CBER Chief Peter Marks Explores Alternatives to Clinical Holds.
Peter Marks, the head of the Center for Biologics Evaluation and Research, has acknowledged an uptick in clinical holds for cell and gene therapies during the height of the pandemic, and is considering "alternatives" to manage them. Meanwhile, Tessera Therapeutics has announced preliminary data from five preclinical programs using its "gene writers" to tweak specific letters or insert entirely new sequences of DNA. An FDA independent advisory panel has voted in general support of recommending Pfizer's RSV vaccine, Abrysvo, to protect infants from the respiratory virus. Third-party manufacturer Catalent has announced a series of dramatic steps to right its business, including replacing top executives and site managers. Novo Nordisk is hitting the brakes on a national advertising campaign for obesity drug Wegovy to keep demand in check.
