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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
Teva Launches Ahzantive (Biosimilar, Eylea) Across Key EU Markets
Shots: 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…
June 5, 2026
Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)
Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept)  Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…
June 4, 2026
Lundbeck Partners with Cradle to Accelerate AI-Driven Biotherapeutics Discovery
Shots: Lundbeck and Cradle entered a partnership to leverage AI-powered protein engineering for the discovery and optimization of biotherapeutics, with an initial focus on 2 antibody programs targeting CNS diseases Lundbeck will deploy Cradle’s generative AI platform in its first end-to-end AI-guided protein engineering workflow, using iterative feedback from experimental data to discover & optimize…
June 4, 2026
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