Iluvien

Type: Product
Name: Iluvien
First reported Jul 01 2014 - Updated Jul 01 2014 - 1 reports

Repeat-Use Procedure for Iluvien receives positive outcome in 10 European countries

Alimera Sciences has announced a positive outcome for its Repeat-Use Procedure for Illuvien, a treatment for diabetic macular edema, in an additional 10 European countries, according to a company press release.As part of the regulatory process, the company ... [Published Orthopedics Today - Jul 01 2014]
First reported Jul 01 2014 - Updated Jul 01 2014 - 1 reports

Watertown firm expands availability of eye treatment in Europe

PSivida Corp., the Watertown-based maker of eye treatments, has entered the national phase of marketing approval in 10 additional countries in the European Union.PSivida, will soon receive marketing authorizations in Belgium, the Czech Republic, Denmark, ... [Published Business First of Buffalo - Jul 01 2014]
First reported Jun 30 2014 - Updated Jul 01 2014 - 1 reports

Benzinga's Top #PreMarket Gainers

MannKind (NASDAQ: MNKD) shares gained 11.50% to $11.15 in pre-market trading following the Friday's conditional FDA approval for Afrezzaa.ServiceSource International (NASDAQ: SREV) shares jumped 6.22% to $5.98 in pre-market trading after Altai Capital ... [Published Benzinga.com - Jun 30 2014]
First reported Jun 30 2014 - Updated Jul 01 2014 - 13 reports

Iluvien close to approval in 10 more EU markets

pSivida (ASX:PVA) licensee Alimera Sciences is close to securing marketing authorisations in 10 more European countries for Iluvien in diabetic macular oedema (DMO).Alimera’s application through the EU’s Mutual Recognition Procedure (MRP) has entered ... [Published Australian Life Scientist - Jul 01 2014]
First reported Jun 30 2014 - Updated Jun 30 2014 - 1 reports

Morning Market Movers

MannKind (NASDAQ: MNKD) surged 13.50% to $11.35 following the Friday's conditional FDA approval for Afrezzaa.Dicerna Pharmaceuticals (NASDAQ: DRNA) climbed 12.07% to $21.11 on promising clinical data for DCR-PH1.Enventis (NASDAQ: ENVE) shares jumped 11.39% ... [Published Benzinga.com - Jun 30 2014]
First reported Jun 25 2014 - Updated Jun 25 2014 - 2 reports

Iluvien receives marketing authorization in Italy for chronic DME treatment

Alimera Sciences announced it has received marketing authorization from the Italian Medicines Agency for Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema, according to a company press release.“ Iluvien has ... [Published Orthopedics Today - Jun 25 2014]
First reported Jun 25 2014 - Updated Jun 25 2014 - 1 reports

pSivida licensee gets Italian approval for Iluvien

pSivida (ASX:PVA) licensee Alimera Sciences has secured marketing authorisation in Italy for ocular insert Iluvien as a treatment for diabetic macular oedema.The Italian Medicines Agency has approved Iluvien as a C Class product, meaning it is initially ... [Published Australian Life Scientist - Jun 25 2014]
First reported Jun 23 2014 - Updated Jun 24 2014 - 11 reports

Alimera's ILUVIEN gets marketing authorization in Italy to treat chronic DME

US-based biopharmaceutical firm Alimera Sciences has secured marketing authorization from the Italian Medicines Agency (Agenzia Italiana del Farmaco) for ILUVIEN to treat vision impairment associated with chronic diabetic macular edema (DME) considered ... [Published PBR - News - Jun 24 2014]
First reported Jun 24 2014 - Updated Jun 24 2014 - 1 reports

ASPX Awaits Results, BZYR Creating Buzz, CGIX Opens Wallet, GNCA Hits A High

Allergan Inc. (AGN: Quote) is asking its shareholders to reject Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) buyout offer as it is grossly inadequate.The buyout offer allows Allergan stockholders to exchange each of their Allergan shares ... [Published RTTNews.com - Jun 24 2014]
First reported Apr 28 2014 - Updated Apr 28 2014 - 2 reports

Specialised Therapeutics Australia To License New Drug - Iluvien(R) - To Improve Vision in Patients With Diabetes-induced Vision Loss

MELBOURNE, Australia and ATLANTA, April 28, 2014 /PRNewswire/ -- Australian and New Zealand patients suffering from vision impairment due to a type of diabetes-induced eye disease will have access to a new treatment, following a license deal between Australian ... [Published PR Newswire: Health - Apr 28 2014]
First reported Apr 14 2014 - Updated Apr 15 2014 - 2 reports

pSivida Announces September 26, 2014 PDUFA Date for ILUVIEN®

WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida announces September 26, 2014 PDUFA date for Iluvien for DME ... [Published Business Wire Health News - Apr 14 2014]
First reported Mar 27 2014 - Updated Mar 28 2014 - 2 reports

pSivida Announces Resubmission of New Drug Application for ILUVIEN®

WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida announces resubmission of NDA for ILUVIEN for DME ... [Published Business Wire Health News - Mar 27 2014]

Quotes

...encouraging for the many patients throughout Europe with this devastating disease," said Dan Myers, president and chief executive officer, Alimera. "We will continue to work closely with these countries during the national phase to obtain Iluvien marketing authorization in each one."
...now been granted marketing authorizations in all seven EU countries in which we initially applied," said Dan Myers, Alimera's president and CEO. "Additionally, we are engaged in a Repeat Use Procedure through Mutual Recognition (MRP) to obtain a positive opinion for approval from another10 EU countries."
...Stanislao Rizzo, chairman of the U O Chirurgia Oftalmica, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. "Iluvien is a valuable option for patients who are not sufficiently responding to other treatments."
...Paul Ashton, President and CEO of pSivida. "Additionally, should ILUVIEN be approved by the FDA, we are entitled to a $25 million milestone payment from Alimera in addition to net profit payments on Alimera's sales of ILUVIEN."

