Alimera reports positive interim results from Phase II macular edema trial

www.pharmaceutical-business-review.com | Jun 27, 2008

Alimera Sciences has reported the safety and efficacy results from the first human pharmacokinetic study of Medidur FA, which it intends to market under the tradename Iluvien, if approved by the FDA.

http://www.pharmaceutical-business-review.com/article_news.asp?guid=24A777F6-EF8B-417D-A721-6942590F9019

pSivida: DSMB Again Supports Continuation of the Phase III Clinical Trial of Medidur FA for the Treatment of DME

www.nanowerk.com | Mar 24, 2008

FAME is two, duplicate, double-masked, randomized, multi-center studies that are following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two years of follow-up.

http://www.nanowerk.com/news/newsid=5032.php

DSMB Again Supports Continuation of the Phase III Clinical Trial of Medidur(TM) FA for the Treatment of DME

www.prnewswire.com | Mar 24, 2008

The trial is studying the use of Medidur FA for the treatment of diabetic macular edema (DME). FAME is two, duplicate, double-masked, randomized, multi-center studies that are following 956 patients in the U.S.

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/03-24-2008/0004778822&EDATE=

<b>Independent Data Safety Monitoring Board</b> Supports Continuation of Alimera Sciences Phase III Clinical Trial of Medidur(TM) FA for the Treatment of DME

www.biospace.com | Mar 24, 2008

FAME is two, duplicate, double-masked, randomized, multi-center studies that are following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two yeasrs of follow-up.

http://www.biospace.com/news_story.aspx?StoryID=90252&full=1

PSDVV: DSMB Supports Continuation of the Phase Iii Clinical Trial of IluvienTM - Zibb.com

www.zibb.com

By Fain Hughes, fhughes@knobias.com pSivida Corp. (PSDV) announced that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as

http://www.zibb.com/article/4039338/PSDVV+DSMB+Supports+Continuation+of+the+Phase+Iii+Clinical+Trial+of+IluvienTM

WellCare

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https://www.wellcare.com/formulary_brand/find_mapd_formulary/F

USP chemicals, USP Fine Chemical and USP solutions by Spectrum Chemicals

www.spectrumchemical.com

Spectrum Chemicals is the leading manufacturer USP chemicals offering over 1500 items. Products include USP chemicals, USP test solutions, USP test reagents, USP volumetric solutions and other unusual or hard to find chemicals.

http://www.spectrumchemical.com/retail/usp-chemicals.asp?category_name=usp,%20nf,%20fcc,%20bp,%20jp,%20ep&txtSearch=F&name=

Pediatric Research Equity Act (PREA) Labeling Changes

www.fda.gov

The following applications fell within the scope of the Pediatric Research Equity Act (PREA), contained new pediatric information, and were not related to studies conducted under 505A of the Federal Food, Drug and Cosmetic Act (i.e., pediatric exclusivity incentive program).

http://www.fda.gov/cder/pediatric/Prea_label_post-mar_2_mtg.htm