Specialty pipeline forecast as of February 2010

[chantell.reagan]

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



Additionally, the following list represents specialty pipeline updates for February 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)

Aptocine - phase III results expected this summer (new entry in DrugPipelineForecast)

belatacept - recommended by FDA advisory board

BiovaxID - receives orphan drug designation

carfilzomib - SPA approved by FDA (new entry in DrugPipelineForecast)

Cayston - FDA approved (removed from DrugPipelineForecast)

Diamyd - expected FDA submission in 2011

Dimebon - positive phase III data

edoxaban - new pivotal phase III trial initiated

Egrifta - FDA advisory board and PDUFA dates changed

Elonva - approved in EU

fostamatinib disodium (R788) - phase III to begin 2H2010 (new entry in DrugPipelineForecast)

Gilenia (fingolimod) - priority review granted by FDA

Hematide - top line results expected 2Q10

Heplisav - new trial initiated

Huntexil - positive phase III data reported in EU (new entry in DrugPipelineForecast)

larotaxel - sanofi cuts program (removed from DrugPipelineForecast)

lipromatase - NDA expected to be submitted 1Q10 (new entry in DrugPipelineForecast)

Menveo - FDA approved (removed from DrugPipelineForecast)

Mepact - approved/available in EU

mipomersen - positive phase III data

motavizumab - positive phase III data

Myocet - receives fast-track designation (new entry in DrugPipelineForecast)

necitumumab - in pivotal phase III trial (new entry in DrugPipelineForecast)

Neutroval - biosimilar for Neupogen; BLA accepted

Omapro - FDA advisory board postponed due to extreme weather

perifosine - SPA approved by FDA (new entry in DrugPipelineForecast)

pirfenidone - FDA advisory board to meet 2/10

Pixuvri - FDA advisory board postponed due to extreme weather; safety concerns raised by FDA

Prevnar-13 - FDA approved (removed from DrugPipelineForecast)

Prolia - positive phase III data and new PDUFA date

TNFerade - positive data presented at ASCO

Vpriv (velaglucerase) - 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