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NEWS

Avenzo Therapeutics Join Forces with DualityBio to Develop AVZO-1418 (DB-1418) for Solid Tumors
Shots: Avenzo Therapeutics and DualityBio have signed an exclusive license agreement to develop, manufacture & commercialize the former’s AVZO-1418/DB-1418 across the globe (excl. Greater China) As per the terms, DualityBio will get $50M upfront, ~$1.15B development, regulatory and commercial milestones as well as tiered royalties in Avenzo’s territory AVZO-1418, an EGFR/HER3-targeting ADC developed…
January 8, 2025
Simpson Interventions Receives the US FDA’s 510(k) Clearance for its Shadow Catheter and IDE Approval for its Acolyte Catheter System
Shots: Simpson Interventions reported the grant of IDE by the US FDA to Acolyte Image-Guided Crossing & Re-Entry Catheter System plus 510(k) clearance for its Shadow Catheter Acolyte System intends to enables cardiologists with revascularization of coronary chronic total occlusion (CTO). In Mar 2024, it was designated with the US FDA’s BDD and included…
January 8, 2025
Fresenius Kabi
Fresenius Kabi Canada Receives Health Canada NOC for Otulfi (Biosimilar, Stelara)
Shots: Following the NOC approval of Tyenne (tocilizumab) & Idacio (adalimumab), Fresenius Kabi Canada has received Health Canada NOC for Otulfi (ustekinumab), a biosimilar to Stelara for Crohn's disease, ulcerative colitis, plaque psoriasis, and active psoriatic arthritis NOC approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent…
January 8, 2025
GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)
Shots: GlycoNex has reported a licensing agreement to develop SPD8, a biosimilar version of Amgen’s Prolia and Xgeva (denosumab) The licensee will secure rights for the development, regulatory activities & commercialization of SPD8 in the designated regions. The deal includes development and commercial milestones, supporting GlycoNex's global business operations SPD8 is under P-III…
January 7, 2025
Hologic Completes the Acquisition of Gynesonics for ~$350M
Shots: Hologic has completed the acquisition of Gynesonics, focused on developing minimally invasive women’s health solutions, for ~$350M The acquisition has strengthened Hologic's portfolio with the addition of Sonata System, a minimally invasive solution for heavy periods & fibroids The Sonata System is developed to capture intrauterine images for diagnosis and transcervical treatment…
January 7, 2025
Absci Corporation Collaborates with Invetx to Develop AI-Based Drug Creation Platform for Animal Health
Shots: Absci Corporation & Invetx have entered into a strategic collaboration to develop an innovative Half-Life Extension platform for animal health The alliance will leverage Absci’s generative AI models to develop modular antibody sequences in animals, while Invetx gains rights to use HLE platform for improving therapeutic effect duration & customer convenience of various…
January 7, 2025
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