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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.…
NEWS
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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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Curatis & Neupharma have entered into an exclusive license & development agreement for Corticorelin (C‑PTBE‑01) in Japan to treat Peritumoral Brain Edema
As per the deal, Neupharma will develop & commercialize corticorelin in Japan & fund a pivotal trial to support PMDA approval, in exchange of upfront & regulatory & commercial milestones totaling up…
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The US FDA has cleared all QIAstat-Dx GI Panels for use on the QIAstat-Dx Rise automated syndromic testing system
The clearance enables laboratories to run both GI and respiratory panels on the high-throughput platform, which can process up to 160 tests/day, run 16 samples per batch, and deliver results in ~1hr. using real-time PCR…
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The EMA has received MAA of Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults
MAA was supported by the 3 P-III (CLARITY) trials evaluating Vizz (QD) across the US, in which Vizz met all 1 & 2EPs, showing rapid near vision improvement within 30min., lasting up to 10hrs.
Additionally, LENZ…
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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 &…
Pulse Biosciences Reports Clinical Data on nPulse Vybrance System for Benign Thyroid Nodule Ablation
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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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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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The P-II trial consists of 4 overlapping stages: Stage 1 (vs PBO) for tilrekimig & ompekimig; Stage 2 (dose-ranging) & Stage 3 (ongoing) evaluated tilrekimig, with Stage 3 involving biologic-experienced adults; Stage 4 is an ongoing ompekimig dose-ranging study
Trial met its 1EP with more pts achieving EASI-75 at Wk. 16; PBO-adjusted rates were…
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Agilent Technologies has entered into a definitive agreement to acquire Biocare Medical from investor groups led by Excellere Partners & GHO Capital Partners
As per the deal, Agilent will acquire Biocare in an all-cash transaction valued at $950M, with closing anticipated by Q4’26, after which Biocare will become a part of the Agilent Life…

