On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in…
In this episode of the Knobbe IP+ podcast, Knobbe Martens Chief Diversity & Talent Development Officer Terra Davis speaks with guest Elaine Spector, Harrity & Harrity partner and Advisory Board…
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls.[1] The CDRH intends for…
A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial intelligence…
Market reports indicate the global medical device industry for Q3 2024 saw an increase in merger and acquisition (M&A) activity in terms of value year-over-year. Although deal value decreased compared to…
As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal Circuit on November 8,…
In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson[1], the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal…
TELEFONAKTIEBOLAGET LM ERICSSON v. LENOVO (UNITED STATES), INC. Before Lourie, Prost, and Reyna. Appeal from the Eastern District of North Carolina. Summary: The threshold requirement for anti-suit injunctions, that the…
UTTO INC. v. METROTECH CORP. Before Prost, Taranto, and Hughes. Appeal from the United States District Court for the Northern District of California. Summary: The district court erred in construing…
On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms. The tool defines “genetic modification” as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.
