2020 In Review: Highlights, Lowlights and Forgotten Milestones
Executive Summary
Our interactive timeline tracks the rush of activities that led to the authorization of the first coronavirus vaccines and includes other major non-COVID developments that provide a full picture of this extraordinary year.
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Year Of IP: From The TRIPS Waiver Proposal To The Moderna-NIH Patent Tussle
Intellectual property became front page news in 2021 as the pandemic ignited a debate on the role of patents in accessing COVID-19 vaccines and therapeutics. 2022 will see a decision on the TRIPS waiver, a new USPTO director, and action on a pending march-in petition.
Lilly Gets First Of Its Kind FDA Citation For Trulicity Instagram Post
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.
‘Skinny Label’ Litigation: Generic Firms Rethinking Strategy, May Pursue Legislation
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.