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PathoGenesis is Outward Bound

Executive Summary

PathoGenesis has begun life serving the niche market of cystic fibrosis. But the firm says this focused business model is just the launch point for expansion into other, larger chronic infectious respiratory markets.

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Ocularis Pharma Inc.

Ocularis has found a simple solution-a drug delivered in the form of eyedrops-for the problem of impaired night vision. Poor night vision is a generally unrecognized and largely unstudied phenomenon, but it affects every fourth person, the company believes. Because it's working with a new formulation of an already-approved drug that's available in an injectable formulation for a different indication, it's been able to move quickly into clinical trials.

US High Court Punts On ‘Objective Falsity’ FCA Standard

Can a false-claims suit be filed if doctors have different opinions about whether a treatment was necessary? The Supreme Court won’t say.

Warning Letter Close-Outs – February 2021

No device-related close-out letters were released by the US FDA last month.


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