Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of 254 entries as of 7/13/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of
BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 7/13/09, BioMarin Pharma (NASDAQ: ) announced that patient enrollment has been completed for its Phase I/II clinical trial for BMN-110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. The Company expects to report initial results during 1H10. BMRN stated that the enrollment of 20 patients is a critical milestone for the MPS IVA program and the data generated from this study will be valuable in demonstrating safety and could be instrumental in designing a successful Phase 3 trial, including assessments from the Phase I/II study such as plasma and urine keratan sulfate levels, pulmonary function and walk tests to establish optimal Phase 3 endpoints. During the dose escalation phase of the study, subjects will receive weekly intravenous infusions of BMN-110 in three consecutive 12-week dosing intervals. The objectives of the Phase I/II study will be to evaluate safety, pharmacokinetics, pharmacodynamics and to identify the optimal dose of GALNS for future studies.
On 7/13/09, OSI Pharma (NASDAQ: ) announced that SATURN, a pivotal Phase 3 study of Tarceva (erlotinib), met a key secondary endpoint of extending overall survival in patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population. The new data will be presented during the 13th World Conference on Lung Cancer to be held July 31 to August 4, 2009 in San Francisco.
