Deals Update
Executive Summary
A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.
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Class I Recall For GE Healthcare CARESCAPE Ventilator
The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.
ICMRA’s Pilot On Hybrid Inspections And CMC Changes Seeks Participants
Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.
Kezar’s Lead Asset Bounces Back With Lupus Win
Kezar’s lead asset zetomipzomib has demonstrated clinical significance in a mid-stage lupus trial just weeks after a disappointment in myositis but more robust data are needed for the first-in-class selective immunoproteasome inhibitor.