OncoGenex Pharmaceuticals Inc has recently announced that the Food and Drug Administration panel has approved their additional fast-track designation to their new prostrate cancer drug, OGX-011, in combination with the first-line chemotherapy. The news about the approval of cancer drug by FDA sent OncoGenex Pharmaceuticals’ shares up on the market charts. This fast-track designation is structured to expedite the review of drugs used for the treatment of serious disease and to fill in unmet medical needs. Most of the drugs that are eligible for the designation are likely to receive a priority review. It is easier for the FDA to make their decisions quickly to approve drugs once they have received a priority review.

OncoGenex Pharmaceuticals have already received a fast-track status for second-line treatment with their OGX-011 in combination with

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent