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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…
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…
Rezon Bio’s Warsaw-Duchnice facility Receives the US FDA Approval for Commercial Manufacturing 
Shots:  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…
Sandoz
Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) 
Shots:  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),…
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…