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Magnus Medical’s SAINT Neuromodulation System Gets FDA Clearance to Treat MDD

XTalks

Magnus Medical received exclusive licensing rights to commercialize the SAINT (Stanford Accelerated Intelligent Neuromodulation Therapy) technology from Stanford University. The SAINT Neuromodulation Trial. The California-based medical device company develops brain stimulation technology to treat neuropsychiatric disorders.

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Novartis builds radio-oncology pipeline with iTheranostics deal

pharmaphorum

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body. . billion to buy targeted radioligand therapy Lu-PSMA-617 from Endocyte , shortly after encouraging results in a phase 2 prostate cancer trial.

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Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Remember, some staff may not need protocol-specific training. based sites.

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MIOTIFY platform for digital health products clears AZ road test

pharmaphorum

The Compliant Component Builder platform has already been put through its paces at AstraZeneca, which used it to build a new component to incorporate into one of its existing digital health tools, used for remote monitoring of patients in clinical trials. The algorithms used in healthcare are becoming more complex as well.

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Novartis expands in radio-oncology again with $1.3bn Artios alliance

pharmaphorum

In its second licensing deal in the radio-oncology area in consecutive weeks, Novartis has agreed a $1.3 Last week, it licensed a series of fibroblast activation protein (FAP) targeting agents from iTheranostics that can be used to image and potentially to treat tumours. That was acquired from Endocyte in 2018 in a $2.1

DNA 52
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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022.

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Getting approval will only be the first challenge facing lecanemab

pharmaphorum

First and most obviously is the detailed data from the Clarity AD study reported this week, which will be revealed at the Clinical Trials on Alzheimer’s Congress (CTAD) in November. There will still be much debate about the exact license granted to the drug and cost-effectiveness deliberations, according to Prof Passmore.