More Content

All (61) | News (32) | Reports (0) | Blogs (28) | Audio/Video (0) | Fact Sheets (0) | Press Releases (1)
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Biotech Stock Mailbag: MannKind, Bluebird, Nort... [Published The Street Latest - Jul 14 2014]
Repeat-Use Procedure for Iluvien receives posit... [Published Orthopedics Today - Jul 01 2014]
Watertown firm expands availability of eye trea... [Published Business First of Buffalo - Jul 01 2014]
Iluvien close to approval in 10 more EU markets [Published Australian Life Scientist - Jul 01 2014]
Iluvien Procedure Receives Positive Outcome for... [Published Drug Discovery and Development - Jun 30 2014]
Morning Market Movers [Published Benzinga.com - Jun 30 2014]
Benzinga's Top #PreMarket Gainers [Published Benzinga.com - Jun 30 2014]
Alimera receives marketing authorization for vi... [Published Individual.com - Jun 30 2014]
PSivida Says Iluvien Gets Marketing Authorizati... [Published RTTNews.com - Jun 30 2014]
pSivida Corp. Reports Positive Regulatory Outco... [Published Digital Journal - Jun 30 2014]
Alimera Sciences Announces Positive Outcome Of ... [Published RTTNews.com - Jun 30 2014]
pSivida Corp. Reports Positive Regulatory Outco... [Published Nasdaq - Jun 30 2014]
pSivida Corp. Reports Positive Regulatory Outco... [Published Benzinga.com - Jun 30 2014]
pSivida Corp. Reports Positive Regulatory Outco... [Published EON Communications - Jun 30 2014]
pSivida Corp. Reports Positive Regulatory Outco... [Published Market Pulse Navigator - Jun 30 2014]
pSivida Corp. Reports Positive Regulatory Outco... [Published Business Wire Communications News - Jun 30 2014]
pSivida Corp. Reports Positive Regulatory Outco... [Published Business Wire Health News - Jun 30 2014]
Alimera Sciences' ILUVIEN® Receives Positive Ou... [Published PR Newswire: Health - Jun 30 2014]
Iluvien receives marketing authorization in Ita... [Published Orthopedics Today - Jun 25 2014]
pSivida licensee gets Italian approval for Iluvien [Published Australian Life Scientist - Jun 25 2014]
Alimera Sciences' Iluvien gets marketing author... [Published PharmaBiz - Jun 25 2014]
Alimera's ILUVIEN gets marketing authorization ... [Published PBR - News - Jun 24 2014]
DME treatment gains marketing authorization in ... [Published Modern Medicine - Jun 24 2014]
ASPX Awaits Results, BZYR Creating Buzz, CGIX O... [Published RTTNews.com - Jun 24 2014]
Italian Medicines Agency grants marketing autho... [Published News-Medical.Net - Jun 23 2014]
pSivida Corp Announces ILUVIEN?? Receives Marke... [Published BioSpace - Jun 23 2014]
Alimera’s Iluvien is granted marketing authoriz... [Published Pharma Letter - Jun 23 2014]
pSivida Announces ILUVIEN® Receives Marketing A... [Published Digital Journal - Jun 23 2014]
pSivida Announces ILUVIEN® Receives Marketing A... [Published Business Wire Health News - Jun 23 2014]
Alimera Sciences wins marketing authorisation i... [Published Individual.com - Jun 23 2014]
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Blogs

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pSivida Corp. Reports Positive Regulatory Outco... [Published EON Communications - Jun 30 2014]
WATERTOWN, Mass.--(EON: Enhanced Online News)--pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the regulatory process for marketing authorizations ...
pSivida Corp. Reports Positive Regulatory Outco... [Published Business Wire Communications News - Jun 30 2014]
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the regulatory process for marketing authorizations in ...
pSivida Corp. Reports Positive Regulatory Outco... [Published Business Wire Health News - Jun 30 2014]
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the regulatory process for marketing authorizations in ...
Alimera Sciences' ILUVIEN® Receives Positive Ou... [Published PR Newswire: Health - Jun 30 2014]
ATLANTA, June 30, 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 the positive ...
Alimera's ILUVIEN gets marketing authorization ... [Published PBR - News - Jun 24 2014]
US-based biopharmaceutical firm Alimera Sciences has secured marketing authorization from the Italian Medicines Agency (Agenzia Italiana del Farmaco) for ILUVIEN to treat vision impairment associated with chronic diabetic macular edema (DME) considered ...
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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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