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Genentech

Genentech (Roche) Reveals P-III Trials Findings on Fenebrutinib in Relapsing and Primary Progressive Multiple Sclerosis

Shots: Genentech has reported the P-III trials results, incl. FENhance 2 study assessing fenebrutinib (PO) vs teriflunomide in 1,497 adults with RMS for ~96wks. Trial met its 1EP of reduced annualized relapse rate over ~96wks. with favorable liver safety; additional safety data will be further evaluated; data to be presented in future meeting, along with…

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Merck

Merck Reveals P-III (CORALreef HeFH) Trial Data on Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)

Shots: Merck has highlighted P-III (CORALreef HeFH) trial data assessing enlicitide decanoate (20mg, PO, QD) vs PBO in 303 adults with HeFH at AHA’25 Trial showed significant LDL-C reductions (1EP), along with decreases in non-HDL-C (53%), ApoB (49.1%), & Lp(a) (27.5%) at Wk. 24 in HeFH pts on stable background lipid-lowering therapy. High adherence (97%) &…

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PharmaShots Weekly Snapshots (Nov 03, 2025 – Nov 07, 2025)

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:     Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC  Read More: Daiichi Sankyo  Genentech Reports P-III (ALLEGORY) Trial…

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Novo-Nordisk

Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data on CagriSema for Cardiovascular Risk Factors

Shots: The post hoc analysis of P-III (REDEFINE 1) trial assessed CagriSema (cagrilintide 2.4mg & semaglutide 2.4mg) vs PBO & individual components effects on CV risk factors in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without T2D Trial showed CagriSema reduced systolic BP by -10.9 mmHg over 68wks. (vs -8.8 with semaglutide, & -2.1 with PBO),…

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Genentech

Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)

Shots: Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE period Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…

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Daiichi Sankyo

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC

Shots: Daiichi Sankyo has dosed the first patient with Enhertu in combination with Keytruda in the P-III (DESTINYLung06) trial as a 1L treatment for unresectable, LA/M HER2 overexpressing & PD-L1 (TPS<50%) non-squamous NSCLC Trial will assess Enhertu (5.4mg/kg) + Keytruda vs Keytruda + Pt-based CT + pemetrexed as the 1L treatment in the mentioned pts…

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