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Eli lilly

Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Shots: Eli Lilly has reported P-III (BRUIN CLL-313) trial data assessing Jaypirca (pirtobrutinib; 200mg, PO, QD) vs chemoimmunotherapy (bendamustine + rituximab) in 282 pts with 1L chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions Trial met its 1EP of improved PFS per IRC, while OS was immature but showed a favorable trend &…

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Astrazeneca

AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC

Shots: AstraZeneca has reported P-III (FLAURA2) trial findings on Tagrisso + Pt-based CT as a 1L treatment of pts with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC The P-III (FLAURA2) trial assessed Tagrisso (80mg, QD, PO) + pemetrexed + cisplatin/carboplatin (Q3W for 4 cycles) followed by Tagrisso + pemetrexed maintenance (Q3W) vs…

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PharmaShots Weekly Snapshots (Sep 01, 2025 – Sep 05, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, Animal Health and Biosimilars. Check out our full report below:    Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)  Read More: Merck  AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat…

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Genentech

Genentech Presents Long-Term Efficacy and Safety Data on Vabysmo for Wet Age-Related Macular Degeneration

Shots: Genentech has reported new data from the open-label AVONELLE-X & P-IIIb/IV (SALWEEN) studies of Vabysmo (faricimab-svoa) at Euretina’25 The 2yr. AVONELLE-X study was an extension of P-III (TENAYA & LUCERNE) trials, showing maintained vision & anatomy in wet AMD, with ~80% pts extending dosing to Q3M/Q4M after ~4yrs. of therapy SALWEEN study in Asia…

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Bluejay Therapeutics Reports First Patient Enrolment in P-III (AZURE-2) Trial of Brelovitug for Chronic Hepatitis D

Shots: Bluejay Therapeutics has enrolled its first patient in the P-III (AZURE-2) trial assessing brelovitug (300mg, SC, QW) vs Hepcludex (bulevirtide) for the treatment of chronic hepatitis D Trial will assess the proportion of participants achieving a composite response at Wk. 48, defined as undetectable hepatitis D virus RNA along with normalization of alanine aminotransferase…

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Merck new

Merck Reports Topline P-III (CORALreef Lipids) Trial Data of Enlicitide Decanoate to Treat Hypercholesterolemia

Shots: Merck has reported topline P-III (CORALreef Lipids) trial data assessing enlicitide decanoate vs PBO for the treatment of adults with hypercholesterolemia receiving mod. to high-intensity statins or are intolerant to statins Trial met its 1EP with significant LDL-C reduction at Wk. 24 & achieved 2EPs, showing reduced non-HDL-C, apolipoprotein B, & lipoprotein(a) levels; data…

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Novartis

Novartis Reports P-IV (V-DIFFERENCE) Trial Findings on Leqvio (Inclisiran) for Hypercholesterolemia

Shots: Novartis has reported P-IV (V-DIFFERENCE) trial results evaluating Leqvio (n=898) vs PBO (n=872), both added to personalized lipid-lowering therapy (LLT), in 1,770 hypercholesterolemia pts not at guideline-recommended LDL-C goals Trial showed 85% vs 31% achieved their guideline-recommended LDL-C target after 90 days of treatment, with benefits seen as early as day 30 (81% on…

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