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  • Regulatory NewsRegulatory News

    Public Citizen Again Calls for Ban on Diabetes Drug Victoza

    A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths. Background Victoza was approved by FDA in 2010 as a once-daily injectable treatment for Type 2 diabetes. The drug is an incretin mimetic drug known as a glucon-like peptide-1 (GLP-1) receptor agonist. At the time of its approval, FDA noted...
  • EU Regulators Claim Diabetes Medicines Clear of Safety Fears, but Data Key to Finding

    Diabetes drugs of the GLP-1 and DPP-4 class have recently come under intense scrutiny by regulators on both sides of the Atlantic Ocean, with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) expressing strong concerns that the pancreatic risks associated with the drug might well outweigh their benefits. Now, however, EU regulators have reaffirmed their positive benefit-risk assessment, saying that no new concerns could be identified b...
  • Diabetes Drugs Taken by Millions May be Less Safe than Currently Believed, Reports BMJ

    A class of diabetes drug taken by millions of patients around the world may be considerably more dangerous than originally though, owing to the reticence of pharmaceutical companies to share data and make public the results of some of their studies, claim investigators with the British Medical Journal . Background The class of drugs, known as glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors, have already been the subject of ongoing ...