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Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)
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…
June 8, 2026
Nurix Therapeutics Inks ~$3B Deal with Roche to Advance Bexobrutideg
Shots: 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…
June 8, 2026
Health Canada Accepts the MAA for Kashiv BioSciences’ ADL-018 (Biosimilar, Xolair)
Shots: 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…
June 5, 2026
Chiesi Reports the EC Approval of Lojuxta to Treat Homozygous Familial Hypercholesterolaemia in Pediatric Patients
Shots: 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…
June 5, 2026
Pfizer Licenses Chai Discovery’s AI Platform to Accelerate Biologics Research
Shots: 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…
June 5, 2026
Lupin Receives US FDA Approval for Ranluspec (Biosimilar, Lucentis) 
Shots:  The US FDA has approved Ranluspec (ranibizumab-hkdz), a biosimilar version of Lucentis (ranibizumab)  Ranluspec is an interchangeable ranibizumab biosimilar approved in the US, available in both vials and PFS at 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL) strengths, matching Lucentis  It is a recombinant humanized IgG1 mAb fragment that inhibits VEGF-A and is indicated for wet age-related macular degeneration,…
June 5, 2026
Henlius Reports First US Patient Dosed in Global P-I Trial of HLX17 (Biosimilar, Keytruda) 
Shots:  Shanghai Henlius has dosed the first US patient in the global P-I trial of HLX17, a biosimilar version of Keytruda (pembrolizumab), for the adjuvant treatment of multiple resected solid tumors  P-I multicentre study evaluates the PK, efficacy, safety, and immunogenicity of HLX17 vs Keytruda in pts with resected solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma.…
June 5, 2026
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