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Latest From Syneos Health

REMS Vendor Disruptions Prompt Greater US FDA Scrutiny

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.

Drug Safety FDA

Trials In Focus: Walmart Joins Growing List Of Retailers Entering Clinical Research

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.

Clinical Trials Companies

VBI Poised To Take On GSK, Dynavax As Hep B Vaccination Market Takes Off

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.

Approvals Vaccines

Decentralized Trials Ease Enrollment In Rare Disease Studies

Panel discussion illustrated how decentralized approaches can expand the possibilities of studies in rare diseases, such as cancers with rare genomic alterations.

Clinical Trials Rare Diseases
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