Three Trades on FDA, Clinical Trial Binary Events

 |  Includes: OSIR, RHHBY, THTCF
by: Mike Havrilla

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 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 (OTCQX:RHHBY) 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] (OTC:THTCF) 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).

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