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NEWS

Gedeon Richter
Gedeon Richter Receives the EC Approval for Tuyory (Biosimilar, RoActemra) 
Shots:  The EC has approved Tuyory, a biosimilar version of RoActemra (Tocilizumab) across the EEA countries   Tuyory (tocilizumab) inhibits IL-6 signaling and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis (including polyarthritis), giant cell arteritis, cytokine release syndrome, and COVID-19. It is available in both IV and SC forms, with dosing and presentations matching the reference product   Tuyory was co-developed by Gedeon Richter and Mochida Pharmaceutical …
Kestrel Therapeutics Inks AbbVie Deal Worth up to $1.45B with Option to Acquire
Shots: Kestrel has entered into a strategic agreement with AbbVie, structured as a warrant deal, granting AbbVie an exclusive option to acquire Kestrel upon achievement of key development milestones As per the deal, AbbVie will fund development of KST-6051, with an exclusive option to acquire Kestrel based on development & regulatory milestone completion, representing the…
Profluent Signs ~$2.25B Pact with Eli Lilly to Advance AI-Designed Recombinases for Genetic Medicines
Shots: Profluent has entered into a multi-program strategic research collaboration with Eli Lilly to develop & commercialize custom site-specific recombinases to address diseases with unmet needs As per the deal, Profluent will use its AI models to design & optimize site-specific recombinases for multiple genomic targets, while Lilly will gain exclusive rights to selected assets…
CareDx to Acquire Naveris for ~$260M
Shots: CareDx has entered into a definitive agreement to acquire Naveris, extending CareDx’s Precision Medicine Testing Services strategy into specialty oncology As per the deal, CareDx will acquire Naveris for $160M upfront & up to $100M in revenue milestones; closing is expected in Q3’26 Naveris’ liquid biopsy platform uses TTMV DNA to detect viral DNA…
Astrazeneca
AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma
Shots: The US FDA has approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) for the maintenance treatment of asthma in pts (≥12yrs.); regulatory review is ongoing in the EU, Japan & China Approval was based on the P-III (LOGOS & KALOS) trials evaluating Breztri Aerosphere vs PT009, Symbicort, and PT009 + Symbicort in ~4,300…
Pixee Medical’s Knee+ NexSight Receives the US FDA 510(k) Clearance for Knee Arthroplasty
Shots: The US FDA has granted 510(k) clearance to Knee+ NexSight, its AR-based total knee arthroplasty solution Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need of robot, console, or disposables, while delivering robotic-level accuracy with less invasive tools, reduced blood loss, & seamless workflow integration Knee+ NexSight supports…