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Aegerion Pharmaceuticals

Latest Headlines

Latest Headlines

DOJ wants Aegerion to talk about what it's been saying

Aegerion Pharmaceuticals CEO Mark Beer likes to talk about the company's one and only drug, cholesterol fighter Juxtapid. Maybe a little too much, the FDA said recently in a warning letter about comments he made on television. But Beer has a new audience asking about it, and it is one most CEOs would prefer not to have to face: the Department of Justice.

FDA slaps Aegerion for CEO's fast-and-loose interviews with CNBC

Notice to pharma CEOs: Before you appear on television, brush up on your marketing rules. Aegerion Pharmaceuticals CEO Marc Beer apparently did not, and the FDA has now come calling.

EMA backs approval of key drugs from Celgene and Aegerion

Two drugmakers reported regulatory victories for therapies in the important European market. A European Medicines Agency committee endorsed approval of Celgene's ($CELG) pomalidomide for multiple myeloma and Aegerion's ($AEGR) Lojuxta for a genetic cause of high cholesterol called homozygous familial hypercholesterolemia.

UPDATED: FDA hands Sanofi, Isis an approval for HoFH drug Kynamro

Late Tuesday the FDA came through with an approval for mipomersen (Kynamro), an antisense drug advanced by Isis and partnered with Sanofi's Genzyme. It's the second new drug approved recently for homozygous familial hypercholesterolemia, a rare and dangerous form of high cholesterol.

Much goes into pricing a drug at $295,000

So what goes into landing on $295,000 as the annual cost of a drug that maybe only 3,000 patients a year will use? That is the price tag that NPS Pharmaceuticals ($NPSP) has put on the recently approved Gattex, a treatment for short bowel syndrome.

Last-minute drive at FDA added 6 new drug approvals

Our readers who regularly check our website know that we kept up with the news online. But for everyone else, here's a roundup of the regulatory actions you may have missed.

FDA approves Aegerion's lomitapide for rare cases of HoFH

The FDA has approved Aegerion's new drug for homozygous familial hypercholesterolemia, clearing a path to begin commercialization as the biotech comes to a major turning point.

Genzyme drug gets thumbs up from FDA panel

The tepid 9-6 vote from an FDA advisory panel left the new drug application looking relatively weak compared with a 13-2 vote for rival treatment lomitapide from Aegerion Pharmaceuticals.

Genzyme's mipomersen wins key FDA panel vote for rare cases of HoFH

Genzyme and its partners at Isis Pharmaceuticals ($ISIS) won a key endorsement today for mipomersen, an experimental therapy for homozygous familial hypercholesterolemia. But the tepid 9-6 outcome left the new drug application looking relatively weak compared with the 13-2 vote that greeted the rival drug lomitapide from Aegerion Pharmaceuticals yesterday.

UPDATED: Aegerion wins lopsided FDA panel vote backing rare cholesterol disease drug

A group of FDA advisers took a hard look at Aegerion's ($AEGR) new drug for homozygous familial hypercholesterolemia and concluded that the clear need for a new therapy outshined any safety concerns they might have concerning liver disease. In a lopsided vote, 13 of the outside experts voted to recommend an approval of the drug, with only two voting against.