June 11, 2015By Riley McDermid, BioSpace.com Breaking News Sr. Editor Analysts are weighing in Thursday on the U.S. Food and Drug Administration (FDA)‘s decision yesterday to approve Amgen (AMGN)’s cholesterol lowering drug Repatha, saying investors should take a close look at how the panel made its decision if they want clues about future products and […]

An advisory panel to the U.S. Food and Drug Administration recommended approval of Amgen Inc’s cholesterol-lowering drug Repatha on Wednesday, but said it should be used only in patients at high risk of cardiovascular disease.  The panel voted unanimously to recommend approval of the drug, known also as evolocumab, for patients with homozygous familial hypercholesterolemia […]

A tepid recommendation from an expert advisory panel could limit the sales of new cholesterol drugs, but they could still become $1 billion products in the near term, and generate as much as $15 billion five years from now. Last night, Praluent, an experimental cholesterol drug from Regeneron and Sanofi, received a lukewarm endorsement from a […]

June 10, 2015By Riley McDermid, BioSpace.com Breaking News Sr. Editor Tarrytown, N.Y.-based Regeneron Pharmaceuticals, Inc. (REGN) is enjoying a nice boost Wednesday, the day after the U.S. Food and Drug Administration (FDA) recommended approval for the company’s application for cholesterol lowering drug Praluent (alirocumab). The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. […]

A new type of cholesterol-lowering drug made by Sanofi SA (SASY.PA) and Regeneron Pharmaceuticals (REGN.O) should be approved, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 13-3 to approve the drug, Praluent, the first in a new class of LDL-lowering drugs that inhibit a protein known as […]

The U.S. Food and Drug Administration, responding to a lawsuit filed by Amarin Corp over information the company wants to disseminate for its fish oil drug, said it had no objection to Amarin sharing the data with healthcare providers. The FDA’s letter to Amarin, dated June 8 and filed with a U.S. District Court judge […]

People are more likely to report short-term memory loss after starting cholesterol-lowering drugs known as statins, but the finding probably has nothing to do with the medications, a new study suggests. “It’s a completely false alarm that doesn’t look like it’s real and shouldn’t enter into the equation of whether or not someone should take […]

Amgen Inc’s experimental drug Repatha lowered cholesterol in clinical trials and did not cause a marked disparity in deaths or serious adverse events but showed potential safety issues that should be explored, according to a preliminary review by the U.S. Food and Drug Administration. The review was published on Monday on the FDA’s website before […]

This coming week is likely to be a serious one in the fight against cholesterol. This covers a new class of drugs in the PCSK9 classification, and FDA panels are evaluating more than just one drug candidate. A U.S. Food and Drug Administration (FDA) advisory panel is expected to meet on June 9 to consider […]