Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's “misleading” GLP-1 advertising campaigns while an earlier Novo Nordisk lawsuit proceeds.
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well before a BLA filing to help avoid delays and common regulatory pitfalls. According to a just posted transcript, officials from CBER's Office of Therapeutic Products (OTP) outlined best practices for preparing BLA submissions, with a particular focus on first-time applicants developing advanced therapies.
