Hayes News

Hayes News Service keeps our clients up to date with late-breaking news from clinical trials, coverage decisions, and new product approvals. We focus on emerging technologies with potentially high clinical and financial impact as soon as they are announced publicly.

Our analysts scan more than 75 peer-reviewed journals and news briefings from government agencies, medical associations, and research institutes. Results of selected studies or articles are summarized and posted with a brief commentary on whether the findings are likely to have a substantial impact.

    CMS Posts Proposed Decision Memo on Monoclonal Antibodies for Alzheimer Disease

    On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease, proposing to cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease (AD) under Coverage with Eviden…

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    FDA Safety Alert: Pepaxto

    The Food and Drug Administration (FDA) issued a safety alert for Pepaxto (melphalan flufenamide; Oncopeptides AB) based on results from the OCEAN trial, which demonstrated an increased risk of death.

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    First FDA Approval Based on Real World Evidence

    On July 16, the Food and Drug Administration (FDA) approved a new indication for Prograf (tacrolimus; Astellas Pharma US Inc.) based on observational study data providing real-world evidence (RWE) of effectiveness. It is the first drug approval based on RWE. The newly approved indication is for use in combination with other immunosuppressant drugs to prevent organ rejection i…

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    FDA Safety Alert: NuVasive MAGEC Devices

    The Food and Drug Administration (FDA) issued a safety communication regarding potential mechanical failures and concerns about biocompatibility associated with components of the following NuVasive Specialized Orthopedics MAGEC devices:

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