Specialty pipeline forecast as of January 2010

[chantell.reagan]

For your quick reference, please see the following publicized PDUFA review or advisory meeting dates expected in January 2010.



Additionally, the following list represents specialty pipeline updates for January 2010 from DrugPipelineForecast. Please click on the product name to view update for individual products. To access DrugPipelineForecast, you must be a registered user of DrugManagementForum (click here to register)

Actemra - FDA approved (removed from DrugPipelineForecast)

Ampligen - preclinical data resubmitted to FDA

Ampyra - FDA approved (removed from DrugPipelineForecast)

ANX-514 - NDA submitted

Benlysta - NDA to be submitted 1H2010

Carbaglu - questions arise from FDA advisory board

Cayston - PDUFA date 2/10

Cerepro - recommended in EU

cladribine - positive phase III data

Collatagene - FDA approves SPA (new entry in DrugPipelineForecast)

fingolimod - positive phase III data

Hematide - top-level results expected 2Q2010

LCP-Tacro - in phase III by mid 2010 (new entry in DrugPipelineForecast)

Omapro - FDA advisory board scheduled 2/10

Oncophage - uncertainty of FDA approval

pirfenidone - priority review granted by FDA

Pixuvri - FDA advisory board scheduled 2/10

PLX4032 - phase III trial begins (new entry in DrugPipelineForecast)

recombinant porcine factor IX - phase III to begin 2010 (new entry in DrugPipelineForecast)

recombinant porcine factor VIII - phase III to begin 2010 (new entry in DrugPipelineForecast)

Tavocept - phase III begins (new entry in DrugPipelineForecast)

telaprevir - NDA submission expected in 2H2010

tesamorelin - FDA advisory board canceled for 2/24/10

trelimumab - commercialization agreement (new entry in DrugPipelineForecast)

Uplyso - FDA requiring additional nonclinical data

vicriviroc - negative phase III data

Xiaflex - FDA approved (removed from DrugPipelineForecast)

For more information, or to search additional drugs, please see DrugPipelineForecast

Related link:Everything you need to know about Specialty Pipeline between 10/09 and 3/10