Specialty pipeline forecast as of June 2010

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For your quick reference, please see the following publicized PDUFA review dates expected in July 2010:



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

alemtuzumab – FDA grants fast-track designation

Arcalyst – mixed phase III data

Aridol- negative phase III data

Benlysta – MAA submitted to EU and BLA submission

bosutinib – positive phase III data

Catena – positive phase III data; NDA submission expected 1H2011

Ceplene – NDA submitted with priority review requested

cladribine – NDA resubmitted

custiren – phase III registration trial started

daclizumab – final phase III trial begins

dengue fever vaccine – phase III expected to begin by end of year (new entry in DrugPipelineForecast)

desmoteplase – in phase III (new entry in DrugPipelineForecast)

erbulin – FDA grants priority review with decision expected 9/10; phase III data presented

Genasense – positive phase III data presented

Gilenia – FDA advisory board recommends drug

Hematide- mixed phase III data

HuMax EGFr – positive phase III data

Iluvien – positive phase III data, NDA submitted with priority review requested

ipilimumab – positive phase III data published

Jevtana – FDA approved (removed from DrugPipelineForecast)

microplasmin – positive phase III data presented

motavizumab – FDA advisory board rejects drug and delays PDUFA date

Nautiol – negative phase III data

Octreolin – orphan drug designation with expected phase III trial to begin 2010 (new entry in DrugPipelineForecast)

phenoxodiol – negative phase III data

Pivlaz – in phase III (new entry in DrugPipelineForecast)

Pixuvri – positive phase III data

Pradaxa- positive phase III data

Proellex – FDA partially lifts clinical hold

Prolia – FDA approved (removed from DrugPipelineForecast)

Rhucin – EU issues positive opinion

Stimuvax – FDA allows continuation of phase III

Surfaxin – negative phase II data; expected submission 1H2011

tafamidis – expected NDA submission 2H2010

tanezumab – positive phase III data; d/c enrollment in OA trials

XL-184 – top line results expected 1H2011

Zactima – positive phase III data

Zalbin – feedback from FDA received in the form of a Discipline Letter for specific 900mcg dosage strength

Zymafos – phase III trial delay

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

Related link:Everything you need to know about Specialty Pipeline between 4/10 and 9/10