Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...

Osiris Therapeutics (NASDAQ:OSIR) announced this morning that Health Canada has completed its initial evaluation and issued a priority (180-day) review for PROCHYMAL (remestemcel-L) (mesenchymal stem cells for intravenous infusion), which is seeking approval as an adult stem cell therapy for the treatment of graft vs. host disease (GvHD).

On 7/20/10, the Oncologic Drugs FDA Advisory Committee (ODAC) voted to remove the approved indication for Roche's (RHHBY.PK) AVASTIN (bevacizumab) as a treatment option for metastatic breast cancer. The vote follows a previously issued accelerated approval and is based upon subsequent post-approval results that failed to demonstrate a similar survival benefit that served as the basis for expedited approval.

A final FDA decision is expected later this quarter and the ODAC voted 13-0 against the use of AVASTIN for breast cancer in combination with docetaxel and voted 12-1 against for use in combination with other types of chemo drugs for the treatment of metastatic breast cancer.

On 7/20/10, Theratechnologies (TSX:TH.TO) (THTCF.PK) announced a new FDA timeline for an expected decision during 4Q10 for EGRIFTA (tesamorelin) (injected analog of growth hormone releasing factor), which is seeking approval for the treatment of excess abdominal fat in HIV patients with lipodystrophy. The original PDUFA action goal date was 7/27/10, an FDA Advisory Panel previously voted 16-0 to recommend approval for this New Drug Application (NDA).

Below are summaries of the most recent articles written by Mark Messier at www.BioRunUp.com - please visit the site to read the full articles, in addition to many other free tools and strategies related to binary event investing...

Cumberland Pharma (NASDAQ:CPIX) -- Priority Review PDUFA Date of 9/10/10 for ACETADOTE

Posted: 20 Jul 2010 06:00 AM PDT

Using the subscriber binary event tracking calendar from MikeHavRx.com, I recently came across CPIX.  The company has a sNDA (Supplemental New Drug Application) with priority 6 month review and a PDUFA date of 9/10/10 for its drug, Acetadote. This medication is already the first FDA -approved injectable drug to treat acetaminophen overdose. This sNDA would allow for treatment [...] Click here for my recent overview article on CPIX from earlier this month.

www.mikehavRx.com is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The HavRx Regulatory Catalyst Index update report is currently tracking 608 entries and 413 companies (with approximately 200 stocks trading under $5 per share and 69 private companies). Click here for a subscriber overview article that includes an email archive web link for a 50% discount ($150) promo code off the regular one-year, non-recurring subscription price.

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