In observance of Memorial Day in the U.S., CenterWatch Weekly will not be published Monday, May 27. The next issue will be published Monday, June 3.
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Adapting to the quality and risk management components embedded in the new ICH E6(R3) guidelines may present challenges for sponsors and providers, but it’s sites that may find the task particularly daunting, findings from an Avoca survey show.
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Dynavax announced it received an FDA complete response letter (CRL) on its sBLA for Heplisav-B vaccine because the third-party trial site operator destroyed the data for approximately half the participants.
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This week’s Pipeline features a phase 1 trial approval for myelofibrosis, a phase 3 trial start for diabetic retinopathy and an FDA drug approval for recurrent/metastatic cervical cancer.
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