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PharmaShots Weekly Snapshots (March 10, 2025 – March 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars & Animal Health. Check out our full report below:   Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025  Read More: Incyte  Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at…

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Novo-Nordisk

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Shots: Novo Nordisk has reported P-III (REDEFINE 2) trial data assessing CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, QW, SC) vs PBO in 1,206 obese/overweight pts (~102Kg) and type 2 diabetes for 68wks., and followed flexible dosing protocol with 61.9% pts reaching highest dose after 68wks. Trial met its co-1EPs demonstrated 15.7% superior weight loss…

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Incyte

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Shots: Incyte has reported P-III (TRuE-PN: TRuE-PN1 & TRuE-PN2) clinical program data assessing Opzelura (BID) vs vehicle in ~180 PN pts (≥18yrs.) each for 12wks TRuE-PN1 showed ≥4-point WI-NRS4 improvement at 12wks. (1EP; 44.6% vs 20.6%), with itch relief by Day 7 (22.4% vs 8.0%). It also met its 2EPs, incl. higher IGA-CPG-S-TS score…

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

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below:    GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025  Read More: GSK  Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study…

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Astrazeneca

AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

Shots: AstraZeneca has reported P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (fluorouracil, leucovorin, oxaliplatin, & docetaxel) vs PBO + FLOT in 948 pts with stage II-IVA G/GEJ cancers Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi or PBO for Q4W × 12…

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Tris Pharma

Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots: Tris has reported topline data from P-III (ALLEVIATE-2) trial in post-bunionectomy pts, plus additional data from P-III (ALLEVIATE-1) trial in post-abdominoplasty pts. Data from both trials, plus HAP studies will support the US FDA’s NDA filing in 2025 ALLEVIATE-2 evaluated cebranopadol (400µg QD, PO) vs oxycodone (10mg QID, PO) vs PBO, meeting its…

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Hutchmed

HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China

Shots: HUTCHMED has reported enrollment completion in P-II trial of fanregratinib to treat intrahepatic cholangiocarcinoma (IHCC) in pts with FGFR2 fusion or rearrangement; favorable trial results will support NMPA’s NDA submission The P-II trial of fanregratinib will assess ORR as 1EP whereas PFS, DCR, DoR, & OS as 2EPs in pts (n=87). Topline data…

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