Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 297 entries as of 8/3/09.. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 8/2/09, Savient Pharma (NASDAQ: ) announced it received a complete response letter (CRL) from the FDA for the Company's Biologics License Application (BLA) seeking approval of Krystexxa (pegloticase) as a treatment for chronic gout patients who do not respond to conventional therapy. The CRL cites deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS).

The Company intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter. Under FDA regulations, the Company believes that this meeting is deemed a "Type A" meeting, meaning that the FDA would meet with the Company within 30 days of its receipt of the meeting request. SVNT stated that it is currently targeting a resubmission for early 2010 and expects to provide more details after meeting with the FDA to discuss the CRL. Resubmissions to the Agency are designated as either Class I (60-day) or Class II (six-month) reviews.

On 8/3/09, Repros Therapeutics (NASDAQ: ) announced that, in the interest of patient safety (elevation of liver enzymes), it is voluntarily suspending dosing of all patients in its clinical trials of Proellex.