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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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Medtronic to Acquire Scientia Vascular for $550M

Shots: Medtronic has entered into a definitive agreement to acquire Scientia Vascular, expanding its neurovascular device portfolio As per the deal, Medtronic will acquire Scientia Vascular for $550M, with potential undisclosed earn-out & milestone payments post-acquisition Acquisition will integrate Scientia’s access platform with Medtronic’s neurovascular therapies to support the full procedural workflow for hemorrhagic &…

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Pulse Biosciences Reports Clinical Data on nPulse Vybrance System for Benign Thyroid Nodule Ablation

Shots:  Pulse Biosciences has reported clinical data from the ablation study (n=21), an extension of the initial feasibility study, to assess the outcome durability of the nPulse Vybrance Percutaneous Electrode System for benign thyroid nodules Long-term follow-up showed durable efficacy with ~74% average volume reduction in treated benign thyroid nodules at 15-22mos., continued reduction was…

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J&J

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Approval was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…

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