Mike Havrilla's  Instablog

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.  

Advanced Life Sciences (OTC:ADLS) Cethromycin NDA (once-daily antibiotic for the treatment of community acquired pneumonia - CAP) is pending with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

Clinical Data (NASDAQ:CLDA) announced positive top-line results on 6/2/09 from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase 3 trial. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the FDA for vilazodone for the treatment of MDD by the end of 2009.