If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant treatment with Kisqali ® (ribociclib) in combination with an aromatase inhibitor 1 Recommendation is based on the Phase III NATALEE trial, where Kisqali added to endocrine therapy (ET) significantly reduced the risk of recurrence by 25%... Read More

Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy 1 ,2 Kisqali ® (ribociclib) significantly reduced the risk of recurrence by 25% vs. endocrine therapy (ET) alone; consistent benefit and a well-tolerated safety profile seen across all subgroups in pivotal Phase III NATALEE trial, including... Read More

Novartis secures exclusive global rights across multiple biologic targets to Lindy Biosciences' microglassification technology Collaboration aims to enable high-concentration self-administered drug treatments, improving patient outcomes and compliance Lindy Biosciences to receive an upfront payment of US$20 million and eligible to receive up to US$934 million in milestone payments plus tiered royalties RALEIGH, N.C. / Aug... Read More

Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs. placebo (p<0.0001) 1 Fabhalta is an inhibitor of the alternative complement pathway, activation of which is thought to contribute to the pathogenesis of IgAN 1-4 Despite current standard of care, up to 50% of IgAN patients with... Read More

In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction vs. placebo + supportive care at 36 weeks 1 Endothelin A (ETA) receptor activation contributes to elevated proteinuria in IgAN 2-5 ; atrasentan is a potent, selective ETA receptor antagonist with potential to reduce persistent... Read More

Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over 6 months vs. placebo 1 ; additional 6-month open-label data to be presented at a future medical meeting 2,3 Fabhalta showed a favorable safety profile with no new safety signals 1 C3G, an ultra-rare kidney disease caused by alternative complement pathway overactivation, progresses to kidney failure in ∼50% of patients... Read More

APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN 1 IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide 2 ; complement activation is a key driver of glomerular inflammation in IgAN 3,4 There is a need for effective, targeted therapies for IgAN 2,5 ; up to 30%... Read More

V-INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively) 1 A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while... Read More

APPLY-PNH extension data show that continuous Fabhalta ® (iptacopan) treatment in adults with paroxysmal nocturnal hemoglobinuria (PNH) enabled sustained hemoglobin-level increases to near-normal (≥12 g/dL), blood transfusion avoidance, and improved patient-reported fatigue in the majority of patients, with a safety profile consistent with previously reported data 1-5 Patients switching from anti-C5s to Fabhalta in the... Read More

Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement inhibitor-naïve patients 1-5 In APPLY-PNH, patients who switched to Fabhalta experienced superior increases of hemoglobin levels ≥ 2 g/dL (82.3% vs. 0%) and hemoglobin level ≥ 12 g/dL (67.7% vs. 0%), both in the absence of red blood cell transfusions, vs. patients who continued... Read More

EAST HANOVER, N.J. , Sept. 11, 2023 /PRNewswire/ -- Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune ® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted. Sandimmune ® Oral Solution (cyclosporine oral... Read More

Q2 sales grew +9% (cc 3 , +7% USD) with core operating income growing +17% (cc, +9% USD) Innovative Medicines (IM) sales grew +9% (cc, +7% USD) and core operating income +20% (cc, +12% USD), with core margin reaching 39.0%, (+340 bps cc) Growth driven by continued strong performance from Entresto, Kesimpta, Pluvicto and Kisqali Sandoz sales grew +8% (cc, +5% USD) and core operating income +6% (cc, -5% USD) Q2 operating... Read More

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) patients with residual anemia despite prior anti-C5 therapy 1 Iptacopan demonstrated an 80% difference to anti-C5 in the estimated proportion of patients* achieving 2 g/dL or more hemoglobin-level increases from baseline without the... Read More

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) 1 Topline APPOINT-PNH data were consistent with APPLY-PNH readout and showed a significant proportion of complement-inhibitor-naïve patients treated with iptacopan achieved clinically meaningful increases in hemoglobin levels... Read More

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 endocrine therapy (ET) versus combination chemotherapy (CT) 1 Kisqali plus ET demonstrated a statistically significant progression-free survival (PFS) benefit of one year compared to combination CT; data to be presented at SABCS... Read More