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Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.

Latest From Brenda Sandburg

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.

Ad Complaints FDA

‘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.

Generic Drugs Intellectual Property

Merger Enforcement: FTC And Justice Department Casting Wide Net In Considering Changes

Agencies seek public comment on how they can modernize merger guidelines to enforce antitrust laws. List of questions, including what types of evidence show that a merger could reduce competition, indicate pharma and other mergers will face greater scrutiny.

M & A Enforcement

Lilly Resolves US FDA Concerns About Emgality TV Ads That Were Not Meant To Run Solo

With the Winter Games approaching, case offers lesson for companies with complex advertising packages. Lilly told the agency two commercials featuring Olympic and Paralympic athletes were intended to run sequentially with another ad including indication and risk information.

Ad Complaints Advertising, Marketing & Sales

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.

Intellectual Property Pink Sheet Perspectives

Timeline Illustrates The Meteoric Rise Of Intellectual Property Issues In 2021

Big events from the year included the Biden Administration throwing its support behind the TRIPS waiver proposal, companies inking a slew of licensing deals, and the FDA asking the USPTO how it was addressing patent thickets.

Pink Sheet Perspectives Intellectual Property
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