Below is a summary of updates to the
<font> BioMedReports.com </font> database of over 200 entries included in the
<font> FDA and Clinical Trial Calendars </font> . 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) : On 4/30/09, AMAG reported 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. On 5/12/09, AMAG announced the FDA accepted the Company’s resubmission of its Feraheme™ (ferumoxytol injection) New Drug Application in response to the December 2008 Complete Response letter as a complete, Class 1 response with a PDUFA date of 6/29/09.
On 5/11/09, Immunomedics (NASDAQ:IMMU) provided the following updates for its clinical development pipeline.
UCB SA (EBR:UCB) has completed patient enrollment for their Phase 2b study of epratuzumab in lupus with results expected during 3Q09 calendar year (which is 1Q10 for IMMU fiscal year). The North Central Cancer Treatment Group plans to report final results from its Phase 2 study of epratuzumab with rituximab and chemotherapy in patients with aggressive lymphoma in an ora presentation at the American Society of Clinical Oncology (ASCO) annual meeting on 5/30/09.
Nycomed (privately held) is expected to initiate a Phase 2 study of subcutaneous veltuzumab in patients with rheumatoid arthritis during 3Q09 calendar year (which is 1Q10 for IMMU fiscal year). Data from a Phase 1 study of subcutaneous veltuzumab in B-cell malignancies will be presented in a poster session at the American Society of Clinical Oncology (ASCO) annual meeting on 6/1/09.
Yttrium-90-labeled hPAM4 was granted Fast Track designation for the treatment of patients with pancreatic cancer. Results from Phase 1b study in advanced pancreatic cancer patients will be presented in a poster session at the American Society of Clinical Oncology (ASCO) annual meeting on 5/31/09.
Updated results from the dose-escalation trial of milatuzumab in patients with multiple myeloma will be presented in a poster session at the American Society of Clinical Oncology (ASCO) annual meeting on 5/30/09.
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