FDA Updates: Week of June 27, 2022

July 02, 2022

In COVID-19 news, the FDA has declined an EUA request for Zyesami and Pfizer has submitted NDA for Pavlovid. The regulatory agency has accepted several applications, including an sBLA for Eylea in diabetic retinopathy and the NDA for palovarotene for a rare genetic disorder. The FDA also issued a CRL for a UTI therapy and extended the review of diabetes therapy. And finally, Gilead has resubmitted its twice-year HIV therapy.

Using Predictive and Prescriptive Insights to Close Care Gaps

July 01, 2022

By using a combination of predictive and prescriptive next best action insights, providers can close the gap in care for individual patients by leveraging a combination of data sources — clinical data, patient surveys, SDOH data, and consumer and behavioral data sets — and applying artificial intelligence techniques to create those insights.

ACAP Tackles SDoH Issues

June 30, 2022

The Association for Community Affiliated Plans has launched The ACAP Center for Social Determinants of Health Innovation. The center offers tailored resources, including policy reports, market research, and roundtable educational events, to help health plans, policymakers, and other stakeholders address social issues that impact health and wellbeing

FDA Updates for Week of June 20, 2022

June 25, 2022

FDA approves tumor-agnostic cancer therapy, Clovis pulls Rubraca indication, Purdue launches opioid reversal, FDA plans advisory committee meeting for Xphozah, and Manarini and AbbVie submit applications.