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Bio-Thera Solutions and SteinCares Broaden Collaboration to Commercialize (Biosimilar, Dupilumab) in Latin America
Shots: Bio-Thera Solutions & SteinCares signed an agreement to commercialize a proposed dupilumab biosimilar for inflammatory diseases in Latin America As per the deal, Bio-Thera will handle product development and supply, while SteinCares manages registration and commercialization in Latin America Dupilumab (SC) is a fully human mAb that blocks IL-4 and IL-13 signalling pathways and…
June 26, 2025
Bio-Thera New
Bio-Thera Solutions Reports First Patient Dosing in P-III Study Evaluating BAT8006 for Pt Resistant Ovarian Cancer
Shots: Bio‑Thera reported the dosing of the first patient in a P‑III study assessing the efficacy of BAT8006 vs. the investigator’s choice of single-agent CT in individuals with Pt resistant high‑grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer Early clinical Data (N=133; irrespective of FRα expression or treatment history) presented at ASCO’25, from…
June 26, 2025
GSK Reports the EMA’s MAA Acceptance of Linerixibat for Cholestatic Pruritus
Shots: The EMA has accepted the MAA of Linerixibat to treat cholestatic pruritus in pts with primary biliary cholangitis (PBC) MAA was supported by the P-III (GLISTEN) study (n=238), which showed that Linerixibat significantly and sustainably improved cholestatic pruritus and itch-related sleep interference, meeting all 1EPs & 2EPs. The safety profile aligned with previous studies.…
June 26, 2025
Libertas Bio Licenses Gusacitinib to Sanofi
Shots: Formation Bio reported that its subsidiary, Libertas Bio, has licensed gusacitinib, an oral dual JAK/SYK inhibitor, to Sanofi, which will investigate it in a new, previously unstudied indication through a P-I trial The deal could total up to €545M ($627.64M), including upfront and milestone payments, along with low to mid-teen royalties on future sales…
June 25, 2025
Valorum Biologics and Formycon
Valorum Biologics and Formycon Collaborate to Commercialize FYB203 (Biosimilar, Eylea) Across US and Canada 
Shots:  Formycon has reported that Klinge Biopharma, holder of global rights to FYB203/Ahzantive (aflibercept-mrbb), has signed an exclusive licensing deal with Valorum Biologics for commercialization across the US and Canada  As per the deal, Klinge will receive upfront, milestone, and royalty payments on net sales. Formycon will receive a mid-single—to low-double-digit percentage of all payments…
June 25, 2025
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