FDA Calendar Updates: AMAG Pharma Up, Northfield Labs Down

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.

AMAG Pharma (NASDAQ:AMAG) reported its quarterly results after the market close on Thursday, but the stock was trading higher after-hours by about 20% on news that the FDA was satisfied with observations noted during a recent inspection of the Company's manufacturing facility. AMAG is awaiting a decision by the agency for its iron replacement therapy, Feraheme (ferumoxytol injection), to treat iron deficiency anemia in patients with chronic kidney disease (CKD). AMAG also noted that a re-inspection of its manufacturing facility will not be required as a pre-requisite to FDA approval of Feraheme. AMAG has previously issued guidance on labeling discussions, which are likely to include a broad label that includes both dialysis and non-dialysis patients with CKD.

Northfield Labs (NASDAQ:NFLD) received a Complete Response Letter (CRL) from the FDA on Thursday evening for its PolyHeme BLA for the proposed treatment of life-threatening hemoglobin levels when blood transfusion is indicated and red blood cells may not be available. The CRL states that the Company's pivotal clinical trial failed to meet the pre-specified primary efficacy endpoint and the study data did not support the proposed indication for PolyHeme. Also, the agency noted that safety data of all controlled studies indicated that patients treated with PolyHeme had a higher risk of significant adverse events.

Disclosure: No positions.