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NEWS

Accent Theraoeutics
Accent Therapeutics to Highlight Preclinical Data of ATX-559 and ATX-295 at AACR 2025
Shots: Accent Therapeutics to present preclinical data of ATX-559 (DHX9 inhibitor) & ATX-295 (KIF18A inhibitor) at AACR 2025 Presentation will highlight ATX-559’s activity in cancers exhibiting genomic instability & replication stress in in vivo models, incl. dMMR/MSI-H colorectal & BRCA-altered triple-negative breast cancer, plus ATX-295’s activity in ovarian cancer & its relation with whole genome…
March 26, 2025
GSK
GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)
Shots: The US FDA has approved Blujepa to treat uUTIs in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg) caused by E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus & E. faecalis; commercially available in H2’25 Approval was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing gepotidacin (1500mg, PO, BID for 5 days) vs nitrofurantoin (100mg, PO, BID for 5 days)…
March 26, 2025
Merck & Hengrui
Merck Partners with Jiangsu Hengrui Pharmaceuticals for HRS-5346, Expanding its Cardio-Metabolic Portfolio
Shots: Merck has entered into an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals for HRS-5346 As per the deal, Merck has obtained exclusive rights to develop, manufacture & commercialize HRS-5346 globally excl. Greater China region in exchange for $200M upfront & ~$1.77B in development, regulatory & commercial milestones, along with net sales-based royalties; closing expected…
March 25, 2025
Avatar Medical & FX Shoulder Solutions
Avatar Medical & FX Shoulder Solutions Reports the US FDA’s 510(k) Clearance of brAIn Shoulder Positioning System (SPS) for Arthroscopic Surgeries
Shots: The US FDA has granted 510(k) clearance to brAIn SPS for preoperative planning & implant placement in shoulder surgery brAIn SPS, developed via FX & Avatar, combines AI-driven imaging, with 3D avatar visualization for precise soft tissue assessment to optimize implant positioning & joint function while enhancing accuracy & recovery in comparison to conventional…
March 25, 2025
Alvotech and Xbrane
Xbrane Entered into an Agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) and Parts of its Organization for ~$27.25M 
Shots:  Xbrane has signed an agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) including related IP and parts of its organization, including 40 employees & laboratory equipment at ~$27.25M (~SEK 275M). The transaction closing is subject to approval from Xbrane's shareholders at the EGM on Apr 14, 2025, and FDI approval.   Xbrane will receive SEK…
March 21, 2025
Innovent
Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease
Shots: China’s NMPA has approved Sycume for the treatment of thyroid eye disease (TED) Approval was based on P-III (RESTORE-1) trial in TED pts, which met its 1EP in 2024, with 85.8% pts achieving ≥2mm proptosis reduction at 24wks., along with improved inflammation & QoL; data was presented at WOC, CSE, and CCOS Sycume (teprotumumab…
March 18, 2025
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