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Avita Medical

AVITA Medical Launches Cohealyx for Wound Healing in the US

Shots: AVITA Medical has launched Cohealyx, collagen-based dermal matrix in the US Cohealyx is currently being evaluated in the post-market Cohealyx I trial (enrolment ongoing) to further assess clinical outcomes, wound bed preparation for definitive closure, & patient recovery timelines Cohealyx, developed by AVITA & Regenity Biosciences, is designed to support cellular migration & revascularization, allowing…

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Netramark & Worldwide Clinical Trials

NetraMark Join Forces with Worldwide Clinical Trials to Redefine Clinical Trial Design Using NetraAI Platform

Shots: NetraMark and Worldwide Clinical Trials have entered into a global agreement to utilize NetraMark’s NetraAI platform to advance clinical trial design As per the deal, NetraAI will initially support P-II neuroscience & oncology trials, plus select P-III studies conducted by Worldwide, with broader access extended to Worldwide’s sponsors across all therapeutic areas & trial…

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Daiichi Sankyo & Astrazeneca

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regions Trial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…

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BBOT

BridgeBio Oncology Therapeutics Reports the First Patient Dosing in P-I (KONQUER-101) Trial of BBO-11818 for Advanced Solid Tumors

Shots: BBOT has reported first pts dosing in its P-I (KONQUER-101) trial assessing BBO-11818 for advanced solid tumors, with trial enrolling pts globally In cellular assays, BBO-11818 showed pERK inhibition in selected KRAS G12D & G12V-mutant cell lines at lower concentrations, while reducing viability in KRAS G12D/G12V/G12C mutant cells & exhibiting >500-fold selectivity for KRAS…

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Accord Healthcare

Accord Healthcare Reports the CHMP’s Positive Opinion on Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025 Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…

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Dotmatics 

Siemens to Acquire Dotmatics for $5.1B, Strengthening its Position in Life Science Market

Shots: Siemens has entered into an agreement to acquire Dotmatics for $5.1B from Insight Partners, strengthening its position in the life science market Acquisition will integrate Siemens' manufacturing, industrial simulation, & AI expertise with Dotmatics' complementary offerings, creating an AI-powered product lifecycle management (PLM) portfolio as part of Siemens Xcelerator for seamless R&D-to-manufacturing connectivity  Siemens will…

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Medivis

The US FDA Grants 510(k) Clearance to Medivis’ Spine Navigation Platform

Shots: The US FDA has granted 510(k) clearance to Spine Navigation platform; commercially launched in the US, making it available nationwide to hospitals & ambulatory surgical centers Spine Navigation integrates AI-driven surgical intelligence, real-time insights, & advanced imaging with lightweight AR hardware allowing surgeons ergonomic freedom using hand tracking & voice control in neuro &…

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