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Press Release / Jan 30, 2023

Sandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab biosimilar

Sandoz is seeking approval of high concentration formulation (HCF) adalimumab for use in all indications of reference medicine Upon approval, HCF formulation will offer patients enhanced yet familiar…
Press Release / Jan 24, 2023

Sandoz announces agreement to acquire leading antifungal agent Mycamine® from Astellas, reinforcing hospital offering and leading Anti-Infectives portfolio

Sandoz plans to acquire worldwide product rights for Mycamine® (micafungin sodium) from AstellasAcquiring leading global echinocandin, one of three major antifungal classes, will significantly…
Press Release / Dec 13, 2022

Novartis presents pivotal Phase III APPLY-PNH data at ASH demonstrating investigational oral monotherapy iptacopan superiority over anti-C5

Trial met both primary and most secondary endpoints, showing iptacopan provided transfusion-free hemoglobin-level increases in vast majority of adult paroxysmal nocturnal hemoglobinuria (PNH)…
Press Release / Dec 13, 2022

Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer

EC approval based on results from pivotal Phase III VISION trial, in which Pluvicto® plus best standard of care (BSoC) significantly improved overall survival and radiographic progression-free…
Press Release / Dec 08, 2022

Novartis investigational iptacopan provides clinically meaningful increases in hemoglobin levels in complement-inhibitor-naïve patients with PNH

Phase III APPOINT-PNH study of investigational oral monotherapy iptacopan met its primary endpoint; second positive Phase III topline readout for iptacopan in paroxysmal nocturnal hemoglobinuria (PNH…
Press Release / Dec 06, 2022

Novartis Kisqali® prolonged PFS benefit for pre- and perimenopausal patients with aggressive HR+/HER2− metastatic breast cancer compared to chemotherapy

RIGHT Choice Phase II trial is the first randomized study in patients with aggressive HR+/HER2− metastatic breast cancer (MBC), including visceral crisis, comparing a CDK4/6 inhibitor (CDK4/6i) plus…
Press Release / Apr 26, 2023

Novartis Phase III APPOINT-PNH trial shows investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels, leading to transfusion independence in all treatment-naïve PNH patients

Data at EBMT show primary endpoint met – estimated* 92.2% of complement-inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH) achieving 2 g/dL or more hemoglobin-level increase…
Press Release / Apr 26, 2023

Novartis to present new data across oncology portfolio including Kisqali Phase III NATALEE trial in early breast cancer at ASCO

Primary analysis of NATALEE, the first and only positive Phase III study of a CDK4/6 inhibitor in a broad population of patients with stage II and III HR+/HER2- early breast cancer at risk of…
Press Release / Apr 26, 2023

Novartis Cosentyx® gains positive CHMP opinion for hidradenitis suppurativa

Positive opinion paves way for first new treatment option in hidradenitis suppurativa (HS) in nearly a decade Committee for Medicinal Products for Human Use (CHMP) opinion based on robust Phase…
Press Release / May 04, 2023

Sandoz to exclusively commercialize six products in the US, reinforcing global leadership position in off-patent medicines

Agreement offers exclusive rights to commercialize six products in key areas of anti-infectives and oncology. Products from Adalvo slated for near- to mid-term launches, with four out of six…