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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
Xcell Biosciences and ThermoFisher Enter Into a Joint Research Collaboration to Advance Cell Therapies
Shots: Xcell Biosciences entered into a strategic collaboration with ThermoFisher Scientific to advance the development of Treg and TIL cell therapies for autoimmune and solid tumor treatments The joint research aims to develop methodologies for enhancing the efficacy of Tregs and TILs, while streamlining and scaling cell therapy manufacturing for improved accessibility and reproducibility across…
June 25, 2025
DARZALEX (Daratumumab) Receives Positive CHMP Opinion for High-Risk Smouldering Multiple Myeloma
Shots: Janssen-Cilag (Johnson & Johnson) announced that the CHMP of the EMA has recommended approving DARZALEX (daratumumab) SC as the first therapy for adults with high‑risk smouldering multiple myeloma (SMM) The CHMP’s recommendation is based on the P-III (AQUILA) study data evaluating efficacy and safety of fixed-duration monotx. daratumumab SC compared with active monitoring (N=390)…
June 24, 2025
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