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.

    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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    FDA Issues Emergency Use Authorization for Actemra to Treat COVID-19

    On June 25, 2021, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Actemra (tocilizumab; Genentech Inc.) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal m…

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