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