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  • BioElectronics Making BIG News This Week (BIEL)
    he BioElectronics Corp (Public, OTC BIEL) has been making news this week, with the announcement of their schedule for filing with the U.S. Food and Drug Administration for 510 (NYSE:K) pre-marketing clearance. It has also been announced the biotech company is a runner up in the 2009 Technology Innovation winners for their wearable drug-free patch using electromagnetic energy for pain relief.

    BioElectronics is seeking clearance for their over the counter ActiPatch Therapy and Recovery RX products. In a statement by BioElectronics CEO Andrew Whelan the company is excited that they will soon begin the clinical study data, and usability studies for the product that is for the treatment of musculoskeletal complaints of pain. The ActiPatch that is for the pain relief of the heal and foot pain is also able to be used in painkilling treatment of postoperative edema, and superficial soft tissue treatment.

    Whelan went on to state that they believe this will be a $100 million dollar annual market for the company in treating pain and the clinical data that has been collected by Dr. David G. Genecov is strong, showing it is 100 percent safe and effective.  The BioElectronics CEO believes, along with the ActiPatch FDA clearance for other treatments will help the company to gain fast approval for the OTC clearance.

    During the next few weeks Whelan states the corporation will file additional applications with the FDA for palliative treatment for postoperative edema and for pain in superficial tissue, which will allow them to market the product in the general surgical market. BioElectrionics plans for their clinical studies to end over the next few months

    Tags: BIEL
    Sep 15 8:11 PM | Link | 3 Comments
  • Eye Drops Win Unanimous FDA Approval
    The pharmaceutical company ISTA Pharmaceuticals (Nasdaq: ISTA) won unanimous support for the approval of their new drug for the treatment of itchy eyes name Bepreve eye drops. The eye drops are designed to treat patients with itchy eyes due to allergies and is for patients ages 2 years and up.  The company’s shares showed the favorable approval jumping as much as 30 percent and hitting a 17 month high of $5.53.

    The vote by the Food and Drug Administration was 7-0 due to the fact they  believed that ISTA had proved the effectiveness and safety of Berpreve , along with the fact that the eye medication will be sold by prescription only.

    In a statement by executive chairman of Averion International Corp. and panel member Philip Lavin, the studies that Ista provided all delivered the same evidence of effectiveness and safety for the eye drops Bepreve that is due to formally be approved on September 12th.

    Frank Pinkerton an analyst for SunTrust Robinson Humphrey has predicted the newly approved eye drops will reach $12 million in sales by 2010.

    The side effect evidence that was shown in their latest testing showed about 25 percent of the patients that were being treated with the eye drops is a bitter aftertaste.

    The eye drop medication Bepreve will be available to ophthalmologists throughout the United States during the fourth quarter of 2009 according to the President and Chief Executive Officer of ISTA Vicente Anido Jr., Ph.D.

    Sep 11 2:54 PM | Link | Comment!
  • FDA Update and Applications Awaiting Approval (CTIC NSPH, AUXL)

    Cell Therapeutics, Inc. (Public, NASDAQ:CTIC) recently released their second quarter figures for 2009 and stated it was a transforming quarter for the company, in which they eliminated 44.5% of their outstanding debt. They also released data on their latest drug at the American Society of Clinical Oncology Annual Meeting and have also completed their submission of the New Drug Application to the U.S. Food and Drug Administration.

    The data presented was, phase III results in June that were hopeful and now the announcement on August 24, 2009 the CTIC Company has secured funding to complete the pre-clinical trials for their drug Pixantrone to treat refractory aggressive non-Hodgkin’s Lymphoma.

    In other biotech news, Auxilium Pharmaceuticals, Inc. (Public, NASDAQ:AUXL) filed the Biologics License Application for their drug to treat Dupuytrent’s contracture called XIAFELEX in February, and are awaiting their date of August 28, 2009 by the Prescription Drug User Fee Act. This new medication will battle the progressive disease of connective tissue that lies beneath the skin in the palm causing fingers to contract. The only option till now has been surgery to correct the contracted fingers of people suffering from Dupuytrent’s contracture.

    Nanosphere, Inc. (Public, NASDAQ:NSPH) has announced that they have submitted a 510(k) application to the FDA for their influenza and respiratory syncytial virus test (RSV), complete with sample to result automation. The company believes this will have a greater sensitivity than the rapid tests that are currently available and will combine ease of use with a faster turnaround time.

    Tags: AUXL
    Aug 27 6:17 PM | Link | Comment!
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