Scientific American – “Current monoclonal antibodies fail against COVID virus variants, so drugmakers want to use a fast-track test for new ones…In an e-mail to Scientific American, an FDA spokesperson said the agency is concerned as well, and it will work with drug companies on expedited development of preventive therapies for immunosuppressed patients. But the FDA has not said when it will decide if immunobridging lab data will be sufficient for mAbs. Pharmaceutical makers are anxious for an answer. “We are working hard to get new mAbs available as quickly as we can in a scientifically sound and safe way,” says Christos Kyratsous, who heads infectious disease research at the biotech company Regeneron. “Obviously I wish were a moving a bit faster in terms of our interactions with regulators.” Still, he says, “I’m optimistic we can get there.”
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