Regulatory
As AstraZeneca released its 2021 annual financial report, a BBC documentary suggested that the way scientists and politicians politicized its COVID-19 vaccine may have cost lives.
It’s uncertain if the origins of COVID-19 will ever be determined, but the current top theories split about evenly between a lab leak from the Wuhan Institute of Virology and a natural evolution from bats to animals to humans at a Wuhan “wet market.”
The U.S. Food and Drug Administration announced they are investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib).
FDA Action Alert for February 7
This particular renewal panel discussion took an unexpected turn, focusing on Biogen’s controversial drug.
The company indicated that its timeline for an accelerated approval request for its own Alzheimer’s drug, donanemab, was no longer on schedule for the first quarter after the CMS draft guidance.
Gilead Sciences revealed in a call with analysts that the hold has now been expanded to additional magrolimab studies.
Shares of LogicBio Therapeutics have fallen more than 57% this morning after the company announced that its gene therapy for pediatric patients with methylmalonic acidemia has been placed on clinical hold by the U.S. Food and Drug Administration.
Finally, Pfizer has submitted the request to FDA to grant emergency use status to their vaccine for children. Here’s everything you should know about the vaccine.
Details about the U.S. government’s contract with Pfizer for 10 million doses of Paxlovid are emerging, with some unusual elements.
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