Johnson and Johnson (JNJ) recently presented long-term data from two phase III clinical trials of Simponi (golimumab), carried out on rheumatoid arthritis (RA) patients. It was observed that patients taking Simponi every four weeks achieved sustained improvements through one year. The data were presented at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting held last month.

Data from the first trial – GOlimumab After Former anti-TNF (tumor necrosis factor) Therapy Evaluated in RA (GO-AFTER) revealed that patients previously treated with TNF inhibitors (adalimumab, etanercept or infliximab) responded as well as showed continued response to the drug for an entire year. At week 52, data measured by American College of Rheumatology (ACR 20) response found a 20% improvement in arthritis symptoms in 63% of patients receiving the drug while 41% of the patients achieved a 50% improvement in arthritis symptoms measured by ACR 50 response.

Results from the second trial

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Vimovo Demonstrates Benefit Over Naproxen Yesterday, at the American College of Gastroenterology meeting in San Diego, Pozen (POZN) released data from two phase III trials comparing Vimovo (formerly PN400) to enteric-coasted naproxen (ECN) in patients with osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) who are at risk of developing NSAID-associated gastric ulcers. The data demonstrated that patients taking Vimovo experienced significantly greater reduction in severity of dyspepsia (SODA) and overall treatment evaluation for dyspepsia (OTE-DP) compared to patients taking ECN. The OTE-DP results showed 43-46% of the patients on Vimovo reporting positive change at month six vs. only 28-34% on ECN. The results were highly statistically significant. Plus, patients taking Vimovo also had discontinuation rates far below ECN, at 3-5% vs. 11-12%, respectively. The safety of Vimovo was also superior to ECN, with only 2% of the patients experiencing erosive duodenitis as compared to 10-14% for ...

Yesterday, Schering-Plough Corp. (SGP) and Johnson & Johnson (JNJ) announced the approval of their drug Simponi (golimumab) in the European Union for the treatment of rheumatoid arthritis and other immune system disorders. The drug was approved by the U.S. Food and Drug Administration (FDA) in April 2009.   As a reminder, Schering acquired co-development rights to Simponi in the third quarter of 2005 from Johnson & Johnson’s biotech arm, Centocor Inc., which had developed and discovered the drug. Johnson & Johnson enjoys exclusive marketing rights of Simponi in the U.S., while Schering-Plough holds marketing rights outside the U.S.  excluding Japan, Indonesia and Taiwan where the drug will be co-marketed with other vendors subsequent to regulatory approvals.   Simponi, a next-generation, fully human, anti-tumor necrosis factor (TNF), received European approval as a once-a-month treatment for rheumatoid arthritis (RA), psoriatic arthritis (PA) and ankylosing spondylitis (AS), which is a ...

Dr Stock Pick HOT News & Alerts!

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FREE Daily Stock Alerts From DrStockPick.com

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Wednesday September 30, 2009

DrStockPick.com Stock Report!

COV, PWRM, MSFT, CSRH, NKE, CVAT, ABT

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COV, Covidien plc

COV engages in the development, manufacture, and sale of healthcare products for use in clinical and home settings worldwide. The company operates through four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products, and Medical Supplies.

COV said Wednesday it received Food and Drug Administration clearance for its new endotracheal tube, a device that helps patients breathe.

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PWRM, Power 3 Medical Products Inc, PWRM.OB

Power3 Medical Products, Inc. is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the

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Monday September 28, 2009

DrStockPick.com Stock Report!

XRX, PWRM, ABT, CSRH, CMCSA, CVAT, FMCN

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XRX, Xerox Corp.

XRX engages in the development, manufacture, marketing, servicing, and financing of document equipment, software, solutions, and services worldwide.

XRX said Monday it will buy Affiliated Computer Services Inc. for $6.4 billion in cash and stock to create a $22 billion business that combines XRX’s copiers, printers and document management services with the “business process outsourcing” of Dallas-based ACS., joining the expensive race among technology companies to broaden their offerings.

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PWRM, Power 3 Medical Products Inc, PWRM.OB

Power3 Medical Products, Inc. is a leading bio-medical company engaged in

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For Immediate Release

Chicago, IL - July 1, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Pozen (POZN), Kimberly-Clark Corporation (KMB), Enterprise Products Partners (EPD), Teppco Partners (TPP) and Chevron Corporation (CVX).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Tuesday's Analyst Blog:

Pozen Files For Approval of Vimovo

Today, Pozen (POZN) announced the submission of the new drug application (NDA) to the U.S. FDA, seeking marketing approval for Vimovo (proposed trade name for PN-400) for the treatment of signs and symptoms of osteoarthritis, rheumatoid arthritis and

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Today Pozen (POZN) announced the submission of the new drug application (NDA) to the U.S. FDA, seeking marketing approval for Vimovo (proposed trade name for PN-400) for the treatment of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers.

Vimovo is a combination of 500mg enteric coated naproxen and 20mg immediate release esomeprazole. In early December 2008, Pozen released positive top-line data from its 400-301/-302 phase III program testing PN-400 (20mg esomeprazole / 500mg naproxen) vs. 500mg enteric coated naproxen alone. Results show that 400 patients total in both trials taking PN-400 experienced statistically significant fewer number of confirmed gastric ulcers by endoscopy compared to 400 subjects receiving enteric coated naproxen during the six-month period.

Pozen expects to receive a milestone payment of $10 million when the NDA is formally accepted for review by the FDA. We

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In a Schedule 14A proxy statement filed on May 20, 2009 Merck & Co. (MRK) disclosed that it had received notification from Johnson & Johnson's (JNJ) Centocor subsidiary of its intention to terminate, through arbitration, the distribution agreement with Schering-Plough Corp (SGP) for Remicade and golimumab (Simponi). As we detailed in prior reports and blogs, we had expected some sort of challenge from J&J, so the recent news comes as no surprise.In March 2009 Merck and Co. and Schering-Plough announced a merger agreement whereby the companies would combine in a deal currently valued at approximately $48.8 billion. The deal was structured as a "reverse-merger" with Schering-Plough being the surviving entity. Merck believes that the "reverse-merger" structure will avoid triggering a change-of-control provision in Schering-Plough's agreement with J&J relative to rights to Remicade and golimumab.J&J discovered both compounds and licensed ex-U.S. marketing rights ...

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Theravance [THRX: 14.54, 0.00 (0.00%)]: On 4/24/09, the FDA accepted as complete for review Theravance’s response to the February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is

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The recent volatility from the Healthcare sector has left many investors weary about where to place their money. General market swings aside, M&A activity and legislative developments have intensified the uncertainty in the sector, but have also lead to many investment opportunities.

M&A has been very exciting and has ramped up heavily in the last few months.  Pfizer[PFE: 14.04, 0.00 (0.00%)] and Wyeth, Roche and Genentech [DNA: 0.00, N/A (N/A)], Merck [MRK: 27.16, 0.00 (0.00%)] and Schering-Plough, Gilead [GILD: 44.37, 0.00 (0.00%)] and CV Therapeutics have all hit the headlines.  Obama’s Healthcare Budget Plan has stirred up heavy trading in recent weeks, putting downward pressure on the Managed Care and Pharmaceuticals sectors, while giving a boost to the Generic Drugmakers. The market has rallied in the past week.  Is your portfolio ready

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