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Latest From Syneos Health
McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.
SIGA provides an update on its monkeypox program, while Massive Bio announces progress on its AI platform for connecting cancer patients to trials, with additional updates from BridgeBio, the Oncology Institute, and CROs Caidya, Charles River Labs, Syneos Health and PPD parent Thermo Fisher Scientific.
VBI Vaccines obtained FDA approval of its three-antigen hepatitis B vaccine PreHevbrio and will take on GSK’s Engerix-B and Dynavax’s Heplisav-B as CDC recommends universal HBV immunization.
Panel discussion illustrated how decentralized approaches can expand the possibilities of studies in rare diseases, such as cancers with rare genomic alterations.
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