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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

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

Could Aduhelm Be Taken Off Market If CMS Proposal Stands? ‘Everything Is On The Table,’ Biogen Says

Company execs say there has been four-fold increase in doctors infusing the Alzheimer’s drug and despite lack of support from major institutions, individual physicians at Cleveland Clinic and elsewhere have voiced support for Aduhelm. Biogen is “cautiously optimistic” about lecanemab Phase III trial.

Medicare Reimbursement

Enzyvant’s Path From Complete Response Letter To FDA Approval For Rethymic Included CMC Revamp

Two-year journey after CRL did not start with a meeting with US FDA, but rather a ‘pause’ to better understand agency’s perspective, execs say. Firm would later develop a roadmap with FDA to overcome manufacturing issues for the the first tissue-based therapeutic approved by the agency.

Complete Response Letters Manufacturing
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