Good morning, everyone, and how are you today? We are doing just fine, thank you, now that the Pharmalot campus has settled down. The short person is hunched over the laptop for another day of remote learning and the official mascot is finally starting to snooze after a long constitutional. All of which means that we can focus on the matters at hand — brewing cups of stimulation and foraging for items of interest. On that note, here is the latest menu of tidbits to get you started. Hope that all goes well today and that you stay safe. …
The AstraZeneca (AZN) Covid-19 vaccine trial in the U.S. is expected to resume as early as this week after the Food and Drug Administration completed its review of a serious illness in a study participant, Reuters reports. The trial has been on hold since Sept. 6, after a participant in the company’s UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis. It was unclear how the FDA would characterize the illness.
While Lilly is correct to say they have not yet received a warning letter for the issues at their NJ facility, may one observe that those letters often take over a year for a domestic facility? Add the second 483 and one wonders if a rewrite is in process, or not. “Time will tell.”
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