FDA rejected Pfizer’s Biologics License Application for its proposed epoetin alfa biosimilar to Amgen’s Epogen, citing significant violations of good manufacturing practice regulations for finished pharmaceuticals at the company’s drug manufacturing facility, Hospira Inc., in McPherson, KS.
The Biden administration has left NIH in a weakened state, intensifying politicization of science on Capitol Hill and eroding the bipartisan support the government’s premier biomedical research agency has traditionally enjoyed.
