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Tag: amgens
Amgen's bone drug succeeds in late-stage study
2015-09-02 07:45:14| Biotech - Topix.net
Amgen Inc said its experimental bone drug was found to be more effective than an already marketed drug in a late-stage study. Amgen's drug, romosozumab, met the main goal of showing a significant difference over Eli Lilly & Co's teriparatide in improving total hip bone density by the 12th month in postmenopausal women with osteoporosis.
Tags: study
drug
bone
succeeds
FDA approves Amgen's cholesterol-lowering drug Repatha
2015-08-28 02:31:47| Biotech - Topix.net
WASHINGTON: The U.S. Food and Drug Administration on Thursday approved Amgen Inc's Repatha drug for patients with hereditary forms of high cholesterol and those with cardiovascular disease. Last month the FDA approved a similar drug from Regeneron Pharmaceuticals Inc and Sanofi SA.
Tags: drug
fda
approves
fda approves
FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements
2015-04-03 07:01:53| Biotech - Topix.net
Late last week, the U.S. Food and Drug Agency dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their application and information on their manufacturing processes. At issue is the meaning of the term " shall " and whether the information-sharing and advance-notice provisions of the Biologics Price Competition and Innovation Act that a biosimilar applicant "shall providea copy of the application submitted [to FDA]and such other information that describes process or processes used to manufacture the biological product" is a mandatory requirement or an optional action for the biosimilar applicant.
Tags: requirements
citizen
applicant
petition
Expedia to move headquarters to Amgen's campus on Seattle's waterfront
2015-04-02 10:09:08| Biotech - Topix.net
Online travel company Expedia is moving from Bellevue to Seattle, where it will take over Amgen's campus on the waterfront, a source close to the deal said Wednesday. Seattle Mayor Ed Murray has scheduled a Thursday morning press conference to announce that a "major publicly traded firm" will relocate its headquarters and bring "several thousand employees" to Seattle.
Tags: move
campus
headquarters
expedia
Exclusive: Amgen's new leukemia drug to carry $178,000 price tag
2014-12-17 23:05:29| Biotech - Topix.net
Amgen Inc on Wednesday said its new type of treatment for a deadly form of leukemia would cost about $178,000 when it becomes available on Thursday, which would make it one of the world's most expensive cancer drugs. Company spokeswoman Danielle Bertrand said the price for the infused medicine, called Blincyto, would reflect two courses of treatment, at $89,000 per cycle.