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Panel recommends approval of new cholesterol drug
2015-06-10 01:17:05| Biotech - Topix.net
A Food and Drug Administration advisory committee on Tuesday recommended approval of a new type of experimental cholesterol-fighting drug that could be more potent and carry fewer side effects than statins, which are among the most prescribed drugs in the United States. The agency will likely follow the advisory committee's advice when it decides whether to approve the drug, alirocumab from Sanofi SA and Regeneron Pharmaceuticals Inc., for patients later this summer.
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Fight over hot new cholesterol drugs may be won in milligrams
2015-05-26 09:24:03| Biotech - Topix.net
Two powerful and innovative cholesterol drugs likely to be approved this summer both target the same protein and have been shown to sharply lower LDL in high-risk patients. But there is at least one significant difference between the two offerings: the dosages in which they will be sold.
Amgen First To Win EU Backing For New Kind Of Cholesterol Drug
2015-05-22 15:59:36| Biotech - Topix.net
Amgen Inc's closely watched new cholesterol drug, Repatha, has been recommended for approval in Europe, putting the U.S. drugmaker ahead in a race with rival Sanofi SA. Repatha, or evolocumab, belongs to a new class of cholesterol-lowering drugs known as PCSK9 inhibitors that have the potential to drastically reduce the risk of heart attacks when used in addition to standard treatment.
Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol
2015-03-22 06:59:40| Biotech - Topix.net
Amgen today announced that an application seeking marketing approval of RepathaTM for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labour and Welfare in Japan. Repatha is being developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.
Experimental cholesterol drugs cut heart risk, but questions remain
2015-03-15 22:33:26| Biotech - Topix.net
Studies of a new class of experimental cholesterol-lowering drugs signal that they may reduce by half the risk of heart attack and other major cardiovascular problems compared to standard treatment alone. San Diego: Studies of a new class of experimental cholesterol-lowering drugs signal that they may reduce by half the risk of heart attack and other major cardiovascular problems compared to standard treatment alone.
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