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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…
Thermo Fisher Scientific to Divest Microbiology Unit to Astorg for ~$1.08B
Shots: Thermo Fisher Scientific has agreed to sell its microbiology business to Astorg for ~$1.075B, incl. cash & a $50M seller note, as part of its portfolio optimization strategy The divested unit, which offers antimicrobial susceptibility testing and culture media solutions, generated $645M in revenue in 2025 and operates within Thermo Fisher’s Specialty Diagnostics segment…
Eli Lilly to Acquire Ajax Therapeutics for ~$2.3B
Shots: Eli Lilly has entered into a definitive agreement to acquire Ajax Therapeutics, incl. its lead asset AJ1-11095, strengthening Lilly's capabilities in blood cancers As per the deal, Lilly will acquire Ajax for ~$2.3B in cash, inclusive of an upfront payment & subsequent clinical & regulatory milestone payments AJ1-11095 (PO, QD), a Type II JAK2…
Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression
Shots: The US FDA has granted IDE approval to initiate RESONATE Early Feasibility Study of Motif XCS System in pts with treatment-resistant depression, who have received ≥2 medications The trial will assess 12mos. safety of Motif XCS System & procedure post-implantation & measure symptom reduction, quality of life, anxiety, & cognitive function using standard assessments…
Tanabe Pharma Report the EC Approval of Onerji for Parkinson’s Disease (PD) 
Shots:  The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm   Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the…