuing takeover targets tougher

Basel, August 22, 2020 — Novartis announced today that the Phase III COMBI-i study evaluating the investigational immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar ®  (dabrafenib) and Mekinist ®  (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. The trial was conducted among untreated patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600 mutation-positive cutaneous melanoma, compared to Tafinlar + Mekinist alone3.

Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® + Mekinist® in advanced melanoma

Novartis (NVS) gains an FDA nod for Kesimpta (ofatumumab) as a subcutaneous injection for relapsing multiple sclerosis. The drug is expected to be available early next month.

FDA Nods to Novartis' Kesimpta for Relapsing Forms of MS

FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

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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 intellectual property reflects the innovation and investment needed to invent and develop treatments that improve and extend people’s lives.

Novartis announces US District Court for the District of Delaware upholds validity of Gilenya® (fingolimod) dosage regimen patent

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