After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.
Seeking the root causes and possible solutions to the chronic drug shortages plaguing the U.S. health care system, the FTC and Health and Human Services jointly issued a request for information regarding how group purchasing organizations and drug wholesalers may be contributing to the shortages of generic drugs.
The U.S. Federal Trade Commission (FTC) has drawn blistering criticism over the past couple of years over its handling of merger and acquisition (M&A) activity, criticism that was anything but blunted in a Jan. 31 webinar on the subject.
What’s the status of the U.S. FTC’s investigation into pharmacy benefit managers’ (PBMs) role in prescription drug prices? Inquiring minds in the Senate really want to know, especially since the investigation began more than 18 months ago. “We urge the FTC to complete its 6(b) study in a timely manner,” 14 senators, led by Sens. Chuck Grassley (R-Iowa) and Maria Cantwell (D-Wash.), wrote in a Jan. 22 letter to FTC Chair Lina Khan.
The history of med-tech patent litigation is replete with long-running conflicts that test the willpower of the participants, which increasingly seems to be the case in a series of lawsuits between Masimo Corp. and Apple Inc.
Privacy laws and enforcement in the U.S. are seemingly growing by the week on both the state and federal levels, with the Federal Trade Commission (FTC) serving as one of the players in the federal enforcement game. The FTC has released a statement warning developers of data that are working as model-as-a-service companies to be wary of any illicit uses of data acquired to assist in development of artificial intelligence algorithms, a warning that these developers and their customers would do well to heed.
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
A threat to biopharma innovation arrived at a larger scale in 2023 in the form of greater U.S. FTC scrutiny, calling into question the legitimacy of certain M&As and deals.
The holidays are looking brighter for Masimo Corp. with two bits of good cheer this week for the company. Apple Inc. confirmed to BioWorld that it will preemptively pull two smartwatches from its website and retailers in response to a Masimo infringement case that persuaded the International Trade Commission to block their import.
After years of battling to retain its hold on Grail Inc., Illumina Inc. finally announced that it will be unwinding the ill-fated acquisition of the multi-cancer early detection test maker. In addition to stiff opposition from activist investor Carl Icahn that cost Illumina’s previous CEO and board chair their positions, European and U.S. regulators have consistently opposed the deal.
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