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

On 7/27/10, Antares Pharma (AMEX:AIS) announced that its pivotal study for ANTUROL (transdermal oxybutynin ATD gel) met the primary endpoint with a statistically significant reduction in urinary incontinence episodes for both doses evaluated (56 / 84mg daily). An open-label extension study is ongoing to assess safety and is expected to be completed by 4Q10 with plans to file a New Drug Application (NDA) by year-end.

On 7/27/10, Hologic (NASDAQ:HOLX) announced that a meeting of the FDA Radiological Devices Advisory Panel is scheduled for 9/24/10 to review the Company's PMA submission for the Selenia Dimensions 3-D Digital Mammography Tomosynthesis System, seeking marketing clearance as a new method (3-D vs. 2-D imaging) for breast cancer screening / diagnosis.

On 7/27/10, Omeros (NASDAQ:OMER) announced that the first patient was enrolled in a Phase 2b study to evaluate OMS302 (anti-inflammatory plus pupil dilating Pharmaco-Surgery combo agent) following cataract eye surgery. OMER plans to enroll about 200 patients and advance the compound into Phase 3 development in 2011 contingent upon successful completion of the Phase 2b study.

Caraco Pharma Labs (AMEX:CPD) reported its quarterly results and provided an update following the June 2009 seizure of inventory from is MI manufacturing facilities and FDA Consent Decree. CPD is working with cGMP consultants to regain FDA compliance, and the Agency replied on 6/24/10 that the protocol to re-gain compliance was acceptable. As of 6/30/10, CPD has 33 pending ANDAs at the FDA, which includes 29 products and four tentative approvals.

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 617 entries and 428 companies (with approximately 200 stocks trading under $5 per share and 78 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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