Shots:
Engitix & GSK have entered a strategic research collaboration & option agreement to identify & validate novel therapeutic targets that drive liver fibrosis regression using Engitix’s human extracellular matrix (ECM) platform & multi-omics datasets
As per the deal, Engitix will receive ~£44.5M (~$59.3M) upfront & near-term payments, along with ~£118M (~$157.3M) per target in…
Shots:
The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease
BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…
Shots:
In TRIUMPH-1 trial & nested studies in knee osteoarthritis pain & OSA, retatrutide met all 1EPs at 80wks., with weight loss of 25.9% (9mg) & 28.3% (12mg). At 12mg, 65.3% pts achieved a BMI <30 & 33.3% reached BMI <25, while those with BMI ≥35 lost ~85 lbs through 104wks. It also reduced WOMAC…
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Nurix has entered a global collaboration with Roche to develop & commercialize bexobrutideg (PO), a BTK targeted protein degrader, which is under P-II/III trial for chronic lymphocytic leukemia
Nurix will receive $700M upfront & ~$2.3B in milestones. Development costs will be shared (40% Nurix & 60% Roche), with both co-commercializing the drug & equally…
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AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression
Trial showed a 46.6% reduction in 24-hr. UPCR from baseline at 34wks. vs 5.6% with PBO, as early as Wk. 10 & sustained through 34wks. The results were consistent…
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Kashiv BioSciences has reported that Health Canada has validated and accepted the MAA for ADL-018, a biosimilar version of Xolair (omalizumab)
Omalizumab is approved for multiple allergic & inflammatory conditions, incl. mod. to sev. persistent asthma (≥6yrs.), CRSwNP (≥18yrs.), chronic spontaneous urticaria (≥12 yrs.), & IgE-mediated food allergy (>1yr.)
Additionally, Alvotech & Kashiv BioSciences have…
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The EC has approved Lojuxta (lomitapide capsules) for the treatment of children (≥5yrs.) with Homozygous Familial Hypercholesterolaemia (HoFH), alongside diet & other lipid-lowering treatments, incl. LDL-apheresis
Approval was based on the P-III (APH-19) trial evaluating Lojuxta in 43 pediatric pts (5 to 17yrs.) with HoFH
Trial met its 1EP, showing a mean 53.5% reduction…
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Pfizer & Chai Discovery have entered into a licensing agreement, allowing Pfizer to integrate Chai’s AI-driven drug discovery platform into its biologics research workflows
As per the deal, Pfizer will integrate Chai’s AI platform into its drug discovery engine, gaining early access to the Chai-3 model & a customized AI model built using Pfizer’s…
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Teva has launched Ahzantive, a biosimilar version of Eylea, in EU, with pre-filled syringe launches beginning in May 2026 in France, Germany, Spain, & the Netherlands, and additional market launches planned later in 2026
Ahzantive received EC approval in 2025 for the treatment of wet age-related macular degeneration, diabetic macular edema, visual impairment due…
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Otsuka reported the ongoing P-III (VISIONARY) trial data assessing Voyxact (sibeprenlimab; n= 320) vs PBO (n=152) in preserving kidney function in IgAN pts over a 24mos. treatment period
At 12mos., Voyxactimproved kidney function with a mean eGFR change from baseline of +0.7 vs -4.8 mL/min/1.73 m², achieving the KDIGO treatment goal of limiting annual kidney…

