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Top Three Reasons Why Your Medical Device Needs a Clinical Trial

Advarra

While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. This is how the product achieves its therapeutic effect.

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Eli Lilly Designs P-Tau Biomarker Assay for Early Alzheimer’s Disease Diagnosis

The Pharma Data

Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November. Detection – a ruthenium-labeled isoform-specific anti-tau antibody.

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Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa. Developing an efficacious vaccine against malaria has been a huge challenge.

Vaccine 105
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Can your LNP manufacturing platform cope with the pace of the mRNA revolution?

Pharmaceutical Technology

LNPs are an adaptable, modular technology and when combined with microfluidic mixing, have the potential to accelerate development and commercialisation timelines and provide drug developers with an early foothold into a largely untapped market. There was a lot of cynicism and questions, like: ‘Why would you want to use single use?