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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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FDA says yes to MedCognetics breast cancer screening AI

pharmaphorum

The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world. It cites data estimating there is ten-fold higher demand for radiology services than available capacity, with around half of practitioners “experiencing depression or burnout” due to “unmanageable caseloads.”

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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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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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Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. Evusheld was generally well-tolerated in the trials.

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Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

The Pharma Data

2-4 Evusheld was generally well-tolerated in the trial.(2-4). Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(10) and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function.