News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
CDMO AGC Biologics will produce Tzield (teplizumab-mzwv), a recently-approved T1D treatment from Provention Bio, at its Seattle protein biologics manufacturing site.
The FDA wants to simplify COVID-19 immunizations and will discuss various ideas for future immunization strategies at an advisory committee meeting this week.
Amgen joins the Winn Award Program that was set up by Bristol Myers Squibb, with plans to extend the reach of clinical trials into underserved patient populations in the US.
Regenxbio has begun recruiting for its Phase I/2 gene therapy trial in Duchenne muscular dystrophy (DMD).
In the US, 2022 heralded the next chapter for biosimilars, including US FDA approval of in new therapeutic areas, additional interchangeable designations, and litigation relating to biosimilars of more recent biologics.