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Takeda

Takeda Reports Positive P-III (KEPLER) Results of Entyvio in Pediatric Ulcerative Colitis

Shots: Takeda reported positive data from the global P-III (KEPLER) study evaluating IV ENTYVIO (vedolizumab) in children and adolescents (ages 2–17) with moderate to severe ulcerative colitis (UC) who had inadequate response to conventional therapies and/or TNF antagonists Nearly half (47.3%) of pts achieved the 1EP of clinical remission at Wk. 54, while 34.7% achieved…

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ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients

Shots: The P-III (LATITUDE) trial assessed Cabenuva (cabotegravir + rilpivirine) in 453 adults facing adherence challenges, where 306 virally suppressed pts were randomized to Cabenuva (Q4W; n=152) or ART (QD, PO; n=154), with results published in The NEJM At 48wks., Cabenuva reduced the cumulative risk of regimen failure (1EP) to 22.8% vs 41.2%, with fewer virologic failures…

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Eli lilly

Eli Lilly Reports the P-IIIb (TOGETHER-PsO) Trial Data on Taltz + Zepbound for Adults with Psoriasis and Obesity or Overweight

Shots: Eli Lilly has reported P-IIIb (TOGETHER-PsO) trial data assessing Taltz (ixekizumab) + Zepbound (tirzepatide) vs Taltz alone in 274 adults with mod. to sev. plaque psoriasis & obesity/overweight with ≥1 additional weight-related comorbid condition At 36wks., the trial met its 1EP with 27.1% pts reaching PASI 100 & ≥10% weight loss compared to 5.8% pts. Trial…

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Novartis

Novartis Reports Topline P-III (RemIND) Trial Results on Remibrutinib in Chronic Inducible Urticaria (CIndU)

Shots: Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines Trial met its 1EP for the three prevalent subtypes of CIndU, incl. symptomatic dermographism, cold urticaria, & cholinergic urticaria, delivering significantly higher complete response rates at Wk. 12 Additionally, Novartis has submitted…

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Pfizer New

Pfizer Reports P-III (BREAKWATER) Trial Cohort 3 Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)

Shots: Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC In Cohort 3, the combination improved PFS as assessed by BICR, with OS showing meaningful prolonged improvement; ORR results were…

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Eli lilly

Eli Lilly Reports P-III (LIBRETTO-432) Trial Findings on Retevmo (Selpercatinib) in RET Fusion-Positive NSCLC

Shots: Eli Lilly has reported P-III (LIBRETTO-432) trial data assessing Retevmo vs PBO in 151 pts with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy, if indicated Trial met its 1EP, showing improvement in investigator-assessed EFS in early-stage (II-IIIA) pts, plus OS data was immature but demonstrated a…

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Innocare Pharma

InnoCare Pharma Reports First Patient Dosing in P-II/III Trial of Soficitinib for Chronic Spontaneous Urticaria

Shots: InnoCare has dosed the first patient with soficitinib (ICP-332) in the P-II/III trial for the treatment of chronic spontaneous urticaria Additionally, the company has completed enrolment in soficitinib’s P-III trial for mod. to sev. atopic dermatitis & P-II trial for vitiligo Soficitinib (ICP-332) is a selective TYK2 inhibitor in development for T-cell–mediated autoimmune diseases,…

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