The accompanying table [click to enlarge] includes an updated calendar of 73 expected FDA decision dates. Click here for my previous articles and FDA calendars , including several companies with expected decisions before year-end expected to have major stock price impacts, but keep in mind the backlog of delayed decisions that is building means that none of the dates are certain to produce final decisions.
Genzyme (GENZ) could hear back from the FDA as early as Monday for approval of Myozyme at the 2,000L bioreactor scale for large-scale production, which was endorsed by an FDA panel in late October. Genzyme also submitted a sNDA earlier this week to expand the use of Clolar for adults with acute myeloid leukemia (AML) and should hear back from the FDA by the end of January whether the application is accepted and granted a priority review of six months.
A decision is also possible in December for JNJ and Medarex (MEDX) for a biological agent, Stelara (ustekinumab), in the treatment of psoriasis – with a FDA panel endorsement this past June and clinical trial results in September which showed it was more effective than Amgen's (AMGN) Enbrel in a short-term, 12-week study of patients with moderate to severe plaque psoriasis.
After reviewing the transcript of JNJ's most recent conference call, I have a correction on this calendar for ustekinumab as the BLA was originally filed on 11/29/07, resulting in a standard 10-month review target date of 9/29/08, which was then delayed by three months for a new PDUFA target of 12/29/08. Also, the correct PDUFA date for another biological agent for JNJ, golimumab (CNTO 148), should be 4/27/09 (instead of 3/27/09 as previously published) since the BLA was filed 6/27/08.
A decision is also possible in December for JNJ and Medarex (MEDX) for a biological agent, Stelara (ustekinumab), in the treatment of psoriasis – with a FDA panel endorsement this past June and clinical trial results in September which showed it was more effective than Amgen's (AMGN) Enbrel in a short-term, 12-week study of patients with moderate to severe plaque psoriasis.
After reviewing the transcript of JNJ's most recent conference call, I have a correction on this calendar for ustekinumab as the BLA was originally filed on 11/29/07, resulting in a standard 10-month review target date of 9/29/08, which was then delayed by three months for a new PDUFA target of 12/29/08. Also, the correct PDUFA date for another biological agent for JNJ, golimumab (CNTO 148), should be 4/27/09 (instead of 3/27/09 as previously published) since the BLA was filed 6/27/08.
$9.35 (11/30/08)
