Positive cardiovascular outcomes data for Victoza were outlined at ADA, and Novo Nordisk said it plans to file an sNDA with FDA seeking a broad indication to include reduction in major adverse cardiac events (MACE). The indication is different than the one Lilly is pursuing for Jardiance.
Novo Nordisk AS is preparing to file an sNDA with FDA and European regulators for the glucagon-like peptide-1 (GLP-1) agonist Victoza (liraglutide) this fall to incorporate new data highlighting the drug’s cardiovascular benefits.
The Danish diabetes specialist presented positive data from the LEADER cardiovascular outcomes trial, testing Victoza versus placebo in patients with...
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
