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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

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INSIGHTS+ Uncategorized

Disease of the Month – Angina 

Shots:  Characterized by discomfort or pain in the chest, Angina develops when the heart does not receive adequate oxygen-rich blood  PharmaShots' Disease of the Month report aims to familiarize the general population with conditions impacting communities worldwide. The report outlines disease characteristics, types, symptoms, diagnosis, treatments, epidemiology, market size, clinical trial analysis, patient advocacy groups (PAGs),…
June 25, 2025

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News

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

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GSK New
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GSK Receives the US FDA’s Approval for Benlysta to Treat Active Lupus Nephritis (LN)

Shots: The US FDA has approved Benlysta (belimumab) 200 mg/mL Autoinjector for SC use in pts (age≥5) with active LN receiving standard therapy Benlysta (belimumab) is a BLyS-specific inhibitor that reduces B cell survival and differentiation by binding to soluble BLyS, targeting autoreactive B cells. With this approval, GSK offers a first-of-its-kind at-home SC option…
June 25, 2025

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INSIGHTS+

New Drug Designations – May 2025  

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA    The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others   …
June 24, 2025

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