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Examples
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-- Momenta is a PC necklace that works a bit like a DVR for your life.
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Both Amphastar and Momenta, which is based in Cambridge, Mass., submitted applications seeking FDA approval of their generic versions of Lovenox heparin sold by Sanofi-Aventis SA.
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At this week's massive Comdex computer show in Las Vegas, which traditionally attracts 100,000 people, some 15 companies will introduce similar pen-based machines; one, a California start-up called Momenta, will let users choose between an electronic pen or a keyboard.
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In August CAPS All-Star latimerburned called Momenta "a bit of a gamble.
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Momenta is selling its generic Lovenox in partnership with Sandoz, a unit of Switzerland's Novartis AG.
New Generic Lovenox Receives FDA Approval Alicia Mundy 2011
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As the FDA's consideration of both companies' applications dragged on for years, Amphastar complained that the FDA was biased toward Momenta.
New Generic Lovenox Receives FDA Approval Alicia Mundy 2011
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In the fall of 2010, a report by the Government Accountability Office, Congress's watchdog agency, said FDA actions involving heparin-related issues had contributed to a public perception of bias toward Momenta and risked the agency's integrity.
New Generic Lovenox Receives FDA Approval Alicia Mundy 2011
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Momenta said in an earnings call in August that generic Lovenox had generated over $1 billion since its launch in the fall of 2010.
New Generic Lovenox Receives FDA Approval Alicia Mundy 2011
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In 2008, the Momenta founder was given a leading role by FDA officials in an high-profile agency task force investigating the source of heparin contamination from China linked to 81 deaths in the U.S. When the task force said it identified the contaminant in the Chinese supplies, Momenta's stock price rose.
New Generic Lovenox Receives FDA Approval Alicia Mundy 2011
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That requirement put Amphastar back at the same starting point as Momenta and came after Momenta's founder, a Massachusetts Institute of Technology scientist, lobbied the head of the FDA's drug division for tougher approval standards for drugs like generic Lovenox.
New Generic Lovenox Receives FDA Approval Alicia Mundy 2011
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