· ISIN: XS0432810116

Novartis Entresto® US patent upheld by US Court of Appeals

Basel, January 13, 2025 – Novartis is pleased with the decision by the US Court of Appeals for the Federal Circuit (CAFC) that affirms the validity of the Entresto® (sacubitril/valsartan) combination patent....

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Most recent update: 13.01.2025 | 06:15
13 January 2025 06:15AM
Novartis Entresto® US patent upheld by US Court of Appeals
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Basel, January 13, 2025 – Novartis is pleased with the decision by the US Court of Appeals for the Federal Circuit (CAFC) that affirms the validity of the Entresto® (sacubitril/valsartan) combination patent....
© Globe Newswire
30 December 2024 05:45AM
Novartis intrathecal onasemnogene abeparvovec Phase III study meets primary endpoint in children and young adults with SMA
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Ad hoc announcement pursuant to Art. 53 LR...
© Globe Newswire
10 December 2024 02:00PM
Longer-term Novartis Kisqali® NATALEE data show durable reduction in distant recurrence in broad population of patients with early breast cancer
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Basel, December 10, 2024 – Novartis today announced results from an updated analysis of the pivotal Phase III NATALEE trial of Kisqali® (ribociclib) that underscore the extended efficacy beyond the duration of treatment in combination with endocrine therapy (ET). Results showed a sustained reduction in distant recurrence of 28.5% (HR=0.715; 95% CI...
© Globe Newswire
08 December 2024 05:30PM
Longer-term data for Novartis Scemblix® reinforce superior efficacy with favorable safety and tolerability profile in adults with newly diagnosed CML
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Basel, December 8, 2024 – Novartis today announced positive, longer-term results from the pivotal Phase III ASC4FIRST trial with Scemblix® (asciminib) showing superior major molecular response (MMR) rates at week 961. The study compared the MMR rate of Scemblix to investigator-selected standard-of-care (SoC) tyrosine kinase inhibitors (TKIs) (imati...
© Globe Newswire
06 December 2024 06:15AM
New Phase IIIB data shows Novartis Fabhalta® improved hemoglobin levels in adult patients with paroxysmal nocturnal hemoglobinuria who switched from anti-C5 therapy
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Basel, December 6, 2024 – Novartis today announced positive topline results from APPULSE-PNH, a Phase IIIB study evaluating the efficacy and safety of twice-daily oral monotherapy Fabhalta® (iptacopan) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who were switched from anti-C5 therapies (Hb ≥10g/dL following treatment with eculi...
© Globe Newswire
27 November 2024 06:15AM
Novartis Kisqali® receives European Commission approval in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence
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Basel, November 27, 2024 – Novartis announced today that the European Commission (EC) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurr...
© Globe Newswire
25 November 2024 06:15AM
Novartis highlights new 96-week results from Phase III Scemblix® ASC4FIRST trial at ASH and late-breaking analysis from Phase III Kisqali® NATALEE trial at SABCS
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Basel, November 25, 2024 – Novartis will present data from more than 65 abstracts, including investigator-initiated trials at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition and the 2024 San Antonio Breast Cancer Symposium® (SABCS)....
© Globe Newswire
21 November 2024 06:00AM
Novartis upgrades mid-term guidance and highlights deep pipeline in core therapeutic areas to drive long-term growth
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Ad hoc announcement pursuant to Art. 53 LR...
© Globe Newswire
19 November 2024 01:00PM
Novartis ranks first in 2024 Access to Medicine Index
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Basel, November 19, 2024 – Novartis has ranked first in the 2024 Access to Medicine Index (ATMI) report published today, highlighting the company’s leadership in improving access to medicines around the world....
© Globe Newswire
29 October 2024 07:03PM
Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile
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Ad hoc announcement pursuant to Art. 53 LR...
© Globe Newswire
29 October 2024 06:00AM
Novartis continues strong momentum in Q3 with 10% sales growth, 20% core operating income growth, and important innovation milestones; raises FY 2024 guidance
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Ad hoc announcement pursuant to Art. 53 LR...
© Globe Newswire
26 October 2024 11:50PM
Novartis oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial 
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Basel, October 27, 2024 – Novartis today presented 12-month data from the Phase III APPEAR-C3G study at American Society of Nephrology (ASN) Kidney Week 2024 showing that patients with C3 glomerulopathy (C3G) treated with oral Fabhalta® (iptacopan) in addition to supportive care experienced clinically meaningful, sustained results at one year.1...
© Globe Newswire
24 October 2024 05:15AM
Novartis ribociclib (Kisqali®) recognized as Category 1 preferred breast cancer adjuvant treatment by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
