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.

BeiGene

BeiGene out-licensed ex-China rights for tislelizumab, its China-approved anti-PD-1 antibody, to Novartis in a $2.2 billion agreement. Inmagene in-licensed global rights to four novel pre-clinical immunological candidates from Hutchison China MediTech in a deal that has a potential value of $920 million.

Week In Review: BeiGene Signs $2.2 Billion Deal With Novartis For PD-1

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Novartis (NVS) gets Breakthrough Therapy designation by the FDA for ligelizumab for the treatment of chronic spontaneous urticaria.

Novartis' (NVS) Ligelizumab Gets Breakthrough Therapy Status

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Novartis (NVS) in-licenses BeiGene's anti-PD-1 monoclonal antibody, tislelizumab, in major markets outside of China.

Novartis (NVS) In-Licenses Anti-PD-1 Antibody from BeiGene

Beigene stock jumped Tuesday on a cancer drug development deal with Novartis worth up to $2.2 billion, as Vir Biotechnology also announced a hepatitis B tie-up with Gilead Sciences. The post Beigene Surges Closer To Breakout On $2.2 Billion Deal With Novartis appeared first on Investor's Business Daily.

Beigene Surges Closer To Breakout On $2.2 Billion Deal With Novartis

Novartis AG (NVS) CEO Vas Narasimham Presents at 39th Annual J.P. Morgan Virtual Healthcare Conference (Transcript)

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BGNE--BeiGene and Novartis enter into a collaboration to develop, manufacture and commercialize tislelizumab, BeiGene's anti-PD-1 antibody.

BeiGene Announces Collaboration with Novartis to Develop and Commercialize Anti-PD-1 Antibody Tislelizumab

Basel, January 11, 2021 — Novartis has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field. Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Novartis expands Oncology pipeline with in-licensing of tislelizumab from BeiGene

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Novartis has underperformed other healthcare stocks so far. Value remains within normal P/E range.

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Novartis (NVS) gets CRL from the FDA for its cholesterol drug, inclisiran, due to unresolved facility inspection-related conditions.

Novartis (NVS) Gets CRL From the FDA for Cholesterol Drug

The FDA's inability to inspect an overseas manufacturing facility is holding up an application for inclisiran.

FDA Refuses to Approve Novartis' $9.7 Billion Cholesterol Drug for Now

Basel, December 18, 2020 — The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of December 23, 2020, due to unresolved facility inspection-related conditions. The conditions will be conveyed to the European manufacturing facility within 10 business days. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the Novartis NDA may be approved. No onsite inspection was conducted. If it is determined that a facility inspection is needed to approve the application, the FDA will define an approach for scheduling once safe travel may resume based on public health need and other factors.

Novartis receives complete response letter from U.S. FDA for inclisiran

Novartis (NVS) to buy neuroscience company, Cadent, for up to $770 million.

Novartis (NVS) to Acquire Neuroscience Company for Up to $770M

Novartis said on Thursday it had entered into an agreement to acquire U.S.-based neuroscience company Cadent for up to $770 million, gaining full rights to Cadent's neuroscience portfolio.

Novartis to buy neuroscience company Cadent for up to $770 million

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cadent Therapeutics, a privately held clinical stage biopharmaceutical company focused on the development of therapies for the treatment of cognitive, mood, and movement disorders, announced today that it has reached a definitive agreement with Novartis, under which Novartis will acquire all of the outstanding capital stock of Cadent Therapeutics. Upon the closing of the agreement, Cadent will receive a $210 million upfront payment and will be eligible for up

Cadent Therapeutics Enters Agreement to be Acquired by Novartis

Novartis (NVS) gets positive review from the FDA Advisory Committee to support the use of Entresto in the treatment of patients with heart failure with preserved ejection fraction.

Novartis' (NVS) Entresto Gets FDA Panel Nod for Expanded Use

Novartis' bid to pump up sales of its Entresto heart failure medicine beyond $5 billion annually got a boost when a U.S. Food and Drug advisory panel recommended it be used to treat a different form of the disease.

Novartis' bid to boost Entresto sales beyond $5 billion gets FDA panel lift

Basel, December 16, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto® (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF), both based on trials that included active comparators (valsartan and enalapril, respectively)1,2.

Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF

Novartis' (NVS) late-stage study on ruxolitinib in COVID-19 patients did not meet its primary endpoint.

Novartis' (NVS) COVID-19 Study Fails to Meet Primary Endpoint

Basel, December 15, 2020 — Novartis today announced positive findings from the first interpretable results of the Phase III KESTREL study, assessing the efficacy and safety of Beovu® (brolucizumab) 3 mg and 6 mg in diabetic macular edema (DME). Following KITE*, KESTREL is the second pivotal Phase III study of Beovu in DME. The trial met its primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline of Beovu 6 mg to aflibercept 2 mg at year one. The trial also met its key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 521. (Beovu 6 mg is the marketed dose for wet AMD.)

Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema

Basel, December 14, 2020 — Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint1. Initial data show there was no statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by Day 29, compared to SoC alone1. The trial also did not show clinically relevant benefit among secondary and exploratory endpoints including mortality rate by Day 29, and time to recovery (no longer infected, or ambulatory with no or minimal limitations)1.

Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19

Basel, December 9 , 20 20 — Novartis today announced new Kisqali® (ribociclib) data demonstrating consistent efficacy benefit with Kisqali plus endocrine therapy across the main intrinsic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer. The largest biomarker analysis of efficacy in intrinsic subtypes evaluated whether there was a correlation between these subtypes and efficacy outcomes in patients treated with Kisqali across the three Phase III MONALEESA trials1. The findings will be presented in an oral presentation at the 2020 San Antonio Breast Cancer Virtual Symposium.

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