Robotic-assisted surgery-focused Intuitive Surgical Inc. revealed its second-quarter results late July 21, with worldwide Da Vinci procedures falling about 19% vs. the same period of 2019. Driven by this decline, second quarter 2020 instruments and accessories (I&A) revenue fell by 20% to $461 million, vs. $579 million in the second quarter of 2019.
The U.S. government will pay $1.95 billion to Pfizer Inc. and Biontech SE for the first 100 million doses of their jointly developed mRNA-based COVID-19 vaccine once Pfizer manufactures it and receives the FDA’s approval or emergency use authorization. The two companies agreed, as part of Operation Warp Speed, to begin delivering 300 million doses of a COVID-19 vaccine in 2021.
Interludes of classical music. Little kids talking in the background. Unmuted mics as panelists multitask. Gurgles of “underwater” sound. Periods of silence as speakers forget to unmute. And then the technical problems – lots of them. Such are the challenges of addressing a virtual FDA advisory committee in the time of COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, AGTC, Jazz, MC2, Redhill.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Channel Medsystems, Lifesignals, OralDNA Labs, Paige.
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