Replies to post #140084 on Biotech Values

[DewDiligence]

JNJ submits BLA/MAA for Simponi in ulcerative colitis:

http://finance.yahoo.com/news/janssen-submits-applications-requesting-approval-200500341.html

If approved in this indication, Simponi will compete with Humira (among other choices).

[DewDiligence]

FDA briefing docs for Humira-in-UC panel next Tuesday:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm316785.htm

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM316786.pdf

Note: Humira is already approved for UC in the EU (#msg-74255837), it’s ninth (!) indication there.