Life Sciences Antitrust Quarterly Update Q3 2026

Building on the momentum from the first half of the year, dealmaking in the life sciences space remained robust in the third quarter of 2026.¹ As before, a wide range of buyers — from Big Pharma to small and midsize companies — continued to use strategic M&A to build scale and add pipeline and commercial assets. These same buyers, particularly the largest pharma players, increasingly explored collaborations, licenses, and royalty transactions to access new technologies and fund development. M&A in adjacent industries such as medical devices also remained strong, including Boston Scientific’s proposed acquisition of Penumbra.

The current antitrust environment continues to support this robust dealmaking, even as the agencies have shown the willingness to investigate and challenge transactions that present a clear horizontal overlap or a credible risk to future competition.

FTC Review of Boston Scientific/Penumbra — Issuance of Second Request 

As discussed in previous updates, the FTC has a long history of enforcement activity in the medical device space, including litigated challenges to the Illumina/GRAIL and STERIS/Synergy Health deals and numerous consents involving serial acquirers such as Medtronic, Johnson & Johnson, and Abbott Laboratories.² Boston Scientific’s proposed acquisition of Penumbra fits this fact pattern and shows that, even in a generally accommodating antitrust environment, the FTC will continue to take close looks at medical device transactions.

Boston Scientific and Penumbra entered into a definitive agreement dated January 14, 2026, in a cash-and-stock transaction valuing Penumbra at approximately $14.5 billion. The parties made their HSR filings on February 13, and each received an FTC Second Request on March 16.³

While industry reporting characterized the companies’ broader portfolios as largely complementary — Penumbra’s mechanical thrombectomy and neurovascular capabilities would add to Boston Scientific’s established presence in cardiology and peripheral interventions⁴ — the parties compete directly in embolization devices.⁵ Peripheral embolization coils are used to stop blood flow and control bleeding, particularly in peripheral arteries or veins. Speculation is that this overlap is the most likely driver of the FTC’s interest.⁶

The Second Request fits within the FTC’s historical interest in medical device transactions that bring together close competitors in a discrete product area, even if their respective portfolios may be otherwise complementary. The FTC’s recent challenges to Edwards/JenaValve and GTCR/Surmodics (discussed at length in previous updates) demonstrate the agency’s continued willingness to litigate such cases, although the outcomes also show how closely the analysis turns on the record in each transaction.⁷

Given this track record, parties considering deals in this space are well advised to prepare for robust FTC engagement. Assembling key advocacy and materials likely to be called for by voluntary access letters, including top customer lists and contact information, can help expedite the process on the front end and can be particularly useful for those seeking to resolve an investigation in the initial waiting period.

Record HSR Penalty in DOJ Settlement With KKR

On August 26, 2026, the DOJ announced a proposed settlement requiring KKR to pay a $250 million civil penalty to resolve allegations of serial HSR Act violations. The complaint alleged that KKR failed to comply with its HSR obligations in at least 16 transactions from 2021 onward, including by omitting required documents, submitting altered documents, and, on two occasions, failing to make required filings.⁸

While the settlement is notable for both the amount of the penalty (more than 20 times any prior HSR penalty obtained by DOJ) and the alleged pattern of conduct, it should not be read as a change in the HSR rules or as an indication that the agencies will seek similar penalties for isolated or inadvertent filing errors. However, the case does reinforce a basic point for deal teams: Responsive documents must be collected and submitted completely and accurately, and final documents cannot be edited for an HSR filing. It also serves as yet another reminder of the importance of early antitrust involvement, including for repeat acquirers. Counsel can help identify reportability issues, determine which materials are responsive, and advise on document practices to ensure that all relevant HSR rules are observed. 

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Beyond the United States, European and UK regulators are continuing to shape the regulatory environment for life sciences, including scrutinizing potentially exclusionary conduct by established industry players and creating a regulatory framework that fosters innovation and supports the safe deployment of emerging healthcare technologies.

EU Scrutiny of Market Foreclosure Strategies in Life Sciences

The European Commission has issued preliminary findings that Sanofi may have abused its dominant position in France and Germany by carrying out a “misleading communication campaign” to disparage a rival flu vaccine.

