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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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ImmunityBio’s Anktiva + BCG Receives EC Conditional Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100) Trial showed a 71% CR rate, with a median duration of CR of 26.6mos., plus DoR range was as long as…

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Unnatural Products Signs ~$1.8B Licensing Deal with Novartis to Develop Macrocyclic Peptide Therapeutics

Shots: Unnatural Products has entered a research collaboration & licensing agreement with Novartis for an undisclosed cardiovascular program developed using UNP’s AI-enhanced macrocycle platform Under the deal, Novartis will handle IND-enabling studies & subsequent clinical development, manufacturing, & global commercialization of products emerging from the collaboration As per the terms, UNP will receive ~$100M in…

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Accord BioPharma’s Filkri (Biosimilar, Neupogen) Receives the US FDA Approval

Shots: FDA has approved Filkri, a biosimilar to Neupogen (filgrastim), for pts receiving myelosuppressive CT, those with AML receiving induction or consolidation CT, cancer pts undergoing bone marrow transplant, pts with sev. chronic neutropenia, & pts exposed to myelosuppressive radiation Approval was supported by 2 studies in healthy adults, with PK/PD assessed in one, &…

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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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Cytokinetics Reports the EC Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The EC has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with first EU launch expected in Germany by Q2’26 Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by…

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