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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19:08 EDTALIMAlimera's Iluvien receives final draft guidance from U.K.'s NICE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announced that the United Kingdom's National Institute for Health and Clinical Excellence, or NICE, has issued final draft guidance indicating that Iluvien is not recommended for the treatment of chronic diabetic macular edema, or DME, considered insufficiently responsive to available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 In response to the final draft guidance, Alimera is now developing a Patient Access Scheme, or PAS, to address the Appraisal Committee's cost concerns that pose a barrier to access for people in the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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November 17, 2014
11:46 EDTALIMAlimera Sciences' ILUVIEN receives marketing approval in Ireland
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10:02 EDTALIMOn The Fly: Analyst Initiation Summary
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08:55 EDTALIMAlimera Sciences initiated with a Buy at Summer Street
Target $12.
November 12, 2014
07:43 EDTALIMAlimera Sciences' Iluvien receives marketing authorization in Belgium
Alimera Sciences,announced that the Belgian Federal Agency for Medicines and Health Products has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. Approval in Belgium marks the fourth European approval through the Repeat-Use application procedure and the 12th approval worldwide, including the recent U.S. approval for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. To date, ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom and Germany. ILUVIEN is pending approval in an additional six European Union countries included in the Repeat-Use application procedure. These countries are the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands and Poland.

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