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Trial assessed Lilly’s retatrutide (4, 9 & 12mg) with dose escalation vs PBO in adults with obesity/overweight & ≥1 weight-related comorbidity & without diabetes, meeting 1EP of 19% (4mg), 25.9% (9mg) & 28.3% (12mg) weight loss at 80wks.
In 2EPs, retatrutide reduced waist circumference by 16.3cm (4mg), 21.8cm (9mg), & 24.1cm (12mg) vs 3.6cm.…
NEWS
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The US FDA has accepted sNDA & granted Priority Review to Kerendia (finerenone) for the treatment of chronic kidney disease (CKD) associated with type 1 diabetes (T1D)
sNDA was supported by the global P-III (FINE-ONE) trial assessing Kerendia (10 or 20mg, QD) + SoC vs PBO in 242 pts with CKD associated with T1D
Kerendia…
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Medtronic has announced its intent to acquire SPR Therapeutics for an upfront payment of ~$650M, aiming to expand its neuromodulation portfolio with temporary peripheral nerve stimulation (PNS) tech for chronic pain management
Acquisition will add SPR’s FDA-cleared SPRINT PNS System to Medtronic’s pain management portfolio, which showed over 71% pts experienced significant pain relief…
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The CHMP has recommended Vijoice (alpelisib) for pts (age≥2 yrs) with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders who require systemic therapy
EMA’s recommendation is supported by a retrospective study of 57 PROS pts (age≥2 yrs) treated with alpelisib through a compassionate use program. Pts achieving at least a 20% reduction in the size of 1–3 abnormal growths or tumours after 24 wks, based…
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The CHMP has recommended Jascayd (nerandomilast) for the treatment of adults with IPF and PPF
Opinion was supported by the P-III (FIBRONEER-IPF and FIBRONEER-ILD) trials; both trials met their 1EPs, showing nerandomilast slowed lung function decline vs PBO through Wk-52. Nerandomilast also demonstrated a favorable safety/tolerability profile, with no liver monitoring requirement and PBO-like discontinuation rates as monotx.
Jascayd (PO, BID) is a PDE4B inhibitor with antifibrotic and…
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Reflow Medical has reported the DEEPER CORONARY study results evaluating the short-term safety of the coronary Spur Elute Sirolimus-Eluting Retrievable Stent System for coronary ISR at EuroPCR 2026
6mos. results showed 100% freedom from MACE & all-cause mortality in nine treated pts, while all patients demonstrated improved CCS angina class with a median improvement of…
Shots:
Eli Lilly has acquired Engage Biologics, combining Engage’s Tethosome platform with Lilly’s genetic medicines capabilities & portfolio
As per the deal, Eli Lilly acquired Engage for ~$202M in cash, incl. an upfront payment and subsequent development milestones payments
The Tethosome platform is a non-viral DNA delivery system that combines engineered DNA payloads, lipid nanoparticles,…
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Incyte and Genesis have expanded their collaboration to accelerate the discovery of novel molecules for Incyte-selected targets by deploying Genesis’ GEMS molecular AI platform across a broader range of challenging targets in Incyte’s portfolio
Incyte will provide experimental data to enhance GEMS’ capabilities, plus the companies will add ≥5 new targets, with options for…
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QIAGEN to integrate its Digital Insights bioinformatics business with NVIDIA accelerated computing & the NVIDIA BioNeMo platform to strengthen AI applications in drug discovery
Partnership leverages graph-based AI that apply retrieval & reasoning techniques across biomedical knowledge graphs to help researchers analyze complex biological data & validate AI-generated insights, supporting practical applications across the…
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Pfizer has reported its P-II trial data assessing the safety, tolerability & immunogenicity of a 4 dose series of PF-07872412 (25vPnC) vs 4 doses of PREVNAR 20 at mos. 2, 4, 6 & 12-15 in infants
25vPnC vaccine generated higher immune responses against serotype 3 vs Prevnar 20, with geometric mean titers 8.8-fold higher…

