Shots:
The US FDA has granted 510(k) clearance to Philips for its Spectral CT Verida system, an AI-powered detector-based spectral CT platform for diagnostic imaging
Verida integrates always-on spectral imaging with AI-based deep learning reconstruction to enhance image quality, reduce noise, and improve diagnostic precision across radiology, cardiology, and oncology applications
The system enables simultaneous…
NEWS
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Aligos has entered into an exclusive license agreement with Xiamen Amoytop Biotech, granting Amoytop rights to develop & commercialize pevifoscorvir sodium in Greater China for chronic hepatitis B virus (HBV) infection
As per the deal, Aligos will receive an $25M upfront & ~$420M in clinical, regulatory, & sales milestones along with tiered, high single-digit…
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Interna has entered into a research collaboration with Daiichi Sankyo via its Daiichi Sankyo Research Institute Boston to evaluate its MNM technology as a delivery enhancer for targeted therapeutic modalities
As per the deal, the companies will integrate MNM molecules with targeting approaches to enhance intracellular delivery & therapeutic performance, initially focusing on preclinical…
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The US FDA has accepted LEO Pharma's sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev. chronic hand eczema (CHE); regulatory review is ongoing in the EU
sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE…
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Mabwell has entered a licensing and commercialization agreement with a Malaysian partner for its denosumab biosimilars, Mailishu (biosimilar, Prolia) and Maiweijian (biosimilar, Xgeva)
As per the deal, the partner will handle registration and commercialization in Malaysia
While Mabwell will oversee the development, manufacturing, and supply of the products
Ref: Mabwell | Image: Mabwell | Press Release
Related News: Mabwell Initiates P-III Trial for 9MW2821 in TNBC…
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CareDx has entered a definitive agreement to divest its Lab Products business, incl. PCR & NGS-based transplant diagnostics, to EuroBio Scientific for $170M in cash
Divestiture aims to streamline operations and refocus on core Precision Medicine Testing Services and digital solutions, while retaining exclusive North America rights to distribute post-transplant monitoring IVD tests, incl. AlloSeq…
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The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults
Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup
Rapiblyk…
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The US FDA has granted clearance to Cala kIQ Plus system, a wearable neurostimulation device, for the treatment of action hand tremor in essential tremor (ET) & Parkinson's disease (PD)
The Cala kIQ device provides temporary relief of hand tremors in adults with essential tremor & Parkinson’s disease, incl. postural & kinetic tremors, using transcutaneous…
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Health Canada has approved ARS Pharma's neffy 2mg (adrenaline nasal spray) to treat allergic reactions (anaphylaxis) in adults & children (>30kg)
In Nov 2024, ARS Pharma granted ALK exclusive rights to commercialize neffy outside the US, incl. EU, Canada, UK, & select markets in exchange for $155M in upfront & milestones till date, ~$310M…
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The US FDA has granted Breakthrough Device Designation to the urine-based Multi-Cancer Early Detection (MCED) test
The non-invasive platform analyzes volatile organic compounds (VOCs) using spectroscopy & machine learning to detect multiple cancers from a single urine sample
The test provides an alternative to blood-based screening, supporting scalable population screening, while the designation enables…

