STAT+: Pharmalittle: We’re reading about Regeneron buying 23andMe, the Novavax Covid shot, and more
The FDA finally approved Novavax's Covid-19 vaccine, but placed restrictions on it that its two competitors in the U.S. do not face
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of meetings, deadlines, and messages has returned. But what can you do? There is no pause button to stop the world from spinning. So this means one thing: time to dig in to the tasks at hand. On that note, we have assembled a menu of tidbits to help you get started. Meanwhile, we have also fired up the coffee kettle for another cup of stimulation. Our choice today is banana split. We hope that your day is simply smashing and that you conquer the world. And as always, do keep in touch if something juicy and insightful arises. …
The U.S. Food and Drug Administration has finally approved Novavax’s Covid-19 vaccine, but in doing so has placed restrictions on it that its two competitors in the U.S. market do not face, STAT tells us. The long-awaited license limits use of the vaccine to people 65 and older and people aged 12 to 64 who have at least one medical condition that puts them at higher risk of severe illness if they contract Covid. The vaccine has been available under an emergency use authorization. The FDA missed an April 1 deadline to rule on Novavax’s application and it was reported that political appointees in FDA Commissioner Marty Makary’s office overrode career staff, who recommended issuing the license. Makary has raised concerns about the fact that the clinical trials supporting Novavax’s application had been done several years earlier — which is not abnormal for a vaccine application — targeting a version of the SARS-CoV-2 virus that circulated then.
Regeneron Pharmaceutical reached an agreement to buy the consumer genetics firm 23andMe out of bankruptcy for $256 million, although the deal is subject to bankruptcy court and regulatory approvals, STAT writes. The biotech said it would continue 23andMe’s consumer business and use the data the company has collected for drug development. It said it is prepared to detail its intended use of customer data, including privacy protections and security controls, for the review of a court-appointed, independent customer privacy ombudsman “and other interested parties.” The deal would appear to bring to a close a dramatic series of events for 23andMe, which became a widely known consumer brand but suffered as a business. It could also ease concerns about the privacy of 23andMe’s customer data. With 23andMe entering bankruptcy in March, stoking uncertainty about its future, experts have advised customers to download and then delete their data.
