FDA Calendar Updates: CTIC, ALKS, AMLN, LLY

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.

Amylin Pharma (NASDAQ:AMLN), Eli Lilly (NYSE:LLY), and Alkermes (NASDAQ:ALKS) announced today that a NDA was filed for FDA approval of a once-weekly version of exenatide (Byetta LAR) as once weekly formulation for type 2 diabetes which is administered by subcutaneous injection. The companies previously announced that an analysis of clinical trial databases showed no increased risk of heart-related side effects in patients taking standard Byetta as new diabetes treatments have come under closer scrutiny by the FDA recently.

Cell Therapeutics (NASDAQ:CTIC) announced today that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed or is refractory to standard treatment options. On 4/14/09, CTIC began a rolling submission of a NDA to the FDA for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTI expects to complete the submission during 2Q09 and will request priority review (six month) which if granted could lead to an approval decision from the agency during 4Q09.

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