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, 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

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

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

The CEO of the world’s second-largest pharmaceutical company takes our career questionnaire.
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Novartis CEO Vas Narasimhan always keeps a fossil in his bag

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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Eli Lilly, Novartis Have Most Valuable Pipeline Drugs

EAST HANOVER, N.J., Aug. 13, 2020 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) accepted the company's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US.

Novartis announces FDA filing acceptance of Xolair® (omalizumab) prefilled syringe for self-administration across all indications

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Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

Basel, August 4, 2020 — Novartis today announced positive results from the Phase II ELARA trial of Kymriah® (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee. CRR is a standard measure of patient response to therapy in FL. No new Kymriah safety signals were observed. Results from the ELARA trial will be presented at an upcoming medical meeting and included in US and EU regulatory submissions.

Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma

Europe granted approval for Novartis drug Cosentyx in treating moderate-to-severe plaque psoriasis in patients age 6 to under 18, after successful Phase 3 testing, sending NVS stock rising.
The post Novartis Stock Lifted As Psoriasis Drug Notches EU Approval appeared first on Investor's Business Daily.

Novartis Stock Lifted As Psoriasis Drug Notches EU Approval

Basel, August 3, 2020 — Novartis, a leader in immuno-dermatology and rheumatology, today announced the European Commission (EC) has granted the approval for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to

Novartis Cosentyx® receives EU approval for first-line systemic treatment in pediatric psoriasis

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Basel, July 24, 2020 — Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of Adakveo ®  (crizanlizumab) for the prevention of recurrent vaso-occlusive crises (VOCs), or pain crises, in patients with sickle cell disease aged 16 years and older. Adakveo can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.

Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease

With pantry-loading trends reversing, as well as weakness in some deferrable ophthalmology and dermatology products, growth has stalled in Q2.

Novartis Q2 Struck By Deferrable Portfolio Elements, But Pipeline Continues To Develop

Novartis AG's (NVS) CEO Vas Narasimhan on Q2 2020 Results - Earnings Call Transcript

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