Iluvien

Type: Product
Name: Iluvien
First reported 10 hours ago - Updated 7 hours ago - 1 reports

Sustained Release Ocular Drug Delivery Systems Market, 2014-2024

Sustained Release Ocular Market, 2014-2024 Given the intricacy of the anatomy and physiology of the eye, it is quite challenging to deliver an ophthalmic drug effectively to a specific ocular site. Several barriers have to be overcome for successful ocular ... [Published MarketResearch.com - 10 hours ago]
First reported Apr 15 2014 - Updated Apr 15 2014 - 3 reports

Alimera/pSivida Seek FDA Approval for Iluvien - Analyst Blog

The Prescription Drug User Fee Act (PDUFA) date for Alimera and pSivida Corp. 's ( PSDV ) Iluvien is now set for Sep 26, 2014.We note that Alimera had suffered a setback in Oct 2013 when it received the third CRL from the FDA. The FDA refused to approve ... [Published Nasdaq - Apr 15 2014]
First reported Apr 14 2014 - Updated Apr 15 2014 - 1 reports

Today’s Top Biotech Stories: Lexicon, Alimera, and Akebia

Let's take a quick look at three biotech stocks -- Lexicon Pharmaceuticals (NASDAQ: LXRXLexicon soars on positive top-line results for LX4211Lexicon justLexicon reported that LX4211 achieved its primary endpoint of reducing mealtime insulin use as well ... [Published Motley Fool - Apr 14 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 1 reports

Alimera Sciences Announces New PDUFA Date For Iluvien

/PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that... ... [Published Drugs.com - Apr 15 2014]
First reported Apr 14 2014 - Updated Apr 15 2014 - 8 reports

pSivida partner gets new PDUFA date for Iluvien

pSivida (ASX:PVA) licensee Alimera Sciences will know by late September whether the US FDA has approved the company’s fourth new drug application for diabetic macular edema (DME) treatment Iluvien.The regulator has set a new Prescription Drug User Fee ... [Published Australian Life Scientist - Apr 15 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 2 reports

Spain microvascular complications of diabetes market to report a dip in sales within the diabetic neuropathy market during mid 2014

- PharmaPoint: Microvascular Complications of Diabetes - Spain Drug Forecast and Market Analysis to 2022 - a new market research report on companiesandmarkets.comThe entire market for microvascular complications of diabetes (MCD) â diabetic nephropathy, ... [Published PR inside - Apr 11 2014]
Entities: Diabetes, Spain, OZURDEX, Iluvien
First reported Apr 10 2014 - Updated Apr 10 2014 - 1 reports

:: Alimera awaits Iluvien decision

SUBSPECIALTY NEWS SUBSPECIALTY NEWS Company targets both wet and dry AMD.■ Armed with $97.2 million of new funding from stock sales and venture capital, Ophthotech (New York, NY) recently announced an ambitious drug development program aimed at providing ... [Published Retinal Physician - Apr 10 2014]
First reported Apr 10 2014 - Updated Apr 10 2014 - 1 reports

pSivida CEO to Discuss Company's Sustained Release Delivery System for Biologics at Two Upcoming Conferences

By a News Reporter-Staff News Editor at Clinical Trials Week -- pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release products for treating eye diseases, announced that pSivida's president and chief executive officer, ... [Published HispanicBusiness.com - Apr 10 2014]
First reported Apr 01 2014 - Updated Apr 01 2014 - 2 reports

PSIVIDA : CEO to Discuss Company’s Sustained Release Delivery System for Biologics at Two Upcoming Conferences

pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development ofsustained release products for treating eye diseases, today announcedthat pSivida’s president and chief executive officer, Dr. Paul Ashton,will discuss pSivida’s Tethadur™ technology ... [Published 4 Traders - Apr 01 2014]
First reported Mar 27 2014 - Updated Mar 28 2014 - 2 reports

Alimera refiles eye implant in the US

The move marks the fourth time the company has submitted a New Drug Application to the US Food and Drug Administration for Iluvien, after a third rejection last ... ... [Published Big News Network - Mar 28 2014]
First reported Mar 27 2014 - Updated Mar 28 2014 - 14 reports

Mass. Mover PSivida tries again to win FDA approval

Continue reading belowWatertown-based pSivida Corp. has resubmitted its application for approval to market Iluvien, a treatment for diabetic macular edema, a potentially blinding condition that affects about one million Americans. In October, the Food ... [Published Boston Globe - Mar 28 2014]
First reported Mar 21 2014 - Updated Mar 21 2014 - 2 reports

Alimera Vs. pSivida, A Comprehensive Comparison

By Alberto Savrieno :Much has been written about pSivida ( PSDV ) since the FDA surprisingly entered into labeling discussions with the company about ILUVIEN, the ocular insert for diabetic macular edema. The labeling discussions came after a third failure ... [Published BioPortfolio - Mar 21 2014]

