Shots:
Saluda Medical has reported full commercial launch of EVA in the US following its approval in Dec 2024
Saluda Medical will present new clinical data on EVA and the Evoke SmartLoop System at ASPN 2025, featuring 11 abstracts, one oral presentation, & over 37 total publications, incl. 36-month efficacy results from the EVOKE Study…

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Quince Therapeutics has completed enrolment in its P-III (NEAT) trial to assess eDSP (6 infusions once every 21–30 days) vs PBO in Ataxia-Telangiectasia pts (n=105), incl. 83 pts (6-9yrs.) in primary analysis population & 22 pts aged ≥10yrs.
Trial will assess change from baseline to the last efficacy visit using RmICARS as the 1EP; pts…

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Nicox has granted Kowa exclusive global rights to develop & commercialize NCX 470 for glaucoma or ocular hypertension, excl. territories already licensed to Ocumension (China, Korea & Southeast Asia) & to Kowa (Japan)
As per the deal, Nicox will receive $8.7M (€7.5M) upfront & near-term milestones tied to positive topline P-III (Denali) trial data…

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The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster)
Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before use
Additionally, Shingrix prefilled…

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Accuro 3S ultrasound system & SpineNav-AI received FDA clearance to provide anatomical guidance during needle or catheter placement; further regulatory filings for advanced features are planned, alongside ongoing clinical collaborations, limited release, & upcoming full market launch
Accuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…

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FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026)
BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…

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Welcome to the 2025 edition of Know Your Investor, highlighting leading venture capital firms shaping the future of healthcare innovation
This edition highlights Invus, an investment firm focused on supporting life sciences companies committed to advancing breakthroughs that enhance public health
In 2024, Invus invested around $4.15B across six funding rounds, expanding its portfolio…

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AstraZeneca has reported P-III (CARES) trial findings assessing anselamimab (QW for 4wks. then Q2W till completion) + SoC vs PBO + SoC in pts (N=406) with stage IIIa (n=281) & stage IIIb (n=125) light chain (AL) amyloidosis
Trial did not meet its 1EP of time to all-cause mortality & frequency of CV hospitalisations. However,…