An administrative law judge has decreed that the acquisition of Grail Inc., by Illumina Inc., would not represent a suppression of competition in the market for multicancer early detection (MCED) tests, clearing a way for an acquisition that was initially valued at more than $7 billion.
Illumina Inc., of San Diego, is struggling to complete the regulatory side of its acquisition of Grail Inc., of Menlo Park, Calif., thanks in part to the U.S. Federal Trade Commission’s (FTCs) ongoing review of the transaction. However, Illumina is also facing stiff winds in Europe where the General Court of the European Union rejected the company’s bid to push the deal through despite the opposition of the European Commission (EC).
The U.S. Federal Trade Commission (FTC) has been moving aggressively on privacy issues in connection with health data in the past two years, but the agency has issued an advisory of sorts to collectors of these data points. The FTC said July 11 that it intends to crack down on violators in an effort to protect data privacy.
The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers to crack down on some of those schemes.
News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices.
The U.S. Federal Trade Commission has signed off on an amendment to the divestiture plan for Boston Scientific Corp. (BSX), of Marlborough, Mass., related to the acquisition of British Technology Group plc (BTG).
As part of a settlement in a class action suit, Vyera Pharmaceuticals LLC and its parent company, Phoenixus AG, of Baar, Switzerland, agreed last week to pay up to $28 million to a proposed class of third-party payers that covered Daraprim (pyrimethamine).
Regulatory agencies across the globe had their hands full in 2020 and 2021 in responding to the COVID-19 pandemic, but that is just one reason that regulatory frameworks for artificial intelligence are lagging. Several regulatory proposals have been floated, but one of these hints at a need for regulatory harmonization, a requirement that seems certain to add yet more drag to a process that is already years behind the technology.
The Health Breach Notification Rule set forth by the U.S. Federal Trade Commission in 2009 was not initially directed toward health apps used strictly for non-medical uses, but the FTC has indicated it will enforce the rule for developers of these non-medical apps as well. The risk is substantial for these developers as the civil penalties for breaches can reach $44,000 per violation per day, which in the case of a mass breach could present a profound financial risk.
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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