Drug Safety

Novo Nordisk presented topline results from its Phase III semaglutide studies at the Clinical Trials on Alzheimer’s Disease meeting, Lilly SVP Ronald DeMattos advocated for anti-amyloid brain shuttles to reduce ARIA and Eisai presented subcutaneous Leqembi data.

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.

After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, adding a black box warning about liver injury along with suggested liver and cardiac monitoring.

After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, limiting treatment to ambulatory Duchenne muscular dystrophy patients.

The Alfasigma subsidiary will voluntarily take Ocaliva off the market after a request from the US FDA, which put Intercept’s trials of the primary biliary cholangitis drug on a clinical hold.

Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.

Gingko Bioworks has released a large language model designed to improve mRNA stability.

The injection for radicular leg pain appears likely to be approved, but with a very prescriptive label to help balance safety concerns and a lack of long-term outcomes data.

The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.

The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.

Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.