Review: 'Through the Shadowlands’ describes Julie Rehmeyer's ME/CFS Odyssey
I should note at the outset that this review is based on an audio version of the galleys and the epilogue from the finished work. Julie Rehmeyer sent me the final version as a PDF, but for some reason my text to voice software (Kurzweil) had issues with it. I understand that it is...
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Hemispherex settles lawsuit for 2.75 millions

Discussion in 'General ME/CFS News' started by Kati, Jun 3, 2015.

  1. Kati

    Kati Patient in training

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    http://www.bizjournals.com/philadel...-biotech-hemispherx-biopharma-settlement.html


    Exerpt:
    A Philadelphia biotechnology company has tentatively agreed to pay $2.75 million to resolve a lawsuit brought by its shareholders, who allege the company made “material misrepresentations and omissions” regarding the status of a new drug application for its lead new drug candidate.

    The class action lawsuit was filed against Hemispherx Biopharma, which has spent more than three decades developing Ampligen for a variety of possible uses. It is currently studying the drug’s potential use as a therapeutic and preventative vaccine enhancer.

    In 2007, Hemispherx filed a new drug application for Ampligen seeking to market the drug as a treatment for chronic fatigue syndrome.

    The Food and Drug Administration rejected the application in 2009 saying the clinical data submitted did not provide “credible evidence” of the product’s effectiveness. The agency suggested Hemispherx conduct an additional clinical study for Ampligen.

    Instead Hemispherx (NYSEMKT:HEB), in 2012, submitted additional analyses of data from a previously conducted clinical trial as part of its response to the concerns raised by the FDA when it rejected the Ampligen application.

    In early 2013, the FDA once again rejected Hemispherx’s application for Ampligen — after an advisory panel voted not to approve the drug in December 2012 — stating data submitted with the application did not provide substantial evidence of Ampligen ‘s effectiveness in treating patients with chronic fatigue syndrome, or sufficient information to determine whether the drug was safe when used to treat patients with the condition.
     
  2. Hutan

    Hutan Senior Member

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    New Zealand
    (Sorry if this has been posted previously. It was reported in the emerge Australia journal).

    http://finance.yahoo.com/news/hemispherx-enters-collaboration-emerge-health-123000467.html


    PHILADELPHIA, March 9, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB)(the "Company" or "Hemispherx"), reported today that it has executed an agreement with Emerge Health Pty Ltd. ("Emerge") to seek approval of Ampligen, an experimental immunotherapeutic, for Chronic Fatigue Syndrome in Australia and New Zealand and to commence distribution of Ampligen in both countries on a named-patient basis, where deemed appropriate.

    Hemispherx and Emerge will collaborate on seeking regulatory approval from Australia's Therapeutic Goods Administration ("TGA") and New Zealand's Medicines and Medical Devices Safety Authority ("Medsafe").

    Under an exclusive license to sell, market, and distribute Ampligen in Australia and New Zealand to treat Chronic Fatigue Syndrome, Emerge will implement regulatory-compliant programs to educate physicians about Ampligen for CFS and seek orphan drug designation and approval of Ampligen to treat CFS. Hemispherx will support these efforts and will supply Ampligen at a predetermined transfer price.

    Chris Rossidis, Co-Founder and COO of Emerge, said, "This agreement with Hemispherx represents an opportunity which is exactly why Emerge was formed, to provide Australian and New Zealand patients with products that their physicians believe would be helpful. Given that there is no product approved specifically for the treatment of Chronic Fatigue Syndrome anywhere in the world, and at estimated prevalence rates of CFS in Australia and New Zealand, there could be 50,000 to 150,000 CFS patients with no dedicated treatment of this debilitating disease. We hope to be able to start providing Ampligen to the most severe of these patients during this year."​

    Note - Emerge Australia is a not-for-profit patient support organisation. 'Emerge', the company that is working with Hemispherx, is reported to be unrelated to Emerge Australia.
     
  3. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    australia (brisbane)

    Interesting, I didn't think Australia would be interested in ampligen. Do we know if this May be due to Griffith university looking to study the effects of ampligen. I know dr Peterson is interested in this as well as has connections with Griffith university cfs me researchers.
     
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  4. Hutan

    Hutan Senior Member

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    heapsreal likes this.
  5. CFS_for_19_years

    CFS_for_19_years Hoarder of biscuits

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    USA
    http://www.hemispherx.net/content/investor/default.asp?goto=828
     
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