Shots:
Cepheid has received IVDR CE marking for the Xpert GI Panel, a multiplex PCR assay designed to detect 11 clinically relevant GI pathogens from a single stool sample using the 10-color multiplexing technology on GeneXpert Systems
The assay simultaneously identifies bacterial, viral, & parasitic pathogens directly from stool specimens in Cary-Blair transport media, requiring…
NEWS
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The GATHER1 & GATHER2 studies assessed Izervay (QM) vs sham in pts with GA secondary to AMD for 18 & 12mos., respectively, where in GATHER2, pts were later re-randomized to Izervay QM or Q2M for 24mos.
In the driving-eligible pts (BCVA of ≥70 ETDRS letters; n=403), Izervay reduced the risk of losing driving eligibility…
Shots:
IQVIA is expanding its collaboration with Kexing Biopharm to advance a global multi-product biosimilar development and commercialization program
As part of the collaboration, IQVIA will provide end-to-end development, regulatory, analytics, and commercialization support to accelerate Kexing’s global biosimilar expansion while maintaining high quality and scientific standards
The collaboration also integrates IQVIA’s AI-enabled clinical trial capabilities to streamline protocol design, site selection,…
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Trial assessed eneboparatide (ENB; QD, SC) vs PBO for 24wks. in 202 adults with HypoPT on active vitamin D & oral Ca supplements; Pts then continued ENB (ENB/ENB) or switched from PBO to ENB (PBO/ENB) in a 28wk. OLE
Trial met its composite 1EP, with 31.1% pts achieving normalized albumin-adjusted sCa levels & independence…
Shots:
Isomorphic Labs has reported a $2.1B Series B financing round led by Thrive Capital, with participation from existing investors Alphabet & GV alongside new backers MGX, Temasek, CapitalG, & the UK Sovereign AI Fund
The company plans to use the capital to further develop & deploy its AI-powered drug discovery platform, IsoDDE, accelerate internal…
Shots:
BI has entered into a global licensing agreement with Immunitas for a preclinical antibody program being developed for chronic inflammatory & autoimmune diseases
As per the deal, BI will obtain global rights to develop, manufacture, & commercialize the antibody program in exchange for an upfront payment, up to €407.5M (~$479.6M) in development, regulatory, &…
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Rigel has entered into an exclusive, global license agreement with Arvinas & Pfizer to develop, manufacture & commercialize FDA-approved Veppanu (vepdegestrant) for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer.
As per the deal, Rigel will pay Arvinas & Pfizer $70M upfront, $15M in upon completion of transition activities, & ~$320M in milestones plus tiered royalties…
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Tolion Health AI has launched Tolion Brain Coach, a new App within its Brain Health Platform designed to deliver personalized, preventive, & predictive insights for cognitive health using AI-driven analytics & wearable-device data
Platform leverages Tolion’s Knowledge Engine & Brain Score to generate tailored recommendations aimed at strengthening cognitive resilience & reducing neurodegenerative disease…
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Novo Nordisk has reported sub-analysis from the STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention for 72wks. in >1,400 obese adults without diabetes (BMI ≥30kg/m²)
Wegovy 7.2mg achieved 20.7% average weight loss vs 17.5% (2.4mg) & 2.4% (PBO); among early responders (≥15% loss by wk. 24), 26.9%…
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Exero Medical has reported clinical trial data assessing xBar monitoring system to detect post-operative anastomotic leaks in colorectal resection surgery pts (n=222)
Study showed that the xBar system detected post-operative anastomotic leaks in colorectal resection pts earlier than standard clinical practice, achieving 100% sensitivity & 88% specificity by post-operative day 3 & identifying leaks…

