Specialty pipeline forecast as of September 2009

[chantell.reagan]

In 4Q09, there are approximately 21 agents awaiting FDA review, in the areas of chronic fatigue syndrome, oncology, cystic fibrosis, osteoporosis, HAE, multiple sclerosis, SLE, transplant and antiinfectives. The following list represents specialty pipeline updates for September 2009 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)

ANX-530 - in phase III (new entry in DrugPipelineForecast)

ANX-514 - in phase III (new entry in DrugPipelineForecast)

belatacept - BLA accepted

brentuximab vedotin - phase III enrollment complete (new entry in DrugPipelineForecast)

Cervarix - FDA advisory board recommends drug

darusentan - positive phase III data

droxidopa - negative phase III data

fingolimod - positive phase III data

Folotyn - FDA approved (removed from DrugPipelineForecast)

Gammaplex - FDA approved (removed from DrugPipelineForecast)

Krystexxa - no additional data needed

Mylinax - NDA submitted

nimotuzumab - in phase III (new entry in DrugPipelineForecast)

omacetaxine - NDA submitted

OSI-906 - phase III study initiated (new entry in DrugPipelineForecast)

prGCD - orphan drug status granted

Prochymal - negative phase III results

Prolia - positive phase III data

romidepsin - upcoming PDUFA date (new entry in DrugPipelineForecast)

Stelara - FDA approved (removed from DrugPipelineForecast)

Trimesta - in phase III (new entry in DrugPipelineForecast)

velaglucerase - fast-track designation granted

VEGF Trap-Eye - completed enrollment for phase III trials (new entry in DrugPipelineForecast)

Xiaflex - positive phase III data; recommended by FDA advisory board

Yondelis - FDA rejects drug

Zenpep - FDA approved (removed from DrugPipelineForecast)

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