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NEWS

Amgen and Kyowa Kirin Report Topline P-III (ASCEND) Study Results of Rocatinlimab in Moderate to Severe Atopic Dermatitis

Shots: The P-III (ASCEND) trial evaluated rocatinlimab (150 or 300mg, Q4W/Q8W) in ~2,600 atopic dermatitis pts who completed 24wks. in ROCKET trial program & continued for 32wks. in ASCEND, which will evaluate long-term safety & efficacy up to 104wks. Trial showed a favorable long-term safety profile (1EP) with low discontinuation rates due to AEs, consistent…
September 9, 2025

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Joshua Salsi from Biocon Biologics in a Riveting Conversation with PharmaShots
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Unlocking Approval: Joshua Salsi from Biocon Biologics in a Riveting Conversation with PharmaShots 

Shots:  The United States has about 38.4 million people living with diabetes, representing 11.6% of the total population. With growing prevalence, there is a significant unmet need for affordable diabetes medications.  Biocon Biologics recently announced the FDA approval of Kirsty, the first and only interchangeable biosimilar to NovoLog (Insulin Aspart).  Joshua Salsi, the Head of…
September 8, 2025

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Eli lilly
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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 &…
September 8, 2025

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Astrazeneca
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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…
September 8, 2025

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WEEKLY SNAPSHOT

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…
September 5, 2025

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Genentech
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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…
September 5, 2025

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NEWS

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…
September 5, 2025

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Merck new
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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…
September 3, 2025

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Novartis
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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…
September 2, 2025

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