Notizia - Recent Pharma, Healthcare and Biotech Happenings

Novo petitions FDA to require copies of Victoza to conduct clinical trials With one drugmaker already trying to pry patent protection off of Novo Nordisk’s blockbuster Victoza before its 2022 expiration, the insulin specialist has taken new steps to deter copies. The Danish drugmaker has filed a citizen petition arguing the manufacturing process for its drug is so complex that equivalence of a copy couldn’t be certain without clinical trials. Actually, the petition, which Novo filed last week, asks the FDA to refrain from approving ANDAs that reference any of its liraglutide-containing drugs, which include Saxenda and Xultophy in addition to Victoza, the dominant GLP-1...