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M. E. Garza
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M.E. Garza is one of the founders of the biotech and healthcare sector news portal BioMedReports.com. He believes in getting the news from credible sources on the street and often reaches out to CEOs and newsmakers directly for interviews and discussions about their companies. Since he began... More
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  • RxNews Recap for Friday 01-22-10. Somaxon, Poniard and GenVec up sharply. Late day rumors launch IR Biosciences (OTC:IRBS) 0 comments
    Jan 23, 2010 4:36 AM

    Shares of IR Biosciences (OTC BB: IRBS) rose dramatically late Friday afternoon on speculation that the company will be announcing either a partnership or that they have been awarded one of the multi-million dollar grant submissions which have been made to the NIH and BARDA (Biomedical Advanced Research and Development  Authority) , as well as to the Armed Forces Institute of Pathology and Walter Reed Army Medical Center through their Combat Wound Initiative Program. According to a recent press release, NIH-funded studies in areas related to Idiopathic Pulmonary Fibrosis, where the Company has filed its first IND (Investigational New Drug application) with the U.S. Food and Drug Administration (FDA), are being pursued at the University of Rochester. Successful research studies have garnered the interest of potential partners, among them the world-renowned peptide manufacturer Bachem Inc. Shares rallied 55% on the day.

    Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), saw its shares rocket over 80% as the specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

    Somaxon met with senior leaders at the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the issues raised by the FDA in the Complete Response Letter Somaxon received in December 2009 relating to the Silenor NDA. No additional safety or efficacy data was required to be included in the resubmission, and the company filed the resubmission with the FDA on January 21, 2010. The company anticipates a decision from the FDA by March 21, 2010.

    “We believe that the dialogue we had with the FDA was constructive,” said Richard W. Pascoe, Somaxon’s president and chief executive officer. “We intend to continue to work diligently with the FDA during the two-month review cycle toward a potential approval for Silenor.”

    GenVec, Inc. (Nasdaq: GNVC) announced today that data from the Company's trial in esophageal cancer were presented at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancer Symposium in Orlando, Florida on January 22, 2010.

    The poster, titled, "Long term survival analysis of multicenter clinical trial using endoscopy (NYSE:END) and endoscopic ultrasound (EUS) guided fine needle injection (NYSEARCA:FNI) of antitumor agent (TNFerade Biologic (TNF)) in patients with locally advanced esophageal cancer," reports on updated efficacy and survival data. In the 24 patients receiving TNFerade in combination with chemoradiation, the median survival was 47.7 months.  Median survival from other historical clinical trials in similar stage disease ranged from 9.7 to 34 months.

    Research presented in the poster received a prestigious ASCO Foundation Merit Award. In addition, the poster received focused attention at the oral review session on esophageal cancer on January 22, 2010.

    "This symposium brings together the greatest thought leaders in this area of oncology and we are pleased to be presenting this analysis at this event," stated Mark Thornton, Ph.D., GenVec's Senior Vice President of Product Development. "The encouraging increases in survival versus historical controls will warrant additional evaluation."

    Shares of GenVec,which have been rising over the last few trading session, shot up 25% on the news and continued to rally in after-hours trading.


    Poniard Pharmaceuticals Inc. (NASDAQ: PARD) was another big mover today as shares were up sharply as investors anticipated positive results from data for the company's cancer drug to be presented at a conference this weekend. Poniard  plans to present data for the drug for the treatment of colorectal cancer at the American Society of Clinical Oncology 2010 Gastrointestinal Cancer Symposium this weekend in Orlando.

    Shares shot up early this morning as a report first released here on BioMedReports to subscribers brought the stock to investors attention. The stock continued to rally throughout the day as other news organizations picked up on the story. The stock closed up over 21% as 23 million shares, 8 x the normal volume, traded hands.

    Other news makers on Friday:

    Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP), today announced that it has entered into definitive agreements with accredited investors to sell in a registered direct offering an aggregate of 2.10 million shares of its common stock at a price of $3.00 per share for aggregate gross proceeds of $6.3 million.

    Acorda Therapeutics, Inc. (Nasdaq: ACOR) late Friday announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (NYSE:MS).

    AMPYRA demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). AMPYRA can be used alone or with existing MS therapies, including immunomodulator drugs.

    “The approval of AMPYRA marks an important milestone for the many people with MS who suffer walking impairment. Difficulty walking is often cited by those with MS as one of the most pervasive and challenging aspects of their disease,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics, adding: “We are enormously gratified to have achieved approval for the only medication indicated to improve walking in people with MS, and we thank all of the clinicians, people living with MS and medical and patient support organizations who joined in this effort over the past decade. Reaching this milestone underscores Acorda’s ongoing commitment to develop innovative therapies for people with neurological diseases.”

    Shares of Acorda closed sharply into the close, up close to 10%.

    Biovail Corporation (NYSE/TSX: BVF) today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial it intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug.

    Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced that it will host an analyst and investor meeting on Thursday, January 28, 2010 from 9:00 am to 11:30 am ET in New York City.

    Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced that five major research reports derived from studies using the Daxor Blood Volume Analyzer (BVA-100) were presented at the annual Society of Critical Care Medicine (SCCM) conference in Miami, FL.The BVA-100 enables measurement of whole blood volume, including plasma volume and red blood cell volume.

    IsoRay, Inc. (AMEX:ISR), announced today that they have expanded their market awareness program by joining StockProfile.com, a customized web-based platform showcasing emerging growth stocks.

    Matrixx Initiatives, Inc. (Nasdaq: MTXX), an over-the-counter healthcare company, announced today that financial results for the fiscal 2010 third quarter, ended December 31, 2009, will be released after the market closes on Monday, January 25, 2010.

    Sanomedics International Holdings (Pink Sheets:SIMH) announced a significant donation to Haiti earthquake relief efforts today, consisting of over $35,000 worth of the company’s Non-Contact Infrared Thermometers.

    Synergy Pharmaceuticals, Inc. (OTC BB: SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today that Dr. Gary S. Jacob, the Company’s President & Chief Executive Officer, will present at the 8th Annual BioPartnering North America (BPN) Conference which is being held on January 24th - 26th, 2010 at the Westin Bayshore Resort in Vancouver, BC.

    Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a Nov. 10, 2009, District Court decision that the Company’s generic version of Takeda’s Prevacid® (lansoprazole) SoluTab does not infringe U.S. Patent No. 5,464,632.

    Themes: biotech, healthcare
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