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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…
NEWS
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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…
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BMS has reported the P-II/III (SUCCESSOR-2) trial data assessing mezigdomide (PO) + carfilzomib & dexamethasone vs carfilzomib & dexamethasone alone in pts with r/r multiple myeloma
The P-III portion showed improved PFS (1EP), with safety consistent with the known profile of the regimen & mezigdomide. The trial will continue to follow pts for survival…
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Rapport Therapeutics has granted Tenacia exclusive rights to develop & commercialize RAP-219 in Greater China across indications, incl. focal onset seizures (FOS) & bipolar mania, with Rapport retaining rights in other territories
As per the deal, Rapport will receive $20M upfront & ~$308M in development & commercialization milestones & other payments, plus mid-single digits…
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FDA has granted priority review to Enhertu’s sBLA for adults with HER2+ breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment, with submission to be reviewed under Project Orbis (PDUFA: Q3’26); review is also ongoing in the EU & Japan
sBLA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu…
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GSK has granted Alfasigma worldwide exclusive rights to develop, manufacture & commercialise linerixibat for cholestatic pruritus in primary biliary cholangitis
As per the deal, GSK will receive $300M upfront, $100M upon FDA approval (based on PDUFA date of Mar 24, 2026), $20M upon EU & UK approval, & ~$270M in sales milestones, along with…

