Updated Calendars of FDA Decisions and Clinical Trials

by: Mike Havrilla

The accompanying tables below [click to enlarge] include:

  • an updated calendar of 80 expected FDA new product decisions and
  • 83 pending clinical trial result estimates and pending FDA re-submissions.

Click here for a link to my previous FDA calendars and click here for a list of 14 extreme FDA trades of companies with market caps below $100M. Below is a summary of new entries and updates on the calendars since I last posted.

1.) Genentech (Private:DNA) expects to report results in mid-April in its Avastin colon cancer adjuvant trial, in addition to pending FDA decisions to expand product labels for Avastin in relapsed brain cancer (gliobalstoma) by 5/5/09, Avastin in combination with interferon alfa-2a for the treatment of metastatic renal cell (kidney) carcinoma by 8/1/09, and Xolair (omalizumab) to extend its use in asthma therapy to kids age 6 and older by the end of October.

2.) Takeda Pharma (OTC:TKPHY) announced that the FDA would miss the 1/18/09 PDUFA date for its Febuxostat NDA in the treatment of hyperuricemia (once-daily oral treatment of high uric acid levels in gout patients). The FDA is simply behind schedule on pending inspection of clinical trial sites and Febuxostat previously was recommended for approval by an advisory panel.

3.) Dendreon (NASDAQ:DNDN) moved up the timeline from mid-year to April for the release of Provenge clinical trial results for prostate cancer as part of its rolling BLA submission.

4.) Genzyme (GENZ) should hear back from the FDA on its sNDA to expand the label for Clolar (clofarabine) in the treatment of adult acute myeloid leukemia - AML). The 1/24/09 date is for the agency to accept the filing and decide if a six-month, priority review will be granted.

5.) ChemGenex Pharma (CXSP) received Orphan Drug status for Omacetaxine in the treatment of Myelodysplastic Syndromes and expected to complete its rolling NDA submission by mid-year.