Every day we scan the headlines for the best items that engage the clinical trial ecosystem, workflow solutions, and more—all the latest news you need to know. Here are today's stories:

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An FDA panel approved Bluebird Bio’s single-use bespoke gene therapy for treating people with a rare inherited blood disorder, beta thalassemia. People affected with beta thalassemia are born with a reduction of normal hemoglobin and red blood cells, which requires a lifetime of ongoing red blood cell transfusions. Bluebird’s Tom Klima told Fierce Pharma the company plans to begin treatment in early 2023.

The Office of Inspector General (OIG) criticized the National Institutes of Health (NIH) in a recent report for not fully enforcing federal requirements for its funded studies. The law states NIH-funded research is published on ClinicalTrials.gov. According to the Inspector General’s report, 50 percent failed to publish within the required timeline, and one-third of the researchers weren’t publishing results. (Regulatory Focus)

Hemanth Kanakamedala, senior director at the Janssen Pharmaceutical Companies of Johnson & Johnson, describes how AI and data science lead to better outcomes in treating difficult immunological diseases. (Clinical Leader)

Meanwhile, in the New England Journal of Medicine, Adam Sherwat, M.D., John T. Brooks, M.D., Debra Birnkrant, M.D., and Peter Kim, M.D., discuss how to manage access to tecovirimat, a drug authorized for treating the current wave of monkeypox, although the drug's “safety and efficacy in humans have not been established."

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                              – Jess, Program Manager

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