Navigation Links
Regeneron Announces Review of Biologics License Application for EYLEA™ (aflibercept injection) Extended by Three Months by FDA
Date:8/16/2011

TARRYTOWN, N.Y., Aug. 16, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency has extended its target date to complete the priority review of the EYLEA Biologics License Application (BLA) for the treatment of neovascular age-related macular degeneration (wet AMD) to November 18, 2011, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date.  

The extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing, and controls (CMC) section of the BLA as a major amendment to the BLA.  The new action date will give the agency additional time to review the information submitted.

About EYLEAVascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body.  Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs.  However, in certain diseases, such as age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit vascular permeability and lead to edema.  

EYLEA (aflibercept injection) for intravitreal use, also known as VEGF Trap-Eye, is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF).  EYLEA is a specific and highly potent blocker of these growth factors.  EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

Regeneron and Bayer HealthCare are collaborating on the global development of EYLEA for the treatment of neovascular age-related macular de
'/>"/>

SOURCE Regeneron Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. BioMed Realty Trust Expands Landmark Leases With Regeneron Pharmaceuticals
2. Regeneron Pharmaceuticals and BioMed Realty Trust Host Ribbon-Cutting Ceremony at the Landmark at Eastview
3. Regenerons Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
4. Regeneron Announces Presentation at the 2010 Deutsche Bank BioFest
5. Regeneron Announces Presentation at the 29th Annual J.P. Morgan Healthcare Conference
6. China-Biotics, Inc. Announces Conference Call to Discuss First Quarter 2009 Financial Results
7. Odyssey Thera Announces Milestone Achievement in Pfizer Alliance
8. InNexus Biotechnology Announces Launch of Large Scale Primate Study of DXL625
9. Anesiva Announces Second Quarter 2008 Financial Results and Update
10. SGX Pharmaceuticals Announces Financial Results for the Three and Six Months Ended June 30, 2008
11. Insmed Announces Financial Results for Second Quarter and Six-Months Ended June 30, 2008
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2015)... , May 28, 2015 ... ) has announced the addition of Jain ... - Technologies, Markets, and Companies" to ... , This report deals with ... aimed at improving patient care by monitoring ...
(Date:5/28/2015)... May 28, 2015 ... has announced the addition of Jain ... Technologies, Markets and Companies"  to their ... report describes and evaluates animal biotechnology ... and pharmaceuticals as well as improvement ...
(Date:5/28/2015)... , May 27, 2015 Research and Markets( ... "Animal Genetics Market by Products, by Testing services - ... The global animal genetics market is estimated ... grow at a CAGR of 8-9% during the forecast ... is mainly driven by increasing animal protein consumption, increasing ...
(Date:5/28/2015)... Research and Markets( http://www.researchandmarkets.com/research/3nl6s2/neuroprotection ) has ... "Neuroprotection - Drugs, Markets and Companies" ... the role of neuroprotection in acute disorders such ... as well as in chronic diseases such as ... of damage to neural tissues are similar in ...
Breaking Biology Technology:Global Therapeutic Drug Monitoring Market 2015-2024 2Global Animal Biotechnology Report 2015 - Technologies, Markets and Companies Analysis to 2024 2Global Animal Biotechnology Report 2015 - Technologies, Markets and Companies Analysis to 2024 3Global Animal Genetics (Canine, Equine, Poultry, Porcine, Bovine, and Genetic Material) Market 2015 - Global Forecast to 2020 2Global Neuroprotection Market Report 2015-2024 - Drugs, Markets and Companies 2Global Neuroprotection Market Report 2015-2024 - Drugs, Markets and Companies 3
(Date:5/11/2015)... SAN JOSE, Calif. , May 11, 2015 ... leading developer of human interface solutions, today announced ... Senior Vice President and Chief Financial Officer, reporting ... Mr. Ali replaces Synaptics, current Chief Financial Officer, ... in December 2014. Mr. Ali ...
(Date:5/10/2015)... -- Fingerprint Cards (FPC) has received an order ... distributor World Peace Industrial Group (WPI), part of WPG Holdings. ... . Deliveries are planned to take place during Q3 ... in China . The order value of ... + 1 000 MSEK for 2015.   Jörgen Lantto, ...
(Date:5/6/2015)... , May 6, 2015 LifeBEAM, a developer ... helmet producer, announced today that they will expand their ... world,s first bio-sensing cycling helmet and the first joint ... two new colors in order to give cyclists more ... In addition, LifeBEAM and Lazer announced their plan to ...
Breaking Biology News(10 mins):Synaptics Appoints Wajid Ali as Senior Vice President and Chief Financial Officer 2Fingerprint Cards Receives Touch Fingerprint Sensor Order of SEK 235 Million 2LifeBEAM and Lazer Announce Expanded Partnership in Bio-Sensing Sports Gear 2LifeBEAM and Lazer Announce Expanded Partnership in Bio-Sensing Sports Gear 3
... major 7.0-magnitude earthquake struck the Haitian capital of Port-au-Prince ... quake was followed by several aftershocks with magnitudes over ... maps suddenly out of date, causing additional challenges to ... can help rescue efforts by providing updated views of ...
... of climate change on the spread of infectious diseases, ... of a nearly $1.9 million grant from the National ... Penn State-led group of researchers. The grant is part ... and Reinvestment Act. Climate change has the potential to ...
... twenty years this team has been trying to identify links ... terrestrial environment because, when all is said and done, rivers ... the kidney is to the human body. River water often ... Within this line of research, the UPV/EHU team is focusing ...
Cached Biology News:First satellite map of Haiti earthquake 2First satellite map of Haiti earthquake 3Stimulus grant to support research on climate and infectious disease 2Impact of eucalyptus plantations on the ecology of rivers 2Impact of eucalyptus plantations on the ecology of rivers 3
ssDNA from PCR DNA in less than 1 hour. No gels, columns, or slurries. Sequence from high quality ssDNA: clearer reads, longer runs....
Immunogen: Synthetic peptide (KLH conjugated): L(506) S K S S S Q I R M S G L P A D N L A T(525) Storage: -20 C, Avoid Freeze/Thaw Cycles...
...
This Universal 24" X 18" (61 X 45.7cm.) shaker platforms will accept any Thermo Forma shaker flask clip....
Biology Products: