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

On 7/23/10, Emisphere (OTCBB:EMIS) announced that the independent data monitoring committee concluded there is no reason to continue Study 2302 for efficacy in osteoarthritis (OA) (although no safety concerns were noted and the decision to continue trial is up to sponsor) while the parallel Study 2301 in OA was previously recommeded to continue Dec. 2009. Both studies will continue with final 2301 data expected during 4Q10 and are evaluating an oral formulation of calcitonin, which is currently marketed as nasal spray and injected formulations.

Momenta Pharma (NASDAQ:MNTA) and the Sandoz generic division of Novartis (NYSE:NVS) announced FDA approval of the Abbreviated New Drug Application (ANDA) for M-Enoxaparin as a complex generic product to the blood thinner LOVENOX, marketed by Sanofi-Aventis (NYSE:SNY). Sandoz and MNTA also have a pending ANDA for M356 (glatiramer acetate injection), which is seeking FDA approval as a complex generic product to Teva Pharma's (NASDAQ:TEVA) multiple sclerosis drug COPAXONE, with a 30-month litigation stay that expires next year.

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...

JAZZ - Run-Up Forming 4 Weeks from FDA Panel

Posted: Fri, 23 Jul 2010 15:57:49 +0000

JAZZ seems to be absolutely stuck at the $8.75 resistance level, however take a look at the chart, it appears we are getting ready to break through, as a nice triangle/ wedge is forming. Obviously we are hoping we can make it through the next few weeks without any of the common ‘biotech surprises', such [...]

FDA Calendar Updates 7/23/10

Posted: Fri, 23 Jul 2010 09:52:31 +0000

MMTIF- 510K Medical Device Application for Breast Cancer Detection ESTIMATE 12/31/10 CPIX- I contacted the company and was told the PDUFA date is actually 9/10/10.  Calendar updated. MNKD - Complete Response Accepted by FDA- PDUFA Date for Afrezza 12/29/10 MELA - FDA Advisory Panel for MelaFind delayed to November. THTCF - Announced their approval date has been [...]

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 613 entries and 421 companies (with approximately 200 stocks trading under $5 per share and 74 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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