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News Breaks
November 27, 2012
05:12 EDTREGNRegeneron's Eylea Injection approved by European Commission
Regeneron Pharmaceuticals announced that Eylea Injection has been approved by the European Commission for the treatment of patients with neovascular, or wet, age-related macular degeneration, also known as wet AMD. According to the European Medicines Agency, or EMA, approved Summary of Product Characteristics, Eylea treatment is initiated with one 2 mg injection per month for three consecutive months, followed by one injection every two months. There is no requirement for monitoring by the physician between injections. After the first twelve months of treatment with Eylea, the treatment interval may be extended based on visual and anatomic outcomes. In such cases, the frequency of monitoring visits is determined by the treating physician and may be more often than the schedule of injections.
News For REGN From The Last 14 Days
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July 30, 2014
16:31 EDTREGNRegeneron, Sanofi announce plan to use priority review voucher for alirocumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the companies intend to use a FDA rare pediatric disease priority review voucher in connection with the Biologics License Application, or BLA, submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, purchased the voucher from BioMarin GALNS, a direct, wholly-owned subsidiary of BioMarin Pharmaceutical (BMRN), which had received it through the FDA's rare pediatric disease priority review voucher program. Sanofi and Regeneron will equally share the purchase price of $67.5M. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.
16:24 EDTREGNBioMarin sells priority review voucher for $67.5M to Regeneron
BioMarin Pharmaceutical (BMRN) announced that it has sold the Rare Pediatric Disease Priority Review Voucher it obtained in February of this year. The company received the voucher under an FDA program intended to encourage the development of treatments for rare pediatric diseases. BioMarin was awarded the voucher when it received approval of VIMIZIM, a new biological product for patients with Mucopolysaccharidosis type IVA, also known as Morquio A syndrome. BioMarin received $67.5M from Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals (REGN), in exchange for the voucher. "Leveraging the sale of the Priority Review Voucher to reinvest in products to treat rare and ultra-rare diseases makes the most sense for BioMarin given our stage of growth," said Jean-Jacques Bienaimé, CEO of BioMarin.
12:33 EDTREGNRegeneron, Sanofi likely to file alirocumab BLA this year, says Piper Jaffray
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12:27 EDTREGNOn The Fly: Midday Wrap
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08:08 EDTREGNSanofi and Regeneron report positive Phase 2 results of alirocumab
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July 29, 2014
18:38 EDTREGNRegeneron receives FDA approval for EYLEA for treatment of DME
Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment of Diabetic Macular Edema, or DME. The approval of EYLEA in DME was based on the one-year data from the phase 3 VISTA-DME and VIVID-DME studies of 862 patients. In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for EYLEA in the treatment of DME. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia. A regulatory submission has been made in the U.S. and Europe for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion.
July 21, 2014
10:02 EDTREGNOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Adeptus Health (ADPT) initiated with a Buy at Dougherty... Amphastar (AMPH) initiated with a Buy at Jefferies... Eclipse Resources (ECR) initiated with a Neutral at SunTrust... Fidelity National (FNF) initiated with a Buy at SunTrust... First American (FAF) initiated with a Buy at SunTrust... GoPro (GPRO) initiated with a Hold at Stifel... Imprivata (IMPR) initiated with an Outperform at Wells Fargo... Lifetime Brands (LCUT) initiated with a Buy at Sidoti... Materialise (MTLS) initiated with a Buy at BB&T... Regeneron (REGN) initiated with a Buy at Argus... STAG Industrial (STAG) initiated with a Buy at Sandler O'Neill... Signature Group (SGGH) initiated with a Buy at B. Riley... TCP International (TCPI) initiated with a Buy at Canaccord... Tessera (TSRA) initiated with a Buy at Craig-Hallum... Xunlei (XNET) initiated with a Perform at Oppenheimer.
07:42 EDTREGNRegeneron initiated with a Buy at Argus
Target $375.
July 18, 2014
06:10 EDTREGNRegeneron announces results from Phase 3 VIVID-DME trial of EYLEA
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