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January 6, 2013
11:50 EDTAMAGAMAG Pharmaceuticals sees FY13 year-end cash/investment $206M-$211M
A 2013 year-end cash and investments balance of between $206 million and $211 million, not including the impact of business development transactions.
News For AMAG From The Last 14 Days
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June 11, 2013
07:42 EDTAMAGBoston Biotech Conferences to host a conference
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June 10, 2013
08:02 EDTAMAGAMAG Pharmaceuticals obtains U.S. commercial rights to MuGard
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June 7, 2013
08:47 EDTAMAGAMAG Pharmaceuticals submits type II variation for Rienso
AMAG Pharmaceuticals announced that its European commercial partner, Takeda Pharmaceutical Company, has submitted a type-II variation to the European Medicines Agency, or EMA, for Rienso. The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia, or IDA, in adult patients with chronic kidney disease to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. The EMA submission is comprised of data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom either did not achieve satisfactory results from or could not tolerate oral iron treatment. More than 1,400 patients were enrolled in the phase III studies, IDA-301 and IDA-302. Patients enrolled in IDA-301 were also eligible to participate in IDA-303, an extension study to evaluate repeat dosing with ferumoxytol. The data from these studies have previously been reported.

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