Since the mid-1980s, therapeutic monoclonal antibodies have become the fastest-growing class of therapeutics. This was due to the numerous pharmaceutical companies that were trying to find more drug ...

First in human (FIH) clinical trials of bispecific immunostimulatory antibodies commonly require a low starting dose based on a minimum anticipated biological effect level (MABEL) approach. To ...

insights from industryNatalie Strickland Global Head of Translational ScienceSynexa Life Sciences In this interview, News Medical speaks with Natalie Strickland, Global Head of Translational Science ...

Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...

Tailored EMA and FDA pathways may waive comparative efficacy studies when analytical and functional similarity are convincingly demonstrated, while preserving clinical confirmation for ...

Assessing the safety and efficacy of biotherapeutics is imperative during the drug development process. In particular, pharmacokinetic (PK) and anti-drug antibody (ADA) assays are conducted to study ...