The full weight of the federal government (and obvious public support) is being brought to bear on the development and approval of a vaccine for COVID-19. But what are the steps involved in that process?...more
In Sandoz Inc. v. Amgen Inc., No. 15-1039 (U.S. June 12, 2017) the Supreme Court held (i) that biosimilar applicants may provide the requisite 180-days’ notice of commercial marketing to the reference product sponsor even...more