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Amgen seeks FDA approval for monthly dosing option for Repatha
2015-09-11 17:48:27| Biotech - Topix.net
Amgen Inc said it had asked the U.S. Food and Drug Administration to approve a monthly single-dosing option for its recently approved cholesterol drug, Repatha. The FDA approved Repatha, one of two approved treatments in a new class of injectable "bad" cholesterol-lowering drugs called PCSK9 inhibitors, on Aug. 27. The drug is approved for patients with hereditary forms of high cholesterol - heterozygous familial hypercholesterolemia and a rarer homozygous form of the condition, in addition to those with cardiovascular disease.
Tags: option
monthly
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seeks
Shall Means Shall . . . Unless It Doesn't - Amgen Inc., et al. v. Sandoz, Inc.
2015-09-03 03:46:17| Biotech - Topix.net
Addressing issues of first impression related to the Biologics Price Competition and Innovation Act of 2009 , which the U.S. Court of Appeals for the Federal Circuit labeled "a riddle wrapped in a mystery inside an enigma," the Court affirmed dismissal of unfair competition and conversion claims under California law, but reversed the denial of a preliminary injunction. Amgen Inc., et al. v.
Amgen, Novartis collaborate for Alzheimer's disease and migraine programs
2015-09-02 11:50:57| Biotech - Topix.net
Amgen today announced a neuroscience collaboration with Novartis in the areas of Alzheimer's disease and migraine. The collaboration accelerates Amgen's potential entry into Alzheimer's disease by teaming up with Novartis on a differentiated and genetically validated Alzheimer's disease program directed at genetically predisposed individuals at risk of developing Alzheimer's disease.
Tags: programs
disease
collaborate
migraine
Amgen wins approval for second biotech cholesterol drug
2015-08-31 08:29:18| Biotech - Topix.net
This undated image provided by Amgen Inc. shows Repatha. Amgen Inc. has won federal approval for the second medicine in a new class of pricey biotech drugs that reduce artery-clogging cholesterol more than older statin drugs that have been used for decades.
Tags: drug
approval
wins
biotech
Amgen wins approval for second biotech cholesterol drug
2015-08-28 00:23:50| Biotech - Topix.net
" Amgen Inc. has won approval for the second medicine in a new class of biotech drugs that reduce artery-clogging cholesterol more than older statin drugs that have been used for decades. The drug Repatha could eventually help millions of Americans who face increased risks of heart disease because they cannot control their cholesterol with existing drugs.
Tags: drug
approval
wins
biotech
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