Everything you need to know about Specialty pipeline from 4/2010 through 9/2010

[chantell.reagan]

DETAILS:

Please click on the product name to view up-to-date details captured by DrugPipelineForecast

Endocrine:
Expected approvals in 3Q2010

o Egrifta – PDUFA date 7/27/10, moved to 4Q10 review
o Prolia – PDUFA date 7/25/10, FDA approved 6/10

Enzyme replacements/modifiers:
Expected approvals in 2Q2010

o Glassia - FDA approved 7/10

Hematology:
Expected approvals in 3Q2010

o Neutroval

Immunologics:
Expected approvals in 2Q2010

obelatacept - PDUFA date 5/1/10; Complete response letter received
oGilenia – PDUFA date 6/2010; FDA advisory board recommends drug 6/10

Expected approvals in 3Q2010

oadenovirus types 4/7
oMonovisc

Oncology:
Expected approvals in 2Q10

o Pixuvri – PDUFA date 4/23/10 (FDA advisory board voted against drug 3/10); Complete response letter received
o Provenge – PDUFA date 5/1/10, FDA approved 4/29/10

Respiratory:
Expected approvals in 2Q10

o Esbriet – PDUFA date 5/4/10 (FDA advisory board recommends drug 4/10, but Complete response letter received 5/10 requests an additional clinical trial)

Expected approvals in 3Q10

o motavizumab – FDA advisory committee scheduled on 6/2/10; FDA advisory board votes against drug in a 14-3 vote; PDUFA date 6/24/10 and Complete response letter received

Latest updates are captured in the Specialty Pipeline Forecast as of March 2010

For more information, longer-term pipeline, or to search for additional drugs, please see DrugPipelineForecast.

About DrugPipelineForecast:
DrugPipelineForecast is a tool developed specifically for managed care professionals to address their unique needs. This is a site which can help you track late-phase pipeline:

o Products in late phase III to approval stages
o All types of information for an in-depth review
o Tabulated format for a quick analysis
o Search and filtering capabilities
o Default and customized reports
o Frequent updates

To access DrugPipelineForecast at no charge (for those who are currently employed by a health plan, PBM, specialty pharmacy, IPA, employer/benefits consultant), you must be a registered user of DrugManagementForum (click here to register)

About DrugManagementForum:
DrugManagementForum is dedicated to the managed care pharmacy and medical policy community, allowing you to connect and share your ideas and solutions to common problems and experiences. It offers a place for users and experts to post questions and comments that are relevant to your practice in the managed care setting.

Benefits of registering with DrugManagementForum:

o Offers managed care professionals to connect and share ideas/solutions to common problems and experiences in drug benefit management
o Objective, unbiased content without a commercial agenda (no pharma sponsorship)
o Exclusive only for those who are currently employed by a health plan, PBM, specialty pharmacy, IPA, employer/benefits consultant, or another organization that is responsible for managing healthcare coverage (those in academia and benefit consulting can also join)
o Free and includes access to the DrugPipelineForecast
o Anonymity is guaranteed (if preferred), see the rules for more details