Pfizer explores options for new vaccine update, Veklury expands to non-hospitalized patients but Regeneron and Lilly therapies stopped in face of Omicron efficacy drop-off.

Promotion does not adequately communicate the diabetes drug’s indication, limits of use and risks, FDA says. It objects to distracting visuals in video and less prominent risk information. Agency had previously relayed its concerns to Lilly about Trulicity promotions.

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights the push behind digital therapeutics, Abbott’s biowearable line, Exec Chats with iRhythm and Cognetivity, Right To Repair rules for tech, and FDA's guidance on 3D-printing.

Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.