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Stock Market & Financial Investment News

News Breaks
November 29, 2012
19:08 EDTALIMAlimera's Iluvien receives final draft guidance from U.K.'s NICE
Alimera Sciences announced that the United Kingdom's National Institute for Health and Clinical Excellence, or NICE, has issued final draft guidance indicating that Iluvien is not recommended for the treatment of chronic diabetic macular edema, or DME, considered insufficiently responsive to available therapies. While the Appraisal Committee acknowledged the clinical effectiveness of Iluvien in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies, it noted that cost-effectiveness thresholds for the product have not yet been met. In response to the final draft guidance, Alimera is now developing a Patient Access Scheme, or PAS, to address the Appraisal Committee's cost concerns that pose a barrier to access for people in the United Kingdom with chronic DME who might benefit from Iluvien. The goal of the PAS will be to determine the appropriate pricing for Iluvien in order to ensure that treatment decisions are based on patient need, rather than cost.
News For ALIM From The Last 14 Days
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September 30, 2014
13:52 EDTALIMAlimera Sciences receives $25M advance from Hercules Technology
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11:15 EDTALIMHigh option volume stocks
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September 29, 2014
10:30 EDTALIMHigh option volume stocks
High option volume stocks: RGEN ALIM TIBX MYCC RDWR ATHL DWA ASNA PSDV BGC
09:52 EDTALIMAlimera Sciences to host conference call
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09:20 EDTALIMOn The Fly: Pre-market Movers
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07:32 EDTALIMAlimera Sciences provides details on FDA approval of Iluvien
Alimera Sciences announced that it will hold a conference call to provide additional information regarding the recent approval by the FDA of ILUVIEN for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery. The Company expects to begin selling ILUVIEN in the U.S. during the first quarter of 2015.
September 26, 2014
16:47 EDTALIMAlimera Sciences up 27% after hours following FDA approval for Iluvien
16:18 EDTALIMAlimera Sciences receives FDA approval for Iluvien
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16:13 EDTALIMpSivida announces FDA approval of ILUVIEN
pSivida (PSDV) announced that the U.S. FDA has approved ILUVIEN for the treatment of diabetic macular edema. It is indicated for patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. A single injection of the ILUVIEN micro-insert provides sustained treatment of DME for 36 months. Approximately 560,000 people in the U.S. are estimated to have clinically significant DME, the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries. ILUVIEN is expected to be commercially available in the U.S. in early 2015. FDA approval of ILUVIEN entitles pSivida to a $25M milestone from its licensee Alimera Sciences (ALIM). pSivida will also be entitled to 20% of the net profits from sales of ILUVIEN in the U.S.
15:46 EDTALIMOptions expected to be active next week
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15:33 EDTALIMAlimera Sciences trading halted, pending news
07:37 EDTALIMFDA PDUFA Date for Alimera Sciences and pSivida's Iluvien is September 26, 2014
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September 25, 2014
17:01 EDTALIMGreat Point Partners reports 6.11% passive stake in Alimera Sciences
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12:50 EDTALIMAlimera Sciences volatility elevated into PDUFA date for Iluvien
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September 23, 2014
06:06 EDTALIMAlimera Sciences enters $35M at-the-market agreement with Cowen
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