Quotes

...the first quarter and to have a PDUFA goal date set for a decision from the FDA," said Dan Myers, Alimera's president and chief executive officer. "We look forward to the FDA's response to our NDA and hope that we will be able to make ILUVIEN available to patients in the United States who are suffering from chronic DME."
On Tuesday, April 8 , at 11:30 am ET , Dr. Ashton will present "Biosimilars vs. Biobetters! Determining the Implications for Product Developers in the Pharmaceutical Industry" at the Biosimilars & Biobetters USA conference in New Jersey . About pSivida Corp. pSivida Corp...
..."We are pleased to resubmit ILUVIEN for approval in the US," said Dan Myers, Alimera's president and CEO. "We look forward to an acknowledgment from the FDA that the response is complete and that a PDUFA date has been confirmed."
"It has one advanced product called ILUVIEN that is in development for DME, a disease of the retina that affects individuals with diabetes and can lead to vision loss and blindness" Cramer said

More Content

All (69) | News (52) | Reports (0) | Blogs (16) | Audio/Video (0) | Fact Sheets (0) | Press Releases (1)
sort by: Date | Relevance
Sustained Release Ocular Drug Delivery Systems ... [Published MarketResearch.com - 10 hours ago]
Alimera/pSivida Seek FDA Approval for Iluvien -... [Published Nasdaq - Apr 15 2014]
Alimera/pSivida Seek FDA Approval for Iluvien -... [Published Zacks.com - Apr 15 2014]
Alimera/pSivida Seek FDA Approval for Iluvien [Published Zacks.com - Apr 15 2014]
Alimera Sciences Announces New PDUFA Date For I... [Published Drugs.com - Apr 15 2014]
pSivida partner gets new PDUFA date for Iluvien [Published Australian Life Scientist - Apr 15 2014]
pSivida CEO says FDA approval of Iluvien will h... [Published Business First of Buffalo - Apr 14 2014]
Today’s Top Biotech Stories: Lexicon, Alimera, ... [Published Motley Fool - Apr 14 2014]
Alimera Says FDA Has Set New PDUFA Date For Ilu... [Published RTTNews.com - Apr 14 2014]
pSivida Announces September 26, 2014 PDUFA Date... [Published Benzinga.com - Apr 14 2014]
Alimera Sciences Announces Sept 26th PDUFA Date... [Published Benzinga.com - Apr 14 2014]
pSivida Announces September 26, 2014 PDUFA Date... [Published Business Wire - Apr 14 2014]
pSivida Announces September 26, 2014 PDUFA Date... [Published Business Wire Health News - Apr 14 2014]
Alimera Sciences Announces New PDUFA Date For I... [Published PR Newswire: Health - Apr 14 2014]
Spain microvascular complications of diabetes m... [Published PR inside - Apr 11 2014]
France microvascular complications of diabetes ... [Published PR inside - Apr 11 2014]
:: Alimera awaits Iluvien decision [Published Retinal Physician - Apr 10 2014]
pSivida CEO to Discuss Company's Sustained Rele... [Published HispanicBusiness.com - Apr 10 2014]
Alimera resubmits new drug application for visi... [Published Individual.com - Apr 03 2014]
PSIVIDA : CEO to Discuss Company’s Sustained Re... [Published 4 Traders - Apr 01 2014]
pSivida CEO to Discuss Company’s Sustained Rele... [Published BioPortfolio - Apr 01 2014]
Alimera resubmits Iluvien NDA to FDA [Published Modern Medicine - Apr 01 2014]
pSivida partner files fourth US NDA for Iluvien [Published Australian Life Scientist - Mar 31 2014]
Cramer’s homework: Buy vaccine maker for ‘spec’? [Published CNBC - Mar 28 2014]
Alimera refiles eye implant in the US [Published Big News Network - Mar 28 2014]
Mass. Mover PSivida tries again to win FDA appr... [Published Boston Globe - Mar 28 2014]
EXAS Gets FDA Panel's Thumbs Up, NRX Ropes In P... [Published RTTNews.com - Mar 28 2014]
Eye Treatment Iluvien (Fluocinolone Intravitrea... [Published P&T Community - Mar 28 2014]
Alimera refiles eye implant in the US [Published Pharma Times - Mar 27 2014]
Alimera resubmits Iluvien new drug application [Published Orthopedics Today - Mar 27 2014]
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Blogs

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pSivida Announces September 26, 2014 PDUFA Date... [Published Business Wire Health News - Apr 14 2014]
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida announces September 26, 2014 PDUFA date for Iluvien for DME ...
Alimera Sciences Announces New PDUFA Date For I... [Published PR Newswire: Health - Apr 14 2014]
ATLANTA, April 14, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its ...
pSivida Announces Resubmission of New Drug Appl... [Published Business Wire Health News - Mar 27 2014]
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida announces resubmission of NDA for ILUVIEN for DME ...
Alimera Sciences Announces Resubmission Of ILUV... [Published PR Newswire: Health - Mar 27 2014]
ATLANTA, March 27, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it ...
pSivida Announces ILUVIEN® for DME Accepted by ... [Published EON Environment - Feb 10 2014]
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida announces ILUVIEN for DME Accepted by National Health Service Scotland ...
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Press Releases

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Alimera Sciences to Release Third Quarter 2013 ... [Published PR Newswire - Oct 31 2013]
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