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FDA OKs breakthrough cholesterol drug for high-risk patients
2015-07-24 21:19:33| Biotech - Topix.net
" The Food and Drug Administration says it has approved a first-of-a-kind drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades. The drug from Sanofi and Regeneron Pharmaceuticals Inc. offers an important new option for millions of patients at high risk of heart disease.
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Sanofi Cholesterol Drug, GSK Malaria Shot May Get EU Okay Friday
2015-07-21 16:29:02| Biotech - Topix.net
Sanofi and Regeneron's new cholesterol drug Praluent could be recommended for approval in Europe as early as this week, along with the world's first malaria vaccine from GlaxoSmithKline.
Amgen wins first approval for new class of cholesterol drugs
2015-07-21 16:29:01| Biotech - Topix.net
REUTERS: Amgen Inc's cholesterol fighting drug was approved by the European Commission, giving the keenly anticipated treatment a head start over a rival drug being developed by Regeneron Pharmaceuticals Inc and Sanofi SA. This is the first approval by any regulator for PCSK9 inhibitors, a new class of biologic drugs that are injected.
FDA panel backs Amgen cholesterol drug for some patients
2015-06-11 08:41:53| Biotech - Topix.net
" Federal health advisers said that a highly-anticipated cholesterol-lowering drug from Amgen Inc. should be approved for patients with dangerously high levels of the artery-clogging substance. But as with their review of a similar drug a day earlier, the Food and Drug Administration experts stressed Wednesday that long-term results are needed to judge the drug's real benefit.
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FDA panel backs first-in-class cholesterol drug
2015-06-10 01:17:06| Biotech - Topix.net
Federal health advisers on Tuesday recommended approval for a highly-anticipated cholesterol drug from Sanofi and Regeneron Pharmaceuticals, but with the caveat that more data is needed about its long-term ability to reduce heart attacks. The expert panel recommended by a 13-3 vote that the Food and Drug Administration approve the injectable drug, called Praluent.
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