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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, 20250Comments
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, 20250Comments
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, 20250Comments
News
Royalty Pharma Purchases Revolution Medicines’ Royalty Rights of Daraxonrasib for ~2B
Shots: Royalty Pharma acquiring Revolution Medicines’ royalties for daraxonrasib (P-III RASolute 302), providing up to $1.25B across five $250M milestone tranches, plus an additional $750M debt facility in three tranches Revolution received the $250M upfront, with future payments tied to P-III data (2026), FDA approval (by Jan 2028), and sales milestones, allowing access to further…
June 25, 20250Comments
Valorum Biologics and Formycon
Uncategorized
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, 20250Comments
GSK New
News
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, 20250Comments
News
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, 20250Comments
Verastem Oncology New
News
Verastem Oncology Reports First Patient Dosing with VS-7375  in P-I/IIa Study for KRAS G12D Advanced Solid Tumors
Shots: Verastem reported the dosing of the first patient (US) for P-I/IIa study (VS-7375-101) assessing the safety, tolerability, and efficacy of VS-7375 The dose-escalation phase of the study starts at 400mg, based on results from a P-I/II study conducted by GenFleet in China, and presented initial safety and efficacy data at ASCO’25 Upon reaching the…
June 25, 20250Comments