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Basel, October 24, 2024 – This month, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for breast cancer were updated to recommend ribociclib (Kisqali®) as a Category 1 preferred CDK4/6 inhibitor (CDK4/6i) adjuvant therapy for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) e...
© Globe Newswire
18 October 2024 10:47AM
Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
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Basel, October 18, 2024 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Kisqali® (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal gr...
© Globe Newswire
17 September 2024 04:55PM
FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer
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Ad hoc announcement pursuant to Art. 53 LR...
© Globe Newswire
16 September 2024 08:15AM
Novartis Kisqali® shows deepening benefit in new analysis, reducing the risk of recurrence by 28.5% in a broad population of patients with early breast cancer
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Basel, September 16, 2024 – In an updated analysis from the pivotal Phase III NATALEE trial, investigational Kisqali® (ribociclib) added to endocrine therapy (ET) shows a deepening benefit beyond the three-year treatment period, reducing the risk of recurrence by 28.5% (HR=0.715; 95% CI 0.609–0.840; P<0.0001), compared to ET alone, in patients w...
© Globe Newswire
28 August 2024 05:15AM
Novartis twice-yearly* Leqvio® demonstrated clinically meaningful, statistically significant LDL-C lowering as a monotherapy in patients at low or moderate ASCVD risk
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Basel, August 28, 2024 – Novartis announced today positive topline results from twice-yearly* Leqvio® (inclisiran) in the Phase III V-MONO study, which met its primary endpoints. Leqvio monotherapy achieved clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus both placebo and ezetimibe in p...
© Globe Newswire
07 August 2024 11:30PM
Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)
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Ad hoc announcement pursuant to Art. 53 LR...
© Globe Newswire
31 May 2024 12:00PM
Novartis Scemblix® Phase III data first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CML
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Basel, May 31, 2024 – Novartis today presents positive results from the pivotal Phase III ASC4FIRST trial as a late-breaking abstract at the 2024 American Society of Clinical Oncology (ASCO) meeting. Scemblix® (asciminib) demonstrated superior major molecular response (MMR) rates at week 48 compared to investigator-selected standard-of-care (SoC) t...
© Globe Newswire
30 May 2024 10:01PM
Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria
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Basel, May 31, 2024 – Novartis today announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria (CSU)1. In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant symptom improvement early, whic...
© Globe Newswire
25 May 2024 10:15AM
Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio
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Basel, May 25, 2024 – Novartis today presented results from a pre-specified interim analysis of the Phase III ALIGN study of atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist, in patients with IgA nephropathy (IgAN)1. Patients treated with atrasentan, in addition to supportive care (maximally tolerated and stable...
© Globe Newswire
25 May 2024 10:00AM
Novartis presents latest Phase III Fabhalta® (iptacopan) data in C3 glomerulopathy (C3G) showing clinically meaningful and statistically significant 35.1% proteinuria reduction vs. placebo
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Basel, May 25, 2024 – Novartis today presented results from the 6-month, double-blind period of the Phase III APPEAR-C3G study of Fabhalta® (iptacopan) at the late-breaking clinical trials session of the European Renal Association (ERA) Congress1. Patients treated with Fabhalta in addition to supportive care achieved a 35.1% (p=0.0014) reduction in...
© Globe Newswire
16 May 2024 09:27AM
Novartis meets all tender offer conditions to acquire MorphoSys AG for EUR 68 per share in cash
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Basel, 16 May 2024 – Today, Novartis BidCo AG, an (indirect) wholly owned subsidiary of Novartis AG, announced the result of its voluntary public takeover offer (the “Offer”) for the shares of MorphoSys AG (“MorphoSys”), including all shares represented by MorphoSys American Depositary Shares (“ADS”). As of the expiry of the acceptance period at 24...
© Globe Newswire
15 May 2024 02:00PM
Novartis highlights pioneering innovation in CML with data from Scemblix® Phase III ASC4FIRST study in newly diagnosed patients at ASCO and EHA
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Basel, May 15, 2024 – Novartis will present data from more than 60 abstracts, including investigator-initiated trials at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2024 Hybrid Congress. The primary results from ASC4FIRST, a pivotal Phase III study of Scemblix® (asciminib) versu...
© Globe Newswire

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