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BioWorld - Wednesday, April 8, 2026
Home » Topics » Regulatory » FTC

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Clinical trials are a regulatory danger zone for unregulated wellness apps

Nov. 12, 2021
By Mark McCarty

The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.


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Clinical trials are a regulatory danger zone for unregulated wellness apps

Nov. 11, 2021
By Mark McCarty

The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.


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Statue of man and horse outside of U.S. FTC building

FTC rule puts potentially anticompetitive mergers back in its crosshairs

Oct. 27, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has restored a rule that requires prior authorization for any mergers that affect a market that was the subject of previous allegations of attempted anticompetitive behavior. The agency’s press release on the change seems to respond to the decision by Illumina Inc. to complete its acquisition of Grail Inc. and its multicancer screening test, as indicated by the statement that the policy would address the behavior of companies that see little risk to their long-term market strategies despite FTC opposition to an acquisition.
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Statue of man and horse outside of U.S. FTC building

FTC memo hints at less than holy reverence for Illumina’s acquisition of Grail

Oct. 26, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has restored a rule that requires prior authorization for any mergers that affect a market that was the subject of previous allegations of attempted anticompetitive behavior. The agency’s press release on the change seems to respond to the decision by Illumina Inc. to complete its acquisition of Grail Inc. and its multicancer screening test, as indicated by the statement that the policy would address the behavior of companies that see little risk to their long-term market strategies despite FTC opposition to an acquisition.
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AI silhouette

FTC eyes streamlined enforcement for algorithm bias, drug patents and right to repair

Sep. 15, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has taken a more assertive stance regarding enforcement of several considerations, most conspicuously about mergers and acquisitions. However, the agency’s push for less cumbersome processes has now been applied to a host of considerations pertinent to the life sciences, including bias found in artificial intelligence algorithms, abuse of drug patents, and repairs for medical equipment, a signal that more frequent and more rapid FTC enforcement is on the near horizon.
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Architectural pillars

FTC attorneys invoke COVID-19 vaccine in case against Illumina/Grail deal

Aug. 24, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) is hardly alone in its antipathy toward Illumina Inc.'s acquisition of Grail Inc., and FTC attorney Susan Musser said Aug. 24 that Illumina’s dominance of the market for next-generation sequencing (NGS) is perhaps the key aspect of the FTC’s case. Musser invoked the wide number of companies that jumped into the fray to develop a vaccine for the COVID-19 pandemic as an illustration of the need to maintain competition in the multicancer testing space.
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Deal illustration

Illumina to wrap up Grail pickup despite impending FTC review

Aug. 19, 2021
By Mark McCarty
Illumina Inc.’s acquisition of cancer diagnostic specialist Grail Inc. is on go in a $7.1 billion transaction that is structured so that it can be unwound with limited impact on Illumina. However, a number of regulatory entities are closely scrutinizing the deal for a potential regulatory challenge, a fact of life that shaved nearly 10% off the value of the company’s shares in early Aug. 19 trading, and which could ultimately scuttle the transaction altogether.
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Website of The Federal Trade Commission

Allergan’s pick-up of Soliton subject to further scrutiny under FTC’s renewed focus of M&A

Aug. 12, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has made no secret of its intent to tighten its oversight of merger and acquisition (M&A) activity, an emphasis that has already been felt in the med-tech space. Soliton Inc., of Houston, said in its latest 8-K filing that the FTC wants to see more information about plans for the company to be acquired by Allergan Aesthetics plc, a demand that at the very least will delay – and potentially derail altogether – the acquisition.
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FTC falling behind in merger reviews

Aug. 4, 2021
By Mari Serebrov
Citing a surge in merger filings, the U.S. Federal Trade Commission (FTC) said it is adjusting its process for reviewing mergers, which means more mergers may be reviewed retroactively.
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Architectural pillars

FTC drops Abbvie suit, relief could be short-lived

Aug. 2, 2021
By Mari Serebrov
Citing a unanimous U.S. Supreme Court ruling in April that denied the Federal Trade Commission’s (FTC) ability to seek restitution or disgorgement, the FTC, on July 30, withdrew its remaining count against Abbvie Inc. involving sham litigation intended to delay generic competition to its blockbuster testosterone replacement drug, Androgel.
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