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Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia

Shots: Aplagon has dosed the first patient with APAC (IV) in its P-IIa (HEALING) trial in Finland for peripheral arterial occlusive disease (PAOD), leading to chronic limb-threatening ischemia (CLTI) Trial will evaluate APAC in ~42 CTLI pts across 4 cohorts to assess safety, efficacy, & effects on thrombo-inflammatory biomarkers. Additionally, an associated PET imaging study with…

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Insulet Reports EVOLUTION 2 Study Results for FCL Automated Insulin Delivery System in Type 2 Diabetes

Shots: Insulet has presented data from the EVOLUTION 2C feasibility study (n=24, 16-70yrs.) assessing its fully closed-loop (FCL) automated insulin delivery system (AID) for T2D at the ATTD’26 Trial showed that the final FCL algorithm increased TIR to an average of 68% with no boluses, a 24% improvement vs standard injection therapy, while TBR remained…

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George Medicines Partners with Ahngook Pharmaceutical to Commercialize GMRx2 in Korea

Shots: George Medicines has entered into an exclusive licensing & supply agreement with Ahngook Pharmaceutical, granting rights to seek regulatory approval & commercialize GMRx2 in Korea for the treatment of Hypertension As per the deal, George Medicines will receive an upfront licensing fee, potential regulatory & commercial milestone payments, as well as stepped royalties on…

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C2N Diagnostics Partners with BeauBrain Healthcare to Offer PrecivityAD2 Blood Test for Alzheimer’s Disease in South Korea

Shots: C2N Diagnostics has entered into an agreement with BeauBrain Healthcare to offer PrecivityAD2 blood test for use in pts (≥50yrs.) with signs or symptoms of mild cognitive impairment or dementia in South Korea Study in The JAMA showed PrecivityAD2 improved diagnostic accuracy of Alzheimer’s disease vs SoC, while research in npj Dementia showed that the test demonstrated 91%…

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UCB Reports P-III (BE BOLD) Trial Results on Bimzelx (Bimekizumab) in Active Psoriatic Arthritis

Shots: UCB has reported the P-III (BE BOLD) trial data assessing Bimzelx vs risankizumab in 553 adults with active psoriatic arthritis, who are either biologic-naïve or were treated with TNF inhibitor with an inadequate or intolerant response Trial met its 1EP, showing superiority over risankizumab in reducing disease activity, as measured by ACR50, at Wk.…

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ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

Shots: The US FDA has granted FTDto ATX-01 for the treatment of Myotonic Dystrophy Type 1 (DM1) ATX-01 showed increased free MBNL, improved splicing abnormalities, & restored function in animal models, & is being evaluated in the P-I/IIa (ArthemiR) study ATX-01 is an RNA-based therapeutic designed to inhibit miR-23b, which results in increased MBNL protein…

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