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

On 7/9/10, Bristol-Myers (NYSE:BMY) announced that the FDA accepted its supplemental New Drug Application (sNDA) for a priority (six-month) review to expand the product label for SPRYCEL (dasatinib) (an oral BCR-ABL inhibitor anti-cancer agent) to include the treatment of adult patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase.

On 7/12/10, Protalix Biotherapeutics (AMEX:PLX) announced that the FDA accepted its NDA for UPLYSO (taliglucerase alfa) and issued a standard, 10-month review period for an expected final decision by the Agency in late February 2011. UPLYSO is a plant-cell expressed form of an enzyme know as gluco-cerebrosidase, seeking marketing clearance for the treatment of Gaucher's disease following the completion of a rolling NDA April 2010 under SPA.           

Merck KGaA (OTC:MKGAY) resubmitted its NDA for cladribine (oral tablets, experimental compound for multiple sclerosis or MS) to the FDA on 6/8/10 following a refuse to file (RTF) notice on 11/30/09. A response is expected from the FDA within 60 days to formally accept the NDA and classify for a standard or priority review designation and the Company announced approval for cladribine in Russia earlier this morning.

Below is the weekly binary event stock watch list published 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.

Vivus (NASDAQ:VVUS) - At the absolute top of this week's watchlist is the FDA Advisory Panel for Qnexa.  We should see the meeting notes either today or tomorrow.  Check here for updates:  FDA Advisory Calendar .  There will be multiple day trading opportunities all week depending on the panel note, votes, and recommendations.  Stay on your toes for this one!

Arena Pharma (NASDAQ:ARNA) / Orexigen Therapeutics (NASDAQ:OREX) - These companies will be watching very closely the FDA panel for VVUS.  It is hard to guage how their share price will be effected by a VVUS decision.  A good panel is good news for weight loss drugs, however there will be more competition on the market.

Jazz Pharma (NASDAQ:JAZZ) / MELA Sciences (NASDAQ:MELA) - I expect biotech traders to move on to the next FDA plays once they pull their money out of VVUS, so I am looking for a nice small boost is JAZZ and MELA as we are only a few weeks out from their FDA Panels.

Isotechnika Pharma (TSX:ISA.TO) - No word yet from the company Isotechnika on a CRL and the 8/3/10 FDA date seems to be still relevant.  Proceed with caution though...

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.

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Disclosure: No positions