Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for

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BioDelivery Sciences International

(NASDAQ:BDSI)

Continuing with the trend of pre-FDA decision BioPharma companies, StocksHaven Investments takes a closer look at BDSI which hopes it’s product Onsolis will strive past approval and make its way onto shelves world-wide.

About BDSI: BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is utilizing licensed and owned drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, significant new formulations of proven therapeutics. Utilizing its drug delivery technologies, the Company is developing formulations of pharmaceuticals aimed at acute (short term) conditions occurring in patients, mostly notably in the areas of pain and fungal infections.

Onsolis: BDSI®’s first application of the lead BEMA™ technology is Onsolis™ (fentanyl buccal soluble film). Onsolis™ utilizes the BioErodible MucoAdhesive (BEMA®) drug delivery technology, which consists of a small, bioerodible polymer

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In April 2009, we are initiated coverage of BioDelivery Sciences International, Inc. (BDSI) with a Buy rating and a $6 price target. Since that time, the shares are up 35% on investors gaining confidence in the pending approval of Onsolis, a transmucosal fentanyl patch for breakthrough cancer pain. The FDA decision is expected on or before June 12, 2009.We view the event as a high likelihood of approval (>80% chance). Approval would be a transformational event for BDSI. Not only would it bring about a $30 million milestone payment from worldwide commercialization partner, Meda AB, but BDSI would also receive double-digit royalties (we estimate 20%) on sales of Onsolis upon launch.The breakthrough cancer pain market is highly competitive, and there are several formulations of fentanyl already on the market, with several more in late-stage development. But we believe that BDSI's BEMA technology offers significant ...

BioDelivery Sciences International, inc. (NASDAQ: BDSI) remains on schedule to meet with the Food And Drug Administration, on Nov. 17 to discuss its Risk Evaluation and Mitigation Strategy for ONSOLIS, its main cancer pain treatment drug.

The company said it has already sent the FDA the information it needs, in advance preparation for the meeting. ONSOLIS (formerly known as BEMA Fentanyl) is for patients who are opoid tolerant. It’s the company’s lead development product.

“Our proposed REMS program will be an important step in helping to assure that prescribers and patients get the benefits of ONSOLIS while minimizing the risks of improper or inappropriate use,” said Dr. Mark A. Sirgo, BDSI president and CEO.

Quality Stocks has kept its eye on BDSi for a while. Biodelivery Sciences is a specialty pharmaceutical company focused on developing products to address growing market opportunities, including conditions such as pain.

In August, The FDA requested conversion of

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