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13 January 2016 | By Oxford Global
In anticipation of our 4th Annual Biosimilars & Biobetters Congress, we spoke to one our expert speakers about the some of the key issues in the industry...
All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should…
10 June 2015 | By Victoria White
Selecta Biosciences has initiated a Phase 1 study to assess the safety, pharmacodynamic profile, and immunogenicity of pegsiticase, a component of SEL-212...
Monoclonal antibodies have come of age as therapeutics; there are now more than 30 antibodies on the market and over 200 in clinical trials. The attractions of therapeutic antibodies lie not only in their potential to make potent drugs but also their relative low risk in comparison to small molecule…
3 June 2015 | By Victoria White
Inovio has said it will advance its DNA vaccine for MERS into a Phase I clinical trial in healthy volunteers in a collaboration with GeneOne Life Science...
