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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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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 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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The EC has approved a higher maintenance dose of Wegovy (7.2mg semaglutide; QW) for chronic weight management in adults with obesity across 27 EU countries
Assessed in STEP UP trial (1,407 adults without diabetes) & STEP UP T2D (512 adults with obesity & T2D) trial, Wegovy 7.2mg achieved 21% mean weight loss vs ~2%…
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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 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 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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The US FDA has accepted the NDA of iberdomide + daratumumab & dexamethasone (IberDd) for the treatment of pts with r/r multiple myeloma, with submission to be reviewed under Project Orbis (PDUFA: Aug 17, 2026)
NDA was supported by the planned analysis of MRD negativity rates in the P-III (EXCALIBER-RRMM) trial assessing IberDd vs…
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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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Teva & Sanofi have reported RELIEVE UCCD LTE study data evaluating duvakitug (450 or 900mg, SC, Q4W) in 130 pts with ulcerative colitis (UC) or Crohn’s disease (CD) following P-IIb (RELIEVE UCCD) induction study
Trial showed that at Wk. 44 of maintenance, 58% (900mg) & 47% (450mg) of UC pts achieved clinical remission per mMS,…

