Good morning. Elizabeth Cooney here, sitting in for Ed Silverman again, wishing him sunny skies and delightful breezes if he’s walking the mascot somewhere off the Pharmalot campus. And coffee, of course. Here are some items to interest for the rest of us. …
Some scientists are questioning why Vertex, whose CRISPR therapy may have cured more than 70 clinical trial participants of sickle cell disease, has not released key information on precisely how CRISPR is affecting the DNA of patients in its trials, STAT writes. Not all scientists agree such information is crucial for investigating any adverse effects years down the road and a Vertex spokesperson said the company had done “extensive” work to understand and rule out risks and was confident in its approach.
The Food and Drug Administration will expedite its review of Biogen’s and Eisai’s experimental Alzheimer’s drug lecanemab, with a decision due by Jan. 6, 2023, the companies said, Reuters reports. Lecanemab, like the partners’ polarizing drug Aduhelm, is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s. Eisai, which reduced its role in Aduhelm, is leading the lecanemab development effort. Aduhelm was approved over the objections of an FDA outside expert panel after only one of two late-stage trials suggested it helped slow cognitive decline.
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