News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More
Executive Summary
News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.
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COVID-19 EUAs To Stay Active After Public Health Emergency Ends
Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.
SVB Failure Could Exacerbate Tight Credit, Drive Biopharma Consolidation
An economist told Scrip that banks could become more cautious about handing out loans to biotech start-ups, driving more M&A in the sector.
SVB UK’s Rescue Good News For Europe’s Fragile Biotech Sector
The British government helped secure HSBC as a buyer for SVB UK, but sector leaders want to see more support in the shape of sustained R&D tax relief.