Shots:
BI has reported P-III (SYNCHRONIZE-1) trial assessing survodutide (BI 456906; 3.6 or 6mg, QW) vs PBO in 725 adults living with obesity or overweight, without type 2 diabetes
Trial met co-1EP, with ~85.1% achieving ≥5% weight loss vs 38.8%, & 16.6% sustained mean loss vs 3.2% after 76wks. (efficacy estimand), mainly driven by fat…
NEWS
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…
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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…
J&J Receives the US FDA Priority Review for Imaavy to Treat Warm Autoimmune Hemolytic Anemia (wAIHA)
Shots:
The US FDA has accepted sBLA & granted priority review to J&J's Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA)
sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period
Trial showed that pts treated with Imaavy…
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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…
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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…
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The US FDA has approved AstraZeneca’s Saphnelo pen (anifrolumab; 120mg, SC, QW, autoinjector) for the treatment of adults with SLE in combination with SoC
Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo pen vs PBO in 367 pts (18-70yrs.) with mod. to sev. SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP); full…
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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…
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The EC has approved Xolremdi (Mavorixafor), under exceptional circumstances, for the treatment of WHIM syndrome
Approval was supported by the global pivotal P-III (4WHIM) trial, PBO-controlled 52-wk study evaluating mavorixafor’s efficacy & safety in pts ≥12 yrs with WHIM syndrome
Xolremdi (PO, QD), a CXCR4 antagonist, is used in pts ≥12 yrs with WHIM syndrome to increase circulating mature neutrophils & lymphocytes
Ref: X4…
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The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions
Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…