As we noted in our February 2026 update, the Commission carried out unannounced inspections (so-called “dawn raids”) at Sanofi’s French and German offices late last year. What followed was a formal investigation and initial findings that Sanofi — which markets an enhanced flu vaccine, Efluelda — had abused its dominant position in the relevant markets by using misleading promotional messaging to healthcare professionals undermining a competing vaccine, Fluad, produced by Seqirus UK Limited.

The Commission reached the preliminary conclusion that Sanofi’s promotional and sales materials had inaccurately stated that the evidentiary basis for Fluad was weaker than for Efluelda, mischaracterized national vaccine recommendations, and incorrectly suggested that official recommendations in Germany favoring Fluad remained scientifically controversial. According to the Commission, this conduct may have hindered Fluad’s uptake and infringed Article 102 of the Treaty on the Functioning of the European Union (TFEU), the EU analogue to Section 2 of the Sherman Act, which prohibits abuse of a dominant market position.

Without admitting liability, Sanofi offered commitments to address the Commission’s concerns, which were formally accepted on October 14, 2026, following a period of market testing. These include issuing corrective communications in France and Germany, including directly to healthcare professionals who received the earlier materials. Until March 2030, Sanofi would also accurately reference national vaccination recommendations in certain promotional materials and avoid unsupported claims criticizing those recommendations, presenting Efluelda as safer or more effective than Fluad or suggesting that Fluad has a weaker evidence base.

In a separate Article 102 matter, the Commission opened a formal investigation in June 2026 into whether Align Technology unlawfully tied its intra-oral scanners to its dental clear aligners branded as “Invisalign.” This is the Commission’s first formal antitrust investigation in the medical devices sector.

Align sells both clear aligners (clear, removable plastic aligners used as a modern alternative to traditional metal braces) and intraoral scanners, marketed as “iTero scanners,” which create 3D scans used by dental professionals to plan treatment and monitor patients’ progress.

The Commission is examining whether Align leveraged its dominant position in clear aligners to steer dental professionals towards its iTero scanners. Its concerns focus on Align’s alleged refusal to approve competing scanners for automated submission to Align of digital scans for Invisalign since 2017 and to accept scans from rival devices, even where those scans use industry-standard file formats.

The Commission considers that these practices may create a “closed ecosystem” around Invisalign, effectively requiring dental professionals to use iTero scanners if they wish to offer Invisalign treatment.

These investigations show the Commission’s willingness to apply Article 102 to assess conduct in the medtech market. Companies with strong market positions should review both their external communications and technical ecosystem strategies to ensure they do not unfairly disadvantage rivals or limit customer choice.

The UK Signals Pro-Innovation Approach to Healthcare AI Regulation

The UK National Commission into the Regulation of AI in Healthcare published its recommendations in September 2026. The National Commission, which was established in September 2025 by the Medicines and Healthcare products Regulatory Agency (MHRA), has been tasked with providing recommendations for a new regulatory framework for AI in healthcare to support the government’s ambition to enable patient access to safe and effective AI technologies and make the NHS the most “AI-enabled healthcare system in the world.”

The National Commission’s recommendations — which have subsequently been accepted by the government — propose an approach under which AI-enabled medical devices will be subject to greater real-world monitoring throughout their working life rather than a premarket approval given at one point in time. For example, the National Commission has recommended that the MHRA introduce staged authorizations for new AI models likened to “L-plates” for learner drivers, meaning models can be deployed under supervision and subject to guardrails while additional evidence is generated. This should enable UK patients to access promising new AI models quickly while enabling regulators to act efficiently if problems emerge as the models evolve.

While the effect of the National Commission’s recommendations remains to be seen, one of its explicit aims is to establish a regulatory environment that attracts investment and supports innovation while ensuring patient protection. This is notable in an era where the UK’s competition watchdog — the Competition and Markets Authority — has instituted a number of reforms in an effort to drive growth and investment in the UK economy after significant public criticism that it was doing the opposite. The government’s message is clear: Investment in AI technologies in healthcare will be encouraged through a flexible regulatory regime that supports innovation while maintaining oversight throughout a product’s lifecycle to protect patients. For life sciences companies and investors, the direction of travel is encouraging, although the detail and timing of implementation will determine whether the UK becomes a preferred early-launch or testing market for healthcare AI.