Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Strategies & Market Trends : Effective Collaboration - Team Research for Better Returns: -- Ignore unavailable to you. Want to Upgrade?

To: The Ox who wrote (2917)	12/18/2013 9:16:05 AM
From: The Ox	Respond to of 8260

Regeneron Pharmaceuticals, Inc. ( REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of August 18, 2014."Diabetes is a growing public health concern and DME is a leading cause of vision loss in patients with diabetic retinopathy," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "We hope to be able to offer a new treatment option to patients who suffer from diabetic macular edema." The EYLEA sBLA submission is based on the positive results from the Phase 3 VIVID and VISTA trials.