Medical Device Legal News with Sam Bernstein: Episode 11
Novo Nordisk May Proceed with Its Ozempic Suit Against DCA Pharmacy. A Tennessee federal court denied DCA Pharmacy’s motion to dismiss a lawsuit filed by Novo Nordisk Inc. alleging a violation of Tennessee state unfair and...more
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more
On August 20, 2024, the Federal Trade Commission (FTC) submitted a comment supporting the FDA’s June 2024 draft guidance “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the...more
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more
On December 18, 2023, the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) (together, the “agencies”) jointly released their final revised 2023 Merger Guidelines, reflecting modest adjustments...more
On December 18, 2023, the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) released the final 2023 Merger Guidelines (the Guidelines). While the final version of the Guidelines reflects...more
The US Federal Trade Commission (FTC) and US Department of Justice Antitrust Division (DOJ) issued their updated Merger Guidelines on December 18, 2023. These guidelines represent a significantly more...more
On December 18, 2023, the Federal Trade Commission (FTC) and the Antitrust Division of the Department of Justice (DOJ) (each an Agency, and collectively, the Agencies) released the final version of revised Merger Guidelines...more
Key Points - - New draft merger guidelines reflect the aggressive approach that has defined merger enforcement in the Biden administration, including novel theories of harm. - Proposed changes to HSR notification will make...more
Welcome to this week's issue of AI: The Washington Report, a joint undertaking of Mintz and its government affairs affiliate, ML Strategies. The accelerating advances in artificial intelligence (“AI”) and the practical,...more
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
On Sept. 18, 2023, 19 Democratic state attorneys general (AGs) filed public comments to the Draft Merger Guidelines (Draft Guidelines) proposed by the U.S. Department of Justice and the Federal Trade Commission (the Agencies)...more
The Federal Trade Commission (“FTC”) and U.S. Department of Justice Antitrust Division (“DOJ”) recently introduced proposed revisions to the existing merger guidelines. The new draft guidelines, if enacted in a form similar...more
In July, the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) released a draft of proposed new merger guidelines, 18 months after FTC Chair Lina Khan and Assistant Attorney General...more
In a recent post, we discussed the 13 guidelines set forth in the recently issued proposed Hospital Merger Guidelines (“Draft Guidelines”) issued by the Federal Trade Commission and the Department of Justice (the “Agencies”)....more
Antitrust enforcers remained active across the globe, with the announcement by the FTC and DOJ of proposed guidelines that have an emphasis on tech mergers in the United States, and several investigations of major tech deals...more
On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more
vOn July 19, 2023, the U.S. antitrust enforcers, the Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) (collectively, the “Agencies”), released draft merger guidelines for public...more
The Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) jointly issued new draft Merger Guidelines on July 19. The draft Merger Guidelines were created with the goal "to better reflect how the agencies...more
The U.S. Department of Justice, Antitrust Division (DOJ), and the Federal Trade Commission (FTC) (and together, the “Agencies”) have released long-anticipated draft merger guidelines (the “2023 Draft Guidelines”) that...more
The U.S. Justice Department (DOJ) and Federal Trade Commission (FTC) (collectively, the “Agencies”) released for public comment draft Merger Guidelines that outline how the agencies evaluate proposed deals. The Agencies have...more
On July 19, 2023, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) issued a draft version of new Merger Guidelines (Merger Guidelines), which would replace the 2010 Horizontal Merger Guidelines and the...more
On the heels of the historic proposed changes to the Hart‑Scott‑Rodino (“HSR”) merger review process, the U.S. Department of Justice Antitrust Division and the Federal Trade Commission released the 2023 Draft Merger...more
On July 19, 2023, the Department of Justice Antitrust Division (DOJ) and Federal Trade Commission (FTC) (together, the Agencies) released a draft set of revised Merger Guidelines (the Revised Guidelines) to set forth the...more