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CytoDyn scores $12M in legal battle win: A huge breakthrough for its antibody drug trials

BioPharma Reporter

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

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Top Three Reasons Why Your Medical Device Needs a Clinical Trial

Advarra

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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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.