Lancefield serological group C Streptococcus dysgalactiae (GCSD) is an emerging cause of fish disease worldwide, largely associated with mariculture in Asia. In the United States (US), GCSD had been a pathogen of minimal concern for fish, but recent cases indicate a putative emergence in wild and cultured freshwater fish populations in the Americas. The current study discusses three novel cases of GCSD‐associated streptococcos...

Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. Following debate at the American Association of Pharmaceutical Sciences National Biotechnology Conference, a group was formed to address these gaps. Over the last 3 years, 44 members from...