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Holland & Knight LLP

Orange Book Concerns Pick Up as Yet Another Issue for Pharmaceutical Manufacturers

Holland & Knight LLP on

Pharmaceutical manufacturers are increasingly finding themselves defending decisions to list in the U.S. Food and Drug Administration's (FDA) Orange Book patents that they assert are associated with their products. The...more

Morrison & Foerster LLP

FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

Morrison & Foerster LLP on

In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more

White & Case LLP

Where Things Stand on Drug Pricing at the Halfway Point of 2023

White & Case LLP on

While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more

Foley & Lardner LLP

One Year of Action Since President Biden’s Executive Order on Competition

Foley & Lardner LLP on

Earlier this month — July 9, 2022 — marked the one-year anniversary of President Biden’s Executive Order on Promoting Competition in the American Economy (Executive Order). The Executive Order was notable in its breadth and...more

Morgan Lewis - As Prescribed

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more

Foley & Lardner LLP

President Biden’s Executive Order on Competition Could Mean Broad Changes Across a Range of Industries

Foley & Lardner LLP on

On Friday, July 9, 2021, President Biden issued a sweeping Executive Order that could have far-reaching implications for businesses across a broad spectrum of industries. The Executive Order takes a government-wide approach...more

Mintz - Health Care Viewpoints

Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 1

Butler Snow LLP on

Welcome to 2019! We hope that your New Year’s resolutions included time to sit down and enjoy our latest edition of Pro Te: Solutio. We have three intriguing articles in this edition, which are sure to provide useful...more

Arnall Golden Gregory LLP

Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors

In recent years, the Federal Trade Commission (FTC) has brought a series of cases involving drug manufacturers allegedly seeking to delay competition from generic drug companies. See, e.g., F.T.C. v. Actavis, Inc., 570 U.S....more

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