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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…
NEWS
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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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The US FDA grants approval for commercial manufacturing of a biosimilar at Rezon Bio’s Warsaw-Duchnice facility
The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and indicates that the site meets regulatory standards for quality systems, technical capabilities, and operational readiness to supply the US market
This approval follows earlier EMA GMP certification and authorization for commercial…
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The US FDA has approved Enzeevu, a biosimilar version of Eylea (aflibercept), for multiple retinal indications, with an anticipated launch in Q4’26
Aflibercept is a recombinant fusion protein that blocks VEGF-A and PlGF, inhibiting abnormal blood vessel growth
Enzeevu (aflibercept-abzv) is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO),…
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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…

