FDA authorizes Regeneron’s Covid drug at lower dose, and in injectable formulation

Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans to seek full FDA approval of its antibody cocktail later this summer.

Regeneron, Roche injectable antibody drug shows efficacy in preventing Covid-19

A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug developer, along with partner Roche, plan to ask regulators to expand the drug’s authorization to include disease prevention.

FDA approves Regeneron drug for rare, inherited form of high cholesterol

The FDA approval clears Regeneron’s drug, Evkeeza, as a treatment for the rarer of two forms of an inherited disease that causes high cholesterol levels. The company already markets Praluent, which treats the more common form of familial cholesterolemia.

MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron

Bari Kowal, vice president of global clinical operations at Regeneron Pharmaceuticals, gives an update on the clinical trials ongoing to develop drugs to fight Covid-19 and provides insights on how the clinical trials landscape and pharma overall must change in the next episode of MedCity Pivot Podcast.

BARDA, DoD give Regeneron $450M contract for Covid-19 antiviral drug

The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.

Regeneron starts late-stage trials of antiviral antibody cocktail in Covid-19

The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.